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NICEATM News Archive

NICEATM News is an email list that distributes announcements about NICEATM and ICCVAM activities and other events of interest to those developing alternatives to animal use for chemical safety testing. NICEATM News announcements distributed in the last three years are listed below. Subscribe to NICEATM News

Messages more than three years old are removed from this page quarterly. Subscribers who wish to view older messages can find them on the NICEATM News home page on the NIH Listserv website.

Date Announcement Deadline/Due Date
Feb 01, 2023
February 10 Webinar to Discuss NAMs for Ecotox Testing

The next webinar in the Physicians Committee for Responsible Medicine’s (PCRM’s) DyNAMic Discussions series will be Friday, February 10 from 10:00 a.m. – 11:30 a.m. EST on the topic “Ecotox: What Can We Do Today?” A printable agenda and information about speakers and topics in the series are available through the DyNAMic Discussions learning portal.

The February 10 event will feature the following presentations:

  • Kristin Schirmer, Swiss Federal Institute of Aquatic Science and Technology “The RTgill-W1 Fish Cell Line Assay for Predicting Acute Fish Toxicity: Development, Acceptance, and Next Steps.”
  • Mark Bonnell, Environment and Climate Change Canada, “Confidence-Based Regulatory Prioritization in Canada Using Version 2.0 of the Ecological Risk Classification Approach for Organic Substances.”

Presentations will be followed by a panel discussion with moderators Eryn Slankster-Schmierer, PCRM; Kristie Sullivan, PCRM; and Gavin Maxwell, Unilever.

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Feb 01, 2023
February 22 Webinar Considers Approaches for Testing Challenging Chemicals

An ASCCT/ESTIV webinar on Wednesday, February 22 from 11:00 a.m.–12:30 p.m. EST will discuss “Gaining Confidence in Advanced Methodologies for Studying Challenging Chemicals.” 

Presenters and abstracts:

  • Jesse Rogers, EPA, will discuss Integrating High Throughput Transcriptomics into a Tiered Framework to Prioritize Chemicals for Toxicity Testing.” Rogers will discuss how high content assays such as high-throughput transcriptomics can be paired with high-throughput screening to inform on putative molecular targets and identify chemicals for further screening in a framework to support chemical risk assessment.
  • Kelly Carstens, EPA, will describe Evaluation of Per- and Poly fluoroalkyl Substances (PFAS) In Vitro Toxicity Testing for Developmental Neurotoxicity.” Carstens will present data showing how a subset of PFAS can perturb neurodevelopmental processes in vitro, and suggest focusing future studies of developmental neurotoxicity on PFAS with certain structural feature descriptors.
  • Anna van der Zalm, PETA Science Consortium International, will discuss A Modern Framework to Establish Scientific Confidence in New Methods. Van der Zalm will present an overview of a modern, flexible framework to establish scientific confidence in non-animal methods for regulatory use, which comprises five essential elements: fitness for purpose, human biological relevance, technical characterization, data integrity and transparency, and independent review.
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Feb 01, 2023
ARDF Offering Research Grants; Apply by April 15

The Alternatives Research and Development Fund (ARDF) awards grants to support research projects that develop alternative methods to advance science and replace or reduce animal use. ARDF is currently accepting applications for this year’s grants, with proposals due April 17

The maximum grant is $40,000. While preference will be given to U.S. applications, proposals are welcome from any nonprofit educational or research institution worldwide. Expert reviews of each proposal will evaluate scientific merit and feasibility and the potential to reduce or replace the use of animals in the near future. Proposals in the fields of research, testing, or education will be considered. Projects may not use intact non-human vertebrate or invertebrate animals, or monoclonal antibodies produced by in vivo methods. Preference will be given to projects that use:

  • In silico and in vitro methods with human cells or tissues.
  • Pathway-based approaches as exemplified by the 2007 National Academy of Sciences report, Toxicity Testing in the Twenty-first Century: A Vision and A Strategy.
Apr 17, 2023
Feb 01, 2023
IFER Accepting Proposals for Graduate Fellowships; Apply by April 30

The International Foundation for Ethical Research (IFER) is accepting applications for 2023-2024 graduate fellowships. These one-year grants of $12,500 support projects by master’s and PhD students in the sciences. Eligible projects will address development, acceptance, and implementation of innovative human-relevant methods that advance science and refine, reduce, or replace the use of animals in research, testing, or education. Special consideration is given to proposals that are likely to replace the use of animals in research. Grants are renewable for up to three years, depending on student progress and availability of funds. Applications are due no later than 11:59 p.m. CST on Sunday, April 30. Contact ifer@ifer.org with questions about the application process.

Apr 30, 2023
Feb 01, 2023
IUCLID Adds New Pharmaceutical Data

The International Uniform Chemical Information Database (IUCLID) has added data from FDA on 348 approved pharmaceuticals. These data from nonclinical animal and human studies can now be used to develop predictive models, analyze correlations between chemicals, and assess the relevance of animal models to humans. IUCLID expects to make more FDA data available later in the year, and also publish a paper explaining the development of the data set. More details on the data release are available on the European Chemicals Agency website

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Feb 01, 2023
OECD Calls for Financial Support of Validation of New Methods

The Working Party of National Coordinators of the OECD Test Guidelines Programme (WNT) has called for “urgent mobilisation of national and regional resources for the demonstration of reproducibility and reliability of methods developed in single laboratories.” In a statement, the WNT notes a lack of funding for studies to demonstrate transferability and reproducibility of a new chemical safety testing method outside the developer’s laboratory. Lack of funding for such validation studies is hindering progress toward implementation of new methods with the potential to reduce use of laboratory animals and better protect human health and the environment. Read the full statement and learn more about the OECD Test Guidelines Programme on the OECD website.

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Jan 23, 2023
Registration Open for MPS World Summit; Sponsorship Opportunities Available

Registration is open for the Second MPS World Summit, to be held in Berlin June 26-30. Discounted early registration is available until March 31; extra discounts are available for members of the European Organ-on-Chip Society. 

The Second MPS World Summit will accept abstracts for oral and poster presentations through February 14. Abstracts are invited on the topic of new developments in microphysiological systems (MPS) and applications of MPS, with a focus on three subtopics:

  • MPS development: bioengineering models and readouts.
  • MPS for industrial and regulatory application: standardization, quality assurance, parallelization and automation.
  • MPS for disease modeling, safety testing and basic research.

Abstracts must be in English and no more than 350 words. 

The Second MPS World Summit will bring together a diverse community representing researchers, industries, healthcare, and regulators to connect, exchange information, and learn about MPS technologies and applications. Sponsorship opportunities for the meeting are available.

Feb 15, 2023
Jan 23, 2023
EPA Seeks Comment by March 20 on Use of NAMs for Endocrine Disruptor Screening

In a January 19 Federal Register notice EPA announced availability of a draft white paper, “Availability of New Approach Methodologies (NAMs) in the Endocrine Disruptor Screening Program (EDSP).” The white paper states that certain NAMs have been validated and may now be accepted by the EPA as alternatives for certain Tier 1 assays used within the EDSP. Others NAMs may be useful for prioritization purposes and for use as other scientifically relevant information, where appropriate, in weight-of-evidence evaluations. EPA is accepting comment on the draft white paper through March 20.

The EDSP was established by the Federal, Food, Drug and Cosmetic Act, which required EPA to develop a screening program to determine whether certain substances may have effects in humans similar to effects produced by naturally occurring estrogens or other endocrine effects. The purpose of Tier 1 EDSP screening is to identify chemicals that have potential biological activity in the estrogen, androgen, or thyroid hormone pathways. Recent EPA research efforts have focused on the development and evaluation of high-throughput in vitro assays and in silico methods as NAMs, including databases and computational models, for use as alternatives to the current suite of assays in the EDSP Tier 1 battery, to accelerate the pace of screening, add efficiencies, decrease costs, and reduce animal testing. 

Mar 20, 2023
Jan 23, 2023
NICEATM and ICCVAM Activities at SOT 2023

A webpage is available listing activities of NICEATM and ICCVAM at the upcoming Annual Meeting of the Society of Toxicology (SOT) on March 19-23.

NICEATM and ICCVAM will have a strong presence at SOT.

  • ICCVAM representative Cecilia Tan (EPA) is chairing and presenting in a continuing education course on “A Training on the OECD Guidance for Characterizing, Validating, and Reporting Physiologically Based Kinetic Models.”
  • NICEATM scientist Helena Hogberg is co-chairing and presenting in a continuing education course on “In Vitro to In Vivo Extrapolation Strategy and Guidance across Organ System Toxicities.”
  • An exhibitor-hosted session sponsored by the National Institute of Environmental Health Sciences will focus on “ICCVAM Progress on Advancing Alternatives: Five Years into the Strategic Roadmap.”
  • NICEATM staff are chairing, co-chairing, or presenting at eight oral presentation sessions and 12 poster sessions.
  • ICCVAM committee members are chairing, co-chairing, or presenting at nine oral presentation sessions and 24 poster sessions.
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Jan 23, 2023
Registration Open for Animal Welfare Information Center Workshops on Searching for Alternatives

Registration is open for upcoming workshops on “Meeting the Requirements of the Animal Welfare Act” offered by the USDA Animal Welfare Information Center. Live virtual workshops will be offered on Wednesday, March 8, from 10:00 a.m.-3:30 p.m. EST and on Wednesday and Thursday, May 3-4, from 1:00-4:00 p.m. EST each day. There is also a self-paced asynchronous version of the workshop available. 

The Animal Welfare Information Center was established to help the regulated community comply with the Animal Welfare Act. The Center provides information on approaches to prevent duplication of animal experimentation and alternative methods that replace, reduce, or refine animal use. More information about the Center, including a new introductory video, is available on the Center's website.

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Jan 18, 2023
EPA Offers Training on ECOTOX Knowledgebase February 7

Register now for the 2nd ECOTOX Knowledgebase Encore Virtual Training, scheduled for Tuesday, February 7 from 11:00 a.m. to 1:30 p.m. EST. The EPA Ecotoxicology Knowledgebase (ECOTOX) is a comprehensive, publicly available tool providing environmental toxicology data on aquatic life, terrestrial plants, and wildlife. 

The virtual training is specifically targeted for decision-makers, providing:

  • An overview of the database content and function
  • Application-oriented use case demonstrations
  • Opportunities for participatory learning and engagement

The event is an encore of the May 2022 training, presenting the same material with expanded opportunity for live interaction in Session 2. Participants may register for one or both sessions; registration is free but required.

Session 1: Presentation and Q&A

11:00 a.m. – 12:30 p.m. EST

This session provides an overview of the knowledgebase content and function with opportunities for participation and Q&A.

Session 2 (Breakout Sessions)

12:30 p.m. – 1:30 p.m. EST

This session includes participant breakout groups to work on case study exercises in small groups, aided by facilitators.

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Jan 18, 2023
Opportunity for Toxicologist at CPSC

CPSC announces a job opportunity for a Toxicologist in the Division of Toxicology and Risk Assessment in the Directorate for Health Sciences. Applicants should have degrees in toxicology or a related field, with advanced degrees preferred. The position is located in Rockville, MD, with no remote option, and will require occasional travel.

Applications must be received by February 10.

Feb 10, 2023
Jan 18, 2023
Postdoc Opportunity at Eawag

Eawag, the Swiss Federal Institute of Aquatic Science and Technology, has a postdoctoral opportunity in computational in vitro fish toxicology in collaboration with the University of Utrecht. The postdoc will develop a modular framework that combines in vitro testing and computational modeling for animal-free prediction of chemical toxicity to fish. Candidates should have PhDs in natural sciences or engineering, with expertise in incorporating experimental biological data into modeling frameworks and good English skills. Apply by February 4.

Feb 4, 2023
Jan 11, 2023
NIEHS Data Sharing Workshop Begins Friday, January 13

NIEHS encourages data sharing to accelerate the identification of environmental linkages to human disease and translation of that knowledge to improve public health.

A new NIH policy on data management and sharing (DMS) goes into effect on January 25. To prepare the environmental health sciences research community for creation and implementation of this plan, the Environmental Health Language Collaborative (EHLC) is hosting a three-day workshop, “Sharing Your Environmental Health Sciences (EHS) Data: Metadata, Standards, and Tools.”

By the end of the workshop, attendees will be able to:

  • Articulate the parts of a DMS Plan and their importance.
  • Appreciate how a DMS Plan can aid in their research.
  • Understand the basics of standards in the context of data management and sharing, including the value of using community-based standards.
  • Know of resources to aid in development and implementation of DMS Plans.

The three workshop sessions will be held on Friday, January 13; Thursday, January 19; and Wednesday, February 1

EHLC is an community-driven initiative supported by NIEHS to advance integrative environmental health research by developing and promoting adoption of a harmonized language.

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Jan 11, 2023
Funding Available to Support Translational Use of MPS; Webinar January 24

Three NIH institutes and FDA are offering funding to establish research centers that will accelerate the translational use of MPS in drug development through regulatory acceptance and adoption for industrial use. The envisioned centers will support development of MPS that are fit-for-purpose for industry needs, have defined contexts-of-use, and will be developed with consideration of applicable expectations to achieve regulatory approval. These centers will further the development of MPS as drug development tools that, once qualified, will be made publicly and commercially available to fill unmet needs in drug development. U.S.-based nonprofit and for-profit institutions are encouraged to apply for funding; foreign institutions are not eligible. Applications will be accepted beginning February 27 and are due by March 28

A pre-application technical assistance webinar for this funding opportunity will be presented Tuesday, January 24, at 3:00 p.m. EST. Register for the webinar by sending an email to zane.martin@nih.gov by Tuesday, January 17

Mar 28, 2023
Jan 11, 2023
IIVS to Present February Webinars on In Vitro Skin Sensitization Methods

Save the dates for two webinars on in vitro toxicology to be presented in February by the Institute for In Vitro Sciences (IIVS) and Givaudan. “Derivation of a Point of Departure from In Vitro Methods for Use in Skin Sensitization Risk Assessment” will feature presentations by Andreas Natsch of Givaudan and Argel Islas-Robles of IIVS. Session 1 focusing on model development will be presented on Tuesday, February 7; Session 2 on applications will be presented on Tuesday, February 14. Both webinars will begin at 9:00 a.m. EST, and registration is free.

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Jan 11, 2023
Analysis Reveals Low Sensitivity of Animal Test for Identifying Lipophilic Skin Sensitizers

A new paper by NICEATM Director Nicole Kleinstreuer and collaborators presents an analysis of data from the mouse local lymph node assay (LLNA), a standard animal test to identify skin sensitizers. A comparison of LLNA and human data indicates that the LLNA has a high false-positive rate for lipophilic chemicals, suggesting that validation of non-animal tests for skin sensitization intended for use with lipophilic chemical should not be based solely upon LLNA data.

Natsch et al. 2023. Reduced specificity for the local lymph node assay for lipophilic chemicals: Implications for the validation of new approach methods for skin sensitization. Reg Toxicol Pharmacol. https://doi.org/10.1016/j.yrtph.2023.105333.

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Jan 09, 2023
ICCVAM Webinar to Consider Approaches to Anchoring Biological Relevance of NAMs

A January 30 webinar will focus on “Emerging Approaches for Anchoring Biological Relevance of New Approach Methodologies.” This webinar is the latest in the Communities of Practice webinar series presented by NICEATM on behalf of ICCVAM

“New approach methodologies” (NAMs) refers to approaches that can be used alone or in combination to provide information on chemical hazard and risk assessment without traditional animal tests. Traditional approaches to evaluating NAMs consider how well the results of chemical tests using NAMs correspond with the results of animal tests of the same chemicals. However, the usefulness of this approach is limited, especially when the animal results are variable or the animal model does not adequately represent the species or effect of regulatory interest. This webinar will discuss approaches to build confidence in NAMs that are based on evaluating the biological relevance of the NAM to the species of regulatory interest. Ongoing activities and key insights will be described in three presentations by speakers from the academic and private sector focusing on applications of small model organisms, organs-on-chips, and models of absorption, distribution, metabolism, and excretion.

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Jan 09, 2023
Submit Abstracts to 12th World Congress by February 10

A draft program is available for the 12th World Congress on Alternatives and Animal Use in the Life Sciences. Organizers are accepting abstracts for platform or poster presentations. Guidelines for developing abstracts are available on the meeting website. Abstracts should align with one of the six major themes of the meeting, which are subdivided into 60 sessions. There is no charge to submit an abstract. Abstracts are due Friday, February 10.

The 12th World Congress will be held in Niagara Falls, Canada, on August 27-31. Registration will be opening soon. Sponsorship opportunities for the meeting are still available; visit the meeting website or contact wc12@uwindsor.ca.

Feb 10, 2023
Jan 09, 2023
EPA Updates NAMs Resources

The EPA Office of Research and Development announces availability of new and updated resources for NAMs development.

  • The EPA CompTox Chemicals Dashboard has been updated. Version 2.1.1 features new Help pages, the ability to visualize structures in Batch Search, updates to production volume data and in vitro to in vivo extrapolation algorithms, and other improvements.
  • A video recording, slide deck, and case study worksheets from virtual training on the Dashboard are available on the EPA NAMs Training webpage; filter on “CompTox Chemicals Dashboard” in the second column of the table.
  • Save the date for a training webinar on EPA’s ECOTOX Knowledgebase to be presented Tuesday, February 7, from 11:00 a.m. to 1:30 p.m. EST
  • Materials are now available from the October 2022 EPA NAMs Conference. A form to provide feedback on the conference is available.

Regular updates on EPA NAMs activities are distributed via the NAMs Update email list.

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Jan 09, 2023
Paper Describes Application of Defined Approaches to Identify Potential Skin Sensitizers

A new paper in Applied In Vitro Toxicology describes the use of non-animal defined approaches to characterize skin sensitization potential of isothiazolinones. These substances are widely used as antimicrobial preservatives in cosmetics and consumer and industrial products. The study by NICEATM scientists and collaborators indicated that defined approaches show promise to support hazard and potency classification and quantitative risk assessment for isothiazolinones.

Strickland et al. 2022. Application of defined approaches to assess skin sensitization potency of isothiazolinone compounds. Appl In Vitro Toxicol. https://doi.org/10.1089/aivt.2022.0014.

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Dec 21, 2022
January 18 Webinar to Discuss Establishing Scientific Confidence in NAMs

A webinar on “Frameworks for Establishing Scientific Confidence in New Approach Methodologies” will be presented on Wednesday, January 18, 2023, at 10:00–11:30 a.m. EST. The January 18 event will continue presentations focused on a recently published paper on building scientific confidence on new approach methodologies (van der Zalm et al., 2022; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9525335/). This webinar will feature Alistair Middleton, Unilever, speaking on “Are Non-Animal Systemic Safety Assessments Protective? A Toolbox and Workflow”; and Amanda Ulrey, Institute for In Vitro Sciences, Inc., speaking on “How Following GIVIMP Aligns Your Work with the Framework.” Presentations will be followed by a panel discussion with the presenters and panelists Nicole Kleinstreuer, NICEATM; Susanne Kolle, BASF; and Anna Lowit, EPA Office of Pollution Prevention and Toxics.

This webinar is a joint presentation of the PCRM DyNAMic Discussions series and the P.E.P. Webinar Series on NAMs for Risk Assessment, co-organized by PSCI, EPA, and PCRM. A recording of a December 7, 2022, webinar focused on the van der Zalm et al. paper is available along with other materials from the DyNAMic Discussions series on the series website.

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Dec 21, 2022
2022 EMGS Bioinformatics Challenge Winners

EMGS has announced the winners of its 2022 Bioinformatics Challenge. First-place was awarded to Ting Li for “DeepDILI: Deep Learning-Powered Drug-Induced Liver Injury Prediction Using Model-Level Representation.” Xi Chen received the second-place award for “AnimalGAN: A Generative AI Alternative to Animal Clinical Pathology Testing.” Both winners are from the Division of Bioinformatics and Biostatistics of the FDA National Center for Toxicological Research. A 2023 Bioinformatics Challenge will be held as part of the 54th EMGS Annual Meeting in Chicago, IL September 9-13, 2023. 

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Dec 14, 2022
Environmental Health Language Collaborative Hosts Webinar December 16

The Environmental Health Language Collaborative (EHLC) is hosting a webinar on Friday, December 16, 1:00-2:00 p.m. EST. Dany Doiron, McGill University Health Centre, will provide an overview of the Canadian Urban Environmental Health Research Consortium (CANUE). CANUE generates, collates, and documents health-relevant standardized urban environmental data for all postal codes in Canada and maintains a working data platform to disseminate these datasets. Doiron’s presentation will describe CANUE’s data holdings and the approach used to gather, document, and disseminate environmental exposure data with researchers from across Canada. EHLC is an community-driven initiative supported by NIEHS to advance integrative environmental health research by developing and promoting adoption of a harmonized language. 

Background Reading:

  • Brook JR, Doiron D, Setton E, and Lakerveld J (2021). Centralizing environmental datasets to support (inter)national chronic disease research: values, challenges, and recommendations. Environ Epidemiol 5(1): e129. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7939427/.
  • Brook JR, Setton EM, Seed, E, Shooshtari M, Doiron D (2018). The Canadian Urban Environmental Health Research Consortium – a protocol for building a national environmental exposure data platform for integrated analyses of urban form and health. BMC Public Health 18(1):114. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5759244/.
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Dec 14, 2022
Slides and Video Available from SACATM Meeting and Population Variability Symposium

The Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) advises ICCVAM, NICEATM, and the Director of NIEHS and NTP on the statutorily mandated duties of ICCVAM and NICEATM activities. The 2022 meeting of SACATM was held on September 21 and 22; slides and video from the meeting are available. The 2023 SACATM meeting is planned for September 21-22 at NIEHS in Research Triangle Park, NC. 

Slides and video are also now available for an October 26-27 NICEATM symposium webinar on “Using New Approach Methodologies to Address Variability and Susceptibility Across Populations.” Visit the NICEATM 3Rs Meetings, Workshops, and Webinars webpage for information about other upcoming NICEATM and ICCVAM events.

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Dec 13, 2022
IATA Focus of December 16 OECD Webinar

A webinar presented by OECD will provide an overview of integrated approaches to testing and assessment (IATA) concepts and the OECD IATA Case Studies project. Speakers will give examples of IATA Case Studies submitted for review and discuss the impact of the project in their areas. The webinar is Friday, December 16 from 2:00–4:00 p.m. CET / 8:00–10:00 a.m. EST

Speakers:

  • Tara Barton-MacLaren, Health Canada, has been contributing to human health risk assessments and methods development under Canada’s Chemicals Management Plan since 2007. She is a leader in translational research bridging innovations in modern toxicology research and human health risk assessment, and serves as the focal point for the development of new approach methods and strategies for the assessment of chemicals existing in the Canadian marketplace.
  • Kristie Sullivan, Physicians Committee for Responsible Medicine, directs efforts to implement human-relevant alternatives to the use of animals in the testing of drugs, chemicals, and other regulated products. She has presented and conducted training on alternatives to animal tests to industry and government scientists supported advancement of nonanimal test methods. She has also served on committees advising federal and international agencies on topics related to implementation of in vitro and in silico methods for regulatory chemical safety assessment.
  • Gavin Maxwell, Unilever, has been involved in the development, evaluation, and application of new approach methodologies for next-generation risk assessment approaches for skin sensitization. He has led European Union cosmetics industry-funded non-animal safety science programs for the past 15 years, and is currently industry co-chair for the European Partnership for Alternatives to Animal Testing.
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Dec 13, 2022
January 19 Webinar Features ASCCT Award Winners

This month’s joint ASCCT-ESTIV webinar will feature presentations by poster award winners of the 2022 ASCCT meeting, both describing NICEATM projects. The webinar is Thursday, January 19, 2023, from 10:00–11:00 a.m. EST

Presenters’ abstracts:

  • Facilitating Global Connections through the Microphysiological Systems for COVID Research (MPSCoRe) Working Group – Amber Daniel, Inotiv, contractor supporting NICEATM. The emergence and global spread of COVID-19 emphasizes the need for effective approaches to prevent, control, and treat infectious diseases. Human cell-based in vitro platforms known as microphysiological systems (MPS) have the potential to effectively model the human lung and other organ systems affected by COVID-19. The MPSCoRe working group was organized to connect key MPS stakeholders to maximize the impact of MPS technologies in understanding disease mechanisms and treatments and reducing animal use while improving human health.
  • Applying Deep Learning Toxicity Models Across the Chemical Universe – Sunggun Lee, Duke University. Traditional toxicity testing generally relies on in vivo or in vitro methods, which are time-consuming, resource-intensive, and frequently result in flawed generalizations to humans. This project refined two novel deep learning models originally developed by FDA. DeepCarc and DeepDILI predict endpoints for carcinogenicity and drug-induced liver injury. These computational models rapidly screen large chemical libraries to prioritize potentially hazardous substances for further examination. Lee conducted this project while a summer student at NIEHS under the mentorship of NICEATM Director Nicole Kleinstreuer.
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Dec 09, 2022
NICEATM Scientist Receives Young Researcher Prize

Shagun Krishna, a postdoctoral fellow within the NICEATM group, has received one of five 2022 Young Researcher Prizes awarded internationally by the Lush Prize. Krishna’s research involves development of a pipeline for cardiovascular risk assessment of pharmaceutical and environmental chemicals. She has led a project to interpret Tox21/ToxCast high-throughput screening assay data, map the assay targets to biological pathways that represent key failure modes in cardiovascular disease, and use the observed patterns of bioactivity to screen and rank chemicals for potential cardiotoxicity. Her research applies cheminformatics, artificial intelligence, and machine learning in a variety of ways, including building structure–activity relationship models and developing evidence maps of the literature supporting environmental contributions to cardiovascular effects.

The Lush Prize offers a global prize fund to support initiatives to end or replace animal testing. This year’s nominees included 65 organizations and representatives from 26 countries. The Young Researcher Prizes are awarded to five young scientists who are focusing their careers on advancing replacements to animal testing. Past Lush Young Researcher Prize winners include NICEATM Director Nicole Kleinstreuer and NICEATM scientist Kamel Mansouri.

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Dec 09, 2022
Symposium Explores Application of NAMs to Tobacco Products

A new publication reports on a 2021 symposium that explored the use of new approach methodologies for regulatory decision making for tobacco products. The symposium illustrated common ground and interest in science-based engagement across the scientific community and stakeholders in support of tobacco regulatory science.
Lee et al. 2022. Advancing new approach methodologies (NAMs) for tobacco harm reduction: synopsis from the 2021 COREST SSPT–NAMs symposium. Toxics. https://doi.org/10.3390/toxics10120760.

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Dec 09, 2022
Paper Describes New Paradigm for Agrochemical Carcinogenicity Assessment

A new publication describes a human-relevant mechanistic approach to assessing carcinogenicity of agrochemicals as an alternative to the traditional rodent cancer bioassay. The paper outlines challenges and opportunities that authorities should consider as they build a roadmap to global acceptance and incorporation of such an approach. Authors of the paper include scientists with PSCI, a frequent NICEATM collaborator, and the European Commission Joint Research Centre, which interacts with ICCVAM via the International Cooperation on Alternative Test Methods.
Hilton et al. 2022. Towards achieving a modern science-based paradigm for agrochemical carcinogenicity assessment. Reg Toxicol Pharmacol. https://doi.org/10.1016/j.yrtph.2022.105301.

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Nov 30, 2022
ASCCT-ESTIV Webinar on Improving Peer Review in Scientific Literature

This month’s joint ASCCT-ESTIV webinar will focus on “Tools & Recommendations for Improving Peer Review in Scientific Literature.” The webinar is Thursday, December 1 from 9:00–10:00 a.m. EST

Presenters’ abstracts:

  • PRIVAT: A tool for improving the peer-review of in vitro studies – Paul Whaley, Evidence-Based Toxicology Collaboration. PRIVAT is a tool to help reviewers and editors achieve consistent and thorough peer-review of in vitro studies in a way that provides transparent, actionable information for editorial decision-making. This presentation will discuss the rigorous evaluation to ensure that this tool is a genuine help to reviewers and editors. Methods and prospects for update of the tool, as well as challenges of improving publishing standards in toxicology, including ensuring data availability, will also be discussed.
  • Increasing reliability of science with open and dynamic methods in academic publications – Sofia Batista Leite, European Commission Joint Research Centre. The European Commission Joint Research Centre convened a group of scientists and publishers to discuss how to clarify reporting of scientific methods and protocols in life science publications and formulate clear action points. This presentation will focus on actions to be undertaken by research institutions, funding bodies, and publishers that can trigger and support the needed culture change.
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Nov 30, 2022
Animal Welfare Information Center Offers Resources, Training in Searching for Alternatives

The Animal Welfare Information Center (AWIC) within the USDA National Agricultural Library of the U.S. Department of Agriculture has updated its 3Rs literature search webpage to help scientists find alternatives to replace, reduce, and refine animal use for research and testing. AWIC provides this information to help those conducting animal research comply with Animal Welfare Act requirements for consideration of alternatives. The 3Rs literature search webpage includes step-by-step instructions for conducting a literature search, literature search examples, worksheets and guides, and frequently asked questions. 

For additional training on searching for animal use alternatives, register for one of AWIC's workshops on “Meeting the Requirements of the Animal Welfare Act.” Virtual workshops are planned for March and May of 2023.

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Nov 30, 2022
PETA Science Consortium International Marks 10 Years of Advancing Non-animal Methods PSCI was established in 2012 to advance animal-free approaches to regulatory tests that protect human health and the environment. The organization collaborates with other scientists to create a world in which robust toxicological assessments are conducted without using animals. To mark 10 years of advancing non-animal methods, PSCI has released a report showcasing its impact in advancing the field of non-animal toxicity testing. The report features successful collaborations with government, industry, method developers, academics, and nongovernmental organizations on precedent-setting projects. 
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Nov 30, 2022
International QSAR Workshop Planned for June 2023 in Denmark

The 20th International Workshop on (Q)SAR in Environmental and Health Sciences will be held face-to-face June 5-9, 2023, in Copenhagen, Denmark. The workshop will bring together scientists, regulators, representatives of industry, and other stakeholders from around the world. This is an excellent opportunity to meet experts in development and application of quantitative structure activity relationships (QSARs), exchange results and experiences, and take part in lively discussions. To receive updates about the workshop sign up at https://www.food.dtu.dk/tilmeldinger/Qsar-2023-mailing-list.

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Nov 17, 2022
Awards Available from CAAT

The Center for Alternatives in Animal Testing (CAAT) at Johns Hopkins University is accepting applications for three grant opportunities.

Information about the following two opportunities is available on the CAAT Awards webpage.

  • The Reduction Award focuses on research projects that reduce animal use by targeting research and testing where animal models lack reproducibility and translational value. This grant is intended for researchers who carry out systematic reviews, meta-analyses, or citation analyses of animal studies or similar work, whose goal is to reduce animal use in science.
  • The Humane Education Award focuses on the development of animal-free training resources for veterinary, medical, or laboratory courses. This grant is proposed for educators and training material developers whose goal is to foster respect and compassion for animals.
  • Each award above includes a prize of $6,000 U.S. Preference will be given to studies with broad applicability and a potentially large impact. Applications should be submitted to Kathrin Hermann at kherma1@jhu.edu. Application deadline is Sunday, December 4.

The third award, the Next Generation Humane Science Award, acknowledges and encourages early-career researchers who focus on replacing the use of animals in research. A first-place award of $5,000 will recognize the work of one scientist; a second-place award of $4,000 may be issued depending on the amount and quality of the applications. Email completed applications to caat@jhu.edu. Application deadline is Sunday, January 31, 2023.

Jan 31, 2023
Nov 17, 2022
News from EURL ECVAM

The following announcements were included in the November newsletter from the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM).

  • EURL ECVAM has appointed a new slate of members for its Scientific Advisory Committee (ESAC) and has launched a continuously open call for applications for membership on subgroups. Peer reviews and other work of the ESAC are normally facilitated by specialized ESAC subgroups.
  • EURL ECVAM has compiled a bibliography of 449 papers published between 2013 and 2019 that used advanced non-animal models for cardiovascular disease research.
  • EURL ECVAM is accepting applications for its 2023 Summer School on Non-animal Approaches, to be held at the European Union Joint Research Centre in Ispra, Italy, from May 23-26, 2023.
  • EURL ECVAM has updated its Endocrine Active Substances Information System (EASIS), a web-accessible database that provides information on endocrine active properties of chemical substances. EASIS currently contains data on over 600 chemicals collected from around 10,000 study entries covering in vitro and in vivo assays in different species, including some human data.
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Nov 17, 2022
Paper Describes AOP for COVID-induced Neurological Damage

A new paper by NICEATM scientist Helena Hogberg and collaborators describes adverse outcome pathways (AOPs) for four neurological conditions that can be induced by COVID-19 infection: anosmia, encephalitis, stroke, and seizure. Organizing knowledge along an AOP is a valuable tool for understanding disease mechanisms and identifying data gaps, supporting development of treatment and prevention strategy. This approach also facilitates synergy between experts from different backgrounds in a fast-evolving field requiring cross-community cooperation.

Hogberg H, et al. 2022. The adverse outcome pathway framework applied to neurological symptoms of COVID-19. Cells. https://doi.org/10.3390/cells11213411.

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Nov 10, 2022
December 7 Webinar to Discuss Scientific Confidence in NAMs

An upcoming webinar, “Frameworks for Establishing Scientific Confidence in New Approach Methodologies, Part 1” will be Wednesday, December 7 from 10:00-11:30 a.m. EST. This webinar is a joint presentation of the PCRM DyNAMic Discussions series and the P.E.P. Webinar Series on NAMs for Risk Assessment, co-organized by PETA Science Consortium International, EPA, and PCRM.

The event will feature two presentations from authors of a recently published paper on building scientific confidence in NAMs: Nicole Kleinstreuer, NICEATM, and Tala Henry, EPA Office of Pollution Prevention and Toxics. Presentations will be followed by a panel discussion with panelists João Barroso, European Commission Joint Research Centre and Warren Casey, NIEHS.

The paper proposes a “framework comprising five essential elements to establish scientific confidence in NAMs for regulatory use: fitness for purpose, human biological relevance, technical characterization, data integrity and transparency, and independent review” (van der Zalm et al., 2022; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9525335/).

To submit a question for the panelists about establishing scientific confidence in NAMs in advance of the event, visit www.slido.com and enter #TSCA-NAMs.

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Nov 10, 2022
NIEHS Offers Assistance Applying for Small Business Grants; Apply by December 12

The NIEHS Small Business Program will soon begin accepting applications for its Applicant Assistance Program (AAP). This free, 10.5-week program is designed to assist small businesses in preparing a Small Business Innovation Research or Small Business Technology Transfer grant application in time for the April 2023 deadline. AAP provides participants with services such as application needs assessment, mentoring, application preparation support, and application review. AAP aims to increase the number of applications from underrepresented small businesses, especially women-owned and socially and economically disadvantaged companies and offers support and resources to help those applicants maximize their chances of success. The application portal opens November 14; submit applications by Thursday, December 12.

Dec 12, 2022
Nov 10, 2022
FDA Issues Final Guidance on Carcinogenicity Testing

In a November 2 Federal Register notice, FDA announced availability of a final guidance document, “S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals.” The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, and offers an integrative approach that provides specific weight-of-evidence criteria that inform whether a 2-year rat study is likely to add value in completing a human carcinogenicity risk assessment. FDA, in this final guidance, considered comments received from the public in response to release of the draft guidance in October 2021.

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Nov 10, 2022
New Publication Describes ICE Data Curation

A new publication describes the data curation workflow for integrating data into the Integrated Chemical Environment (ICE). The ICE data curation process improves the utility of data within ICE for diverse analyses. The process facilitates application of the data in a variety of contexts while preserving data integrity and provenance, providing the structure, reliability, and accessibility needed for data to support chemical assessments.

Daniel et al. 2022. Data curation to support toxicity assessments using the Integrated Chemical Environment. Front Toxicol. https://doi.org/10.3389/ftox.2022.987848

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Nov 02, 2022
Upcoming Webinars to Explore Regulatory Applications of PBPK Models

Join the Physicians Committee for Responsible Medicine’s (PCRM’s) next New Approach Methodology (NAM) Use for Regulatory Application (NURA) event, “Human In, Human Out: Using Primary Population Data for PBPK Analyses,” Thursdays, November 10 and 17 from 10:00 a.m.–1:00 p.m. EST.

In this two-part NURA series, scientists and regulatory experts will present their application of physiologically based pharmacokinetic (PBPK) models within a regulatory context, followed by an interactive discussion. The focus of the webinars is shifting the current standard of absorption, distribution, metabolism, and excretion studies to a more human-relevant standard.

Speakers include:

  • Alicia Paini, esqLABS GmbH
  • Agnes Karmaus, Inotiv (contractor supporting NICEATM)
  • Kiara Fairmen, U.S. Food and Drug Administration
  • Cecelia Tan, U.S. Environmental Protection Agency (EPA)
  • Judy Madden, Liverpool John Moores University
  • John Wambaugh, EPA
  • Dustin Kapraun, EPA
  • Harvey Clewell, Ramboll
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Nov 02, 2022
November 18 Webinar to Discuss Regulatory Applications of NAMs

The fifth event in the PCRM NURA DyNAMic Discussions series, “Moving Beyond Tick-box Toxicology: Stakeholder Partnerships to Facilitate Fit-for-purpose Solutions,” will be Friday, November 18 from 10:00–11:30 a.m. EST. Further information and materials from the first four DyNAMic Discussions events are available on the PCRM website. The November 18 event will feature Doug Wolf, Syngenta, and Monique Perron, EPA, speaking on “A Source-to-outcome Approach for Inhalation Risk Assessment – Industry Government Collaboration.”

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Nov 02, 2022
Apply by December 5 for Grants to Support Development of Non-animal Research and Teaching Methods

Multiple grants are available from the Berlin Animal Protection Commissioner for the development and application of human-relevant, animal-free methods in research and teaching. The application deadline is December 5

The awards and grants are:

  • The Early Career Scientist Award (€30,000) will fund a new project for the development and/or application of NAMs in biomedical research. The project must have demonstrable potential to replace and reduce animal use in this field. National as well as international scientists can apply.
  • The Ongoing Project Award (€30,000) will fund a project that focuses on developing and/or using NAMs. The applicant needs to demonstrate how the additional funding will allow the project to reach its potential in helping to replace animal experiments in biomedical research. National as well as international scientists can apply.
  • Two awards will be given for the Development of New Animal-free Teaching Materials (€10,000 each) to replace the previously practiced use of animals for training or studies in the fields of anatomy, physiology, biochemistry, cell biology, clinical skills, surgery, and pharmacology. National as well as international lecturers and teaching material developers can apply.
  • Lecturers who train students and scientists in the use of animal-free NAMs can apply for a NAMs Teaching Grant (€5,000 each) to equip and run their teaching labs. The money may be used for setting up and running new hands-on training courses and workshops to train the next generation of NAMs scientists. These grants are reserved for lecturers who are teaching and training in Berlin.
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Nov 02, 2022
Submit Abstracts for 2023 MPS World Summit; Travel Awards Available

Abstracts are being accepted for the 2023 MPS World Summit on the topic of new developments in MPS and application of MPS. Deadline for submission is January 31, 2023. The MPS World Summit will be held June 26–30, 2023, in Berlin.

MPS are cell culture systems replicating (patho-)physiology through engineered organ architecture and functionality. They include 3D-(co-)cultures such as organoids, organ-on-chip models, and multi-organ models, as well as the technologies to engineer and analyze these systems. Submitted abstracts should focus on one of three tracks:

  • Track 1: MPS development: bioengineering models and readouts.
  • Track 2: MPS for industrial and regulatory application: standardization, quality assurance, parallelization, and automation.
  • Track 3: MPS for disease modeling, safety testing, and basic research.

Top scored abstracts will be selected for oral presentations at one of 24 scientific sessions. 

Students and postdoctoral researchers are eligible for 20 travel awards. European awardees will be reimbursed for $500 in travel costs and $300 in registration fee costs. International awardees will be reimbursed for $1,200 in travel costs and $300 in registration fee costs. Apply by January 31, 2023.

Jan 31, 2023
Oct 21, 2022
Population Variability Symposium Webinar October 26-27

An October 26-27 NICEATM symposium webinar will consider “Using New Approach Methodologies to Address Variability and Susceptibility Across Populations.” The goals of the symposium webinar are to identify opportunities for NAMs to provide relevant information on population variability and susceptibility to environmental chemicals; and identify information needs where NAMs could be designed or improved to fill that need. A webinar series presented by NICEATM and the Physicians Committee for Responsible Medicine provided background information for the symposium webinar.

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Oct 21, 2022
November 3 Webinar to Discuss NAMs for Genetic Toxicity Testing

On Wednesday, November 3 at 11:00 a.m. EDT, ScitoVation will present “New Approach Methodologies for Genetic Toxicity Assessment and Regulatory Evaluation of New and Existing Substances.”

Genetic toxicity assessments evaluate the ability of a chemical to damage genetic material and are a critical component of chemical risk assessment. Most tests currently used to assess genetic toxicity are laborious, time-consuming, or require animal testing, and fail to provide information to support quantitative dose-response analyses. However, higher throughput NAMs for genetic toxicity assessments can provide efficient, animal-free chemical safety assessments. Data from these NAMs can be analyzed using in vitro to in vivo extrapolation (IVIVE) models to estimate points of departure for genotoxicity endpoints and modernize the assessment of genotoxic substances. Health Canada scientists have developed an integrated in vitro NAM platform for the assessment of chemically induced genetic toxicity. In this webinar, Alexandra Long of Health Canada will provide an overview of this project and describe a case where IVIVE was applied to genetic toxicity data to derive points of departure that are protective of human health.

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Oct 19, 2022
October 21 Workshop to Discuss MPS for Drug Candidate Evaluation

The Pharmaceutical and Bioscience Society International will present an online workshop on “Microphysiological Systems (MPS) as a Tool for Drug Candidate Evaluation: Technologies, Applications, and Regulatory Aspects” on Friday, October 21, from 11:30 a.m. to 4:00 p.m. EDT (8:30 a.m.-1:00 p.m. Pacific time). The workshop is free but you must create an account with the society to register.

MPS are complex in vitro models that mimic physiologically relevant functions of animal or human organs and tissues. These models have the potential to predict both the efficacy and safety of new drugs. This workshop will consider how MPS technologies, such as organ-on-a chip, are being applied during drug development, challenges to the adoption of MPS, and regulatory considerations. This workshop will provide an introduction/overview to MPS, as well as a deeper dive into organ systems such as liver, cardiovascular, and skin.

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Oct 19, 2022
October 27 Webinar Examines Role of Non-animal Tests in Environmental Protection

On Thursday, October 27, Cruelty Free Europe will present “Target Zero: Routes to a Toxic-free Europe Without Animal Testing.” The webinar will take place from 4:00-9:45 a.m. EDT (10:00 a.m.-3:45 p.m. Central European time).

In October 2020, the European Commission adopted its Chemicals Strategy for Sustainability (CSS), part of the European Union’s zero pollution ambition. The strategy’s goals are better protection of citizens and our environment from harmful chemicals and the promotion of safer and more sustainable chemicals. However, changes to key chemicals legislation under the CSS could trigger an increase in animal testing with questionable chances of success for better protection for human health and the environment. This webinar will bring different sectors together to show how we can plot a route to a toxic-free environment using animal-free testing and research. Acting NICEATM Director Nicole Kleinstreuer will be speaking at the event.

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Oct 19, 2022
Register to Attend Lush Prize Conference

The 2022 Lush Prize conference will be held online over two half days on November 9-10. Registration is free and open to anyone. This year’s event will look back over a decade since the launch of Lush Prize in 2012 to review and discuss what progress has been made and look at future focus needs to end animal testing. The program will include a variety of expert speakers across science, lobbying, regulation, policymaking, and public awareness. There will be opportunities for live Q&A, as well as “fireside chat” interviews. NICEATM scientist Kamel Mansouri will be presenting in a session focusing on scientific advances over the last decade.

The Lush Prize offers a global prize fund to support initiatives to end or replace animal testing. This year’s nominees include 65 organizations and representatives from 26 countries. Winners will receive a total of £250,000 in prizes.

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Oct 19, 2022
Opportunities for Scientists at EPA: Apply by Monday, October 24

The U.S. Environmental Protection Agency Office of Chemical Safety and Pollution Prevention has multiple openings for scientists with backgrounds in toxicology or related fields. All positions are located in Washington, DC, with a possible telework option. Applicants must be U.S. citizens. Apply by Monday, October 24.

  • Position RTP-MC-ORG-2022-0003 for a Biologist/Toxicologist is a one-year developmental position for a recent graduate which may lead to term or permanent employment. Applicants should have a bachelor’s degree in biological sciences, chemistry, or a related field.
  • Position RTP-MC-ODH-2022-0012 for a Biologist/Toxicologist is a permanent position for a scientist with a Ph.D. in biological sciences, chemistry, or a related field or equivalent experience.
  • Position RTP-MC-ODH-2023-0004 for a Biologist/Toxicologist/Physical Scientist/Chemist is a permanent position for a scientist with a with a Ph.D. in biological sciences, chemistry, physical science, or mathematics or a related field or equivalent experience.
Oct 24, 2022
Oct 12, 2022
NICEATM Releases ICE 3.7.1

On July 29, NICEATM released version 3.7.1 of the Integrated Chemical Environment (ICE). ICE provides data and tools to help develop, assess, and interpret chemical safety tests. Key features implemented in ICE 3.7.1 are:

  • New and updated chemical property predictions from the Open (Quantitative) Structure-activity/property Relationship App (OPERA) version 2.8 (information about OPERA is available at https://ntp.niehs.nih.gov/go/opera).
  • Improvements in Saagar fingerprints (Sedykh et al. 2021) in the Chemical Quest tool.

The 3.7.1 update also includes bug fixes to optimize functioning of the ICE website.

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Oct 12, 2022
NICEATM and ICCVAM Activities at ASCCT

A webpage is now available summarizing activities of NICEATM and ICCVAM at the ASCCT Annual Meeting. The meeting will be held October 19-21 in Chapel Hill, NC. NICEATM and ICCVAM will have a strong presence at ASCCT. ICCVAM co-chair Anna Lowit is presenting in a continuing education course on “Weighing the Evidence in Safety Evaluation and Risk Assessment: Data Considerations and the Potential for NAM Integration.” NICEATM scientists are giving three platform presentations, and NICEATM and ICCVAM scientists are coauthors on 20 posters.

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Oct 12, 2022
New Paper Describes Workflow for Integrating Exposure with Chemical Effects

A new paper describes a workflow to integrate human ambient exposures to inhaled chemicals with curated hazard data from high-throughput screening assays to identify counties where exposure to the local chemical mixture may affect a common biological target. This workflow demonstrates how new approach methodologies can be used to predict early-stage biological perturbations that can lead to adverse health outcomes from exposure to chemical mixtures. Acting NICEATM Director Nicole Kleinstreuer and NICEATM scientist Agnes Karmaus (Inotiv, contractor supporting NICEATM) are coauthors on the paper.

Eccles KM et al. 2022. A geospatial modeling approach to quantifying the risk of exposure to environmental chemical mixtures via a common molecular target. Sci Total Environ. https://doi.org/10.1016/j.scitotenv.2022.158905.

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Oct 05, 2022
ICCVAM 2020-2021 Biennial Report Now Available

The 2020-2021 ICCVAM Biennial Progress Report is now available. The ICCVAM Authorization Act of 2000 directed ICCVAM to prepare a progress report on its first anniversary and biennially thereafter. The eleventh progress report describes ICCVAM activities and accomplishments from January 2020 through December 2021. Key ICCVAM, ICCVAM agency, and NICEATM accomplishments summarized in the report include:

  • Publication by OECD of Guideline 497, Defined Approaches on Skin Sensitisation, the first internationally harmonized guideline to describe a non-animal approach that can be used to replace an animal test to identify skin sensitizers. Guideline 497 was drafted and sponsored by ICCVAM agency scientists and international partners.
  • Recommendations in March 2021 by the ICCVAM Metrics Workgroup on federal agency progress in promoting alternative toxicological methods.
  • Establishment of the Workgroup on Microphysiological Systems for COVID Research, an international collaborative workgroup to coordinate use of microphysiological systems to reduce animal use in COVID-19 studies and future emerging infectious diseases.
  • Further development of CATMoS, an online resource for in silico screening of organic chemicals for acute oral toxicity. During 2020 and 2021, the utility of CATMoS for predicting acute oral toxicity in research and regulatory contexts was explored in projects conducted by ICCVAM agencies, including EPA and the U.S. Department of Defense.
  • Updates of the NTP’s Integrated Chemical Environment.
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Oct 05, 2022
FDA and NCATS Offering Grants to Develop Tissue Chips for Botulinum Toxin Testing

FDA and NCATS are offering SBIR and STTR grants for the development of neuromuscular junction tissue chips to replace the mouse lethality bioassay as a potency assay for botulinum toxin. A main objective for this funding opportunity would be to position these tissue chips as an alternative test method as a standalone replacement for mouse lethality bioassay.

Applicants are encouraged to contact FDA and NCATS to ensure their study design, qualification plan and objectives are in line with the goals of the funding opportunity. Grantees will be expected to work with FDA and NCATS post-award to develop and implement the final validation plan for the proposed alternative test method.

The key dates are as follows:

  • Open Date (Earliest Submission Date): October 20
  • Letter of Intent Due Date: October 21
  • Application Due Date: November 21 by 5:00 p.m. local time of applicant organization

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. Application instructions are available on the NIH Grants website.

Nov 21, 2022
Oct 05, 2022
OPERA Now Accessible via QSAR Toolbox

OPERA is now available as an extension to the OECD QSAR Toolbox. The Toolbox was co-developed by OECD and the European Chemicals Agency to support animal-free chemical hazard assessment. OPERA is a free and open-source/open-data suite of QSAR models that provides predictions for physicochemical properties, environmental fate parameters, ADME, and toxicity endpoints. OPERA is an ongoing collaboration between NICEATM and EPA and is being constantly being maintained and updated with additional models, data and features.

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Oct 05, 2022
Scientists Invited to Participate in Survey on Non-animal Models

The International Foundation for Ethical Research (IFER) is conducting research regarding the use of non-animal models and opportunities to support the development and use of replacements. IFER invites scientists to share their thoughts about non-animal models in an online survey. The survey should take approximately 20-30 minutes to complete. Completed surveys will be entered into a drawing for a $500 VISA gift card.

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Sep 23, 2022
September 30 Webinar to Focus on NAMs for Risk Assessment

ASCCT and ESTIV are jointly hosting a webinar on “Using NAMs in Risk Assessment” Friday, September 30, from 10:00-11:30 a.m. EDT. Featured speakers are Katie Paul Friedman, EPA, and George Kass, European Food Safety Authority (EFSA).

Brief overview of speakers and topics:

  • “Expectations for new approach methods performance in predicting effects in repeat dose animal studies.” This presentation by Katie Paul Friedman will present an overview of work to characterize benchmark expectations for new approach methodology (NAM) performance in predicting systemic and organ-level effects in repeat dose studies of adult animals using data curated into the Toxicity Reference Database.
  • “EFSA’s roadmap on NAMs and related case studies.” George Kass will present an EFSA roadmap for action on NAMs to reduce animal testing. The roadmap aims to define priorities for the incorporation of NAMs as well as to inform a multiannual strategy for increasing the use of NAMs in human health risk assessment to minimize the need for animal-based verification studies. Ultimately, it envisions that by 2027 the majority of EFSA's requests for additional data will be based on NAMs. The presentation will provide an overview of the roadmap on NAMs and some of the activities currently ongoing in the context of its implementation.
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Sep 23, 2022
Population Variability Webinar Series Concludes October 7

The webinar series on “NAMs to Address Population Variability and Susceptibility” continues October 7 at 9:00 a.m. EDT. In this webinar, Shaun McCullough, EPA, will discuss “Impacts of inter-individual variability on differentiated primary cell-based in vitro models for inhaled chemical safety evaluation.” Chirag Patel, Harvard Medical School, will discuss “Data science approaches to discover and prioritize the exposomic determinants of health.” The webinar series is presented by NICEATM and PCRM. Information and materials about the webinar series are available on the PCRM website.

The webinar series will provide background information for an October 26-27 NICEATM symposium webinar on “Using New Approach Methodologies to Address Variability and Susceptibility Across Populations.” The goals of the symposium webinar are to identify opportunities for NAMs to provide relevant information on population variability and susceptibility to environmental chemicals; and identify information needs where NAMs could be designed or improved to fill that need. The webinar series is being convened in advance of the symposium webinar to highlight NAMs that incorporate variability and susceptibility into the evaluation of chemical safety. 

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Sep 23, 2022
Environmental Health Language Collaborative Hosts Webinar October 7

The Environmental Health Language Collaborative (EHLC) is hosting a webinar on Friday, October 7, 2:00-3:00 p.m. EDT. In this webinar, Karamarie Fecho of Copperline Professional Solutions and the University of North Carolina and Sierra Moxon of Lawrence Berkeley National Laboratory will be presenting on Biolink Model, an open-source standardized data model for semantic harmonization across datasets. The presenters will discuss the potential application of Biolink Model to environmental health science research, with a case study examining the EHLC use case on airborne pollutant exposures and asthma. The presentation will include a discussion on the pros and cons of adopting Biolink Model to support the data harmonization needs of the EHLC community. 

EHLC is an NIEHS-supported community-driven initiative to advance integrative environmental health research by developing and promoting adoption of a harmonized language.  

Background reading: Unni DR., et al. Biolink Model: a universal schema for knowledge graphs in clinical, biomedical, and translational science. Clin Transl Sci 15(8): 1848-1855. https://doi.org/10.1111/cts.13302
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Sep 23, 2022
EPA Offers Training on CompTox Dashboard; New Training Website

Hands-on training on the EPA Computational Toxicology (CompTox) Chemicals Dashboard will be held Tuesday, October 18, 2:00-4:30 p.m. EDT. The CompTox Chemicals Dashboard is a suite of databases and web applications developed by EPA to support the development of innovative methods to evaluate chemicals for potential health risks. The computational toxicology tools and data in the Dashboard help prioritize and characterize chemicals based on potential hazards.

Specifically targeted for decision-makers, this training will provide:

  • An overview of the Dashboard content and function.
  • Application-oriented use-case demonstrations.
  • Opportunities for participatory learning and engagement.

This virtual training will feature Nisha Sipes, Assistant Center Director for Research Translations, Center for Computational Toxicology and Exposure at EPA. The training will include plenary presentations, small group discussions, and a chance to try out skills. The training will be divided into two parts. Registration for one or both sessions is free but required.

Register for Session 1 (2:00-3:30 p.m.)

  • Introduction and overview.
  • Presentation and demonstration of Dashboard features and functionality.
  • Question-and-answer session.

Register for Session 2 (3:30-4:30 p.m.)

  • Breakout sessions: Hands-on case studies.
  • Wrap-up and feedback.

You will receive email confirmations from Zoom with the option to download calendar invitations.

Consistent with the goals of the EPA NAMs Work Plan, EPA has released a new NAMs Training website that makes training materials and opportunities related to EPA-developed risk assessment tools freely available to all stakeholders. These tools offer data and information on environmental chemicals, as well as chemical screening and evaluation techniques and other approaches.

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Sep 23, 2022
Register Now for Lush Prize Conference 2022

The 2022 Lush Prize conference will be held online over two half days on Wednesday, November 9th and Thursday, November 10th. Registration is free and open to anyone. This year’s event will look back over a decade since the launch of Lush Prize in 2012 to review and discuss what progress has been made and look at future focus needs to end animal testing. The program will include a variety of expert speakers across science, lobbying, regulation, policymaking, and public awareness. There will be opportunities for live Q&A, as well as “fireside chat” interviews.

The Lush Prize offers a global prize fund to support initiatives to end or replace animal testing. This year’s nominees include 65 organizations and representatives from 26 countries. Winners will receive a total of £250,000 in prizes. 

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Sep 09, 2022
Webinar Series on Incorporating Population Variability into NAMs Continues September 12

The webinar series on “NAMs to Address Population Variability and Susceptibility” continues September 12 at 1:00 p.m. EDT with a consideration of how tissue chips are being used to address medical needs of genetically susceptible subpopulations. The webinar series is presented by NICEATM and PCRM. Information and materials about the webinar series are available on the PCRM website.

In the September 12 webinar, Passley Hargrove-Grimes, NIH Tissue Chip Program, will discuss how the “Clinical Trials on a Chip” program addresses variability and susceptibility across populations. Arum Han, NanoBio Systems Lab, will discuss developing extracellular vesicle-based therapeutics against pre-term birth through the use of a maternal-fetal interface chip.

The webinar series will provide background information for an October 26-27 NICEATM symposium webinar on “Using New Approach Methodologies to Address Variability and Susceptibility Across Populations.” Registration for the symposium is open.

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Sep 09, 2022
NCSOT Fall Mixer and Annual Meeting; Trainee Abstract Deadline Extended to September 15

Scientists in Research Triangle Park, NC, and surrounding areas are invited to two upcoming events of the North Carolina Society of Toxicology (NCSOT). Visit the chapter’s website at for details.

  • A “back-to-school” mixer will be held on Friday, September 30, from 4:30-7:30 p.m.
  • The chapter’s annual meeting will be Wednesday, October 19 from 9:00 a.m.-5:00 p.m. at the New Student Center at North Carolina Central University in Durham, NC. Undergraduate, graduate, and postdoctoral trainees are invited to submit abstracts for poster or platform presentations. The abstract submission deadline has been extended to Thursday, September 15.
Sep 15, 2022
Sep 09, 2022
Register Now for Pan-American Workshop on Biologicals Testing

The World Health Organization (WHO) and NC3Rs are conducting a review of animal use requirements within WHO guidelines for biologics. As part of that effort, NC3Rs is hosting a series of regional workshops to better understand the potential impact of these changes on manufacturers and regulators globally.

A virtual workshop on Monday, September 26 will focus on requirements in North and South America. Biologicals regulatory agencies and manufacturers from the region will discuss their perspectives on current testing strategies and how changes to WHO guidelines could be implemented to support wider adoption of 3Rs and non-animal approaches. Although the discussions are focused on Pan-America, relevant stakeholders from any region are welcome to attend and participate. 

Biologicals such as vaccines, cytokines, enzymes, and hormones are tested routinely after approval to ensure the safety and potency of products. Many of these tests currently require the use of animals, and a large number of animals are used for this purpose each year. The WHO/NC3Rs project, which is receiving support from NICEATM and FDA, is intended to support recommendations for where non-animal approaches can be adopted.

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Sep 09, 2022
OECD Publishes New Case Studies for Integrated Approaches to Testing and Assessment

OECD has published seven new case studies on the use of integrated approaches for testing and assessment (IATA). OECD develops case studies on IATA to increase understanding and experience with these alternatives to animal testing and support their application to regulatory use. The case studies are issued as publications within the OECD Series on Testing and Assessment.

Two of the new case studies are relevant to recent NICEATM and ICCVAM activities.

  • Series on Testing and Assessment No. 364, Case Study on the Use of Integrated Approaches for Testing and Assessment for DNT to Prioritize a Class of Organophosphorus Flame Retardants: This case study was prepared by a group of NICEATM scientists in collaboration with other NIEHS and EPA scientists. The case study uses a battery of in vitro and complementary non-mammalian animal models (e.g., zebrafish) to prioritize a class of compounds, organophosphorus flame retardants, for further developmental neurotoxicity (DNT) testing.
  • Series on Testing and Assessment No. 367, Case Study on the Use of an Integrated Approach for Testing and Assessment (IATA) for New Approach Methodology (NAM) for Refining Inhalation Risk Assessment from Point of Contact Toxicity of the Pesticide, Chlorothalonil. This case study was developed from an investigation of how an in vitro respiratory model might improve on existing animal models to develop an inhalation exposure risk assessment for the pesticide chlorothalonil. The investigation was discussed in detail at a presentation given by EPA at the 2019 SACATM meeting.
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Sep 06, 2022
Agenda Available for SACATM Meeting; Register to Present Comments by Sept. 13

An agenda is available for the virtual meeting of SACATM on Wednesday, September 21 and Thursday, September 22. Registration to view the meeting is open and will be available through the end of the meeting on September 22. Interested persons can also submit written comments or register to present oral comments during the meeting. Written comments and registration to present oral comments are due by Tuesday, September 13

SACATM is a federally chartered external advisory group of scientists from the public and private sectors, including representatives of regulated industry and national animal protection organizations. SACATM advises ICCVAM, NICEATM, and the Director of NIEHS and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM. Preliminary agenda items for the upcoming meeting include: (1) major ICCVAM accomplishments in 2022; (2) implementing the strategic roadmap: incorporation of alternatives and associated metrics; (3) validation and establishing scientific confidence in new approach methodologies (NAMs); and (4) update on NICEATM computational resources.

Sep 13, 2022
Sep 06, 2022
Apply by October 21 for Grants to Attend In Vitro Methods Training Course

PSCI is sponsoring two scientists to attend a four-day in vitro test methods training course hosted by the Institute for In Vitro Sciences. The training will be held in Gaithersburg, MD from January 30–February 2, 2023, and will cover a variety of toxicological endpoints. Applicants may residents of any country but must work in or be studying to pursue a career in toxicology. Applicants who are students must have completed at least one year of a master’s or Ph.D. program. The application deadline is October 21.

Oct 21, 2022
Sep 06, 2022
NICEATM Publication Honored as Paper of the Month

The current issue of the NIEHS Environmental Factor newsletter honored a recent NICEATM paper as an “Intramural Paper of the Month.” NICEATM and EPA scientists compiled, curated, and analyzed a set of over 2000 chemicals with multiple independent study records to characterize variability and reproducibility of results. Conditional probability analyses revealed that replicate studies only resulted in the same hazard categorization on average at 60% likelihood. The authors concluded that inherent biological or protocol variability likely underlies the variance in the results.

Karmaus et al. 2022. Evaluation of variability across rat acute oral systemic toxicity studies. Tox Sci. https://doi.org/10.1093/toxsci/kfac042.

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Sep 06, 2022
Early Career Scientists Invited to Apply for Fellowships at EPA

Scientists who have recently received bachelor’s or master’s degrees in toxicology, cellular and molecular biology, or related fields are invited to apply for EPA fellowships to conduct high-throughput screening assays for cell proliferation endpoints. Applicants must be U.S. citizens. Apply by September 30.

Sep 30, 2022
Aug 25, 2022
Register for October 26-27 Symposium on Population Variability

NICEATM is organizing an October 26-27 symposium webinar to discuss “Using New Approach Methodologies to Address Variability and Susceptibility Across Populations.” Registration is now open.

Different human populations exhibit different levels of susceptibility to toxic effects from chemical exposure, presenting a complex problem for chemical risk assessment. Human cell-based and computational NAMs could potentially be used effectively to characterize susceptibility of different human populations. The October 26-27 symposium will identify:

  • Opportunities for NAMs to provide relevant information on population variability and susceptibility to environmental chemicals.
  • Information needs for population variability and susceptibility where NAMs could be designed or improved to fill those needs.

Invited speakers will present case studies where NAMs are applied to address variability and susceptibility. The program will also include speakers highlighting the concerns associated with environmental chemicals in specific communities. Presentations will be followed by panel discussions among experts to identify specific topics for follow-up activities.

In advance of the symposium, a webinar series is being convened to highlight NAMs that incorporate variability and susceptibility into the evaluation of chemical safety. The webinar series is being co-organized by PCRM. Information about the webinar series, including recordings of past webinars, is available on the PCRM website

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Aug 25, 2022
September 16 Webinar to Consider Approaches for Testing and Assessment

Join PCRM Friday, September 16 from 10:00-11:30 a.m. EDT for “Integrated Approaches for Testing and Assessment (IATA): NAM-based Safety Assessment Frameworks.” This is the latest webinar in the New Approach Methodologies (NAMs) Use for Regulatory Applications (NURA) series,  "DyNAMic Discussions: The Future is Already Here." All who registered for the original webinar date (September 2) will receive a notice of the new date through Zoom.

September 16 speakers:

  • Nicholas Ball, Dow Chemical Company: Can a framework using NAMs meet regulatory needs for chemical management – EU-REACH as an example.
  • Gladys Ouédraogo, L’Oréal:IATAs for addressing systemic toxicity: a perspective on the safety assessment of cosmetics. 

All materials from the first three webinars in the series, including presenter’s slides, session recordings, and supplementary publications, are available through the DyNAMic Discussions learning portal.>

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Aug 25, 2022
October 3-4 Workshop to Focus on Clustering and Classification

NIEHS is organizing “Clustering and Classification Workshop: Applications to Investigate Adverse Effects of Chemicals on Human Health and Environment.” The workshop will be October 3-4, 8:30 a.m.-3:30 p.m. EDT each day. A preliminary agenda, other information, and a link to register are available on the event webpage.

The workshop will introduce the concept of chemical similarity and explore the uses of different classification and clustering approaches for toxicity research and risk assessment. The invited speakers and expert discussants will identify best practices and guidelines for the application of these approaches. Participation from attendees to round table discussions will be encouraged.

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Aug 09, 2022
Apply by September 22 for NIH Small Business Applicant Assistance Program

Applications are being accepted for the NIH small business Applicant Assistance Program. Apply by September 22.

The Applicant Assistance Program assists small businesses in preparing and submitting a SBIR or STTR application to NIEHS and other NIH Institutes and Centers. The goal of this program is to increase the number of applications submitted by underrepresented small businesses and to increase the number of these applications that are free of errors or omissions and are deemed complete, compliant, and responsive to the review criteria. Only U.S. for-profit companies are eligible for the program, and participating companies must not have received an SBIR or STTR award since 2013.

Sep 22, 2022
Aug 09, 2022
August 30 Webinar to Discuss Modeling of Xenobiotic Metabolism

ASCCT and ESTIV will present a webinar on “Modeling Tools for Better Prediction of the Kinetics and Dynamics of Xenobiotics.” The webinar will be held on Tuesday, August 30 from 10:00-11:00 a.m. EDT.

This webinar will explore how molecular modeling approaches are being used to characterize the kinetics and dynamics of xenobiotics and applied to support use of in vitro data to predict toxicity. Luca Dellafiora, University of Parma, will present “3D Molecular modelling meets toxicology: a useful tool to investigate the TD and TK of food related toxicants.” Nynke Kramer, Wageningen University, will discuss “Measuring and modeling the distribution of test chemicals in in vitro toxicity assays.”

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Aug 09, 2022
EPA to Hold NAMs Conference October 12-13

A draft agenda is available for EPA’s “2022 Conference on the State of the Science on Development and Use of New Approach Methods (NAMs) for Chemical Safety Testing.” The conference will be held in-person at EPA headquarters in Washington, DC on October 12-13. A virtual option will also be available. Registration will open soon.

In 2019, EPA committed to developing and implementing a work plan to reduce the use of vertebrate animals in chemical testing while ensuring protection of human health and the environment. To report progress on these activities, EPA hosts regular conferences to provide updates and solicit input from interested stakeholders. The conferences highlight the state of the science on the development and use of NAMs for chemical safety testing.

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Aug 09, 2022
Webinar Series on Incorporating Population Variability Into NAMs Continues September 12

The webinar series on “NAMs to Address Population Variability and Susceptibility” continues September 12 with a consideration of how tissue chips are being used to address medical needs of genetically susceptible subpopulations. The webinar series is presented by NICEATM and PCRM.

In the September 12 webinar, Passley Hargrove-Grimes, NIH Tissue Chip Program, will discuss how the “Clinical Trials on a Chip” program addresses variability and susceptibility across populations. Arum Han, NanoBio Systems Lab, will discuss developing extracellular vesicle-based therapeutics against pre-term birth through the use of a maternal-fetal interface chip.

The webinar series will provide background information for an October 26-27 NICEATM symposium webinar on "Using New Approach Methodologies to Address Variability and Susceptibility Across Populations.” Registration and further information about the symposium will be available soon.

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Aug 09, 2022
OECD Publishes Guideline for Eye Irritation Defined Approaches and Updates Other Methods

On June 30, OECD published six new test guidelines and 10 updated or corrected test guidelines. One of the new guidelines, “Test No. 467: Defined Approaches for Serious Eye Damage and Eye Irritation,” describes two approaches using non-animal methods and physicochemical properties to predict eye irritation hazard. It is the second guideline describing a defined approach published by OECD, following last year’s publication of Guideline 497 for predicting skin sensitization. Another new test guideline, Test Guideline 492B, describes a new stand-alone method for eye hazard potential using a reconstructed human corneal epithelium. Both new guidelines describe approaches that can replace animal use for eye irritation hazard classification. The updated guidelines include methods to assess skin sensitization, genotoxicity, and acute oral toxicity.

ICCVAM member agencies participate in the development and review of chemical testing guidelines issued by the OECD Test Guidelines Programme. OECD test guidelines are used by government, industry, and independent laboratories of the 38 OECD member countries to assess chemical safety.

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Aug 02, 2022
NICEATM Releases ICE 3.7

On July 29, NICEATM released version 3.7 of the Integrated Chemical Environment (ICE). ICE provides data and tools to help develop, assess, and interpret chemical safety tests. This release will make it easier for users to access ICE data from other applications. Improvements were also made to the site’s appearance and supporting documentation.

ICE version 3.7 implemented REST APIs, which will allow users to access ICE data more easily via database searches outside of the ICE environment.

Other updates in ICE version 3.7 include:

  • More attractive, up-to-date user interface.
  • New Publications section with pages listing journal articles, oral presentations, and poster presentations about ICE.
  • Updates to supporting documentation, including new documentation about site security.
  • New help videos for the ICE PBPK and Curve Surfer tools.
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Aug 02, 2022
Registration Open for SACATM Meeting September 21-22

SACATM will meet virtually on Wednesday, September 21 and Thursday, September 22. Registration to view the meeting is open and will be available through the end of the meeting on September 22. Interested persons can also submit written comments or register to present oral comments during the meeting. Written comments and registration to present oral comments are due by Tuesday, September 13

SACATM is a federally chartered external advisory group of scientists from the public and private sectors, including representatives of regulated industry and national animal protection organizations. SACATM advises ICCVAM, NICEATM, and the Director of NIEHS and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM. Preliminary agenda items for the upcoming meeting include: (1) major ICCVAM accomplishments in 2022; (2) implementing the strategic roadmap: incorporation of alternatives and associated metrics; (3) validation and establishing scientific confidence in NAMs; and (4) update on NICEATM computational resources.

Sep 13, 2022
Aug 02, 2022
Video and Slides Available from ICCVAM Public Forum

Video and slides are now available from the May 26-27 ICCVAM Public Forum. This event is held annually to share information and facilitate direct communication of ideas and suggestions from stakeholders. 

At the public forum, NICEATM, ICCVAM, and representatives from eight ICCVAM agencies described activities both to advance new approaches to safety testing of chemicals and medical products and to reduce the amount of testing required. Representatives of regulatory agencies such as EPA and FDA described initiatives to promote use of new approach methodologies for required testing, and CPSC announced guidance on stakeholder use of alternatives to animal testing. Research-focused presentations described advancements in development of computational approaches and testing platforms such as microphysiological systems.

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Aug 02, 2022
EPA Requests Comment on Nominees for FIFRA Advisory Panel

In a July 28 Federal Register notice, EPA requested comment on a slate of nominees for the FIFRA Scientific Advisory Panel (SAP). The list of nominees and instructions for submitting comments are available in the Federal Register notice. Submit comments by August 29.

The FIFRA SAP serves as a scientific peer review mechanism of EPA's Office of Chemical Safety and Pollution Prevention and is structured to provide independent scientific advice, information, and recommendations to the EPA Administrator on pesticides and pesticide-related issues as to the impact of regulatory actions on health and the environment. Members are scientists who have sufficient professional qualifications, including training and experience, to provide expert comments on the impact of pesticides on human health and the environment. The current slate of nominees was assembled in response to a request for scientists with specific expertise in areas including computational toxicology (new approach methodologies and in vitro to in vivo extrapolation), allergenicity, population modeling, cheminformatics, bioinformatics, and genomics.

Aug 29, 2022
Jul 27, 2022
NIEHS Funding Approaches to Incorporate Genetic Diversity into Toxicity Testing

NIEHS is offering small businesses funding to develop resources and approaches that reflect the variability in responses to chemical exposures based on genetic diversity in the human population. The goal of this funding opportunity is to enhance the capability of introducing genetic diversity in toxicity testing.

Applicants should propose test chemicals or compounds that are relevant for developing and applying genetic diversity resources and provide a rationale for the proposed dose ranges in these studies. Applicants should provide clear, measurable goals (milestones), particular for Phase I applications and Phase I components of fast-track applications.

The key dates are as follows:

  • Open Date (Earliest Submission Date): October 8
  • Letter of Intent Due Date: October 8
  • Application Due Date: November 8 by 5:00 p.m. local time of applicant organization

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Nov 8, 2022
Jul 27, 2022
July 28 Webinar to Focus on Increasing Regulatory Confidence in Non-animal Methods

ASCCT and ESTIV will present a webinar on “Guidance and Standards for Increasing Regulatory Confidence in In Vitro and PBK Models.” The webinar will be held on Thursday, July 28 from 1:00-2:00 p.m. EDT.

Interest is increasing in approaches that combine data from in vitro methods with physiologically based kinetic models to predict chemical toxicity. However, issues remain to be addressed to increase confidence in these approaches to enable their use in regulatory contexts. This webinar will feature two speakers describing guidance documents developed to address these issues. Alicia Paini, esqLABS GmbH, will describe a guidance document issued by OECD describing a scientific workflow for characterizing and validating physiologically based kinetic models developed using NAMs data, highlighting the principles, criteria, and tools laid out in the guidance document. Amanda Ulrey, Institute for In Vitro Sciences, will discuss the OECD guidance document on Good In Vitro Method Practices and provide a strategy of how the document can be used to assess current laboratory processes and increase the reliability and robustness of these processes.

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Jul 27, 2022
August 12 Webinar to Consider Approaches to Validation of New Methods

Join PCRM Friday, August 12 from 10:00-11:30 a.m. EDT for a webinar onNAMs as the New Gold Standard: Bringing Validation into the 21st Century.” 

This is the third webinar in the NAMs Use for Regulatory Applications (NURA) series, “DyNAMic Discussions: The Future is Already Here,” All materials from the first two sessions, including the presenter’s slides, recordings, and supplementary publications are now available through the DyNAMic Discussions learning portal.

The August 12 webinar will feature the following speakers and topics:

  • Amy Clippinger, PETA Science Consortium International, e.V: Establishing Scientific Confidence in New Approach Methodologies.
  • Patience Browne, OECD: The Future of Risk Assessment and International Collaboration.
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Jul 18, 2022
July 19 Webinar on Population Variability and Susceptibility

This is a reminder that the webinar series highlighting NAMs that incorporate population variability and susceptibility into the evaluation of chemical safety will begin on July 19 at 9:00 a.m. EDT. The July 19 webinar will feature two presentations about skin models.

The webinar series prefaces the workshop “NAMs to Address Variability and Susceptibility Across Populations” focused on understanding the state of the science and identifying opportunities for NAMs to address environmental health challenges, now and in the future. The webinar series and workshop are being organized by NICEATM and PCRM.

Speakers:

  • Nicolas Gaudenzio, Chief Scientific Officer at Genoskin: Height-dimensional profiling of immune response to injectable drugs using bio-stabilized natural human skin.
  • Gertrude-Emilia Costin, Director of Laboratory Sciences at the Institute for In Vitro Sciences (IIVS): Pre-clinical assessment of skin tone modulation potential of ingredients and finished products using in vitro efficacy testing strategies based on reconstructed tissue models.

Moderators:

  • Helena Hogberg-Durdock, NICEATM, conducts research in applying in vitro methods to assessing developmental neurotoxicity (DNT) potential of chemicals.
  • Kim To, Senior Statistician at Inotiv (contractor supporting NICEATM), develops computational tools to help communicate and build an understanding of disparate toxicological data.
  • Oluwakemi Oyetade, Toxicology Data Analyst at Inotiv (contractor supporting NICEATM), extracts and analyses of toxicology data/information from various internal and public access databases and across several methods.
Jul 08, 2022
July 19 NTP Zoom Webinar on Population Variability and Susceptibility

NICEATM and PCRM will present a webinar series highlighting NAMs that incorporate variability and susceptibility into the evaluation of chemical safety beginning on July 19 at 9:00 a.m. (EDT). This webinar will feature two presentations about skin models. The webinar series prefaces a workshop on “NAMs to Address Variability and Susceptibility Across Populations” focused on understanding the state of the science and identifying opportunities for NAMs to address environmental health challenges, now and in the future.

The first speaker in the July 19 webinar will discuss donor diversity in ex vivo human skin models related to immune activation. The second speaker will discuss pigmented skin models and their use in pre-clinical efficacy testing of products with potential to modulate skin tone.

Speakers:

  • Nicolas Gaudenzio, Genoskin: Height-dimensional profiling of immune response to injectable drugs using bio-stabilized natural human skin.
  • Gertrude-Emilia Costin, Institute for In Vitro Sciences (IIVS): Pre-clinical assessment of skin tone modulation potential of ingredients and finished products using in vitro efficacy testing strategies based on reconstructed tissue models.

A printable agenda is available through the PCRM learning portal.

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Jul 08, 2022
July 28 ASCCT-ESTIV Webinar Discusses Guidance on PBK Models

ASCCT and ESTIV will present a webinar on “Guidance and standards for increasing regulatory confidence in in vitro and PBK models” on Thursday, July 28 from 1:00-2:00 p.m. EDT

The July 28 webinar will feature the following speakers and presentations:

  • Alicia Paini, esqLABS GmbH: Guidance for Increasing Confidence in Physiologically Based Kinetic (PBK) Models…Are We Ready for a Regulatory Change?
  • Amanda Ulrey, Institute for In Vitro Sciences, Inc. (IIVS): Implementing Good In Vitro Method Practices (GIVIMP) as a Quality Standard in a Laboratory.

Information and materials for past and upcoming ASCCT webinars is available on their website.

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Jul 08, 2022
September 27 OECD Webinar on New Eye Irritation Guidelines

OECD will present a webinar on the Implementation of the first stand-alone NAMs for eye hazard identification into OECD Guidelines: OECD GL 467 and TG 492B on Tuesday, September 27 from 8:00-9:30 a.m. (EDT).   

The webinar will consist of three parts:

  • Draize eye test Reference Database (DRD)
  • OECD Guideline 467 on Defined Approaches for Serious Eye Damage and Eye Irritation
  • OECD Test Guideline 492B on Reconstructed Human Cornea-like Epithelium (RHCE) Test Method for Eye Hazard Identification

OECD prepared this webinar to increase awareness of these newly adopted guidelines for regulatory acceptance and to recognize the efforts of the organisation as well as its stakeholders to commit to 3R principles for chemical hazard testing. These updates can be found on the OECD Test Guidelines for Chemicals page. Other relevant publications can be found on the Series on Testing and Assessment page.

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Jul 08, 2022
Emulate Launches Online Forum for Researchers Using Organ Chips

Emulate is launching Moxi, a Social Network for Organ-on-Chip technology. Moxi is a community for researchers, by researchers, designed as a platform dedicated to connecting with peers, keeping up with the latest news, and collaborating to accelerate science into a new era.

The first 500 Moxi registrants will be entered into a drawing to win an iPad Air. Registrants are also invited to submit an image from their Organ-Chip research, view the submissions, and vote for their favorite. The top vote-getter will win a paid trip to the 2023 MPS World Summit in Berlin. Visit Moxi to View Trending Topics, Explore Conversations of Interest, view entry requirements, and to join the discussion.

Attendees at the 2022 New Orleans MPS World Summit are invited to complete a  survey for feedback so the organizers can make next year’s even better.

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Jul 08, 2022
October 19-21 ASCCT 11th Annual Meeting

The 11th ASCCT Annual Meeting, “Shifting the Paradigm to Next-Generation (Quantitative) Risk Assessment,” will be held October 19-21 in Chapel Hill, NC. The deadline to submit abstracts is July 15. The deadline for poster only submission is September 1.

The meeting will feature the latest science in NAMs and active discussions about the implementation of new science. Students and career scientists are encouraged to attend and present. The meeting will offer awards for students and early-career scientists, mentoring opportunities, and a continuing education course.

Confirmed speakers for the event are as follows:

  • Gavin Maxwell, Unilever
  • Cavin Ward-Caviness, EPA
  • Prof. Ellen Fritsche, IUF - Leibniz Research Institute of Environmental Medicine
  • Tim Shafer, EPA
  • Heather Stapleton, Duke University
  • Katie Paul-Friedman, EPA
  • Dan Villeneuve, EPA

Oral presentation sessions are envisioned to include a focus on:

  • Next Generation Risk Assessment
  • Decision-Making with NAMs
  • Developmental Neurotoxicity
  • Human Data for WoE Toxicology
  • Integrated Approaches to Testing and Assessment
  • Ecotoxicology
Jul 15, 2022
Jul 08, 2022
July 13 Humane Society International (HSI) Webinar

The Humane Society International (HSI) is hosting a webinar on “Regulatory Acceptance and Use of Next-Generation Approaches for Chemical Safety Assessment” on July 13 at 9:00 a.m. EDT (15:00 CET).

As the range of non-animal tools for hazard and exposure assessment continues to grow, regulatory authorities, the regulated industry, and other stakeholders are facing a common challenge to keep up with the rapidly evolving science.

In this process, several practical and ethical questions arise: how do we move away from animal testing? How do we use high-throughput methods (in vitro, in silico) for risk prioritization? How do we include data from toxicogenomics? How do we look at complex toxicological endpoints and biological mechanisms using new-approach methodologies?
This webinar addresses how state-of-the-art science is being used by corporate and government stakeholders in risk assessment and prioritization to ensure protection.

Presenters:

  • Julia Fentem, Unilever: “Next-gen tools for chemical safety assessment”
  • Tara Barton-Maclaren, Health Canada: “Regulatory use of bioactivity-exposure ratios for priority-setting and chemical risk assessment”

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Jun 28, 2022
SBIR/STTR Omnibus Grant Funding Opportunity Announcements

The Department of Health and Human Services has released the 2022 Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Omnibus Grant Solicitations. This funding is available for small business grant applications to support development and commercialization of innovative technologies.

Projects being funded by the National Institute of Environmental Health Sciences under these solicitations include development of toxicity screening, testing, and modeling approaches that support Tox21 and other NTP goals. Areas of high priority include development of:

  • Tools for exposure assessments such as sensors and computational tools and methods.
  • Tools for evaluating environmental health and safety of engineered nanomaterials.
  • Biomonitoring technologies and biological response markers of exposure and response.
  • Assays and model systems for screening compounds for toxicity.

The first deadline for applications under this announcement is September 5

Applicants are strongly encouraged to subscribe to the NIH Guide for Grants and Contracts LISTSERV. You may also subscribe to the SBIR-STTR LISTSERV  to get timely information about the NIH SBIR and STTR Programs.

Sep 5, 2022
Jun 28, 2022
Webinar Series Continues July 8, Considers NAMs for Developmental and Reproductive Toxicity

PCRM will present a webinar on “DART: What can we do today?” on Friday, July 8th from 10:00-11:30 a.m. EDT. This is the next session of the New Approach Methodologies (NAMs) Use for Regulatory Applications (NURA) series, “DyNAMic Discussions: The Future is Already Here.” 

The July 8 webinar will feature the following speakers and presentations:

  • Ramya Rajagopal, Unilever: Mechanistic Evaluation and Application of New Approach Methodologies (NAMs) in an Integrated Approach to Testing Developmental and Reproductive Toxicity (DART) End Points for Next Generation Risk Assessment (NGRA).
  • Kelly Carstens, U.S. Environmental Protection Agency (EPA): Application of Developmental Neurotoxicity (DNT) New Approach Methods (NAMs) for Predicting Human Neurotoxicity

Please note that the session on integrated approaches for testing and assessment previously scheduled for June 24 has been postponed. All current registrants will receive a notice of the new date through Zoom.

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Jun 13, 2022
FDA Science Board to Meet June 14

The FDA Science Board will meet June 14 from 9:00 a.m. to 5:00 p.m. EDT. Meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. Topics considered will include:

  • Challenges in evaluating the safety of dietary supplement and food ingredients with predicted pharmacological activity, utilizing cannabinoids as a case study.
  • Enhanced efforts to spur the development, qualification, and adoption of new alternative methods for regulatory use that can replace, reduce, and refine animal testing and have the potential to provide both more timely and more predictive information to accelerate product development and enhance emergency preparedness.
  • Enhanced efforts to ensure optimal organization, infrastructure, and expertise for data science efforts in alignment with its regulatory scope and evidence-based decision making, in support of FDA’s public health priorities.

For additional information, contact Rakesh Raghuwanshi at rakesh.raghuwanshi@fda.hhs.gov.

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Jun 13, 2022
Session Proposal Deadline for 12th World Congress Extended to June 17

The 12th World Congress on Alternatives and Animal Use in the Life Sciences (WC12) will be held August 27-31, 2023, in Niagara Falls, Canada. WC12 organizers are currently accepting session proposals aligned with the meeting themes:

  • Refinement and Impact on Science
  • Next-gen Education
  • Ethics, Welfare, Policies, and Regulations
  • Human-centered Biomedical Research
  • 21st Century Predictive Toxicology
  • Regulatory Acceptance and Global Harmonization

The deadline for session proposals has been extended to Friday, June 17. Proposals will be accepted for sessions in symposium, workshop, or dynamic panel/debate formats; suggestions of other formats will be considered as appropriate. Meeting organizers strongly encourage that proposals be designed to facilitate participation across multiple disciplines and sectors. Detailed information about proposal submissions is available on the WC12 website.

Jun 17, 2022
Jun 13, 2022
Webinar Series Continues June 24 with Discussions of IATAs

PCRM will present a webinar on “Integrated Approaches for Testing and Assessment (IATA): NAM-based safety assessment frameworks” on Friday, June 24 from 10:00-11:30 a.m. EDT. This is the second session of the New Approach Methodologies (NAMs) Use for Regulatory Applications (NURA) series, “DyNAMic Discussions: The Future is Already Here.” All materials from the first session, including the presenter's slides, the webinar recording, and supplementary publications are now available through the DyNAMic Discussions learning portal.

The June 24 webinar will feature the following presentations:

  • Nicholas Ball, Dow Chemical Company, will discuss the topic “Can a framework using NAMS meet regulatory needs for chemical management – EU-REACH as an example.”
  • Gladys Ouédraogo, L’Oreal, will consider “IATAs for addressing systemic toxicity: a perspective on the safety assessment of cosmetics.”
  • The question-and-answer period and discussion will be moderated by Gavin Maxwell, Unilever, and Eryn Slankster-Schmierer, PCRM.
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Jun 13, 2022
EPA Offers Small Businesses Grants to Develop Applications for Chemical Safety Assessment

EPA will release its 2022-2023 Small Business Innovation Research Phase I Broad Agency Announcement solicitation in mid-June with a close date in mid-August. A list of proposed topics is available on the EPA website. One proposed topic is support for development of software tools and machine-learning applications for systematic review in science assessment for chemical evaluation.

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Jun 02, 2022
June 7-8 Workshop on 3D Tissue Models for Antiviral Drug Development

Registration is still open for the Assay Guidance Workshop on 3D Tissue Models for Antiviral Drug Development, which will be held virtually on June 7-8. The two-day workshop will cover a broad range of critical concepts, including practical approaches and best practices, for developing standardized 3D cellular assays for testing of therapeutics for future pandemic threats.

Sessions:

  • Day 1: Tuesday, June 7, 11:00 a.m. – 4:15 p.m. EDT
  • Day 2: Wednesday, June 8, 11:00 a.m. – 5:15 p.m. EDT

Session topics:

  • Session I: 3D Tissue Models: Utility & Limitations
  • Session II: Utility of the Existing 3D Tissue Models for Antiviral Drug Development
  • Session III: Use of Robust & Reproducible 3D Tissue Models from Drug Discovery
  • Session IV: Summary of Discussions & Perspectives on the Challenges Ahead

The overall goal of this workshop is to help scientists establish robust, reproducible, scalable, consistent, advanced 3D tissue models to study pandemic threat viruses. Acting NICEATM Director Nicole Kleinstreuer will be speaking in Sessions III and IV. The workshop is organized by the National Center for Advancing Translational Sciences. Registration is free.

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Jun 02, 2022
DOT and OSHA Seek Public Input in Advance of International Meetings

The U.S. Department of Transportation (DOT) Pipeline and Hazardous Materials Safety Administration and the Occupational Safety and Health Administration (OSHA) will hold virtual public meetings on Wednesday, June 15. The purpose of the June 15 meetings is to consider public comments and gather information in advance of:

  • The 60th session of the United Nations Sub-Committee of Experts on the Transport of Dangerous Goods on June 27-July 6.
  • The 42nd session of the United Nations Sub-Committee of Experts on the Globally Harmonized System of Classification and Labelling of Chemicals on July 6-8.

General information about both meetings is available in a May 31 Federal Register notice. Interested parties may submit written comments between June 4 and July 5. Details on submitting written comments are available in the Federal Register notice.

Jul 5, 2022
Jun 02, 2022
June 22-23 3Rs Symposium Goes All Virtual

The 9th Annual 3Rs Symposium: Collaboration to Improve Animal Welfare and Rigorous Results will be held June 22-23. Due to increasing incidence of COVID-19, the symposium will be held virtually, and the workshop originally scheduled for June 24 will not be held. The symposium is being organized by Johns Hopkins University along with ICCVAM agencies NIH and USDA.

Attendees at the symposium will learn how innovations in animal models, experimental design, refinements, and many other areas are changing the way animals are used in research. The program will feature presentations and panel discussions from international leaders in animal research and welfare, with Q&A time built-in for virtual participants and networking opportunities for in-person attendees. This symposium has applied for Registry of Approved Continuing Education credits to satisfy veterinary continuing education requirements and offers reduced registration for federal workers, postdocs, and students.

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Jun 02, 2022
New Paper Evaluates Variability Across Rat Acute Oral Systemic Toxicity Studies

NICEATM and EPA scientists compiled, curated, and analyzed a set of over 2000 chemicals with multiple independent study records to characterize variability and reproducibility of results. Conditional probability analyses revealed that replicate studies only resulted in the same hazard categorization on average at 60% likelihood. The authors concluded that inherent biological or protocol variability likely underlies the variance in the results.

Karmaus et al. 2022. Evaluation of variability across rat acute oral systemic toxicity studies. Tox Sci. https://doi.org/10.1093/toxsci/kfac042.

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Jun 02, 2022
Postdoctoral Fellowship Opportunities at NIEHS

Two postdoctoral fellowship opportunities are available within the Spatiotemporal Health Analytics Group at the National Institute of Environmental Health Sciences in Research Triangle Park, NC. The opportunities focus on spatiotemporal geostatistics methods development and climate change exposure and health. For information about either opportunity, contact Kyle Messier at kyle.messier@nih.gov.

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May 26, 2022
June 1 Webinar Presents Respiratory Toxicity Case Study

An upcoming webinar will describe the INSPiRE project, which assessed the value of in vitro models to predict the ability of chemicals to cause portal-of-entry effects on the human respiratory tract. The webinar will be presented by ScitoVation on June 1 at 11:00 a.m. EDT.

Because of differences in physiology, anatomy, and biochemistry between the rat and human respiratory tract and the way they limit the ability of the rat to predict human effects, there has been a shift to develop and use human cell-based approaches to characterize potential portal-of-entry effects of inhaled substances. In this webinar, Amy Clippinger and Andreas Stucki of the PETA Science Consortium International e.V. will describe how the INSPiRE project assessed four chemicals from two distinct chemical classes in two different cell systems using various exposure scenarios and biological endpoints. The results give important insights in how in vitro systems can be used to predict effects on the human respiratory tract and inform regulatory decision-making. All registered participants will receive access to the webinar recording.

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May 26, 2022
Session Proposal Deadline for 12th World Congress Extended to June 10

The 12th World Congress on Alternatives and Animal Use in the Life Sciences (WC12) will be held August 27-31, 2023, in Niagara Falls, Canada.

WC12 organizers are currently accepting session proposals aligned with the meeting themes:

  • Refinement and Impact on Science
  • Next-gen Education
  • Ethics, Welfare, Policies, and Regulations
  • Human-centered Biomedical Research
  • 21st Century Predictive Toxicology
  • Regulatory Acceptance and Global Harmonization

The deadline for session proposals has been extended to Friday, June 10. Proposals will be accepted for sessions in symposium, workshop, or dynamic panel/debate formats; suggestions of other formats will be considered as appropriate. Meeting organizers strongly encourage that proposals be designed to facilitate participation across multiple disciplines and sectors. Detailed information about proposal submissions is available on the WC12 website.

Jun 10, 2022
May 26, 2022
June 28 Webinar Considers Developments in Fish Acute Toxicity Testing

An upcoming NC3Rs webinar will showcase ongoing and novel initiatives that replace, reduce, and refine fish acute toxicity studies. It will be presented on Tuesday, June 28, at 8:00-11:00 a.m. EDT.

The webinar will feature presentations on novel approaches to support replacement of the use of late life stage animals, and a retrospective data analysis project to identify potential reductions in regulatory fish testing. Presenters include:

    • Natalie Burden, NC3Rs
    • Stephan Fischer, aQuaTox-Solutions
    • Melanie Fischer, Eawag
    • Adam Lillicrap, Norwegian Institute for Water Research
    • Michael Lowit, U.S. Environmental Protection Agency

This webinar will be relevant for all academic, regulatory and industry scientists interested in applying the 3Rs in fish acute toxicity testing. There will be a panel discussion at the end of the webinar, with an opportunity for audience members to ask questions. The webinar presentations will be recorded and made available if you are unable to attend live.

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May 26, 2022
Paper Describes Development of In Vitro Skin Sensitization Test Method

The electrophilic allergen screening assay (EASA) has emerged as a promising in chemico method to detect the first key event in the adverse outcome pathway for skin sensitization. A new article in Toxics describes the redesign of EASA into a 96-well plate format that incorporates in-process control measurements to quantify key sources of variability each time the assay is run. ICCVAM members Elijah Petersen (National Institute of Standards and Technology) and John Gordon (U.S. Consumer Product Safety Commission) are coauthors of the article, as are NICEATM scientists Judy Strickland and Jim Truax (Inotiv, contractor supporting NICEATM).

Petersen EJ, Uhl R, Toman B, Elliott JT, Strickland J, Truax J, Gordon J. Development of a 96-well electrophilic allergen screening assay for skin sensitization using a measurement science approach. Toxics. 2022; 10(5):257. https://doi.org/10.3390/toxics10050257.

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May 17, 2022
Register by May 20 to Present Oral Statements at ICCVAM Public Forum

The deadline for registering to present oral public statements for the ICCVAM Public Forum is Friday, May 20. Interested persons may present oral public statements with associated slides on topics relevant to ICCVAM’s mission. Requests to present oral statements during the meeting will be accepted on a first-come, first-served basis as time permits.

Representatives from eight ICCVAM member agencies will describe activities to advance new approaches to safety testing of chemicals and medical products, and to reduce the amount of testing required. Speakers will also provide summaries on NICEATM and ICCVAM activities.

A draft agenda for the May 26-27 ICCVAM Public Forum is available on the webinar information page. Registration is required to view the public forum and will be open through the end of the meeting on May 27.

May 20, 2022
May 17, 2022
May 25-26 Workshop to Focus on Artificial Intelligence and Open Data in Chemical Hazard Assessment

The National Academies of Sciences, Engineering, and Medicine will present a workshop on “Artificial Intelligence and Open Data Practices in Chemical Hazard Assessment.” This two-day workshop will be held on Wednesday and Thursday, May 25 and 26. It is one of two workshops being convened on topics pertinent to the assessment of human health effects by the U.S. Environmental Protection Agency. Registration is required.

Practical application of systematic review methods to the peer-reviewed literature and other data sources for chemical hazard identification is labor-intensive and costly. Advances in artificial intelligence hold promise to ease those constraints through semi-automation of systematic review workflows. Through presentations, discussions, poster sessions, and software tool demonstrations, workshop participants will consider the following questions:

  • What are the key practical hurdles for applying systematic review methods, especially with respect to data extraction, and what computational tools have been applied to address them?
  • What strengths and limitations have been identified through application of artificial intelligence (AI) solutions in systematic review?
  • What are the key opportunities for furthering application of AI in chemical hazard assessment?

This workshop will feature live panel discussions on various tools used to automate and streamline data extraction and evidence synthesis for systematic reviews. Nicole Kleinstreuer, Acting NICEATM Director, will be presenting in a session on “AI and Data Science Applications: Promises and Prospects.”

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May 17, 2022
Recent Papers Describe IVIVE Applications

Two recent papers describe potential applications of IVIVE, which can help to establish a relationship between concentrations of substances that induce in vitro responses and in vivo exposure levels that could result in human or animal adverse effects.

  • A collaboration among three federal offices and Stemina Biomarker Discovery Inc. demonstrated the utility of a Stemina human stem cell-based assay to quantitatively assess a chemical's developmental toxicity potency.
    Chang et al. 2022. Quantitative in vitro to in vivo extrapolation for developmental toxicity potency of valproic acid analogues. Birth Defects Res. https://doi.org/10.1002/bdr2.2019.
  • A comprehensive review paper with authors from eight ICCVAM member agencies and the European Union proposes operational definitions for IVIVE, presents literature examples for several common toxicity endpoints, and highlights their implications in decision-making processes across various federal agencies and international organizations. Current challenges and future needs in applying IVIVE are also summarized.
    Chang et al. 2022. IVIVE: facilitating the use of in vitro toxicity data in risk assessment and decision making. Toxics. https://doi.org/10.3390/toxics10050232
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May 10, 2022
Agenda Available for ICCVAM Public Forum; Registration for Public Statements Closes May 20

A draft agenda is available for the May 26-27 ICCVAM Public Forum. Representatives from eight ICCVAM member agencies will describe activities both to advance new approaches to safety testing of chemicals and medical products and to reduce the amount of testing required. Speakers will also provide summaries on NICEATM and ICCVAM activities.

Registration is required to view the public forum and will be open through the end of the meeting on May 27. Interested persons may also register to present oral public statements with associated slides on topics relevant to ICCVAM's mission. Requests to present oral statements during the meeting will be accepted on a first-come, first-served basis as time permits. The deadline for registering to present oral public statements is Friday, May 20.

May 20, 2022
May 10, 2022
Webinar Series to Explore Overcoming Barriers to NAM Application: First Webinar May 20

As part of its New Approach Methodologies (NAMs) Use for Regulatory Applications event series, PCRM will present a series of interactive seminars, “DyNAMic Discussions: The Future is Already Here.” This series will explore the barriers to transition to a NAMs-based approach to chemical safety assessment and, through examination of case studies, consider what can be done to accelerate this transition. Programs and agendas for the seminar series are available online.

The first event of the DyNAMic Discussions series will be Friday, May 20, 10:00-11:00 a.m. EDT, on the topic of “NAM-centered paradigms for regulatory decision-making: Leaving the animal tests behind.” Acting NICEATM Director Nicole Kleinstreuer will discuss “Acute applications of data-driven evaluations,” and EPA scientist Katie Paul-Friedman will consider “Integration of new approach methodologies for prospective selection of chemicals for additional study.” Each presentation is scheduled to last about 20 minutes, with the remaining 20 minutes reserved for Q&A and audience discussion.

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May 10, 2022
Science Policy Webinar on May 25 to Benefit Ukraine

A special webinar presented by ASCCT and ESTIV will explore the intersection of science and policy while raising money to support humanitarian efforts in Ukraine. “Science for Policy, Policy for Science” will be presented on Wednesday, May 25, 10:00-11:00 a.m. The $10 registration fee will support the relief efforts of the Czech Republic-based organization People in Need.

In this webinar, speakers Kristie Sullivan (PCRM), Francois Busquet (Altertox), and Nataliia Bubalo (National University of Food Technologies of Ukraine) will discuss the impact of science on policymakers and provides advice on how to bring science to policymakers’ attention. The webinar will be of interest to researchers and research organizations aiming to achieve policy impact in that it will highlight knowledge areas and identify processes in which to invest.

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May 05, 2022
Save the Date for 12th World Congress; Session Proposals Due June 3

The 12th World Congress on Alternatives and Animal Use in the Life Sciences (WC12) will be held August 27-31, 2023, in Niagara Falls, Canada. WC12 organizers are currently accepting session proposals aligned with the meeting themes:

  • Refinement and Impact on Science
  • Next-gen Education
  • Ethics, Welfare, Policies, and Regulations
  • Human-centered Biomedical Research
  • 21st Century Predictive Toxicology
  • Regulatory Acceptance and Global Harmonization

Session proposals are due Friday, June 3. Proposals will be accepted for sessions in symposium, workshop, or dynamic panel/debate formats; suggestions of other formats will be considered as appropriate. Meeting organizers strongly encourage that proposals be designed to facilitate participation across multiple disciplines and sectors. Detailed information about proposal submissions is available on the WC12 website.

Jun 3, 2022
May 05, 2022
ASCCT Annual Meeting October 19-21; Abstracts Due July 15

The 11th Annual Meeting of ASCCT will be held October 19-21 in Research Triangle Park, NC. The theme of the meeting is “Shifting the Paradigm to Next-generation (Quantitative) Risk Assessment.” The meeting will feature the latest science in new approach methodologies and active discussions about the implementation of new science. Students and early career scientists are especially encouraged to attend and present. The meeting will offer awards for students and early-career scientists, mentoring opportunities, and a continuing education course.

Abstracts are being accepted through July 15 for poster and oral presentations. Abstracts describing science and policy work representing all aspects of in vitro and computational toxicology are welcome.

Jul 15, 2022
May 05, 2022
Grants Offered to Support Development of Animal-free Antibody Applications

PETA Science Consortium International e.V., the Physicians Committee for Responsible Medicine, and the Alternatives Research and Development Foundation are offering grants for free recombinant antibodies for use in research and testing. Awardees will receive commercially available recombinant antibodies to test in applications that currently use animal-derived antibodies.

Applicants should submit a curriculum vitae and a proposal describing in detail the how the antibody will be used. Awardees will be expected to provide updates to grant sponsors on the progress of their work and publish their results. The offering has a rolling deadline, and grant amounts will vary based on details of the projects.

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May 05, 2022
Publication Describes Application of Skin Sensitization Defined Approaches

Defined approaches to testing that do not use animals are gaining broader acceptance for identification of potential skin sensitizers, but the methods that comprise them have mostly been tested using single chemicals rather than mixtures or formulations. NIEHS and Corteva Agrisciences collaborated to evaluate performance of a defined approach and three individual non-animal test methods to predicting skin sensitization hazard classifications of 27 agrochemical formulations. Results demonstrated that non-animal test methods have utility for evaluating the skin sensitization potential of agrochemical formulations as compared to animal reference data.

Strickland et al. 2022. Application of defined approaches for skin sensitization to agrochemical products. Front Toxicol. https://doi.org/10.3389/ftox.2022.852856.

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May 02, 2022
Videos Available from ICE Training Sessions

Videos are now available from a recent training session on the Integrated Chemical Environment (ICE). The training was organized by the Physicians Committee for Responsible Medicine, and the videos are available on their website.

Attendees at this two-day event learned directly from NICEATM developers how to use ICE tools for data and assay exploration. ICE is a free online suite that houses curated toxicity and physicochemical property data and a variety of tools to analyze and visualize chemical data. These tools provide access to data adhering to FAIR principles-—Findable, Accessible, Interoperable, and Reusable—for analyses including in vitro to in vivo extrapolation and physiologically based pharmacokinetic modeling.

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May 02, 2022
EPA Ecotoxicology Data Resource Virtual Training Session May 17

EPA will hold a virtual training session on its ECOTOXicology Knowledgebase (ECOTOX) Tuesday, May 17 from 12:00-2:00 p.m. EDT. Registration is free but required. Please contact Jessica Daniel for more information.

ECOTOX is a publicly available tool providing single chemical environmental toxicity data on aquatic and terrestrial species. ECOTOX was developed to provide risk assessors and researchers with relevant toxicity data that have been identified and curated from peer-reviewed literature and government reports. New data are added every quarter and are available on a public-facing website.

The May 17 training is specifically targeted for decision-makers and will provide:

  • An overview of the database content and function.
  • Application-oriented use-case demonstrations.
  • Opportunities for participatory learning and engagement.

The virtual training will feature ECOTOX Coordinator Jennifer Olker. The program includes an overview and demonstration of the tool and breakout sessions in which case studies will be reviewed.

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May 02, 2022
EMGS Bioinformatics Challenge Submissions Due August 31

The 2022 EMGS Bioinformatics Challenge is now accepting submissions. More information and links to past winners, as well as a video recording of the 2021 final round competition, can be found on the EMGS website. Abstracts in any one of the following four areas are sought:

  • Novel computational approaches including machine learning and artificial intelligence on high-throughput, high-content, exposure-risk assessment, or clinical data classification.
  • Genetic/genomic toxicological applications of model organism databases.
  • Predictive modeling with genomic/mutation/epimutation datasets and/or toxicology databases.
  • Geospatial analysis that incorporates high-dimensional toxicity, exposure, and/or human health data.

To enter, create one Twitter post with one figure, an abstract of 280 characters (40-70 words) and two hashtags – @EMGSUS and #EBIC22 – by August 31. The abstracts will be evaluated by three criteria:

  • Communicates originality of the work.
  • Clearly explains the data pipeline or computational procedure.
  • Describes interpretation of the results.

Selected participants will receive a $100 monetary award and present their work in the final round competition that will be held as a virtual symposium in Fall 2022. The finalist teams will compete for a grand prize of $1000.

Aug 31, 2022
May 02, 2022
May 24 Webinar Explores PFAS and Cancer

A May 24 webinar held 10:00-11:00 a.m. EDT will address “Do Per- and Poly-fluoroalkyl Substances (PFAS) Cause Cancer in Humans?” The webinar is hosted by the SOT Carcinogenesis Specialty Section. In this webinar, Ella Atlas (Health Canada) and Andrea Winquist (U.S. Centers for Disease Control) will discuss recent findings using transcript profiling to uncover molecular targets of PFAS linked to carcinogenesis. They will also summarize carcinogenicity findings from rodent studies and examine the epidemiological evidence linking exposure to PFAS and cancer in humans.

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May 02, 2022
Recent Publications
  • A recent paper in Frontiers in Toxicology describes a collaborative exercise to evaluate how application of standardized phenotype terminology improves data consistency. The exercise suggested that utilizing a common data standard not only reduces the heterogeneity of reported terms but increases agreement and repeatability among different laboratories. ICCVAM member Stephanie Padilla (EPA) is a coauthor on the paper, and NICEATM scientist Jon Hamm (Inotiv, contractor supporting NICEATM) is senior author.
    Thessen et al. 2022. Implementation of zebrafish ontologies for toxicology screening. Front Toxicol. https://doi.org/10.3389/ftox.2022.817999
  • A new paper coauthored by Acting NICEATM Director Nicole Kleinstreuer examines how parameterization of in vitro to in vivo extrapolation models affects the outputs of those models for predicting thyroid bioactivity. The paper also proposes a range of potentially thyroid-relevant doses that incorporate uncertainty in modeling choices and in vitro assay data.
    Carlson et al. 2022. Impact of high-throughput model parameterization and data uncertainty on thyroid-based toxicological estimates for pesticide chemicals. Environ Sci Tehcnol. https://doi.org/10.1021/acs.est.1c07143
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Apr 25, 2022
NICEATM Scientist Discusses Computational Pipeline for Cardiotoxicity in May 12 Webinar

NICEATM scientist Shagun Krishna will discuss “Computational Cardiotoxicity: Building an AI-assisted Pipeline” at a webinar on Thursday, May 12 at 10:00-11:00 a.m. EDT. The webinar is the last in a series presented by the Health and Environmental Sciences Institute featuring early-career scientists who have conducted compelling research related to cardiovascular safety and risk assessment.

Krishna’s research involves development of a pipeline for cardiovascular risk assessment of pharmaceutical and environmental chemicals. She has led a project to interpret Tox21/ToxCast high-throughput screening assay data, map the assay targets to biological pathways that represent key failure modes in cardiovascular disease, and use the observed patterns of bioactivity to screen and rank chemicals for potential cardiotoxicity. Her research applies cheminformatics, artificial intelligence, and machine learning in a variety of ways, including building structure–activity relationship models and developing evidence maps of the literature supporting environmental contributions to cardiovascular effects.

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Apr 25, 2022
May ASCCT-ESTIV Webinar to Discuss In Vitro Models for Genotoxicity and Carcinogenicity

ASCCT and ESTIV will present a webinar on “Advancing In Vitro Models for Genotoxicity and Carcinogenicity.” The webinar will be held on Monday, May 16 from 11:00 a.m.–12:00 noon EDT.

The webinar featured speakers will be Anouck Thienpont, Vrije Universiteit Brussels, and Silvia Scaglione, React4life. Their research topics are as follows:

  • Anouck Thienpont will describe “A novel prediction model to evaluate genotoxicity based on biomarker genes in human HepaRG™ cells.” Thienpont is a Ph.D. student in the Laboratory of In Vitro Toxicology and Dermato-Cosmetology. His research has focused on the GENOMARK biomarker, covering different modes of action in metabolically competent human HepaRG cells.
  • Silvia Scaglione will discuss “A novel fluidic microphysiological system for 3D cancer tissue culture towards a better understanding of human cancer progression.” Scaglione’s research focuses on better understanding human cancer disease and the preclinical assessment of novel drug therapies. In particular, she and her team have generated a functional and relevant human cancer model through the adoption of a multi-in vitro organ device, a drug-screening platform, for pharmacological treatments and for cell-based therapies and basic research purposes.
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Apr 25, 2022
Proceedings Available from Workshop on NAMs for Human Health Risk Assessment; Next Workshop May 12

A December 9, 2021, workshop considered the potential utility and expectations for the future use of NAMs in risk assessment and to reflect on the challenges to their implementation. Proceedings of the workshop are now available.

During the workshop, experts from academia, industry, government, and other organizations discussed current scientific knowledge with regard to traditional toxicity studies and NAMs. The workshop addressed three critical questions:

  • How are traditional toxicity studies used in informing chemical safety decisions?
  • What do we know about the variability and concordance of traditional mammalian toxicity studies?
  • What are the needs and expectations of different stakeholders?

The workshop was convened by an ad hoc committee of the National Academies of Sciences, Engineering, and Medicine exploring the topic of “Variability and Relevance of Current Laboratory Mammalian Toxicity Tests and Expectations for New Approach Methods for use in Human Health Risk Assessment.” The panel’s goal is to set data-driven and science-based expectations for NAMs based on the variability and relevance of the traditional toxicity testing models. Acting NICEATM Director Nicole Kleinstreuer and ICCVAM Member Elijah Petersen (NIST) are serving on the committee. The panel’s next public workshop will be held on May 12.

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Apr 25, 2022
NICEATM Paper Describes Accessible Interface for Pharmacokinetic Modeling

A new paper in Frontiers in Pharmacology describes applications of tools provided in the NTP Integrated Chemical Environment for pharmacokinetic modeling and in vitro to in vivo extrapolation. The paper highlights recent improvements to these tools and discusses their potential to facilitate broader application and acceptance of these techniques.

Hines et al. 2022. Application of an accessible interface for pharmacokinetic modeling and in vitro to in vivo extrapolation. Front Pharmacol. https://doi.org/10.3389/fphar.2022.864742

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Apr 18, 2022
ICCVAM Public Forum May 26-27; Registration Open

ICCVAM will hold a virtual public forum Thursday, May 26, and Friday, May 27, from 10:00 a.m. until about 4:00 p.m. EDT both days. Information and links to register to attend and to present oral public statements are available on the meeting webpage.

This event is held annually to share information and facilitate direct communication of ideas and suggestions from stakeholders. NICEATM, ICCVAM, and ICCVAM agencies will describe activities both to advance new approaches to safety testing of chemicals and medical products and to reduce the amount of testing required.

Registration is required to view the public forum and will be open through the end of the meeting on May 27. Interested persons may also register to present oral public statements with associated slides on topics relevant to ICCVAM's mission. Requests to present oral statements during the meeting will be accepted on a first-come, first-served basis as time permits. The deadline for registering to present oral public statements is Friday, May 20.

May 20, 2022
Apr 18, 2022
MPS World Summit May 30-June 3; Late-breaking Abstracts Due April 30

The MPS World Summit 2022 will be held at the Hilton New Orleans Riverside and virtually from May 30-June 3. Late-breaking abstracts for poster presentations are due Saturday, April 30. Abstracts should describe new developments and applications of microphysiological systems (MPS). Information about the summit and abstract submission is available on the meeting website.

Summit attendees will present the latest scientific achievements in the area of MPS and discuss advances and challenges. This is the latest in a series of events convened to facilitate stakeholder communication, enable networking among young scientists and MPS thought leaders, promote international standardization and harmonization of MPS, and serve as a global training environment. These events will also lay the groundwork for establishing an international MPS society. The National Center for Advancing Translational Sciences (part of the National Institutes of Health, an ICCVAM member agency) is a major sponsor of the summit.

The European Society for Toxicology In Vitro is sponsoring a best poster award and best oral presentation award (500 EUR each), to be awarded to Ph.D. students or early career scientists presenting their research in the field of in vitro toxicology as first author during the MPS World Summit. An application is required to be considered for the awards and must be submitted by April 30.

The summit will include an education and training workshop to be held Tuesday, May 31, from 9:00-11:45 a.m. Central Time. Workshop participants will attend up to four presentations and demonstrations from leaders in the MPS field. Participants will have a unique opportunity to interact directly with international speakers and to receive a hands-on training on some of the most cutting-edge MPS technologies. Attendance is free but separate registration is required.

Apr 30, 2022
Apr 18, 2022
Webinar Discusses Approaches to Reduce Animal Use for Ecotoxicity Testing

A May 11 webinar will address “Data-Driven Solutions to Reducing Animal Use in Ecotoxicity.”

In this webinar, two EPA scientists discuss computational tools and analyses that EPA is using to reduce animal use for ecotoxicity testing. Carlie LaLone, EPA Office of Research and Development, will describe how the SeqAPASS tool, which uses existing protein sequence data for cross-species extrapolation, can be applied to understanding conservation of biology and predicting chemical susceptibility. Michael Lowit, EPA Office of Pesticide Programs, will discuss an ongoing retrospective analysis of fish acute toxicity test data, which will inform whether there is a basis for reducing the number of species while providing sufficient information to support pesticide registration decisions.

The webinar is the latest in a series on use of new approach methodologies in risk assessment co-organized by the PETA Science Consortium International, EPA, and the Physicians Committee for Responsible Medicine. Information and links to materials from past webinars are available on the PETA Science Consortium International website.

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Apr 18, 2022
Webinar Series Introduces Training on Animal-free Risk Assessment for Cosmetics

The Animal-free Safety Assessment Collaboration has created an education and training program that covers the entire risk assessment process for cosmetics and ingredients without the use of new animal data, from initial problem formulation through to the hazard or risk assessment.

An ongoing webinar series will provide an overview of select modules within the training program to exemplify what is covered by the module in its entirety. Webinars will be presented by members of the module development team.

  • Consumer Exposure – Thursday, April 14.
  • Predictive Chemistry: In Silico Tools and Read-across – Tuesday, April 26.
  • Dosimetry: Internal Exposure and IVIVE – Thursday, May 5.
  • Global Regulatory Landscape – Tuesday, May 10.
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Apr 13, 2022
April 19 Webinar to Present a Case Study on Risk Assessment for Skin Allergy

The SOT Dermal Toxicology Specialty Section will present a webinar, “International Advances in Alternatives and a Next Generation Risk Assessment Case Study for Skin Allergy,” on Tuesday, April 19, at 12 noon EDT.

This webinar will feature Georgia Reynolds from Unilever and Acting NICEATM Director Nicole Kleinstreuer discussing next-generation risk assessment approaches for skin sensitization. A hypothetical skin allergy risk assessment case study of two consumer product exposures will demonstrate how the Unilever Skin Allergy Risk Assessment computational model can be used to calculate a risk metric for a consumer-relevant exposure.

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Apr 13, 2022
April 19-20 Workshop to Discuss New Tools for Neurotoxicology Assessment

NIEHS will present a two-day workshop on “Modernizing Neurotoxicology at NIEHS: Technologies to Applications in Environmental Health Sciences.” The workshop will be held Tuesday, April 19, from 10:00 a.m.-3:45 p.m. EDT and Wednesday, April 20, from 10:00 a.m.-3:15 p.m. EDT. The workshop is free but preregistration is required.

The workshop is being hosted by the NIEHS Faculty for Advancing Neuroscience Cross-divisional Group. The workshop’s goal is to bring together a diverse group of scientists to:

  • Review the latest research applications of several cutting-edge tools in neurotoxicology and lessons learned.
  • Identify the most pressing research questions in environmental health that would benefit from use of these new methods.
  • Develop a strategy to encourage adoption of these new technologies.

In the April 19 afternoon session covering “In Vitro Approaches in Developmental Neurotoxicity Research,” NICEATM scientist Helena Hogberg will describe “A human iPSC-derived 3D brain sphere model to assess developmental neurotoxicity.”

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Apr 13, 2022
May Webinar to Discuss NAMs for Developmental Neurotoxicity

The International Neurotoxicology Association will present a webinar on “Development of New Approach Methodologies (NAMs) that Fill Biological Gaps in the Current In Vitro Developmental Neurotoxicity (DNT) Test Battery.” The webinar will be held on May 19 from 11:00 a.m.-1:00 pm EDT. A full agenda is available for download.

The webinar will be hosted by Chairpersons Lena Smirnova and Melissa Martin. Speakers and their research topics are as follows:

  • Melissa Martin, EPA: “Novel approaches using the multi-electrode array to measure local field potentials and network formation.” Martin is a postdoctoral researcher in the EPA Center for Computational Toxicology and Exposure (CCTE). Her research has focused on developmental nicotine exposure and its effects on the brain and behavior.
  • Lena Smirnova, Johns Hopkins University: “Multiplexed Developmental Neurotoxicity Test in Human Brain Organoids.” Smirnova is a researcher at the Johns Hopkins Center of Alternatives to Animal Testing, where she is leading the Education Program and Program on Microphysiological Systems and Systems Toxicology. Her research focus is on development of new approach methodologies for developmental neurotoxicity testing and understanding gene environmental interactions in autism.
  • Ellen Fritsche, Leibniz Research Institute for Environmental Medicine: “Expansion of the current OECD-EFSA developmental neurotoxicity (DNT)-in vitro battery.” Fritsche’s work focuses on the establishment of alternative in vitro methods for neurotoxicity mode-of-action analyses and screening with a focus on DNT.
  • Megan Culbreth, EPA: “High-throughput phenotypic profiling (HTPP) of chemical-induced changes in human neural progenitor cell morphology for developmental neurotoxicity (DNT) hazard assessment.” Culbreth is a postdoctoral researcher in the EPA CCTE. Her research focuses on the Establishment of alternative in vitro methods for neurotoxicity mode-of-action analyses and screening with a focus on DNT.
  • Jonathan Blum, University of Konstanz: “Use of signaling endpoints to identify neurofunctional disturbances by neonicotinoid pesticides and their metabolites.” Blum is a PhD candidate at the in vitro toxicology and biomedicine chair at the University of Konstanz. He is involved in the implementation of DNT NAMs into screening batteries and in regulatory contexts.
  • Tal Sharf, Neuroscience Research Institute, University of California Santa Barbara: “Intrinsic network activity in human brain organoids.” Sharf is a postdoctoral fellow at the University of California Santa Barbara Neuroscience Research Institute. He has been utilizing interdisciplinary approaches to better understand processes governing human brain function in the context of neurodevelopmental disorders and disease.
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Apr 13, 2022
Nominations for Lush Prize Due June 17

Nominations are being accepted through June 17 for the 2022 Lush Prize, which recognizes advancement toward animal-free testing. The Lush Prize is the largest prize fund in the non-animal testing sector, with a prize fund total of £250,000. Nominations for the prize are accepted in the six categories of Lobbying, Public Awareness, Science, Training, and Young Researcher. Alternatively, the entire £250,000 may be awarded as a Black Box Prize, to recognize a key breakthrough in human toxicity pathways likely to lead to practical non-animal tests that could be accepted by regulators.

Eligibility guidelines are available on the Lush Prize website. Candidates and projects from anywhere in the world are eligible. Requirements of the recipients include attending an awards ceremony and preparing an explanation of the winning project for the ceremony and the Lush Prize website.

Jun 17, 2022
Apr 13, 2022
EURL ECVAM Issues Status Report on Alternatives

EURL ECVAM has issued its 2021 “Status Report on the Development, Validation and Regulatory Acceptance of Alternative Methods and Approaches.” An April 7 news article announced availability of the report.

The report describes research, development, and validation activities, as well as initiatives that promote the regulatory and international adoption and use of alternative approaches and their dissemination. Activities described in the report include:

  • Development of NAMs to identify chemicals with potential endocrine activity.
  • Exploration of approaches to replace, reduce, or refine animal use for batch testing of vaccines.
  • Evaluation of methods to identify potential genotoxins and sensitizers.

EURL ECVAM, which is part of the European Commission's Joint Research Centre, coordinates research and validation studies on alternatives to animal testing within the European Union. EURL ECVAM also shares knowledge about and promotes use of alternative methods.

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Apr 11, 2022
NICEATM Releases ICE 3.6

On March 24, NICEATM released version 3.6 of the Integrated Chemical Environment (ICE). ICE provides data and tools to help develop, assess, and interpret chemical safety tests. This release adds new features to ICE tools, improves usability of ICE data, and adds new reference Chemical Quick Lists.

Tool improvements in ICE version 3.6 include:

  • Ability to limit Chemical Quest searches to chemicals in user-defined lists.
  • New viewing options in Curve Surfer.
  • New filtering options in Curve Surfer and Chemical Quest Results views.
  • Updated view for uploading custom in vivo and in vitro data in the IVIVE tool.

Additions or improvements to data include:

  • Quality control annotations for curated high-throughput screening HTS data.
  • References for acute oral toxicity data.
  • New endpoints for skin sensitization data.
  • Addition and harmonization of endocrine data.
  • Downloadable flat files for all data sets available on the Data Sets page.
  • New reference Chemical Quick Lists for Cancer and Non-Cancer Assessment.
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Apr 11, 2022
EPA Releases httk 2.1.0

On March 26, EPA released version 2.1.0 of the High-throughput Toxicokinetics tool (httk). This R software package enables estimation of chemical concentrations in various parts of the human body from a given exposure. The latest update of httk includes:

More information about EPA’s high-throughput exposure and dose research activities is available on their website.

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Apr 11, 2022
NICEATM Scientist Honored at SOT

At the recent SOT annual meeting, NICEATM scientist Shagun Krishna received two scholarship awards from the Yves Alarie Scholarship Fund and from the Dharm V. Singh Association of Scientists of Indian Origin Student Award Fund. Krishna’s poster, “Applying IVIVE to determine margins of exposure for potentially cardiotoxic chemicals,” was also a finalist for the Best Trainee Abstract award given by the Biological Modeling Specialty Section.

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Apr 05, 2022
Preproposals Due April 15 for CAAT Grants

The Johns Hopkins University Center for Alternatives to Animal Testing is accepting preproposals for the Alan and Helene Goldberg In Vitro Toxicology Grant. This award of up to $40,000 U.S. will fund a project aimed at significantly reducing or replacing use of laboratory animals for a toxicity testing application. Examples of acceptable projects could include providing mechanistic context of in vitro responses to toxicants in human cells, development of adverse outcome pathways, or conducting systematic reviews. Consideration should be given to the translation of the new method to evaluate or predict health outcomes.

To apply, submit a preproposal summarizing the proposed work, including descriptions of the project’s goal and the experimental design and methods to be used. Preproposals are due by April 15. Authors of accepted preproposals will be invited to submit full grant applications later in 2022.

Apr 15, 2022
Apr 05, 2022
Applications Still Being Accepted for Summer School for Innovative Approaches to Science

Applications are still being accepted to attend the second Summer School on Innovative Approaches in Science, which will be held June 7-10 at the North Carolina Biotechnology Center in Research Triangle Park, NC. Applications will continue to be accepted while spaces remain. Attendance is free. Travel awards are available. Applications for travel awards are due April 15.

The Summer School is a four-day educational and training program for undergraduate and graduate students, postdoctoral and other trainees, as well as early-career professionals. The program offers separate tracks for toxicology and biomedical science, each featuring specific applications of current innovative non-animal methods. Attendees will benefit from career development workshops, poster presentations, laboratory tours and demonstrations, networking opportunities, and scientific talks from experts.

Apr 15, 2022
Apr 05, 2022
EURL ECVAM Seeks Members for Scientific Advisory Committee; Apply by May 1

EURL ECVAM is seeing members for the EURL ECVAM Scientific Advisory Committee (ESAC). Interested individuals should apply by May 1.

The main tasks of ESAC are to:

  • Assess the scientific validity of alternative methods/approaches intended for a given purpose.
  • Advise on other scientific matters related to the work of EURL ECVAM and the protection of animals used for scientific purposes.
  • Share its knowledge and experience on alternative methods/approaches used in science.

ESAC is made up of nine experts that serve for terms of five years that can be renewed. Plenary meetings of the committee are typically held once or twice per year; sub-groups focused on a particular topic may meet more often.

May 1, 2022
Apr 05, 2022
April 27 Webinar Discusses Models for Predicting Drug-induced Liver Injury

The Computational Toxicology Specialty Section of the Society of Toxicology will present a webinar on “The Predictive Toxicogenomics Space (PTGS) Modeling Tool Captures Diverse Cellular and Organ Toxicity Mechanisms and Serves for In Vitro Model-Driven Prediction of Drug-Induced Liver Injury.” The webinar will be held April 27 from 11:00 a.m.-noon EDT.

Speakers Roland Grafstrom and Pekka Kohonen of the Karolinska Institutet will describe an artificial intelligence-derived 14-gene component-based predictive toxicogenomics space tool that generates toxicity estimates based on omics data providing broad coverage of toxicity reactions and mechanisms. The tool enables application of in vitro data to assess tissue injury in multiple organs of experimental animals subjected to repeated-dose toxicity bioassays, including the accurate prediction of human drug-induced liver injury.

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Mar 31, 2022
ICCVAM Member Honored by SOT Specialty Section

In an awards ceremony on Wednesday, March 30, ICCVAM member Suzanne Fitzpatrick (FDA) was presented with the inaugural Outstanding Contribution to Regulatory Safety Evaluation Award by the SOT Regulatory and Safety Evaluation Specialty Section. This award recognizes an individual who has made significant contributions in the areas of regulatory and safety evaluation.

Fitzpatrick is the Senior Advisor for Toxicology at the FDA Foods Program. She is co-chair of an international work group on advancing new predictive toxicology test methods for food safety and also chairs the FDA’s Alternative Methods Work Group, which is currently focusing on in vitro microphysiological systems. A longtime ICCVAM member, Fitzpatrick is the principal FDA representative to ICCVAM and to the Tox 21 partnership.

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Mar 30, 2022
NICEATM Papers Honored by SOT Specialty Sections

Two 2021 publications with NICEATM coauthors were recognized in awards ceremonies on Tuesday, March 29 organized by the respective specialty sections.

  • Clippinger et al. 2021. Human-relevant approaches to assess eye corrosion/irritation potential of agrochemical formulations. Cutan Ocul Toxicol 40(2):145-167. https://doi.org/10.1080/15569527.2021.1910291
    Winner, Best Paper, In Vitro and Alternative Methods Specialty Section.
  • Mansouri et al. 2021. CATMoS: Collaborative Acute Toxicity Modeling Suite. Environ Health Perspect. 2021 Apr;129(4):47013. https://doi.org/10.1289/EHP8495.
    Honorable Mention, Best Paper, Biological Modeling Specialty Section
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Mar 28, 2022
Paper Considers New Approach for Carcinogenicity Assessment of Agrochemicals

A new paper in Regulatory Toxicology and Pharmacology describes development of a framework for a risk assessment-based weight of evidence determination of the need for rodent cancer bioassays for safety assessment. The reporting framework was developed to support a chronic toxicity and carcinogenicity study waiver rationale for agrochemicals but could also be applied to endpoints other than chronic toxicity and carcinogenicity, and for chemicals other than agrochemicals. Coauthors on the paper include ICCVAM member Warren Casey, NIEHS, and ICCVAM co-chair Anna Lowit, EPA.

Hilton et al. 2022. Rethinking chronic toxicity and carcinogenicity assessment for agrochemicals project (ReCAAP): A reporting framework to support a weight of evidence safety assessment without long-term rodent bioassays. Regu Toxicol Pharmacol. https://doi.org/10.1016/j.yrtph.2022.105160.

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Mar 25, 2022
April 14 Webinar to Discuss NAMs for Developmental Neurotoxicity and Respiratory Sensitization

ASCCT and ESTIV are hosting a webinar on Thursday, April 14 from 11:00 a.m. to noon EDT, “Development and Evaluation of NAMs for New Endpoints: Developmental Neurotoxicity and Respiratory Sensitization.”

  • Sabina Burla, Luxembourg Institute of Science and Technology, will describe “A 3D alveolar in vitro model for the prediction of chemical respiratory sensitizers and irritants.” Physiologically relevant test systems for the respiratory tract are essential to anticipate the sensitizing potential of chemicals. Burla will describe a study was to evaluate the performance of a 3D alveolar-capillary barrier, which was shown to have the potential to distinguish respiratory sensitizers from irritants. In addition, prohaptens tested in the system were correctly identified as respiratory sensitizers; such chemicals reported as false negatives by other NAMs for respiratory sensitization evaluation.
  • Kelly Carstens, EPA, will discuss “Evaluation of in vitro new approach methodologies for developmental neurotoxicity.” Carstens will summarize a study that used a supervised machine learning approach to identify the most informative endpoints in classifying a reference chemical for developmental neurotoxicity (DNT). The five most important features included three cytotoxicity endpoints, network formation, and neurite outgrowth endpoints. This work highlights current obstacles in DNT NAM data interpretation, including a limited set of reference negatives and the question of whether cytotoxicity should be considered off-target or is relevant to deriving key DNT-related points-of-departure.
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Mar 23, 2022
Overview of ICE Tools: Workshop April 18-19

An online training session April 18-19 will feature demonstrations by NICEATM scientists on new features of the Integrated Chemical Environment (ICE). Registration is free but is required to attend. The session is being presented by the Physicians Committee for Responsible Medicine.

ICE is a free online suite that houses curated toxicity and physicochemical property data and a variety of tools to analyze and visualize chemical data. These tools provide access to data adhering to FAIR principles-—Findable, Accessible, Interoperable, and Reusable—for analyses including in vitro to in vivo extrapolation and physiologically based pharmacokinetic modeling. Attendees at this two-day event will learn directly from NICEATM developers how to use ICE tools and have questions answered in a Q&A session.

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Mar 23, 2022
Report Examines Application of AOPs

The European Union Joint Research Centre (JRC) has issued “Adverse Outcome Pathway Framework – Study Report.” The report describes a JRC study conducted to learn more about the uptake of the Adverse Outcome Pathway (AOP) Framework in settings where decisions are made and policy formed about chemical safety and toxicity. The study focused on stakeholders in industry and in regulatory agencies, working in regulatory toxicology, risk assessment or risk management. Stakeholders were asked questions to determine the extent of the uptake of the framework, what facilitated it, or what may be challenging it.

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Mar 23, 2022
USDA AWIC Updates Website

The Animal Welfare Information Center (AWIC) of the U.S. Department of Agriculture’s National Agricultural Library is reorganizing and modernizing its webpages to improve user experience and streamline information discovery. AWIC’s webpages that discuss topics such as the Animal Welfare Act and Housing, Care, and Welfare of Animals have been updated with new content and design. Updates of other pages, including those on Animal Use Alternatives and AWIC Workshops & Trainings will be published throughout 2022.

AWIC provides a variety of resources for exploring alternatives to animal use for research, teaching, and testing, including assistance with literature searching for alternatives to animal use and workshops on meeting the requirements of the Animal Welfare Act. The next virtual workshop (free) is scheduled for May 11.

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Mar 23, 2022
Linda Birnbaum Honored by the Yale School of Public Health

Linda Birnbaum, Ph.D., will receive the 2022 Winslow Medal from the Yale School of Public Health. The award will be presented at an online event on Monday, April 11, at 12 noon-1:30 p.m. EDT. At the event, Birnbaum will discuss “Environmental Health: Past, Present, and Future.”

Birnbaum is the former Director of NIEHS and NTP. During her tenure, she was a strong supporter of NICEATM and ICCVAM. Prior to her appointment as NIEHS and NTP Director in 2009, she spent 19 years at EPA, where she directed the division focusing on environmental health research. She has received numerous awards from professional societies and citizen's groups, and is an active member of the scientific community as both an organizational leader and an author.

The Winslow Medal, the highest honor awarded by the Yale School of Public Health, is given in honor of Charles-Edward Amory Winslow, the founder of the school and a pioneer of modern public health in the United States. It is awarded to an individual who has had a distinguished career in public health, as exemplified by outstanding achievement in public health leadership, scholarship, and contribution to society.

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Mar 23, 2022
Postdoctoral Fellowship Opportunities
  • The National Center for Advancing Translational Sciences is seeking candidates for a postdoctoral position focusing on applying genomic tools to toxicology and pharmacology. Activities will include development of novel human cellular 3-D and co-culture models to study cardiovascular disease, as well as neurological and renal diseases.
  • The University of California, Berkeley, is seeking candidates for a postdoctoral position who have backgrounds in biomolecular modeling and chemical informatics with an interest in chemical toxicology, data management, and analysis. The focus of this position will be to develop one or more integrated databases for large sets of biomolecular computational data and experimental or literature sources of chemical toxicology data.
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Mar 14, 2022
Slides and Video Available for ICCVAM Webinar

Slides and video from the January 25 ICCVAM Communities of Practice Webinar on “New Approach Methodologies to Assess (Developmental) Neurotoxicity” are now available. In this webinar, two speakers from U.S. federal research and regulatory agencies described key issues and ongoing activities in alternatives to animal testing to predict chemical effects on the developing and adult nervous system.

Please mark your calendar for Thursday and Friday, May 26-27, when ICCVAM will present its annual Public Forum. At this virtual event, representatives of ICCVAM member agencies will describe activities to advance new approaches to safety testing of chemicals and medical products and to reduce the amount of testing required. Registration and other information will be posted on the event webpage when available.

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Mar 14, 2022
March 17 Webinar to Focus on Chip Models for Lung and Skin

ASCCT and ESTIV are hosting a webinar, March 17 from 9-10:30 a.m. EDT, “Maturing Three-dimensional Toxicology Models of the Barrier Organs: Examples from Lung and Skin.”

  • Patricia Zoio, NOVA University of Lisbon, will present “Full-thickness skin-on-a-chip model for in vitro drug testing and disease modelling.” Zoio will describe use of a reconstructed human skin model as a tool for drug discovery, disease modeling, and basic research. This innovative low-cost skin-on-a-chip model with integrated electrodes could provide a new in vitro tissue system compatible with long-term studies of skin diseases for evaluating the safety and efficacy of novel drugs.
  • Sabrina Madiedo-Podvršan, Université de Technologie de Compiègne, will present “Developing and investigating a new in vitro hepato-pulmonary co-culture model for the toxicological study of inhaled xenobiotics.” This presentation will describe two kinds of lung/liver models: a developmental model that allows for the technical setup of the co-culture platform, and a physiological-like model that better approximates a human in vivo situation. These models hold promise for a new physiologically relevant way of studying inhalation toxicology.
  • Samuel Constant, Epithelix, will discuss “3D Human airway epithelial models to study SARS-CoV-2 pathogenesis and to discover antivirals.” Since the first step of SARS-CoV-2 infection is taking place in airway epithelial cells, it is logical to use a 3D airway epithelial model as a drug testing platform. This presentation will highlight how Epithelix reconstituted human airway epithelial models can be used to characterize viral infection kinetics, tissue-level tropism, and transcriptional immune signatures induced by SARS-CoV-2.
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Mar 14, 2022
Opportunity for Displaced Ukrainian Scientist at CAAT The Center for Alternatives to Animal Testing (CAAT) at the Johns Hopkins Bloomberg School of Public Health is providing an opportunity to a scientist at any level of experience who has been displaced from their home institution due to the recent Ukraine invasion. Preference is given to the disciplines of toxicology, artificial intelligence, cheminformatics, bioinformatics, developmental biology, stem cell biology, or neuroscience. Contact caat@jhsph.edu for more information. CAAT also welcomes inquiries from sponsors and philanthropic donors interested in supporting expansion of this program initiative beyond the single position currently offered.
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Mar 10, 2022
NICEATM and ICCVAM Activities at SOT and ACS

A webpage is now available summarizing activities of NICEATM and ICCVAM at the March 27-31 SOT annual meeting. Please refer to this page as you plan your SOT itinerary.

NICEATM and ICCVAM will have a strong presence at SOT. NICEATM scientists are coauthors on 14 posters and three platform presentations. ICCVAM members are coauthors on an additional 19 posters and six talks. Acting NICEATM Director Nicole Kleinstreuer will speak at a continuing education course on “Conceptual Models in Immunotoxicology: Leveraging Biological Knowledge, Alternative Approaches, and Computational Strategies for the Future of Risk Assessment.” NICEATM scientist Helena Hogberg will speak at a continuing education course on “Next-Level Neurotoxicology: New Technologies to Advance Visualization of Spatial Molecular Alterations and Behavioral Phenotyping.”

The week before SOT, NICEATM scientist Bethany Cook (Inotiv, contractor supporting NICEATM) will present a poster at the American Chemical Society (ACS) spring meeting. The poster describes recent updates to the NTP Integrated Chemical Environment, which provides data and tools to help with development and evaluation of new testing approaches. The ACS spring meeting will be March 20-24.

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Mar 10, 2022
Building Trust in the Evidence Base for Chemical Risk Assessment: Webinar March 16

An upcoming webinar will focus on “Building Trust in the Scientific Evidence Base Supporting Chemical Risk Assessment and the Role of the AOP Framework.” The webinar will be Wednesday, March 16, from 8:00-9:30 a.m. EDT. It is organized by OECD and the Joint Research Centre (JRC) of the European Commission.

The webinar will focus on the report, “Addressing Evidence Needs in Chemicals Policy and Regulation,” published last month by the JRC. This report summarizes the key insights from a study on stakeholder perceptions of the main challenges facing chemicals regulation and of alternative approaches to conducting toxicological studies. The webinar will be an opportunity to hear the main findings of the report and a set of actionable recommendations, including how knowledge management systems can be designed in a user-centric fashion to address current challenges, with the AOP Framework being a prominent example.

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Mar 10, 2022
EPA Launches New Chemicals Collaborative Research Program; Workshop April 20-21

EPA is launching an effort to bring innovative science to the review of new chemicals before they enter the marketplace. A virtual workshop on this effort, the New Chemicals Collaborative Research Program, will be held April 20-21 from 1:00-5:00 p.m. EDT each day.

This multi-year research program will refine existing approaches and develop and implement new approach methodologies to ensure the best available science is for new chemical evaluations conducted under the Toxic Substances Control Act. Workshop attendees will hear an overview of the program and have an opportunity to provide input during topic-focused breakout sessions and a general public comment period.

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Mar 10, 2022
Travel Awards Available for Summer School on Innovative Approaches in Science

Three organizations are offering travel awards to the Summer School on Innovative Approaches in Science. Applicants for all awards must be enrolled in the Summer School; note that all awards are limited to attendees enrolled in a specific track.

  • The PETA Science Consortium International e.V. is offering up to $1,100 U.S. to offset airfare and hotel expenses for a graduate student, postdoctoral fellow, or early-career scientist participating in the Summer School’s toxicology track. The award recipient must attend all four days of the Summer School. Apply by April 1.
  • The American Society for Cellular and Computational Toxicology is offering a $1,000 U.S. award to support attendance of a graduate student or postdoctoral trainee participating in the Summer School’s toxicology track. Applicants must be conducting or display a strong interest in human-relevant science that does not envision future use of animals. Apply by April 15.
  • The Physicians Committee for Responsible Medicine is offering a $1,000 U.S. award to support attendance of a student or early-career researcher participating in the Summer School’s biomedical science track. Applicants must be conducting or display a strong interest in human-relevant science that does not envision future use of animals. Apply by April 15.

The Summer School will be held June 7-10 at the North Carolina Biotechnology Center in Research Triangle Park, NC. The program will highlight modern alternatives to the use of animals, including in vitro and computational modeling, in toxicology and biomedical sciences. The Summer School is being organized by the Physicians Committee for Responsible Medicine; NIEHS scientist Warren Casey is on the steering committee.

Apr 1, 2022
Mar 10, 2022
BraCVAM Launches New Website

The Brazilian Centre for Validation of Alternative Methods (BraCVAM) has launched a new website. The website is currently only available in Portuguese but there are plans to launch an English-language version.

BraCVAM is an office within the Brazilian government’s Oswaldo Cruz Foundation, which coordinates health research for the Brazilian Ministry of Education and Public Health. BraCVAM functions as the focal point within Brazil to identify or receive requests for test method validation and implements appropriate validation studies with the National Network of Alternative Methods to the Use of Animals within the Brazilian Ministry of Science, Technology, Innovations, and Communications. For more information about BraCVAM, email bracvam@fiocruz.br.

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Feb 24, 2022
SOT Session on Cross-species Extrapolation: Input Requested from Members

A session titled “Cross-Species Extrapolation: Opportunities in a 21st-Century Regulatory Nonanimal Testing World” is planned for Tuesday, March 29 during the upcoming SOT annual meeting. Four invited speakers will share their views on the changing regulatory context that provides opportunities for cross-species extrapolation to inform a nonanimal testing paradigm for assessing human and environmental health. The session will be held as a roundtable to encourage discussion between researchers and regulators.

The session is being organized by the SOT Sustainable Chemistry through Contemporary Toxicology Specialty Section, the In Vitro and Alternative Methods Specialty Section, and the Women in Toxicology Special Interest Group. The session organizers invite interested SOT members to provide their opinions on the opportunities and challenges of using cross-species extrapolation and bioinformatics to support regulatory decision-making. Please respond by March 1.

Mar 1, 2022
Feb 24, 2022
March 16 Webinar Presents an Introduction to Ontologies

The Evidence Based Toxicology Consortium will present a webinar on “Ontologies for Toxicology” on Wednesday, March 16, at 10:00 a.m. EDT.

Application of ontologies to toxicology and environmental health holds the promise to help improve research standards, make data sharing easier, make research more findable, and contribute to automating systematic review. However, people often find it difficult to grasp what ontologies are, what they do, and how to use them. In this webinar, three experts in this field will introduce ontologies and answer questions about their use.

Relevant reference: Whaley et al. 2020. Knowledge organization systems for systematic chemical assessments. Environ Health Perspect. https://ehp.niehs.nih.gov/doi/10.1289/EHP6994.

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Feb 24, 2022
Paper Describes In Silico Alternative to Animal Testing for Acute Toxicity

A new paper in Environmental Health Perspectives describes STopTox, a comprehensive collection of computational models that can predict the toxicity hazard of small organic molecules. STopTox was developed through a collaboration among NICEATM, the University of North Carolina – Chapel Hill, Duke University, and the Federal University of Goias in Brazil. Acting NICEATM Director Nicole Kleinstreuer and NICEATM scientists Judy Strickland and David Allen (Inotiv, contractor supporting NICEATM) coauthored the paper.

Borba et al. 2022. STopTox: an in silico alternative to animal testing for acute systemic and topical toxicity. Environ Health Perspect. https://ehp.niehs.nih.gov/doi/10.1289/EHP9341.

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Feb 17, 2022
February 23-24 Workshop to Consider NAMs for Regulatory Decision-making

A workshop on “Increasing Confidence in New Approach Methodologies for Regulatory Decision-making” will be held next Wednesday and Thursday, February 23-24, from 8:00 a.m.-noon EST each day. The workshop is free and open to the public.

The workshop aims to raise awareness of currently available NAMs and explore how regulatory application and acceptance of these tools can be accelerated by overcoming the most significant barriers to their implementation. Acting NICEATM Director Nicole Kleinstreuer will discuss “Validation and standardization of latest NAMs.” The workshop will be of interest to academic, regulatory, and industry scientists engaged in the development and application of NAMs.

The workshop is being presented by NC3Rs in collaboration with the British Toxicology Society and the UK Health and Safety Executive’s Chemicals Regulation Division.

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Feb 17, 2022
Skin Sensitization Webinar Series Concludes March 9

The third and final webinar in a series on “Current Concepts in Quantitative Risk Assessment for Skin Sensitization” will be presented Wednesday, March 9, from 9:00-10:30 a.m. EST. If you registered for the previous webinars in the series, you do not need to register for subsequent webinars.

The webinar topic is “Opportunities and New Approaches for Quantitative Risk Assessment.” Petra Kern, Procter & Gamble will discuss “Next-generation quantitative risk assessment for skin sensitizing cosmetics and fragrances,” and Marco Corvaro, Corteva Agriscience, and Susanne Kolle, BASF, will describe “Assessing skin sensitization potential and potency of pesticidal products with advanced NAMs.”

This webinar series has provided an overview of the current state of the science in the rapidly developing field of quantitative risk assessment of skin sensitizing chemicals. The webinars are intended as background for a planned workshop in 2022 on quantitative risk assessment of skin sensitizing pesticides but they are of interest to the broader scientific community as they are relying on the development of concepts and methods in other areas such as cosmetics, fragrances, and consumer products. The webinar series is organized by NICEATM, the Swiss Centre for Applied Human Toxicology, and the Swiss State Secretariat for Economic Affairs.

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Feb 17, 2022
ARDF Grants Available, Apply by April 15

ARDF awards grants to support research projects that develop alternative methods to advance science and replace or reduce animal use. ARDF is currently accepting applications for this year’s grants, with proposals due April 15.

The maximum grant is $40,000. While preference will be given to U.S. applications, proposals are welcome from any nonprofit educational or research institution worldwide. Expert reviews of each proposal will evaluate scientific merit and feasibility and the potential to reduce or replace the use of animals in the near future. Proposals in the fields of research, testing, or education will be considered. Projects may not use intact non-human vertebrate or invertebrate animals. Preference will be given to projects that use:

  • In silico and in vitro methods with human cells or tissues.
  • Pathway-based approaches as exemplified by the 2007 National Academy of Sciences report, Toxicity Testing in the Twenty-first Century: A Vision and A Strategy.
Apr 15, 2022
Feb 14, 2022
Grants Will Support Development of Tissue Models for Cancer Research

The National Cancer Institute is offering grants to support the development and characterization of state-of-the-art biomimetic tissue-engineered technologies for cancer research. Projects supported by this funding will become part of the Cancer Tissue Engineering Collaborative (TEC) Research Program. The goals of the Cancer TEC Program are to (1) catalyze the advancement of innovative, well-characterized in vitro and ex vivo systems available for cancer research, (2) expand the breadth of these systems to several cancer types, and (3) promote the exploration of cancer phenomena with biomimetic tissue-engineered systems.

Applications for funding will be accepted beginning on May 5, with applications due June 5 and quarterly thereafter through February 2025. Grants of up to $400,000 will be awarded to fund projects that can continue up to five years. Eligibility for these grants is open to for-profit and nonprofit institutions within and outside the United States.

Jun 5, 2022
Feb 14, 2022
JRC Report Discusses Evidence Needs for Chemicals Policy Development

The European Union Joint Research Centre has issued a report, “Addressing Evidence Needs in Chemicals Policy and Regulation.” The report provides insights into key stakeholder perceptions of the main challenges facing chemicals regulation. It also examines stakeholder views on alternative approaches to conducting toxicological studies and the role and value of the adverse outcome pathway framework. The report puts forward a set of actionable recommendations including how knowledge management systems can be designed in a user-centric fashion to address current challenges. The Joint Research Centre is planning a webinar in March to raise awareness of the report.

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Feb 09, 2022
WHO Seeks Information on Application of 3Rs to Biologicals Testing

The World Health Organization (WHO) and NC3Rs are conducting a review of animal use requirements within WHO guidelines for biologics. As part of that effort, NC3Rs is surveying national regulatory authorities and national control laboratories about opportunities and barriers to adoption of replacement, reduction, and refinement alternatives and use of non-animal approaches in quality control, batch, and lot release testing of biologicals. Please respond by March 4.

Biologicals such as vaccines, cytokines, enzymes, and hormones are tested routinely after approval to ensure the safety and potency of products. Many of these tests currently require the use of animals, and a large number of animals are used for this purpose each year. The WHO/NC3Rs project, which is receiving support from NICEATM and FDA, is intended to support recommendations for where non-animal approaches can be adopted. The project is currently in an information-gathering phase, with a survey of biologicals manufacturers having been conducted in 2021. Data collected will be anonymized and published in a peer-reviewed journal or as a report on the NC3Rs website, and/or presented at scientific meetings or webinars.

Mar 4, 2022
Feb 09, 2022
February 24 Webinar to Focus on Serum-free Cultures

ASCCT and the European Society for Toxicology In Vitro are co-hosting a webinar, “Serum-free Cultures: Why and How?” It will be presented Thursday, February 24, from 9:30-10:30 a.m. EST.

Eliminating fetal bovine serum from cell culture media overcomes the ethical and legal challenges associated with its use and bolsters the reproducibility of in vitro research. Increasingly, scientists are focusing on replacing fetal bovine serum as a supplement in cell culture media with animal-free components. This webinar will explore development of animal-component-free culture conditions for two in vitro test systems.

  • Barbara Jozef of EAWAG: the Swiss Federal Institute of Aquatic Science and Technology will describe efforts to develop a serum-free formulation capable of supporting cell proliferation of the rainbow trout gill cell line, RTgill-W1, which is the platform for the first internationally accepted in vitro assay to predict chemically induced acute fish toxicity.
  • Aline Chary of the Luxembourg Institute of Science and Technology will present a case study in which commercially-available media without fetal bovine serum has been used to culture A549, an immortalized human epithelial alveolar-like cell line commonly used in respiratory research.
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Feb 09, 2022
Abstracts Due in March for ICT 2022

Abstracts are being accepted for the 2022 International Congress of Toxicology (ICT 2022), which will be held in Maastricht, Netherlands from September 18-21. Deadline for early reviewing is March 1, and the final abstract submission deadline is March 31. Submitted abstracts will be considered for poster presentations or short oral communications. Abstract submitters may apply for awards and travel fellowships. More information is available on the meeting website under menu items “Awards” and “Travel Fellowships.”

Registration for ICT 2022 is now open; the deadline to be eligible for the early bird fee is May 15. The detailed program and registration information are available on the meeting website.

Mar 31, 2022
Feb 09, 2022
Abstract Deadline Extended to February 14 for MPS World Summit in June

Abstracts are being accepted for presentations at the MPS World Summit 2022, to be held at the Hilton New Orleans Riverside from May 30-June 3. Abstracts should describe new developments and applications of MPS. Top scored abstracts will be selected for an oral presentation at one of 14 scientific sessions. Information about abstract submissions is available on the meeting website. The abstract deadline has been extended to February 14.

MPS comprise a number of bioengineering breakthroughs that reproduce organ architecture and function in vitro. Fueled by stem cell technologies, a broad variety of human models and test systems have emerged. A global conference on MPS was identified by opinion leaders in the field as a key step forward in the maturation and harmonization of the area. About 30 international companies and organizations, including NICEATM, have teamed up to initiate a series of annual MPS World Summits to present the latest scientific achievements, discuss advances and challenges, and enable communication between young and newly interested scientists and pioneers of the MPS field. These events will facilitate stakeholder communication, enable networking among young scientists and MPS thought leaders, promote international standardization and harmonization of MPS, and serve as a global training environment. They will also lay the groundwork for establishing an international MPS society.

Feb 14, 2022
Feb 09, 2022
Workshop Report Provides FDA and Industry Perspectives on MPS Applications

A report recently published in ALTEX summarizes a workshop at which FDA and the pharmaceutical industry’s Innovation and Quality Microphysiological Systems (IQ MPS) Affiliate considered drug development applications of complex in vitro models (CIVMs) such as MPS. Participants were able to build a general consensus on the need for animal CIVMs for preclinical species to better determine species concordance. They also determined that use of CIVM technologies in drug development applications will require qualification which will vary depending on the specific context of use. ICCVAM members Paul Brown, Suzanne Fitzpatrick, and Donna Mendrick co-authored the report.

Baran et al. 2022. Perspectives on the evaluation and adoption of complex in vitro models in drug development: Workshop with the FDA and the pharmaceutical industry (IQ MPS Affiliate). ALTEX. https://doi.org/10.14573/altex.2112203.

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Feb 09, 2022
New Paper Describes Computational Model to Predict Chemically Induced Cardiotoxicity

A paper in the journal Biology describes development of a computational approach to predict whether a chemical would affect the human ether-a-go-go-related gene (hERG) potassium channel. This function regulates heart rhythm and is often involved in drug-induced cardiotoxicity. Tox21 screening data were used to develop machine learning approaches that use statistical models to predict the probability of a new chemical to cause cardiotoxicity via this mechanism. Acting NICEATM Director Nicole Kleinstreuer is senior author on the paper.

Krishna et al. 2022. High-throughput chemical screening and structure-based models to predict hERG inhibition. Biology. https://doi.org/10.3390/biology11020209.

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Jan 24, 2022
ICCVAM Webinar on (Developmental) Neurotoxicity Testing January 25

Registration is still open for the ICCVAM Communities of Practice webinar “New Approach Methodologies to Assess (Developmental) Neurotoxicity.” The webinar is scheduled for Tuesday, January 25, at 10:00 a.m. EST. Registration for the webinar will remain open until the end of the webinar.

The nervous system has unique characteristics and can have different sensitivity to toxic substances compared to other organ systems. Effects of chemicals on the nervous system can be affected by concurrent exposures to other substances. During early life stages, exposure to neuroactive drugs and environmental toxins can interact and/or interfere with developmental processes of the brain, which can in turn result in structural and/or functional alterations. Traditional (developmental) neurotoxicity tests use mammals, but the high cost and low throughput of these tests make them impractical to use for all chemicals of potential concern. In addition, it is challenging to correlate the interpretation of animal data to complex human neurological effects. Therefore, interest is increasing in exploring human cell-based assays, computational systems, and other alternatives to traditional animal tests that can be used to predict chemical effects on the developing and adult nervous system.

New approach methodologies (NAMs) are any non-animal technology or approach, or combination of these, that can be used to provide information on chemical hazard and risk assessment. This webinar will discuss NAMs that are being considered or developed for assessing potential effects of chemicals on the nervous system. Key insights and ongoing activities will be described in two presentations featuring speakers from U.S. federal research and regulatory agencies.

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Jan 24, 2022
February 15 Webinar to Discuss Tools for Carcinogenicity Assessment

The SOT Computational Toxicology and Carcinogenesis Specialty Sections will present the second of a two-part webinar series, “Integrating computational tools into carcinogenicity assessments,” on February 15, 2022 from 10:00-11:00 a.m. EST.

This webinar will cover computational tools and predictive models for assessing carcinogenicity and discussion of opportunities to improve on current methods used in safety evaluation of drugs and potentially hazardous chemicals. Emilio Benfenati, Istituto Mario Negri, Italy, will discuss use of read-across software to predict toxicity of botanicals, and Raymond Tice, RTice Consulting, will review current status and future needs for in silico models to predict carcinogenicity. The topics explored will be of interest to trainees including undergraduate and graduate students, postdoctoral fellows, and those who are interested in expanding their knowledge base of carcinogenesis or computational toxicology. Slides and recordings of past webinars are available on the Carcinogenicity Specialty Section webpage.

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Jan 20, 2022
Birnbaum, Clippinger Honored by SOT

Two scientists with ties to NICEATM and ICCVAM have been named as 2022 award recipients by the Society of Toxicology.

Linda Birnbaum, Ph.D., DABT, ATS, will receive the 2022 SOT Merit Award, which recognizes an SOT member who has made distinguished contributions to toxicology throughout an entire career in areas such as research, teaching, regulatory activities, consulting, and service to the Society. Birnbaum is Scientist Emeritus at NIEHS, a role she assumed in 2019 after a ten-year tenure as NIEHS Director. While serving as NIEHS Director, Birnbaum was a strong supporter of NICEATM and ICCVAM. An advocate for advances in toxicology and risk assessment throughout her career, she played a key role in the 2013 reinvention of ICCVAM that set the stage for ICCVAM’s notable accomplishments and increased productivity in recent years.

Amy Clippinger, Ph.D., will receive the 2022 SOT Enhancement of Animal Welfare Award, which recognizes an SOT member for contributions made to the advancement of toxicological science through the development and application of 3Rs methods. Clippinger is President of PETA Science Consortium International e.V. In that role, she frequently collaborates with NICEATM and ICCVAM agency scientists to advance alternatives to animal testing. Her publications in the past year include descriptions of alternatives to animal use for pyrogen testing, eye irritation and corrosion, and inhalation toxicity, with coauthors from ICCVAM agencies including NIEHS, EPA, CPSC, and NIST. Clippinger is currently a member of SACATM, ICCVAM’s advisory committee.

Birnbaum and Clippinger will receive their awards on March 27 at a ceremony at the SOT Annual Meeting in San Diego.

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Jan 20, 2022
January 27 Webinar to Discuss Inhalation Risk Assessment

The SOT In Vitro and Alternative Methods Specialty Section will present a webinar, “Inhalation Toxicity: In Vitro to Human Risk Assessment” on Thursday, January 27, at 11:00 a.m. EST. This webinar will cover inhalation toxicity from in vitro testing to use of these data in human health risk assessment. The session will include two sets of speakers, followed by a joint discussion. The first speaker, Shawn McCullough of EPA, will focus on in vitro inhalation models and parallel findings from human studies. The second set of speakers, Iris Muller and Maria Baltazar of Unilever, will discuss application of in vitro data for use in human health risk assessment for consumer products.

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Jan 20, 2022
Apply by February 18 to Attend Summer School on Innovative Approaches in Science

Apply by February 18 to attend the Summer School on Innovative Approaches in Science, to be held June 7-10 at the North Carolina Biotechnology Center in Research Triangle Park, NC. The program will highlight modern alternatives to the use of animals, including in vitro and computational modeling, in toxicology and biomedical sciences. The Summer School is being organized by the Physicians Committee for Responsible Medicine; NIEHS scientist Warren Casey is on the steering committee.

Feb 18, 2022
Jan 20, 2022
Submissions for 2022 CRACK IT Challenge Due February 28

NC3Rs is inviting sponsors to submit proposals for CRACK IT Challenges. CRACK IT funds collaborations between industry, academics, and subject matter experts to deliver 3Rs benefits, either by improving business processes or developing a commercial product. Proposals for the current round of CRACK IT Challenges are due February 28

CRACK IT sponsors define the Challenges and work with the NC3Rs to set out the business case and 3Rs benefits. Sponsors are required to provide in-kind contributions and/or funding to help solve the Challenges. Sponsors may choose to fund a single-phase challenge, which focuses on the validation of new technologies, prototypes and methods that are closer to market, or a two-phase challenge, which may include research, development and validation of new technologies, prototypes, and methods.

Feb 20, 2022
Jan 20, 2022
Report Available from Toxicology Forum Workshop on Carcinogenicity

A report is available from the December 2020 Toxicology Forum workshop on “Assessing Chemical Carcinogenicity: Hazard Identification, Classification, and Risk Assessment.” At this workshop, challenges related to assessing chemical carcinogenicity were organized under the topics of (1) problem formulation; (2) modes-of-action; (3) dose-response assessment; and (4) the use of new approach methodologies (NAMs). Participants acknowledged the scientific limitations of the traditional rodent chronic bioassay, but also identified knowledge gaps that need to be overcome to facilitate the further development and uptake of NAMs. Key among these was development of adverse outcome pathway networks that could guide development of integrated approaches to testing and assessment. NIEHS scientist Warren Casey coauthored the report.

Felter et al. 2022. Assessing chemical carcinogenicity: hazard identification, classification, and risk assessment. Insight from a Toxicology Forum state-of-the-science workshop. Crit Rev Toxicol. https://doi.org/10.1080/10408444.2021.2003295.

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Jan 11, 2022
January 21 Webinar to Discuss Genotoxicity Assays

ASCCT and ESTIV are co-hosting a webinar, “Advances in Genotoxicity: Reconstructed Skin Comet and Micronucleus Assays.” It will be presented Friday, January 21, from 10:00-11:30 a.m. EST.

The in vitro genotoxicity test battery has a high sensitivity for prediction of in vivo genotoxic/carcinogenic agents but tends to overpredict the genotoxicity hazard, resulting in misleading positive results. To address this, the Cosmetics Europe Genotoxicity Task Force has established two in vitro skin genotoxicity models as follow-up assays to the in vitro test battery for substances with dermal exposure: the reconstructed skin comet assay and the reconstructed skin micronucleus test.

In this webinar, Stefan Pfuhler, Procter & Gamble, and Kerstin Reisinger, Henkel AG & Co., report on the completed validation of these assays. Both assays exhibited good sensitivity and specificity. A combination of these assays enables detection of DNA damage leading to all three types of genotoxic damage (mutation, clastogenicity, and aneugenicity). The high predictivity for the expected in vivo outcome observed for these higher tier in vitro assays supports their use as follow-up tests to the standard test battery. This tiered strategy shows great promise as an in vitro-only approach for genotoxicity testing of dermally exposed substances, and both assays were recently accepted into the OECD test guideline development program.

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Jan 11, 2022
Abstracts Due January 31 for MPS World Summit in June

Abstracts are being accepted for presentations at the MPS World Summit 2022, to be held at the Hilton New Orleans Riverside from May 30-June 3. Abstracts should describe new MPS developments and applications. Top scored abstracts will be selected for an oral presentation at one of 14 scientific sessions. Abstracts must be submitted by January 31.

MPS comprise a number of bioengineering breakthroughs that reproduce organ architecture and function in vitro. Fueled by stem cell technologies, a broad variety of human models and test systems have emerged. A global conference on MPS was identified by opinion leaders in the field as a key step forward in the maturation and harmonization of the area. About 30 international companies and organizations, including NICEATM, have teamed up to initiate a series of annual MPS World Summits to present the latest scientific achievements, discuss advances and challenges, and enable communication between young and newly interested scientists and pioneers of the MPS field. These events will facilitate stakeholder communication, enable networking among young scientists and MPS thought leaders, promote international standardization and harmonization of MPS, and serve as a global training environment. They will also lay the groundwork for establishing an international MPS society.

Jan 31, 2022
Jan 05, 2022
ICCVAM Webinar on (Developmental) Neurotoxicity Testing January 25

Registration is open for the ICCVAM Communities of Practice webinar “New Approach Methodologies to Assess (Developmental) Neurotoxicity.” The webinar is scheduled for Tuesday, January 25, at 10:00 a.m. EST.

The nervous system has unique characteristics and can have different sensitivity to toxic substances compared to other organ systems. Effects of chemicals on the nervous system can be affected by concurrent exposures to other substances. During early life stages, exposure to neuroactive drugs and environmental toxins can interact and/or interfere with developmental processes of the brain, which can in turn result in structural and/or functional alterations. Traditional (developmental) neurotoxicity tests use mammals, but the high cost and low throughput of these tests make them impractical to use for all chemicals of potential concern. In addition, it is challenging to correlate the interpretation of animal data to complex human neurological effects. Therefore, interest is increasing in exploring human cell-based assays, computational systems, and other alternatives to traditional animal tests that can be used to predict chemical effects on the developing and adult nervous system.

This webinar will discuss NAMs that are being considered or developed for assessing potential effects of chemicals on the nervous system. Key insights and ongoing activities will be described in two presentations featuring speakers from U.S. federal research and regulatory agencies.

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Jan 05, 2022
NICEATM Seeks Information on Efficacy Testing of Ectoparasiticides

In a December 21 Federal Register notice, NICEATM requested available data and information on approaches and/or technologies currently used to predict the efficacy of ectoparasiticides without using animals. Responses should be submitted by Friday, January 28.

NICEATM supports efforts to develop, validate, and implement alternatives to animal use for testing of chemicals and medical products. These include approaches used to evaluate the efficacy of ectoparasiticides on dogs and cats, such as products to prevent flea and tick infestations. Currently, the standard tests for this endpoint use animals that can experience significant discomfort and distress during the study.

Respondents to this data request should provide information on any activities relevant to the development or validation of alternatives to in vivo test methods currently used by federal agencies for regulatory and other decision contexts. Submitted information will be used to assess the state of the science and determine technical needs for non-animal test methods used to evaluate the efficacy of ectoparasiticides on dogs and cats and to facilitate their incorporation into a testing strategy for regulatory purposes.

Jan 28, 2022
Jan 05, 2022
March Workshop to Assess Impact of Changes in Animal Testing Requirements for Biologicals

Manufacturers, regulators, and others involved in quality control and batch release testing of biological products in Europe are invited to a workshop on “Implementing the 3Rs in WHO Guidelines: Understanding the Impact on Quality Control and Batch Release Testing of Biologicals in Europe.” The workshop will be held Wednesday, March 2, 5:00-10:30 a.m. EST (10:00 a.m.-3:30 p.m. GMT).

NC3Rs is working with the World Health Organization (WHO) to review animal testing requirements within their guidelines for the quality control and batch release testing of biologicals. The aim of this project is to identify opportunities for the wider integration of 3Rs approaches and recommend these for implementation by the WHO through the Expert Committee on Biological Standardization. The upcoming event is one of a series of regional workshops to better understand the potential impact of these changes on manufacturers and regulators globally. The output from these workshops will inform the recommendations made to the WHO. Other workshops are being planned to cover North/Central America, Latin/South America, Africa, and Asia/Oceania.

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Jan 05, 2022
Apply by April 30 for IFER Graduate Fellowships

The International Foundation for Ethical Research (IFER) is accepting applications for graduate fellowships. These one-year grants of $12,500 support projects by master’s and Ph.D. students in the sciences. Eligible projects will address development, acceptance, and implementation of innovative human-relevant methods that advance science and refine, reduce, or replace the use of animals in research, testing, or education. Special consideration will be given to proposals that are likely to replace the use of animals in research. Grants are renewable for up to three years, depending on student progress and availability of funds. Applicants must be beginning or beyond their second year of graduate school as of September 2022. Applications are due Saturday, April 30.

Apr 30, 2022
Jan 05, 2022
Videos Available from September 2021 SACATM Meeting

Videos from the September 2021 SACATM meeting are now available. Minutes from the meeting will be posted to this page following review and approval by the committee.

SACATM is a federally chartered external advisory group of scientists from the public and private sectors that advises ICCVAMNICEATM, and the Director of the National Institute of Environmental Health Sciences and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM. The September 2021 meeting’s agenda included detailed discussion of two topics of current interest to ICCVAM: reducing or replacing animal use for ecotoxicity testing and new approaches to validation of new testing methods.

The next SACATM meeting is scheduled for September 21-22. Information about the meeting will be posted on the NTP website when it is available.

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Dec 22, 2021
Helena Hogberg Joins NICEATM

On December 6, Helena Hogberg joined NICEATM as an NIEHS staff scientist. Hogberg will conduct research drawing on her broad expertise in applying in vitro methods to assess developmental neurotoxicity (DNT) potential of chemicals.

Hogberg received her Ph.D. in toxicology from Stockholm University and performed her doctoral research at EURL ECVAM in Ispra, Italy. She developed new in vitro approaches to detect chemicals with DNT potential, focusing on gene expression and electrical activity recordings. During a postdoctoral fellowship at CAAT, Hogberg explored the application of a broader set of in vitro models to DNT, including organotypic models, induced pluripotent stem cells, and transcriptomics and metabolomics approaches. After completing her fellowship, she was appointed as a research associate and later deputy director of CAAT. In these roles Hogberg administered a variety of CAAT programs and research activities and continued her own research on DNT.

Hogberg currently serves on the OECD DNT expert group; EPA Scientific Advisory Panel for the Federal Insecticide, Fungicide, and Rodenticide Act; the EPA expert group on NAMs for DNT assessment; and the Scientific Advisory Board for the European Commission-funded Horizon 2020 grant, “Novel Testing Strategies for Endocrine Disruptors in the Context of Developmental NeuroToxicity (ENDpoiNTs).”

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Dec 22, 2021
Publication Provides Updated Guidance on Good Cell and Tissue Culture Practice

A new publication updates guidance on Good Cell and Tissue Culture Practice previously issued in 2005 and known as GCCP 1.0. The update, GCCP 2.0, was required to reflect advances in complexity in cell models and address a resulting need for more comprehensive quality management to ensure reproducibility and quality derived scientific data. GCCP 2.0 describes six main principles to consider when performing cell culture: characterization and maintenance of essential characteristics, quality management, documentation and reporting, safety, education and training, and ethics.

The effort to develop GCCP 2.0 followed the 2018 publication of the OECD guidance document on Good In Vitro Methods Practices. The final GCCP 2.0 document reflects hundreds of recommendations from participants in a CAAT-coordinated Scientific Advisory Committee that had over 50 members. NICEATM scientists Helena Hogberg (NIEHS) and David Allen (ILS, contractor supporting NICEATM) are co-authors on the GCCP 2.0 document.

Pamies et al. 2021. Guidance document on Good Cell and Tissue Culture Practice 2.0 (GCCP 2.0) [published online ahead of print]. ALTEX. https://doi.org/10.14573/altex.2111011.

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Dec 22, 2021
Publication Details Findings of ICCVAM Nanomaterials Workgroup

A new paper in ALTEX details findings of a survey of U.S. federal agencies conducted by the ICCVAM Nanomaterials Workgroup (NanoWG). Established in 2020, the NanoWG characterized U.S. agency requirements and needs for the testing of engineered nanomaterials in order to avoid the use of animals while fulfilling those requirements. In addition to presenting the workgroup’s survey findings, the paper discusses the role of dosimetry and interference/bias controls in supporting the ability of NAMs to provide robust results in nanomaterials testing.

Petersen et al. 2021. U.S. federal agency interests and key considerations for new approach methodologies for nanomaterials [published online ahead of print]. ALTEX. https://doi.org/10.14573/altex.2105041.

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Dec 14, 2021
December 16 Webinar to Feature Award-winning Speakers

ASCCT and ESTIV will hold a webinar Thursday, December 16 at 10:00 a.m. EST. The webinar will feature presentations on development and application of in vitro data that won awards at the two societies’ 2021 annual meetings.

  • Agnes Karmaus, Integrated Laboratory Systems LLC (contractor supporting NICEATM), will discuss “Gaining Context for High-Throughput In Vitro Data: Annotation Approaches and Visualization Tools.” Karmaus will describe a mapping approach for high-throughput screening assay endpoints that provides a robust assay grouping schema in a toxicological endpoint-based framework. This curation and annotation is available in the NTP Integrated Chemical Environment (ICE). Karmaus’ presentation won the inaugural Applied In Vitro Toxicology award at the 2021 ASCCT annual meeting.
  • Saskia Galanjuk, Leibniz Research Institute for Environmental Medicine, will describe “The Human Induced Pluripotent Stem Cell (hiPS) Test as an Alternative Method for Developmental Toxicity Testing.” The hiPS test is a non-animal in vitro test to evaluate the embryotoxic potential of substances. In the test, human stem cells develop into cardiomyocytes that can be evaluated using functional assays and quantitative PCR to assess chemical effects. Galanjuk’s presentation won the ESTIV best poster award at the EUROTOX 2021 congress.
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Dec 14, 2021
NICEATM-organized Workgroup Supporting Research Efforts for COVID Omicron Variant

A workgroup co-organized by NICEATM and NC3Rs is coordinating activities among investigators to apply MPS to investigations of the Omicron variant of the SARS-CoV-2 virus that causes COVID-19. Workgroup members met with representatives of the World Health Organization (WHO) on December 3 to discuss research needs relevant to the biology and treatment of Omicron and the potential for MPS to provide human-relevant platforms for rapidly addressing those needs. A spreadsheet detailing relevant research capabilities is available on the WHO website.

The MPS for COVID Research working group was established by NICEATM and NC3Rs to coordinate the use of MPS to reduce animal use in studies of COVID-19 and future emerging infectious diseases. Workgroup members include researchers, MPS model developers, therapeutic/vaccine manufacturers, and international regulators; new members are welcome.

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Dec 14, 2021
January 31 Workshop to Consider Regulatory Needs for Chemical Risk Assessment

An upcoming workshop will focus on “Current and Future Regulatory Needs for Chemical Risk Assessment.” The goal of the workshop, to be held Monday, January 31, 2022, from 7:00-11:00 a.m. EST (1:00-5:00 p.m. Central European Time), is to obtain stakeholder input on regulatory needs for risk assessment of chemicals with the potential to cause chronic systemic human health effects. A preliminary program for the workshop is available.

The workshop is sponsored by the European Commission’s Horizon 2020 Union project, “Risk Assessment of Chemicals Integrating Human Centric Next Generation Testing Strategies Promoting the 3Rs” (RISK-HUNT3R). The goal of RISK-HUNT3R is to develop integrated approaches to next-generation risk assessment tailored for a variety of industry sectors and relevant regulations. Strategies will focus on chronic systemic human health effects and use innovative mechanism-based, human-relevant in silico and in vitro NAMs. ICCVAM member Stephen Ferguson, NIEHS, serves on the RISK-HUNT3R Scientific & Regulatory Advisory Board.

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Dec 08, 2021
EPA Releases Updated NAMs Work Plan

EPA has released an update of its New Approach Methodologies Work Plan. The update of the EPA workplan addresses recommendations made by the ICCVAM Metrics Workgroup in its report, “Measuring U.S. Federal Agency Progress Toward Implementation of Alternative Methods in Toxicity Testing.” In its updated work plan, EPA commits to reporting summary metrics on reducing vertebrate animal testing and use annually on its website beginning in the fourth quarter of 2022.

Reducing the use of vertebrate animals for toxicity testing is a priority for EPA. As such, the Agency is working on development and application of NAMs. NAMs are defined as any technology, methodology, approach, or combination that can provide information on chemical hazard and risk assessment to avoid the use of animal testing. In this document, which updates a work plan released in June 2020, EPA describes its updated roadmap and identifies tangible steps to achieving a reduction in the use of vertebrate animals for toxicity testing and related research while ensuring the Agency’s activities fully protect human health and the environment.

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Dec 08, 2021
WHO Presents Webinars on Chemical Risk Assessment

The World Health Organization (WHO) is presenting a series of webinars to support new trainers in designing educational programs in chemical risk assessment and to share experience between new and more experienced trainers. Topics for the three webinars include identifying and characterizing the audience for training; identifying content and developing learning activities; and choosing a format and assessment methods for the training. The webinar series began November 30 and will continue through March 2022.

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Dec 08, 2021
ASPIS Collaboration Unites Ongoing EU Alternatives Projects; Workshop Planned for November 2022

The European Union (EU) has brought three ongoing projects to advance alternatives together under the “Animal-free Safety Assessment of Chemicals: Project Cluster for Implementation of Novel Strategies” (ASPIS) collaboration. ASPIS, established in November, will coordinate efforts among the ONTOX, PrecisionTOX, and RISK-HUNT3R projects to advance sustainable, animal-free, and reliable chemical risk assessment. Updates on ASPIS activities will be presented at a workshop to be held November 24-25, 2022, during the 21st International Congress of the European Society for Toxicology In Vitro (ESTIV 2022) in Barcelona, Spain.

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Nov 24, 2021
CAAT Symposium November 30 to Discuss NAMs for Developmental Neurotoxicity

The Center for Alternatives for Animal Testing (CAAT) at the Johns Hopkins Bloomberg School of Public Health will present a virtual symposium, “Alternative Approaches in Developmental Neurotoxicity,” on Tuesday, November 30, from 10:00 a.m.- 1:00 p.m. EST. Symposium presenters will discuss the status of new approach methodologies for developmental neurotoxicity. The symposium will also honor Helena Hogberg as she departs CAAT to join NICEATM at NIEHS.

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Nov 24, 2021
Apply by December 3 for Next Generation Humane Science Award

CAAT sponsors the Next Generation Humane Science Award to acknowledge and encourage early-career researchers who focus on replacing animal experiments. The 2021 award will provide a prize of up to $5,000 recognizing the work of one scientist, or it may be shared among two or more scientists. Factors considered in the evaluation of applications include the potential of the work to replace animal experiments and be used in a regulatory context. Candidates must be U.S. citizens or permanent residents working at U.S.-based institutions and have received Ph.D. or equivalent degrees no earlier than 2012. Applications are due December 3.

Dec 3, 2021
Nov 24, 2021
Skin Sensitization Webinar December 8

The second webinar in a series on “Current Concepts in Quantitative Risk Assessment for Skin Sensitization” will be presented Wednesday, December 8, from 9:00-10:30 a.m. EST. Nicole Kleinstreuer of NICEATM and Denise Bloch of the German Federal Institute for Risk Assessment will speak on “Methods for Hazard and Exposure Assessment.” If you registered for the first webinar in the series, you do not need to register for subsequent webinars.

This webinar series will provide an overview of the current state of the science in the rapidly developing field of quantitative risk assessment of skin sensitizing chemicals. The webinars are intended as background for a planned workshop in 2022 on quantitative risk assessment of skin sensitizing pesticides but they are of interest to the broader scientific community as they are relying on the development of concepts and methods in other areas such as cosmetics, fragrances, and consumer products. The webinar series is organized by NICEATM, the Swiss Centre for Applied Human Toxicology, and the Swiss State Secretariat for Economic Affairs.

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Nov 24, 2021
National Academies Workshop on NAMs December 9

A workshop on “New Approach Methods (NAMs) for Human Health Risk Assessment” will be held Thursday, December 9, from 10:00 a.m. – 3:00 p.m. The workshop is being convened by an ad hoc committee of the National Academies of Sciences, Engineering, and Medicine. Acting NICEATM Director Nicole Kleinstreuer and Elijah Petersen of the National Institute of Standards and Technology are among the members of the National Academies committee, which is conducting a consensus study on “Variability and Relevance of Current Laboratory Mammalian Toxicity Tests and Expectations for NAMs for use in Human Health Risk Assessment.” Kleinstreuer and Petersen are both members of ICCVAM. The goal of this study is to set data-driven and science-based expectations for NAMs based on the variability and relevance of the traditional toxicity testing models.

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Nov 22, 2021
Free Support Offered for NIH Small Business Grant Applicants; Apply by December 10

The NIH Applicant Assistance Program provides free support for companies that are planning to apply for a Phase I NIH SBIR or SSTR award. NIEHS participates in the Applicant Assistance Program and provides funding for development of improved methods for toxicity testing or computational approaches for predictive toxicology. Applications for the program must be submitted by December 10. A Q&A webinar for applicants will be presented on Monday, December 6, at 2:00 EST; a link to register is available on the Applicant Assistance Program information page.

Dec 10, 2021
Nov 22, 2021
Lush Prize Conference November 24-25

Registration is open for this year’s Lush Prize conference, to be held Wednesday, November 24 and Thursday, November 25, from 8:00-11:00 a.m. (1:00-4:00 p.m. UK time) each day. The theme of this year’s conference is “The Role of Public Awareness in the Replacement of Animals in Safety Testing.”

The Lush Prize is a global prize fund to support initiatives to end or replace animal testing. With £250,000 awarded each cycle, it is the largest prize fund in the non-animal testing sector. Acting NICEATM Director Nicole Kleinstreuer and NICEATM scientist Kamel Mansouri are both past recipients of the Lush Prize Young Investigator Award.

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Nov 22, 2021
Prize Offered to Support Advances in Animal-free Antibodies: Apply by January 15

The European Coalition to End Animal Experiments is offering a €10,000 prize to support and recognize development and application of animal-free antibodies in biomedical laboratory procedures. The aim of this prize is to highlight the versatility and superiority of animal-free antibodies and encourage their acceptance and use for research and therapeutic purposes.

The application deadline for the prize is January 15, 2022. Only European researchers are eligible, and projects must not use any animal-derived materials. Projects can be ongoing or completed and should focus on the innovative development or application of animal-free antibodies for research or medical purposes. The prize winner will receive financial support to attend an event in Brussels in spring of 2022 to accept the prize and give a short presentation.

Jan 15, 2022
Nov 22, 2021
Save the Date for Summer School on Innovative Approaches to Science in June 2022

PCRM is organizing the Summer School on Innovative Approaches to Science, to be held June 7-10, 2022, at the North Carolina Biotechnology Center in Research Triangle Park, NC. The program will highlight modern alternatives to the use of animals, including in vitro and computational modeling, in toxicology and biomedical sciences. NIEHS scientist Warren Casey is on the Summer School’s steering committee.

Applications for the Summer School will be accepted beginning in December. A form to sign up to receive updates is available on the Summer School webpage.

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Nov 16, 2021
Training on Application of NAMs for Medical Device Safety

A free training symposium on “New Approach Methodologies (NAMs) for Medical Devices” will be presented December 2-3 from 10:00 a.m.-1:30 p.m. EST each day. The symposium is part of the series “NAM Use for Regulatory Application” presented by the Physicians Committee for Responsible Medicine.

Attendees at this event will learn about qualifying NAMs through the FDA Medical Devices Development Tools program, how to perform in silico chemical characterization, and how to use available in vitro methods for assessing irritancy, biocompatibility, pyrogenicity, and thrombogenicity. Discussion sessions will allow participants to present questions to panelists. Speakers include ICCVAM member Jennifer Goode of the FDA Center for Devices and Radiological Health.

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Nov 16, 2021
Webinar on Integrating Computational Tools into Carcinogenicity Assessments

The SOT Carcinogenesis and Computational Toxicology Specialty Sections are co-hosting a webinar on “Integrating Computational Tools into Carcinogenicity Assessments.” It will be presented Tuesday, December 14, at 10:00-11:00 a.m. EST.

The webinar will explore computational tools and predictive models for assessing carcinogenicity. Speakers will also address opportunities to improve on current methods and increase their implementation in safety evaluations for drugs and potentially hazardous chemicals.

  • Mark Cronin of Liverpool John Moores University will provide an overview of in silico methods to predict carcinogenicity, including read-across, structural alerts, and quantitative structure-activity relationships. His presentation will consider future applications of machine learning and artificial intelligence.
  • Federica Madia of the European Commission Joint Research Centre (JRC) will discuss the EURL ECVAM curated database of genotoxicity and carcinogenicity results and the potential application of these data to regulatory science.
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Nov 16, 2021
Webinar on Standardization of PBPK Modeling Practice

The SOT Biological Modeling Specialty Section is hosting a webinar on “Standardization of PBPK Modeling Practice.” It will be presented Friday, January 14, 2022, at 12:00 noon-1:00 p.m. EST.

The lack of a standardized template for PBPK model coding and analysis reporting has hindered the sharing, reusing, and reviewing of developed models and thus the acceptance of PBPK models as risk assessment tools by regulatory agencies. In this webinar, two EPA scientists will describe their recent efforts in this area and how standardization of model coding and reporting will facilitate acceptance of PBPK modeling in risk assessment.

  • Cecelia Tan will present a harmonized reporting template that can be adopted and customized by public health agencies receiving PBPK model submission. The template can also serve as general guidance for submitting PBPK-related studies for publication in journals or other modeling sharing purposes.
  • Paul Schlosser will present a PBPK model coding template in the freely available R language by using a case study on per- and polyfluoroalkyl substances. The template is designed to make the review process more efficient and less error-prone.
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Nov 16, 2021
Recordings Available from “Nix the Six” Series

Recordings and materials are now available from the “Nix the Six” virtual training series presented in September and October by the Physicians Committee for Responsible Medicine. The five webinars in this series focused on available methods and strategies for avoiding or reducing animal tests when assessing chemicals and pesticides for six acute endpoints commonly referred to as the “6-pack.” Speakers included NICEATM scientist Kamel Mansouri (Session 1, “Oral and Dermal Toxicity”), ICCVAM member Joanna Matheson, CPSC (Session 3, “Skin and Eye Irritation”), and Acting NICEATM Director Kleinstreuer (Session 5, “Opportunities and Outlook”).

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Nov 16, 2021
World Health Organization Activities to Advance Alternatives to Animal Testing

Two recent publications highlight activities by the World Health Organization (WHO) to advance alternatives to animal testing.

  • WHO has issued a “Framework for the Use of Systematic Review in Chemical Risk Assessment.” Systematic review is a method for identifying, selecting, appraising, and synthesizing available evidence to answer a research question in a way that maximizes transparency and minimizes bias and error. In the context of chemical risk assessment, it has the potential to reduce animal use and improve decision-making. NIEHS scientists Andy Rooney and Brandy Beverly contributed to the WHO report.
  • A new paper in Biologicals describes a WHO collaboration with the United Kingdom NC3Rs to review animal-based testing methods described in WHO manuals, guidelines and recommendations for biologicals. The goal is to identify where updates can lead to a more harmonized adoption of replacement, reduction, and refinement of animal use in batch release testing requirements.
    Lilley et al. 2021. Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals. Biologicals. https://doi.org/10.1016/j.biologicals.2021.10.002.
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Nov 16, 2021
Publication Describes Canadian Regulatory Perspective on Alternatives

A new paper in Frontiers in Toxicology provides the first Canadian regulatory update on how Health Canada is advancing the incorporation of alternative, non-animal strategies for the evaluation of pest control products and industrial chemicals. Health Canada participates with ICCVAM and other international partners in the International Cooperation on Alternative Test Methods.

Bhuller et al. 2021. Canadian regulatory perspective on next generation risk assessments for pest control products and industrial chemicals. Front Toxicology 3:748406. https://doi.org/10.3389/ftox.2021.748406.

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Nov 09, 2021
Workshop November 10 on Assessing Biocompatibility of Dental Materials

An online workshop on “Robust, Predictive Alternative Methods for Assessing Biocompatibility of Dental Materials” will be held Wednesday, November 10 from 9 a.m. to 3 p.m. EST. The focus of this workshop is NAMs that could be used to predict the biocompatibility of dental materials.

The workshop will bring together key stakeholders from academia, NIH, NIST, and FDA. Participants will discuss major challenges in the biocompatibility assessment of new dental restorative materials during early stages of product development, explore potential solutions to overcome limitations in predictive preclinical testing, and establish opportunities for collaboration in this domain. The agenda includes presentations from five ICCVAM members: Acting NICEATM Director Nicole Kleinstreuer, John Elliott (NIST), Elijah Petersen (NIST), John Gordon (CPSC), and Simona Bancos (FDA Center for Devices and Radiological Health).

The workshop is being organized by NIST and the National Institute of Dental and Craniofacial Research. For more information, contact Elijah Petersen at elijah.petersen@nist.gov.

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Nov 09, 2021
February Symposium on AOPs; Submit Abstracts by December 3

Adverse outcome pathways (AOPs) are a conceptual framework for describing causal linkages between perturbations of biological systems and resulting adverse effects to human health or the environment. The Society for Advancement of Adverse Outcome Pathways (SAAOP) is sponsoring an AOP Community of Practice Symposium in February 2022. Participants in this virtual event can attend any or all of the three half-day sessions. Sessions will provide an opportunity to learn more about AOPs and their applications, as well as how to develop novel AOPs or to contribute to existing AOPs.

SAAOP invites submission of abstracts relevant to development, reviewing, or use of AOPs. Selected abstracts will be presented in three one-hour sessions during the workshop. Submit abstracts by December 3.

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Nov 09, 2021
November 30 Webinar to Discuss Maintaining Cell Culture Quality

ASCCT and the European Society for Toxicology in Vitro are co-hosting a webinar, “How to Control and to Maintain the Quality of Cell Cultures.” It will be presented Tuesday, November 30, from 10:00-11:00 a.m. EST.

An increasing number of animal tests can now be replaced by cell-based assays. The various validated methods provide good predictivity and high precision, but the reliability of the assays very much depends on the quality of cell culture. As cells are living organisms, many factors can affect the proper function of cells and have an impact on the outcome of an assay. In this webinar, Oliver Wehmeier of acCELLerate GmbH will discuss preventing microbial contamination, the importance of regular mycoplasma testing, and the problem of cross-contamination among cell lines. Also, variances caused by the cells and the cultivation process will be addressed, and guidance for a Good Cell Culture Practice as the essential basis for running reliable and precise cell-based assays will be introduced.

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Nov 09, 2021
Publications Available from KMD Symposium

The kinetically derived maximum dose (KMD) refers to the dose at which a departure from dose proportionality or linear pharmacokinetics (PK) is observed. A September 2020 symposium organized by NICEATM, the EPA Office of Pesticide Programs, and the Health and Environmental Sciences Institute reviewed the application of the KMD in toxicity testing. Symposium presentations summarized commonly raised technical and scientific issues related to the use of KMD as an approach to select doses in toxicology testing studies or to interpret dose-response study results.

Two publications developed following the symposium are now available in Regulatory Toxicology and Pharmacology:

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Nov 09, 2021
Publication Describes Skin Sensitization Risk Assessment for Cosmetic Products

A new paper describes a hypothetical skin allergy risk assessment of two consumer products, face cream containing 0.1% coumarin and deodorant containing 1% coumarin. The risk assessment demonstrates application of the computational Skin Allergy Risk Assessment (SARA) predictive model developed by the consumer products company Unilever. NICEATM is working with Unilever to test and further develop the SARA model.

Reynolds et al. 2021. A hypothetical skin sensitisation next generation risk assessment for coumarin in cosmetic products. Regul Toxicol Pharmacol. https://doi.org/10.1016/j.yrtph.2021.105075.

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Oct 27, 2021
NICEATM Releases ICE 3.5

On October 11, NICEATM released version 3.5 of the Integrated Chemical Environment (ICE). ICE provides data and tools to help develop, assess, and interpret chemical safety tests. This release adds expanded capabilities and new data to the existing ICE resources.

ICE version 3.5 includes the following expanded capabilities:

  • New result selection options in the Chemical Quest and Curve Surfer tools.
  • Application of Saagar fingerprints (described in Sedykh et al. 2021: https://doi.org/10.1021/acs.chemrestox.0c00464) to Chemical Quest searches.
  • Ability to display AC50 plots in Search results.

In addition, updated data have been added for acute oral toxicity, cancer, and skin sensitization, and modeling tools are using updated absorption, distribution, metabolism, and excretion data.

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Oct 27, 2021
CAAT NAMs Workshop for Early Career Scientists; Apply by November 7

The Johns Hopkins University Center for Alternatives to Animal Testing (CAAT) and the Animal Protection Commissioner of Berlin invite early career scientists to apply for a two-day online workshop on new approach methodologies (NAMs) in biomedical research. The program will include presentations and interactive sessions with established scientists from academia, industry, government, and non-government organizations. Topics to be discussed will include publishing research using NAMs, finding funding for NAMs research, and training opportunities in NAMs.

The workshop is free but attendees must preregister by November 7. Registrants have the option to submit abstracts describing their research involving NAMs; up to ten early career scientists will be selected to present at the workshop.

Nov 7, 2021
Oct 27, 2021
EPA Calls for Nominations for Board of Scientific Counselors; Due by November 12

In an October 18 Federal Register notice, EPA called for nominations for technical experts to serve on its Board of Scientific Counselors, a federal advisory committee to the Office of Research and Development. Nominations are due by November 12.

The board consists of non-EPA scientists, engineers, and economists who are experts in their respective fields. EPA will consider nominees from industry, business, public and private research institutes or organizations, academia, government (federal, state, local, and tribal) and non-government organizations, and other relevant interest areas. Nominees are sought with expertise in a variety of fields, including environmental modeling, exposure science and assessment, information and data science, NAMs, physiologically based pharmacokinetic modeling, risk assessment, and toxicology.

Nov 12, 2021
Oct 27, 2021
NICEATM Activities at ASCCT; NICEATM Scientist Honored

The ASCCT annual meeting was held virtually from October 12-14. NICEATM scientists and ILS contractors supporting NICEATM presented four oral presentations and nine posters. A list of NICEATM activities at ASCCT is available on the NTP website; posters presented will be available for download from this page soon.

At the meeting, Agnes Karmaus, ILS (contractor supporting NICEATM) was recognized as the inaugural winner of the Applied In Vitro Toxicology (AIVT) award for her ASCCT presentation describing annotation and visualization of high-throughput assay data used in ICE. The AIVT award, given by the journal Applied In Vitro Toxicology, recognizes an early-career scientist whose work has made a lasting impact on the implementation of NAMs.

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Oct 27, 2021
Paper Describes MPS Application to Study COVID Effects on the Brain

A new article in ALTEX describes opportunities to use MPS, also known as organs-on-chips, to study brain cell infection by SARS-CoV-2 and its relevance to COVID-19 effects on the human brain. The article, co-authored by Acting NICEATM Director Nicole Kleinstreuer, explores the potential of MPS to address pathogenesis of neurological signs, their long-term consequences, and possible interventions.

Kang et al. 2021. COVID-19 – prime time for microphysiological systems, as illustrated for the brain. ALTEX. https://doi.org/10.14573/altex.2110131.

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Oct 20, 2021
October 2021 News for EURL ECVAM

Articles in the October EURL ECVAM newsletter highlight applications of non-animal and computational approaches to understanding COVID-19; availability of new models for immuno-oncology and neurodegenerative disease research; and new methods for identifying skin sensitizers. The newsletter also includes links to recent publications, job opportunities, and upcoming events.

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Oct 20, 2021
New Publication Discusses Testing Strategies

The September issue of Applied In Vitro Toxicology focuses on integrated strategy approaches in toxicology. Integrated strategy approaches provide a means by which information on chemical toxicity from several sources can be combined to provide a prediction of human risk as good or better than that provided by an animal test. Acting NICEATM Director Nicole Kleinstreuer is a co-author of the introduction to the special issue, which provides an overview of integrated strategy approaches and the applications discussed in the issue articles.

Eskes et al. 2021. Usefulness and applicability of integrated strategy approaches in toxicology. Appl In Vitro Toxicol. https://doi.org/10.1089/aivt.2021.0021.

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Oct 20, 2021
ECHA Publishes Advice on Using Non-animal Methods for Skin Sensitization

The European Chemicals Agency (ECHA) has published advice to stakeholders on how to advance the use of non-animal test methods for identification of skin sensitizers. The advice focuses on application of OECD Guideline 497, “Defined Approaches for Skin Sensitization,” issued in June. An October 13 press release describes the ECHA advice and the potential impact of Guideline 497.

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Oct 20, 2021
Video Available from September 21 Skin Sensitization Webinar

NICEATM is hosting a webinar series on “Current Concepts in Quantitative Risk Assessment for Skin Sensitization” in collaboration with the Swiss Centre for Applied Human Toxicology and the Swiss State Secretariat for Economic Affairs. Video from the first webinar in the series, “Introduction to Skin Sensitization and Contact Dermatitis,” is now available on the NTP website. Visit this page to register for the upcoming webinars in the series on December 8, 2021, and March 9, 2022.

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Oct 20, 2021
November 3 Webinar Reviews Eye Irritation Test Methods

A November 3 webinar will address “Application and Use of In Vitro and Ex Vivo Eye Irritation Test Methods.” The webinar is the latest in a series on use of new approach methodologies in risk assessment co-organized by the PETA Science Consortium International, EPA, and the Physicians Committee for Responsible Medicine.

In the webinar, Hans Raabe of the Institute for In Vitro Sciences will review human-relevant approaches to assess eye irritation and describe features of available non-animal test methods that guide selection of test methods to optimize ocular safety assessments. João Barroso of the European Commission Joint Research Centre will provide an overview of non-animal approaches accepted or under consideration by OECD and of relevant revisions of the United National Globally Harmonized System for Classification and Labelling of Chemicals

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Oct 20, 2021
October 25 Workshop Focuses on Dog Use in Agrochemical Evaluation and Registration

A virtual workshop on October 25 will feature presentations by scientists from government, industry, and animal welfare organizations on reducing the use of the 90-day dog study in international regulation of agrochemicals. “Challenges and Opportunities for Overcoming Dog Use in Agrochemical Evaluation and Registration” is being presented by the Center for Alternatives to Animal Testing at the Johns Hopkins Bloomberg School of Public Health.

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Oct 14, 2021
FDA Draft Guidance on Carcinogenicity Testing; Comment by December 6

In an October 5 Federal Register notice (86 FR 54982), FDA announced draft guidance for industry, “S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals.” The draft guidance expands the testing scheme for assessing human carcinogenic risk of small molecule pharmaceuticals. It introduces an integrative approach that provides specific weight-of-evidence criteria that inform whether a 2-year rat study adds value in completing a human carcinogenicity risk assessment. The draft guidance also adds a plasma exposure ratio-based approach for setting the high dose in the rasH2-Tg mouse model. FDA is accepting comments on the draft guidance through December 6.

Dec 6, 2021
Oct 14, 2021
Faculty Position in Computational Toxicology at Purdue University

Purdue University is seeking candidates for a tenure-track Assistant/Associate Professor position in computational toxicology in the College of Human and Health Sciences. The successful candidate will lead an independent research program that utilizes state-of-the-art computational approaches to advance understanding of how environmental exposures adversely affect human health. The candidate will also develop new College courses focused on the use of "big data," artificial intelligence, machine learning, and other computational approaches to human health and disease.

Review of applications will begin October 15 and continue until the position is filled. Candidates must have Ph.D.s in toxicology, computational biology, or a related field and productive postdoctoral research experience. Evidence of prior success in extramural funding is preferred.

Oct 15, 2021
Oct 14, 2021
NIEHS Seeks Candidates for Chief, Mechanistic Toxicology Branch

NIEHS is seeking a dynamic, highly motivated scientist to serve as Chief of the Mechanistic Toxicology Branch (MTB) in the Division of the NTP (DNTP). The MTB conducts investigative toxicology studies in support of DNTP projects for screening, prioritization, and mechanistic understanding of xenobiotic effects on human health.

The ideal candidate will have a research-based professional degree (Ph.D., M.D., Pharm.D., or D.V.M.) in the life sciences, with extensive experience in in vivo and in vitro toxicology studies. They must demonstrate strategic and visionary leadership for identifying and matching new scientific technologies with the needs of the DNTP, while also understanding the limitations of data generated through these approaches for public health decision-making. The applicant should be recognized for their scientific expertise within the national and international scientific community. The applicant will have demonstrated a commitment to applied and translational research with unique insights into how to build trust in decision-making stakeholders. They will also have demonstrated experience leading diverse scientific research programs, including participation in multi-institutional programs and national and international consortia. Applications should be received by November 6.

Nov 6, 2021
Oct 14, 2021
Eawag Seeks Group Leader in Systems Biology for Aquatic Toxicology

The Swiss Federal Institute of Aquatic Science and Technology (Eawag) is seeking a scientist with a strong record of accomplishment to lead a research program to advance aquatic toxicology by applying systems biology. Eawag conducts research, education, and expert consulting to achieve the dual goals of meeting direct human needs for water and maintaining the function and integrity of aquatic ecosystems. The successful candidate for this position will establish a group with high international visibility that will strengthen mechanistic understanding of the complex interactions of environmental stressors with aquatic organisms.

Applicants should have Ph.D.s in field such as systems biology, engineering, physics, biomathematics/statistics, or in environmental science with emphasis on biological systems modeling. Excellent communication in English and teamwork skills are essential. The successful candidate will be expected to acquire third party funding, recruit Ph.D. and master’s students, and contribute to Eawag’s mandate in teaching and expert consulting. Applications should be submitted by November 30.

Nov 30, 2021
Oct 05, 2021
ICCVAM Members to Speak at Webinar on New OECD Guideline

In June 2021, OECD issued a guideline on defined approaches for skin sensitization. Development of the new guideline was sponsored by NICEATM in collaboration with other U.S. government agencies and scientists from Canada and the European Union. This document represents a new type of product for OECD and will enable a non-animal approach to identifying potential skin sensitizers to be used worldwide.

A webinar on Monday, October 18, at 8:00 a.m. EDT will discuss the implementation of the new guideline in OECD member countries. The webinar is free and open to the public. Presenters at the webinar will include Acting NICEATM Director Nicole Kleinstreuer; Anna Lowit, EPA, ICCVAM co-chair; and Paul Brown, ICCVAM member from the FDA Center for Drug Evaluation and Research.

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Oct 05, 2021
Workshop on Accelerating Global Deletion of the Abnormal Toxicity Test

A free virtual workshop on Thursday, October 14, will consider actions needed to advance global deletion of the abnormal toxicity test. This test, also known as the general safety test or the innocuity test, is an animal test to detect potentially harmful extraneous contaminants in injectable biological products. The test has declined in use due to its numerous drawbacks and limitations but is still included is some regulatory requirements. The goal of the upcoming workshop is to identify actions to make the deletion of the test a global concrete achievement. International organizations and funding bodies, industry representatives, and regulatory stakeholders are invited to share their view and discuss the respective experiences in a multi-stakeholder environment.

The workshop is being presented by the Animal-free Safety Assessment Collaboration and organized by the Humane Society International and the European Federation of Pharmaceutical Industries and Associations in collaboration with the International Alliance for Biological Standardization.

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Oct 05, 2021
Next NICEATM Skin Sensitization Webinar December 8

NICEATM is partnering with the Swiss Centre for Applied Human Toxicology and the Swiss State Secretariat for Economic Affairs to present a webinar series on “Current Concepts in Quantitative Risk Assessment for Skin Sensitization.” The next webinar in the series on December 8 will consider the topics of methods for skin sensitization hazard and potency determination using currently available non-animal test methods, as well as exposure assessment and quantification.

The webinar series is free and open to the public. Those who registered to view the first webinar are automatically registered for the second webinar. A video from the first webinar in the series, which presented an introduction to skin sensitization and contact dermatitis, will be posted on the webinar series webpage when available.

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Oct 05, 2021
MPS World Summit December 9-10; Abstracts Due October 21

The second Microphysiological Systems (MPS) World Summit will be held virtually Thursday, December 8. The theme of the meeting is “Systems Engineering of MPS.” This is the latest in a series of meetings with the goal of bringing together a global audience to create a roadmap for MPS technologies and establish an international society. The meeting is free and open to the public.

Meeting organizers are accepting abstracts for oral and poster presentations through October 21. Abstracts should be in English, 300 words or less, and relevant to the topic of new developments in MPS. Young scientists (35 and under) submitting abstracts can apply for consideration for a travel award that will support in-person attendance at a hybrid conference to be held in New Orleans in May-June 2022. For more information about abstract submission, see this flyer or email info@mpsworldsummit.com.

Oct 21, 2021
Oct 05, 2021
Opportunities for Programme Management Officers at the United Nations

The United Nations has an opening for a Programme Management Officer supporting the secretariat of the Strategic Approach to International Chemicals Management (SAICM). The SAICM is a policy framework to promote chemical safety around the world. Candidates should have at least a master’s or equivalent degree in environmental science or management, business administration, economics, or related field, and at least five years’ experience in project or program management, preferably in the context of environmental management. Candidates should be fluent in written English; a working knowledge of French and another UN language is desirable. The position is located in Geneva.

The Programme Management Officer P3 (position 156105) will support the coordination of the work of the SAICM Emerging Policy Issues and the SAICM Issues of Concern in the lead up to the fifth session of the ICCM. The Officer will also participate in the development, implementation and evaluation of the SAICM work program as it relates to the Emerging Policy Issues and Issues of Concern; monitor and analyze program/project development and implementation; review relevant documents and reports; identify problems and issues to be addressed and proposes corrective actions; liaise with relevant parties; and identify and track follow-up actions. Apply by November 10.

Nov 10, 2021
Sep 21, 2021
National Academies Committee Examining Mammalian Toxicity Tests to Meet September 23

The first meeting of the National Academies’ Committee on Variability and Relevance of Current Laboratory Mammalian Toxicity Tests and Expectations for New Approach Methods (NAMs) for Use in Human Health Risk Assessment will be held on Thursday, September 23, with a public session from 1:00-2:15 p.m. EDT. Information about the meeting and a link to register is available on the National Academies' website.

The public session will include discussions with EPA staff regarding the statement of task, reasons for the committee’s study, and description of the types of committee recommendations that would be most useful. There will then be a brief period to allow public comments on the committee’s task (two minutes maximum per commenter, preferably one speaker per organization). If you plan to comment, please indicate this on your registration. You may also send comments or any written materials for consideration to BEST@nas.edu by 12:00 noon EDT on September 23.

Sep 23, 2021
Sep 21, 2021
Webinar Discusses Animal Testing Requirements for REACH

A webinar on Thursday, October 21, at 11:00 a.m. EDT will consider “EU REACH Regulation, EU Cosmetic Regulation, and New Animal Tests on Cosmetic Ingredients.” The webinar is presented by the American Society for Cellular and Computational Toxicology and the European Society for Toxicology In Vitro.

Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) is the most important chemical regulation in the European Union (EU), requiring all manufacturers and importers of chemicals produced in quantities above 1 ton/year to register these substances. The registration includes a detailed risk assessment, often based on new animal testing. While the EU Cosmetic Regulation has banned new in vivo tests of both finished cosmetics and cosmetic ingredients, in practice animal tests are still being conducted on many cosmetics ingredients to fulfill REACH requirements. In this webinar, Costanza Rovida of Konstanz University and Jean Knight of White Rabbit Beauty will discuss their recent study that highlights this conflict.

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Sep 21, 2021
OECD Launches QSAR Toolbox Version 4.5

QSAR Toolbox is a free software application intended for use by governments, chemical industry and other stakeholders for filling gaps in toxicity data needed for assessing the hazards of chemicals. QSAR Toolbox was developed by OECD in close collaboration with the European Chemicals Agency.

QSAR Toolbox version 4.5 includes an automated workflow for defined approaches for skin sensitization based on the recently released OECD Guideline 497. Other new features of version 4.5 include:

  • Human skin sensitization data for over 1000 substances compiled by NICEATM and the German Federal Institute for Risk Assessment.
  • New photosensitivity data on 73 substances.
  • A workflow editor that allows user development of automated and standardized workflows for predicting or grouping of chemicals.
  • Improved interaction with the International Uniform Chemical Information Database (IUCLID).
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Sep 21, 2021
Opportunity at NIEHS for Staff Scientist in Biological Systems Modeling

NIEHS is recruiting a Staff Scientist to lead the development and application of multi-scale computational models to better understand and predict adverse human-health outcomes associated exposure to environmental chemicals. The candidate should be an experienced scientist who will serve as a subject-matter expert in the field of multi-scale modeling of biological systems and provide technical leadership in developing and applying computational tools to predict chemical-induced toxicity and identify underlying mechanisms and modes of action.

The candidate must have a doctoral-level degree in computational science, mathematics, bioengineering, computational genetics, bioinformatics, toxicology, statistics, or related fields, and at least two years of post-degree research experience. Candidates must demonstrate experience applying large-scale mechanism based mathematical modeling techniques in life sciences, including experience in building, validating, and using complex, system level models of biological systems and critically assessing different methods for simulation of single species, communities, and populations. Apply by Wednesday, October 13.

Oct 13, 2021
Sep 09, 2021
Register by Friday Sept. 17 to Present Public Comments at SACATM

The annual meeting of ICCVAM’s advisory committee, the Scientific Advisory Committee on Alternative Toxicological Methods, is on September 28-29. An agenda, abstracts, and background materials are now available for the virtual meeting.

Agenda items for the upcoming meeting include: (1) major ICCVAM accomplishments in 2021; (2) regulatory needs and research applications for ecotoxicity testing; (3) evolving approaches to validation; and (4) update on NICEATM computational resources. Written and oral comments are invited for the agenda topics. The deadline to register to submit comments is Friday, September 17. Registration to view the meeting will be available through the end of the meeting on September 29.

SACATM is a federally chartered external advisory group of scientists from the public and private sectors that advises ICCVAM, NICEATM, and the Director of the National Institute of Environmental Health Sciences and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM.

Sep 17, 2021
Sep 09, 2021
EMGS Bioinformatics Challenge Finalists to Present September 22

A webinar on Wednesday, September 22, at 4:30 p.m. EDT will feature presentations by the four finalists in the EMGS 2021 Bioinformatics Challenge:

  • Predicting Molecular Initiating Events from High Throughput Transcriptomic Screening using Machine Learning (lead institution: EPA).
  • Leveraging Zebrafish High-throughput Screening Data and Conditional Generative Adversarial Networks to Advance Predictive Toxicology (lead institution: North Carolina State University).
  • Transcriptomic Meta-Analyses Reveal a Molecular Fingerprint Underlying Hepatic Cholestasis Response (lead institution: ScitoVation LLC).
  • Exposome Target Prediction with Coupled Matrix-Matrix Completion (lead institution: University of Michigan).

The webinar is being presented in conjunction with the 2021 EMGS Virtual Annual Meeting, but it is free and open to the public, and registration for the meeting is not required to attend.

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Sep 09, 2021
Paper Describes New and Updated ICE Tools

A new paper in Computational Toxicology describes recent updates to the Integrated Chemical Environment. ICE provides data and computational tools to support chemical safety testing, allowing a broad range of users to interact with annotated and curated data. This paper includes an overview of the newest ICE tool, Chemical Quest, which allows users to search within the extensive ICE database for structurally similar chemicals to a target chemical or substructure.

Abedini et al. 2021. Application of new approach methodologies: ICE tools to support chemical evaluations. Comput Toxicol. https://doi.org/10.1016/j.comtox.2021.100184.

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Sep 03, 2021
Program Available for ASCCT Annual Meeting; Poster Abstracts Due Sept. 10

ASCCT is hosting their annual meeting virtually from October 12-14. The overarching theme for this year’s meeting is “Practical Applications of New Tools in Toxicology”. The agenda will include five sessions of oral presentations, posters, and other engagement opportunities. The meeting is free and open to the public but registration is required: register by October 8.

Abstracts are still being accepted for static poster presentations and are due by September 10. Abstracts should be related to in vitro and in silico toxicology, broadly defined and including science, policy, and regulatory topics.

Sep 10, 2021
Sep 03, 2021
Postdoctoral Opportunity at EPA Center for Computational Toxicology and Exposure

A postdoctoral research opportunity is available at the EPA Office of Research and Development’s Center for Computational Toxicology and Exposure located in Durham, North Carolina. Applications must be received by September 24.

This project focuses on developing computational models to predict the safety of chemicals without running tests on whole animals. The research participant will be part of a team that includes biologists, bioinformaticians, and toxicologists. The participant may evaluate a series of current hypotheses regarding the in vitro to in vivo relevance of the data and will generate and test new hypotheses as appropriate. This research will require integration of in vitro screening data from a variety of assay technologies, in vivo physiology, and toxicokinetic data and models. The participant will gain training in the general areas of computational biology, bioinformatics data science, mathematical modeling, data management, and computational toxicology.

This full-time appointment is initially for one year and may be renewed for 3-4 additional years upon EPA recommendation subject to availability of funding. The candidate should have received a doctoral degree in a relevant field within the last five years or be currently pursuing such a degree. Preferred candidates will have software development experience in Python, R, Java, or C, and proficiency in the use of relational databases. Candidates must be U.S. citizens.

Sep 24, 2021
Sep 03, 2021
Postdoctoral Opportunity at Indiana University Biocomplexity Institute

The Biocomplexity Institute at Indiana University has a postdoctoral position developing multicellular, multi-scale mechanistic computational models of wound closure, epiboly, and early embryonic development in zebrafish. The position is offered in partnership with Purdue University’s National Science Foundation-funded EMBRIO Institute and is located at the Indiana University Luddy School of Informatics, Computing, and Engineering in Bloomington, IN. Contact James Glazier at jaglazier@gmail.com with questions. Applications must be received by October 7.

The research participant will work with faculty and student researchers to develop Cellular Potts and particle-based biomechanical models of zebrafish tissue dynamics and implement them in the CompuCell3D and Mechanica modeling frameworks. The models will be used to perform virtual experiments exploring hypotheses about the interplay of biochemical signaling and mechanics leading to emergent regulation in tissue dynamics. The participant will receive training from members of the Biocomplexity and EMBRIO Institutes and relevant collaborators in developmental and cellular biology and computational, mathematical, agent-based, and biological modeling.

The successful candidate will initially receive a 12-month full-time non-tenure track appointment, with the potential for the appointment to be extended annually for a maximum term of four years, subject to satisfactory performance and funding. The candidate should have a doctoral degree in bioengineering, biophysics, mathematical biology or a closely-related field. Commitment to and expertise in developmental biology are essential. Prior publications in agent-based modeling, especially multicellular or biological network modeling are required.

Oct 7, 2021
Aug 26, 2021
Applicant Assistance Program for NIH Grants: Webinar August 30

The NIH Applicant Assistance Program (AAP) provides free support for for-profit companies that are planning to apply for a Phase I NIH SBIR or STTR award. The AAP is open to current and future entrepreneurs developing innovative technology ideas in the healthcare space that who have not previously received NIH SBIR or STTR grants. This includes applicants seeking grants from NIEHS to support development of chemical safety testing methods that reduce or replace animal use. Information about small business grants available from NIEHS and NIEHS’ participation in the AAP is available on the NIEHS website.

Applications for the AAP are due September 22. Potential applicants can learn more about the AAP at an informational webinar on Monday, August 30, from 12:30-2:00 p.m. EDT. The webinar is hosted by the National Cancer Institute. The informational webinar will be followed by a Q&A webinar on Wednesday, September 8, at 2:00 p.m. EDT.

Sep 22, 2021
Aug 26, 2021
USDA Updates Guidance on Reference Standards; Comments Due September 20

USDA is updating Veterinary Services Memorandum (VSM) 800.211, Guidance for Master Reference Qualification, Requalification, Dating, and Monitoring. The revision of VSM 800.211, which was last updated in 2011, seeks to clarify and provide additional detail regarding dating of newly licensed product Master References and monitoring the stability of those references. This updated memorandum also includes guidance on reference qualification and requalification, including guidance for use of in vitro methods for this purpose. Comments on the revision of VSM 800.211 are requested by Monday, September 20.

Sep 20, 2021
Aug 26, 2021
EURL ECVAM Scientific Advisory Committee Issues Recommendations on Skin Sensitization Method

The EURL ECVAM scientific advisory committee has issued “ESAC Opinion on the Scientific Validity of the GARDskin and GARDpotency Test Methods.” ESAC, the EURL ECVAM Scientific Advisory Committee, advises EURL ECVAM on scientific issues. It conducts independent peer reviews of validation studies of alternative test methods and assesses their scientific validity for a given purpose. The new report relates to the peer review of the GARDskin and GARDpotency in vitro test methods for skin sensitization. The ESAC considers that GARDskin can contribute to skin sensitization hazard identification in a weight-of-evidence approach. However, ESAC identified issues with the GARDpotency assay that need to be addressed before it can be used for regulatory purposes.

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Aug 24, 2021
Agenda and Other Materials Available for September 28-29 SACATM Meeting

An agenda, abstracts, and background materials are now available for the virtual SACATM meeting on September 28-29. Registration to view the meeting will be available through the end of the meeting on September 29. Interested persons may also register to submit comments for consideration at the meeting. The deadline to register to submit comments is Friday, September 17.

SACATM is a federally chartered external advisory group of scientists from the public and private sectors that advises ICCVAMNICEATM, and the Director of NIEHS and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM. Agenda items for the upcoming meeting include: (1) major ICCVAM accomplishments in 2021; (2) regulatory needs and research applications for ecotoxicity testing; (3) evolving approaches to validation; and (4) update on NICEATM computational resources.

Sep 17, 2021
Aug 24, 2021
Postdoctoral Opportunity at EPA Center for Computational Toxicology and Exposure

A postdoctoral research opportunity is available at the EPA Office of Research and Development’s Center for Computational Toxicology and Exposure located in Durham, North Carolina. Applications must be received by September 20.

This project focuses on refining and advancing EPA's tools for high-throughput toxicokinetics (HTTK). The research participant will join a high-performing team supporting the advancement of HTTK and will be mentored in conducting independent research. Depending upon the participant's interests, the project may address (1) new mathematical toxicokinetic models for occupationally relevant routes of exposure and sensitive populations; (2) new methods, and potentially a new R package, for the analysis of in vitro toxicokinetic measurements; (3) analysis of machine learning tools for extrapolating from existing data; (4) analysis of new in vitro toxicokinetic data; and/or (5) new approaches for evaluating in vitro predictions with in vivo data.

This full-time appointment is initially for one year and may be renewed for 3-4 additional years upon EPA recommendation subject to availability of funding. The candidate should have received a doctoral degree in a relevant field within the last five years or expect to complete such a degree by September 24. Relevant fields include biomedical engineering, informatics, computer science, signal processing, machine learning, chemistry, physics, applied mathematics, pharmacology, or statistics. Candidates must be U.S. citizens.

Sep 20, 2021
Aug 24, 2021
Applications Being Accepted for Regulatory Testing Specialist at PCRM

PCRM is hiring a Regulatory Testing Specialist to join the Research and Regulatory Affairs Team. The Regulatory Testing Specialist will work to promote alternatives to the use of animals in toxicological testing and research, with an emphasis on international guidelines and activities. The applicant should have a master’s or doctoral degree in toxicology, pharmacology, cell biology, or a related field and at least two years of experience in a non-governmental organization, government, or industry position related to regulatory testing and/or compliance. Experience with OECD test guidelines and regulatory requirements is a plus. This full-time position is based in PCRM’s offices in Washington DC but may be performed remotely from any location in the United States

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Aug 18, 2021
ICCVAM Members to Serve on National Academies Panel Examining Mammalian Toxicity Tests

Acting NICEATM Director Nicole Kleinstreuer and Elijah Petersen of NIST are among the provisional members of a committee being convened by the National Academies of Sciences, Engineering, and Medicine for the consensus study, “Variability and Relevance of Current Laboratory Mammalian Toxicity Tests and Expectations for New Approach Methods (NAMs) for use in Human Health Risk Assessment.” Kleinstreuer and Petersen are both members of ICCVAM. The National Academies’ Board on Environmental Studies and Toxicology is accepting comment on the composition of the committee through August 29.

This study will review the variability and relevance of existing mammalian toxicity tests, specifically in the context of human health risk assessment. It will set data-driven and science-based expectations for NAMs based on the variability and relevance of the traditional toxicity testing models. 

Aug 29, 2021
Aug 18, 2021
PCRM Offering Training of Alternatives to Animal Use for Acute Toxicity

PCRM will present five virtual training and discussion sessions focused on available methods and strategies for avoiding or reducing animal tests when assessing chemicals and pesticides for six acute endpoints commonly referred to as the “6-pack.” Methods and strategies presented will be applicable to pesticides, antimicrobials, and other products. The series will be held on consecutive Thursdays starting on September 9. For a complete schedule and to register, visit https://www.pcrm.org/ethical-science/animal-testing-and-alternatives/nura.

Each session in the “Nix the Six” virtual training series will feature three to four short lectures and a roundtable discussion in a Zoom Webinar format. Attendees will be able to ask questions and provide comments; other applications may be used to enable additional interaction between attendees and panelists. Registrants may attend any or all of the sessions, which are free and open to the public. Speakers include NICEATM scientist Kamel Mansouri (Session 1, “Oral and Dermal Toxicity”), ICCVAM member Joanna Matheson, CPSC (Session 3, “Skin and Eye Irritation”), and acting NICEATM Director Kleinstreuer (Session 5, “Opportunities and Outlook”).

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Aug 18, 2021
NIH to Present Bioinformatics and Computational Biology Symposium

The NIH Office of Research Services will present a Bioinformatics and Computational Biology Symposium on Thursday, September 9, from 9:30 a.m.-3:00 p.m. The symposium is free and open to the public but registration is required. Complete information is available on the event webpage; a link to register can be found on the left menu.

The symposium includes a morning plenary session with the keynote presentation, “Big data for health and disease” and talks on DNA structure, proteomic tumor analysis, and data integration to study COVID-19. The afternoon session includes concurrent tracks on single-cell sequencing and genomics.

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Aug 18, 2021
Webinar to Discuss Standards for Implementation of Organs-on-chips

ASCCT and the European Society for Toxicology in Vitro are co-hosting a webinar “Organs-on-chips: New Science and Standards for Implementation.” It will be presented Friday, September 10, from 10:00-11:30 a.m. EDT.

The webinar will feature two presentations:

  • “Organ-on-Chip models for bioavailability, biotransformation, and (sub)chronic toxicity studies”: Meike van der Zande, Wageningen Food Safety Research, will discuss the design and characterization of intestinal and liver organ-on-chip systems and their potential applications in pharmacology and toxicology.
  • “The many roles of standards for organ on chip”: Monica Piergiovanni, European Commission Joint Research Centre, will summarize a workshop that brought researchers, developers, standards authorities, and regulators together to build a list of areas where standards would contribute to wider acceptance and use of organs-on-chips.

 

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Aug 18, 2021
University of New South Wales Seeks Collaborators for 3Rs Research Projects

The University of New South Wales in Sydney, Australia, has approved $250,000 (AUD) for research proposals that address one or more of the following criteria:

  • Show promise for replacing or substantially reducing the number of animals used in research.
  • Establish or significantly develop new methodologies.
  • Develop animal welfare applications for the University's Tecniplast digital ventilated caging system.

Funding applicants must be academic staff of the University of New South Wales, but collaborations are welcome. Applications are due September 20; for more information, visit the University of New South Wales website or contact Malcolm France.

Sep 20, 2021
Aug 12, 2021
August 18 Webinar to Provide Overview of ICE

The NIEHS Office of Data Science will present a webinar on “The Integrated Chemical Environment: Computational Tools and Curated Data to Support Toxicity Assessment” on Wednesday, August 18, at 11:00 a.m. EDT. The webinar is free and open to the public. To join the webinar on August 18, go to https://nih.zoomgov.com/j/1607258769.

NTP’s Integrated Chemical Environment (ICE) provides access to high-quality, curated, regulatory-relevant toxicological and chemical data and in silico predictions of chemical properties to support chemical evaluations, data integration, and model development. In this webinar, John Rooney, ILS (contractor supporting NICEATM), will describe how ICE uses annotations and graphic displays to provide context for high-throughput assay results. He will demonstrate some ICE tools and present case studies showing how these tools can be used for chemical analyses and comparisons.

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Aug 12, 2021
September 21 Webinar to Provide Overview of Skin Sensitization

NICEATM is partnering with the Swiss Centre for Applied Human Toxicology and the Swiss State Secretariat for Economic Affairs to present a webinar series on “Current Concepts in Quantitative Risk Assessment for Skin Sensitization.” The first webinar, which provides an introduction to skin sensitization and contact dermatitis, will be Tuesday, September 21, at 9:00 a.m. EDT. The webinar is free and open to the public. Information about the webinar series and a link to register for the September webinar are available on the webinar series webpage.

Despite progress in the adoption of new approach methods as alternatives to traditional animal tests, quantitative risk assessment of skin sensitizing chemicals remains a challenging process. This webinar series will provide an overview of the current state of the science in this rapidly developing field. While the main focus of the webinars will be on testing of pesticides, the webinars will be of interest to the broader scientific community as they rely on the development of concepts and methods in other areas, e.g. cosmetics, fragrances, and consumer products.

The September 21 webinar will feature David Basketter, DABMEB Consultancy Ltd., speaking on the history and current state of play for skin sensitization testing, and Wolfgang Uter, University of Erlangen-Nurnberg, discussing the epidemiology of contact dermatitis with a focus on occupational exposure and monitoring.

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Aug 12, 2021
Article Reviews Activities of MPS Working Group

A feature article published online July 28 in Drug Discovery Today reviews progress in the effort to apply microphysiological systems (MPS, also known as “tissue chips”) to the development of therapies for COVID-19. Coauthors Nicole Kleinstreuer, acting Director of NICEATM, and Anthony Holmes, National Centre for the Replacement, Refinement and Reduction of Animals in Research (United Kingdom), describe the establishment of a global working group to coordinate activities around MPSs and COVID-19 and to maximize their scientific, human health, and animal welfare impacts.

Kleinstreuer, N. and Holmes, A. 2021. Harnessing the power of microphysiological systems for COVID-19 research. Drug Discovery Today. https://doi.org/10.1016/j.drudis.2021.06.020

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Aug 03, 2021
Postdoctoral Opportunity in Cheminformatics at NIEHS

A postdoctoral position is available in the Predictive Toxicology Branch in the Division of the NTP at NIEHS in Research Triangle Park, North Carolina. Applications will be accepted until October 18 or until the position is filled.

The position will support a project to develop a comprehensive in-house in silico modeling pipeline that will combine best practices in data-curation, data-mining and predictive machine-learning tools and serve as a resource for DNTP and cross-divisional NIEHS collaborators. The postdoctoral fellow will be co-mentored by NIEHS scientists Kamel Mansouri and Charles Schmitt.

The applicant should have a Ph.D. or equivalent degree in a relevant discipline and no more than five years of postdoctoral experience. They should have experience in cheminformatics and computational chemistry; statistics and advanced data mining methods; and machine learning and artificial intelligence algorithms. They should also have experience with programming languages (Python, Matlab, Java), modeling and molecular simulation tools, and the KNIME environment.

Oct 18, 2021
Aug 03, 2021
NICEATM Activities at World Congress

The 11th World Congress on Alternatives and Animal Use in the Life Sciences will take place virtually August 23-September 2. Acting NICEATM Director Nicole Kleinstreuer is on the scientific committee for the conference, and she and other NICEATM scientists will be giving over 20 platform and poster presentations. Presentations will also be given by Acting Predictive Toxicology Branch Chief Warren Casey and other ICCVAM committee and workgroup members.

A schedule of NICEATM and ICCVAM presentations at World Congress is available on the NTP website.

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Aug 03, 2021
SBIR/STTR Omnibus Grant Funding Opportunity Announcements

The Department of Health and Human Services has released the 2021 Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Omnibus Grant Solicitations. This funding is available for small business grant applications to support development and commercialization of innovative technologies.

Projects being funded by NIEHS under these solicitations include development of toxicity screening, testing, and modeling approaches that support Tox21 and other NTP goals. Areas of high priority include development of:

  • Tools for exposure assessment, including assessment of exposure to nanomaterials
  • Improved or expanded testing methods for toxicity screening
  • Computational approaches for predictive toxicology
  • Technologies such as alternative or improved methods for fixing and preserving tissues

The first deadline for applications under this announcement is September 5. More information is available on the NICEATM website.

Sep 5, 2021
Aug 03, 2021
August 5 Webinar Considers Threshold of Toxicological Concern Values

The SOT Computational Toxicology Specialty Section will present a webinar “Moving from One-Size-Fits-All to Fit-for Purpose TTC Values” on Thursday, August 5, at 11:00 a.m. EDT. The webinar is free and open to the public.

Threshold of toxicological concern (TTC) values have historically been derived from datasets of structurally diverse compounds that span a wide range of toxicological or carcinogenic potency. However, there is increasing interest in developing fit-for-purpose TTC values for compounds in specific use categories or structural classes. Speakers Ron Brown, Risk Sciences Consortium, and Grace Patlewicz, EPA, will explore recent efforts to develop fit-for-purpose TTC values and describe the factors that should be considered when deriving TTC values for compounds in specific use or structural categories.

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Jul 29, 2021
Slides and Video Available from ICCVAM Public Forum

Slides and video are now available from the May 27 ICCVAM Public Forum. The Public Forum featured 13 presentations from nine ICCVAM member agencies describing activities supporting replacement, reduction, or refinement of animal use for chemical safety testing. Representatives of nine ICCVAM stakeholder organizations presented statements during the meeting. Topics addressed by the commenters included validation of new methods and incorporation of human-relevant data; communicating effectively with the public about the validity of non-animal methods; and the need for international agreement on testing requirements.

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Jul 29, 2021
September 16 Webinar to Discuss New Non-animal Test for Fish Toxicity

The internationally accepted RTgill-W1 cell line assay for acute fish toxicity will be discussed in a webinar to be presented on Thursday, September 16, at 9:00 a.m. EDT. The webinar is being presented by the Swiss Federal Institute of Aquatic Science and Technology, the Health and Environmental Sciences Institute, and Aquatox Solutions Ltd.

The RTgill-W1 cell line assay was recently adopted by OECD, and is the first internationally accepted cell-based test for acute fish toxicity. The webinar will provide an overview of the assay and discuss its advantages, limitations, and potential future applications and developments.

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Jul 29, 2021
Paper Describes Validation Study of Endocrine Test Method

A new paper discusses validation of the AR-CALUX test method, which identifies chemicals with the potential to interact with the androgen receptor. Warren Casey, Acting Chief of the Predictive Toxicology Branch at DNTP is a co-author of the paper, which found the method was able to detect androgen receptor agonists and antagonists.

Milcamps et al. 2021. Reliability of the AR-CALUX in vitro method used to detect chemicals with (anti)androgen activity: results of an international ring trial. Toxicol Sci. https://doi.org/10.1093/toxsci/kfab078.

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Jul 13, 2021
July 13 Webinar to Discuss In Vitro Platforms for Cardiotoxicity Testing

“Putting In Vitro Platforms at the Heart of Cardiotoxicity Testing” will be the focus of a webinar to be presented Tuesday, July 13 at 9:00 a.m. EDT by the National Centre for Replacement, Refinement & Reduction of Animals in Research.

A typical investigative animal study to assess cardiac contractility of drugs prior to clinical trials can use up to 24 dogs. Applying in vitro platforms early in drug development could significantly reduce these numbers. The webinar will present the results of the 2013 InPulse CRACK IT Challenge to develop a human-based in vitro system to assess cardiotoxicity in new drugs.

Chris Denning, University of Nottingham, will describe the technologies developed under the CRACK IT Challenge, how they were validated, and how they have been applied across various sectors. Peter Clements, GlaxoSmithKline (GSK), will describe the rationale behind the challenge and how GSK will apply the technologies developed. He will also discuss the wider scientific and 3Rs benefits of these models compared to traditional in vitro and in vivo approaches.

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Jul 13, 2021
Kleinstreuer to Participate in July 15 Livestreamed Event on Artificial Intelligence

Acting NICEATM Director Nicole Kleinstreuer will be one of five experts presenting their work on artificial intelligence at a livestreamed event on Thursday, July 15, at 6:00 p.m. EDT. Experts in different industries will present case studies and perspectives on how computational approaches can be applied to learning and problem-solving.

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Jul 13, 2021
July 21 Webinar Considers Toxicological Aspects of COVID-19

ASCCT and the European Society for Toxicology In Vitro will present a webinar on “Bridging Toxicology and Research: COVID-19 Initiatives” on Wednesday, July 21, at 10:00 a.m. EDT.

Marco Travaglio, University of Cambridge, will present the results of his study examining links between COVID-19 and air pollution. He found that multiple markers of poor air quality, including nitrogen oxides PM2.5, are associated with increased COVID-19 deaths in England. Maria João Amorim, Instituto Gulbenkian de Ciência, will discuss the CIAO project, which focuses on modeling the pathogenesis of COVID-19 using the adverse outcome pathway framework. This crowdsourcing effort is building evidence about the biological mode of action of the virus with the goal of informing policy and healthcare decisions.

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Jul 13, 2021
Registration Open for September 28-29 SACATM Meeting; Submit Comments by September 17

Registration is open for the virtual meeting of SACATM on September 28-29. Interested persons may also register to submit comments for consideration at the meeting. The deadline to register to submit comments is Friday, September 17; registration to view the webcast will be open until the meeting ends on September 29.

SACATM is a federally chartered external advisory group of scientists from the public and private sectors that advises ICCVAM, NICEATM, and the Director of NIEHS and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM. Preliminary agenda items for the upcoming meeting include: (1) major ICCVAM accomplishments in 2021; (2) regulatory needs and research applications for ecotoxicity testing; (3) evolving approaches to validation; and (4) update on NICEATM computational resources. More information about the meeting is available in a June 30 Federal Register notice.

Sep 17, 2021
Jul 13, 2021
EMGS Bioinformatics Challenge Finalists to Present September 22

A webinar on Wednesday, September 22, at 4:30 p.m. EDT will feature presentations by the four finalists in the EMGS 2021 Bioinformatics Challenge:

  • Predicting Molecular Initiating Events from High Throughput Transcriptomic Screening using Machine Learning (lead institution: U.S. Environmental Protection Agency).
  • Leveraging Zebrafish High-throughput Screening Data and Conditional Generative Adversarial Networks to Advance Predictive Toxicology (lead institution: North Carolina State University).
  • Transcriptomic Meta-Analyses Reveal a Molecular Fingerprint Underlying Hepatic Cholestasis Response (lead institution: ScitoVation LLC).
  • Exposome Target Prediction with Coupled Matrix-Matrix Completion (lead institution: University of Michigan).

The webinar is being presented in conjunction with the 2021 EMGS Virtual Annual Meeting, but it is free and open to the public, and registration for the meeting is not required to attend.

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Jul 13, 2021
New Paper Considers Data Quality for In Silico Models

Acting NICEATM Director Kleinstreuer and NICEATM scientist John Rooney (ILS, contractor supporting NICEATM) are co-authors of a recent paper that discusses the impact of input data on artificial intelligence models. The article reviews efforts to improve confidence in the robustness of toxicological data. Case studies demonstrate the effect of data curation on the performance of artificial intelligence models for predicting skin sensitization and skin irritation.

Alves et al. 2021. Curated data in — trustworthy in silico models out: the impact of data quality on the reliability of artificial intelligence models as alternatives to animal testing. ATLA. https://doi.org/10.1177/02611929211029635.

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Jun 30, 2021
Grants for Application of Colon/Intestine Chips: Apply by June 30

Emulate, Inc., a leader in organ-on-chips technology, has developed an in vitro system that combines organoids and organs-on-chips technology to more faithfully recreate human biology. Their Colon Intestine-Chip Grant Program will offer one researcher the hardware, chips, cells, and scientific support needed to get started using Organs-on-Chips technology for colon research.

Applications must be received by June 30. One grant winner will be selected and receive over $130,000 of equipment, including the essential hardware, chips, validated cells, and scientific support to apply this technology to their research. Applicants must not be current users of the Emulate Human Emulation System. Equipment can only be shipped to facilities in the U.S., Canada, European Union, United Kingdom, or Switzerland.

Jun 30, 2021
Jun 30, 2021
Abstract Submission Open for ASCCT 2021: Deadline July 23 for Oral Presentations

ASCCT is hosting their annual meeting virtually from October 12-14. The overarching theme for this year’s meeting is “Practical Applications of New Tools in Toxicology”. The agenda will include five sessions of oral presentations, posters, and other engagement opportunities.

The abstract deadline for the ASCCT annual meeting has been extended. Abstracts to be considered for oral and “flash” poster presentations are due by July 23. Abstracts to be considered for static poster presentations only are due by September 10. Abstracts should be related to in vitro and in silico toxicology, broadly defined and including science, policy, and regulatory topics.

Volunteers are still needed for the meeting organizing committee; if you are interested, please contact the Secretary at ksullivan@ascctox.org.

Jul 23, 2021
Jun 30, 2021
Call for Submissions of Endocrine Disruptor Test Methods for Prevalidation Studies

The European Union Public-private Partnership for the Pre-validation of Endocrine Disruptors Characterization Methods (PEPPER) is seeking candidate methods for prevalidation studies. Candidate methods should have been developed in Europe in response to an identified need relevant to regulatory identification of endocrine disruptors. Methods should have an established protocol and historical data, not require specialized or expensive equipment, and have the potential to reduce or replace animal use for endocrine disruptor identification.

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Jun 30, 2021
Opportunities for Scientists at IIVS

The Institute for In Vitro Sciences, Inc. (IIVS) is a non-profit research and testing laboratory dedicated to the advancement of in vitro methods worldwide. IIVS is unique in its position as a high-quality testing laboratory that also offers technical and educational resources to advance the field.

IIVS currently has openings for the scientific positions listed below.

  • Biologist I: Entry-level laboratory scientist position; candidate should have at least an A.A./A.S. degree in biological sciences.
  • Toxicologist I: Develops and performs a variety of toxicology studies; candidate should have either a master’s degree and 3+ years of relevant experience or a Ph.D.
  • Toxicologist I/Study Director: Develops and performs a variety of toxicology studies and participates in management of dermal and ocular programs; candidate should have either a master’s degree and 3+ years of relevant experience or a Ph.D.
  • Laboratory Administrative Support Specialist: ensures GLP compliance and prepares and reviews protocols and reports; candidate should have at least a B.A./B.S. in biological sciences or equivalent experience.
  • Respiratory Toxicology and Immunology Scientist: Develops and performs a variety of toxicology studies and participates in development of the respiratory sensitization program; candidate should have a Ph.D. and up to 3 years of relevant experience.
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Jun 21, 2021
June 23 Webinar Considers Stem Cells in Toxicology

ASCCT and the European Society for Toxicology in Vitro are co-hosting a webinar “Human Induced Pluropotent Stem Cells (hiPSC) in Toxicology”. The webinar will feature two presentations:

  • Catherine Verfaillie, Leuven University, Belgium: Multicellular 3D liver models based on hiPSC-derived liver cells
  • Anne Marie Vinggard, National Food Institute, Technical University of Denmark: Novel human pluripotent stem cell-based assays to predict developmental toxicity

The webinar will be held on Wednesday, June 23 from 10:00-11:30 a.m. EDT.

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Jun 21, 2021
Applications Being Accepted for Regulatory Testing Specialist at PCRM

PCRM is hiring a Regulatory Testing Specialist to join the Research and Regulatory Affairs Team. The Regulatory Testing Specialist will work to promote alternatives to the use of animals in toxicological testing and research, with an emphasis on international guidelines and activities. Applicants should have a master’s or doctoral degree in toxicology, pharmacology, cell biology, or a related field and at least two years of experience in a non-governmental organization, government, or industry position related to regulatory testing and/or compliance.

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Jun 16, 2021
NICEATM Releases ICE 3.4

On June 7, NICEATM released version 3.4 of the Integrated Chemical Environment (ICE). ICE provides data and tools to help develop, assess, and interpret chemical safety tests. This release adds new tools and expanded capabilities to the existing ICE resources.

ICE version 3.4 includes the following new tools and expanded capabilities:

  • Chemical Quest (Beta): uses fingerprints to predict structure similarity.
  • Drawing of 2D structures (part of the Chemical Quest tool): users can draw their own structures and query ICE for all chemicals that are similar to the drawn structure.
  • Query by multiple chemical identifiers: CASRNs, DTXSIDs, SMILES or InChiKeys are now accepted as inputs into all ICE tools.
  • Send assays to other ICE tools: users can switch between ICE tools and keep the same assays selected.

New data and data updates include:

  • DART in vivo assays from NTP and the European Chemicals Agency.
  • Dermal irritation in vivo assays (rat Draize skin irritation/corrosion test).
  • Updates to ICE curated high-throughput screening data and data from OPERA.
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Jun 16, 2021
OECD Issues Guideline for Skin Sensitization Assessment and Other New Documents

The OECD Test Guidelines Programme has issued a new test guideline, Defined Approaches for Skin Sensitisation. Development of the new guideline was sponsored by NICEATM in collaboration with other U.S. government agencies and scientists from Canada and the European Union. This document represents a new type of product for OECD, and will enable a non-animal approach to identifying potential skin sensitizers to be used worldwide. Validation against a curated set of human data indicates that this approach predicts human skin sensitization hazard better than the accepted animal test.

Other documents approved by OECD include:

  • A new test guideline describing use of a reconstructed human epidermis model for phototoxicity assessment.
  • Updates of six test guidelines for eye and skin irritation and skin sensitization.
  • Two new test guidelines for aquatic toxicity tests.
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Jun 16, 2021
Kamel Mansouri Receives QSAR 2021 Promising Early Career Award

The QSAR 2021 Conference Organizing Committee selected DNTP/NICEATM scientist Kamel Mansouri as the recipient of the QSAR 2021 Promising Early Career Award. The award recognizes an early career scientist that demonstrates significant contributions to the field of non-animal testing methods and shows promise in continuing to have a meaningful role in the field. The award was presented at the awards luncheon on June 9.

Mansouri is a computational chemist at NIEHS. He led an international project to build computational models to predict whether substances might be toxic when ingested. He is also the lead developer of OPERA, a free and open-source/open-data suite of quantitative structure activity relationship models that provides predictions of physicochemical properties, environmental fate parameters, and toxicity endpoints.

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Jun 07, 2021
NASA Providing Support for MPS Research: Conference June 8

The National Aeronautics and Space Administration (NASA) Science Mission Directorate’s Biological and Physical Sciences Division is announcing a multi-agency initiative, “Extended Longevity of 3D Tissues and Microphysiological Systems for Modeling of Acute and Chronic Exposures to Stressors (3DTANDMPS)”. The initiative kicked off with a virtual Pre-Proposers Conference to eld on June 8, 12 noon EDT. This conference enabled NASA to provide potential proposers with information, or emphasize existing information that may benefit proposers. Proposers also had the opportunity to pose questions and receive answers and request clarifications. 

This announcement is focused on adapting existing 3D tissues and microphysiological systems (MPS) to extend the current longevity of the 3D tissues and MPS to at least 6 months. Proposals for this initiative are due June 28, 2021. For more information about the initiative contact Lucie Low.

Jun 28, 2021
Jun 03, 2021
Draft EPA Risk Assessment for Chlorothalonil Available; Submit Comments by July 20

A notice published by EPA in the May 21 Federal Register announced availability of draft human health and/or ecological risk assessments for several pesticides. EPA is accepting public comment on the risk assessments through July 20. The Federal Register notice includes instructions on how to submit comments.

One of the pesticides covered by this announcement is the fungicide chlorothalonil, which was the subject of a case study to use an in vitro model to develop an inhalation risk assessment. The case study is described in an article in the 2018-2019 ICCVAM Biennial Report. Data from the in vitro model was used to derive human inhalation risk, which is included in the document “Chlorothalonil: Revised Human Health Draft Risk Assessment for Registration Review.” This and other documents relevant to the chlorothalonil evaluation are available in a docket on Regulations.gov.

Jul 20, 2021
Jun 03, 2021
16th Annual Multicell Virtual-Tissue Modeling Online Summer School and Hackathon

CompuCell 3D is hosting their 16th Annual Multicell Virtual-Tissue Modeling Online Summer School and Hackathon from August 1-8. Anyone with a current or potential interest in mechanistic modeling of biological systems is invited to participate in the event. The course covers multicellular modeling, which applies to developmental and tissue biology, tissue engineering, emergent diseases like cancer, in-host modeling of infection and immune response and tissue-level toxicology. No specific programming or mathematical experience is required.

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Jun 03, 2021
Registration Open for 11th World Congress; Summary of NICEATM Activities

Registration is open for the 11th World Congress on Alternatives and Animal Use in the Life Sciences, to be held online August 23-September 1. The World Congress online platform will provide a unique place for discussions of the most important topics relevant to replacement, reduction, and refinement of animal use in the life sciences.

NICEATM has had three abstracts accepted to World Congress for oral presentations and nine accepted for poster presentations. Acting NICEATM director Nicole Kleinstreuer is also participating in six sessions as a speaker, co-chair, or roundtable discussant. Information about NICEATM and ICCVAM activities at World Congress will be available soon on the NICEATM website.

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Jun 03, 2021
Upcoming Events in the Environmental Health Language Collective

NIEHS is fostering a community-driven initiative, the Environmental Health Language Collaborative, to advance integrative environmental health research by developing and promoting adoption of a harmonized language. This initiative will facilitate answering large-scale complex research questions that require integration of multiple disparate data sources by developing language standards for describing data and biomedical knowledge.

To kick-start the initiative, NIEHS is hosting a series of virtual events:

  • June 24, 1:00-4:00 p.m. EDT: The Value of Creating Language and Community in Catalyzing Knowledge-Driven Discovery in Environmental Health Research
  • July 20, 1:00-4:00 p.m. EDT: A Primer on Using Terminologies, Vocabularies, and Ontologies for Knowledge Organization
  • September 9-10, 9:00 a.m.-5:00 p.m. EDT: Catalyzing Knowledge-Driven Discovery in Environmental Health Sciences through a Harmonized Language

The events will be recorded and made available on the pre-workshop website for those unable to attend. If you have questions about the initiative, community, or the workshops, please contact Stephanie Holmgren.  

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Jun 03, 2021
Video Available: May 12 Updates on Activities Related to 21st Century Toxicology

A video is available from a May 12 meeting covering “Updates on Activities Related to 21st Century Toxicology.” This is an annual event organized by the Center for Alternatives to Animal Testing (CAAT) and the Animal-Free Safety Assessment Collaboration. The video recording of the webinar can be found on the CAAT YouTube page.

The meeting featured updates on efforts to advance toxicity testing in the 21st century. Presentations from leaders in the field included an update from acting NICEATM Director Nicole Kleinstreuer on ICCVAM and NICEATM activities.

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Jun 03, 2021
Materials from Standardization of Organ on Chips Workshop Available

Materials are now available from an April 28-29 virtual workshop, “Putting Science into Standards - Organ on Chip: Towards Standardization.” The workshop was organized by the Joint Research Centre of the European Commission, the European Committee for Standardization, and the European Committee for Electrotechnical Standardization.

Organs-on-chips, or more broadly microphysiological systems, are innovative devices that emulate human/animal biology and can reproduce one or more aspects of an organ’s functionality. The goal of this workshop was to facilitate the exchange of views on the future development of this technology, its application areas, and stakeholder needs in order to identify how European standardization can support safe, widescale deployment of these systems. The workshop included eight plenary sessions and three themed parallel breakout sessions.

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May 27, 2021
NICEATM to Collaborate with Unilever on Development of Predictive Model for Skin Sensitization

NICEATM has entered into an agreement with consumer products company Unilever to collaboratively test and further develop their Skin Allergy Risk Assessment (SARA) predictive model. SARA is a computational model that uses a variety of input data to estimate a probability that a chemical will cause an allergic skin reaction in humans. NICEATM will test the SARA model using a variety of chemical data sets, including chemicals of interest to U.S. and international regulatory agencies. NICEATM and Unilever will also work together to expand the SARA model to include data generated by NICEATM. The intent is to make the SARA model openly available for public use along with other NICEATM predictive models. Availability of the SARA model will help further reduce animal use for the endpoint of skin sensitization, and will improve upon existing efforts by providing points of departure for quantitative human risk assessment.

Information about other NICEATM projects to evaluate alternatives to animal use for skin sensitization is available on the NTP website.

Reference: Reynolds et al. Probabilistic prediction of human skin sensitizer potency for use in next generation risk assessment. Comput Toxiol 9:36-49. https://doi.org/10.1016/j.comtox.2018.10.004

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May 20, 2021
Video, Slides Available from MPSCoRe Spring Workshop

MPS provide human cell-based platforms that enable the study both of normal organ function and effects on organ function by toxicants or pathogens. On April 1, NICEATM and the National Centre for the Replacement, Refinement, and Reduction of Animal Research (NC3Rs) co-hosted a Spring Workshop for the Microphysiological Systems for COVID Research (MPSCoRe) working group.

Meeting attendees were individuals and organizations that represent MPS stakeholders as well as COVID researchers. The agenda featured talks from two sessions, “MPS Models for Testing Therapeutics” and “MPS Models for Understanding Disease Mechanisms”, followed by a Roundtable discussion. To view a recording of the presentations and other materials from the meeting, visit the NICEATM MPS page.

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May 20, 2021
Abstract Submission Open for ASCCT Annual Meeting, Deadline July 15

ASCCT is hosting their annual meeting virtually from October 12-14, 2021. The overarching theme for this year’s meeting is “Practical Applications of New Tools in Toxicology”. The agenda will include five sessions of oral presentations, posters, and other engagement opportunities.

Abstracts for oral and poster presentations are due by July 15, 2021. Abstracts should be related to in vitro and in silico toxicology, broadly defined and including science, policy, and regulatory topics.

Jul 15, 2021
May 12, 2021
May 18 Webinar Reviews In Vitro Assays for Genotoxic and Carcinogenic Potential and Cellular Stress

ASCCT and the European Society for Toxicology in Vitro are co-hosting a webinar “New Approach Methods in Genotoxicity and Mechanistic Toxicity Testing for the Animal-free Safety Assessment of Novel Pharmaceuticals and Chemicals”. The webinar will feature a presentation from Giel Hendriks, CEO of Toxys, who will talk about the development of in vitro cell-based assays for chemical safety assessment with the focus on understanding the mode-of-action of toxic compounds. The webinar will be held on Tuesday, May 18, from 10:00-11:00 a.m. EDT.

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May 11, 2021
Applications Being Accepted for Staff Scientist Within NICEATM

The National Institute of Environmental Health Sciences is seeking an experienced scientist to join NICEATM. Candidates must have:

  • Specialized experience in nonanimal alternatives and in vitro testing strategies.
  • Strong background in toxicology, physiology, molecular biology, and/or related biological science disciplines.
  • Understanding of principles used for chemical and safety hazard evaluations and risk assessment.
  • Knowledge of environmental factors capable of adversely affecting human health.
  • Experience with model systems for predicting human health effects, such as microphysiological systems, organotypic cultures, stem cell based approaches, and ‘omics technologies.
  • Understanding of the goals and activities of NICEATM and its working relationship with ICCVAM, DNTP, NIEHS, NIH, and other federal agencies, as well as experience working with NGOs, chemical industry scientists, and research organizations.

Review of applications will begin on June 3. Applicants must have a PhD, DVM, ScD, MD, or equivalent in toxicology or related fields, with at least five years of research experience after receiving the final degree, such as postdoctoral research and/or equivalent experience in their field. Application packages should include a full curriculum vitae and a 3-4 page statement of research experience and interests as well as three letters of recommendation. Please include in your CV a description of mentoring and outreach activities, especially those involving women or other underrepresented groups in biomedical research.

Jun 3, 2021
May 06, 2021
Agenda Available for May 27 ICCVAM Public Forum

An agenda is available for the ICCVAM public forum, which will be presented virtually Thursday, May 27 from 9:00 a.m. until about 4:30 p.m. EDT. This event is held annually to share information and facilitate direct communication of ideas and suggestions from stakeholders. NICEATM, ICCVAM, and a number of ICCVAM agencies will describe activities both to advance new approaches to safety testing of chemicals and medical products and to reduce the amount of testing required.

Registration is required to view the public forum webcast and will be open through the end of the meeting on May 27. Interested persons may also register to present oral public statements with associated slides on topics relevant to ICCVAM's mission. Requests to present oral statements during the meeting will be accepted on a first-come, first-served basis as time permits. The deadline for registering to present oral public statements is May 14.

May 14, 2021
May 06, 2021
Call for Nominations: National Academies Panel to Review the Variability and Relevance of Mammalian Toxicity Tests

An ad hoc committee of the National Academies of Sciences, Engineering, and Medicine will provide the U.S. Environmental Protection Agency with a review of the variability and relevance of existing laboratory mammalian toxicity tests for human health risk assessment. This review will inform the development of approaches for validation and establishing scientific confidence in using new approach methodologies (NAMs). The panel will also develop recommendations on expectations associated with NAMs when they cannot be compared with human studies. The work of the study committee will be informed by:

  • An initial public workshop organized by a subgroup of the committee.
  • A literature review that addresses the variability and human relevance of current laboratory mammalian toxicity tests and approaches to validation and establishing scientific confidence in using NAMs.
  • Public information gathering meetings organized by the study committee.

Nominations are due May 13 for committee members and reviewers for this study. Nominees should have expertise in the fields of in vitro assay development, model systems toxicology, human health risk assessment, biostatistics, veterinary medicine, or in silico and in vitro alternatives to animal testing systems. For more information, contact Clifford Duke at cduke@nas.edu.

May 13, 2021
May 06, 2021
Paper Describes Global Collaboration to Develop Predictive Models for Acute Oral Toxicity

A paper published April 30 in Environmental Health Perspectives describes a NICEATM-led international project to build computational models to predict whether substances might be toxic when ingested. The project produced the Collaborative Acute Toxicity Modeling Suite (CATMoS), which was developed specifically to help reduce or replace animal use for regulatory testing. An article about the paper is featured in the current issue of the National Institute of Environmental Health Sciences Environmental Factor newsletter.

Mansouri et al. 2021. CATMoS: Collaborative Acute Toxicity Modeling Suite. Environ Health Perspect 129(4):47013. https://ehp.niehs.nih.gov/doi/full/10.1289/EHP8495

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May 04, 2021
May 12 Webinar to Present Updates on Activities Related to 21st Century Toxicology

The Center for Alternatives to Animal Testing and the Animal-Free Safety Assessment Collaboration are hosting their annual meeting on Wednesday May 12, 10:00 a.m.-12:30 p.m. EDT. The topic of this year’s meeting is “Updates on Activities Related to 21st Century Toxicology”.

The meeting will feature updates on efforts to advance toxicity testing in the 21st century (TT21C), and leaders in the field will provide brief presentations, including an update from acting NICEATM Director Nicole Kleinstreuer on ICCVAM and NICEATM activities. Ample time will be reserved for discussion among webinar participants. This annual meeting has been held in the past as a satellite meeting of the SOT annual meeting. This year, however, with SOT held virtually, it was decided to hold the TT21C meeting virtually as well, and to do so independently from the SOT meeting.

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May 04, 2021
May 13 Webinar Will Discuss Incorporating Non-animal Methods Into TSCA Testing

A webinar on “Incorporating Non-animal Alternatives Into Toxicity Testing Under TSCA” will be presented on Thursday May 13, at 1:00-4:00 p.m. EDT. This half-day workshop will bring together toxicity data generators, users, and a wide variety of stakeholders to discuss and make recommendations on the opportunities and challenges in minimizing chemical tests on vertebrate animals. Topics to be considered include effectively communicating with relevant stakeholders and the role of NAMs in improving the assessment of chemicals on vulnerable populations. The workshop will include breakout groups considering the topics of: regulatory flexibility; information gaps NAMs can fill; engaging with stakeholders; EPA directive to eliminate mammalian testing by 2035; and metrics.

The workshop is being hosted by the Physicians Committee for Responsible Medicine, the Johns Hopkins Bloomberg School of Public Health, the UCLA School of Law, and the Environmental Law Institute.

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May 04, 2021
Webinar Series to Consider In Silico and In Vitro Approaches for Inhalation Risk Assessment

PETA-SCI, Unilever, EPA, and Syngenta are co-organizing a virtual workshop series on “Using In Silico and In Vitro Approaches for Next Generation Risk Assessment of Potential Respiratory Toxicants”. The workshop series will take place on May 19, May 26, and June 2, 8:00 a.m. to 10:00 a.m. EDT. The webinars will be listening only. Registration for the individual webinars is available on the PETA-SCI website.

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May 04, 2021
SOT Poster Presentations Available on NICEATM Website

Posters presented by NICEATM at the SOT annual meeting, held virtually from March 12-16, are now available on the NICEATM webpage. NICEATM and ICCVAM had a strong presence at meeting, presenting ten posters as well as coauthoring seven others. The next annual SOT meeting will be held in San Diego March 27-31, 2022. More information about this meeting can be found on the event webpage.

NICEATM will be presenting four posters at the 19th International Workshop on (Quantitative) Structure-Activity Relationships in Environmental and Health Sciences on June 7-10.

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May 04, 2021
Paper Summarizes EU Regulatory Requirements for Human Health Assessment of Chemicals

A new review article by the European Union (EU) Joint Research Centre, a participant organization in the International Cooperation on Alternative Test Methods, summarizes current EU regulatory requirements for the human health assessment of chemicals. This summary takes into account the respective requirements and constraints imposed by the EU Cosmetics Products Regulation, which bans animal testing for these products, and the EU REACH (registration, evaluation, and authorization of chemicals) regulation, which imposes information requirements for chemicals manufactured in or imported into the EU. The review considers the critical endpoints and identifies the main challenges in introducing alternative methods into regulatory testing practice. It complements efforts involved in implementing the Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States with regards to defining testing needs as a prerequisite to implementation of alternatives to animal testing.

Pistollato et al. 2021. Current EU regulatory requirements for the assessment of chemicals and cosmetic products: challenges and opportunities for introducing new approach methodologies. Arch Toxicol. https://doi.org/10.1007/s00204-021-03034-y

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Apr 21, 2021
BDRP Annual Meeting June 24-July 1; Late-breaking Abstracts Due May 7

The Society for Birth Defects Research and Prevention (BDRP) will hold their 61st annual meeting virtually from June 24-July 7. Registration for the meeting is required. The meeting will feature award presentations, keynote speakers, platform sessions, and poster sessions. The program agenda is available.

Late-breaking abstracts are being accepted for poster sessions and are due May 7. Posters will be presented on June 28, 29, or 30 from 3:30–4:30 p.m. EDT. During the poster sessions, authors will have their own “virtual rooms” to discuss their research face-to-face with other meeting attendees.

May 7, 2021
Apr 21, 2021
NICEATM Activities at QSAR 2021; Registration Deadline May 8

The 19th International Workshop on (Quantitative) Structure-Activity Relationships in Environmental and Health Sciences (QSAR 2021) will be held virtually June 7-10, 2021. The meeting program is available and registration is open; the registration deadline is May 8.

Acting NICEATM Director Nicole Kleinstreuer, NICEATM computational chemist Kamel Mansouri, and senior toxicologist Agnes Karmaus (ILS, contractor supporting NICEATM) are serving on the organizing committee for QSAR 2021. NICEATM will be presenting four posters at QSAR 2021 describing NICEATM tools and data resources for development and evaluation of new chemical safety testing approaches. Information on NICEATM activities at QSAR 2021 is available on the NICEATM website.

May 8, 2021
Apr 21, 2021
New Review Article Describes Non-animal Approaches to Eye Irritation Testing

Acting NICEATM Director Nicole Kleinstreuer and other NICEATM scientists are co-authors on a new review article in Cutaneous and Ocular Toxicology that describes available non-animal test methods and their relevance to eye anatomy and mechanisms of eye irritation in humans. Combinations of the reviewed methods may be used in development of human-relevant integrated testing approaches.

Clippinger et al. Human-relevant approaches to assess eye corrosion/irritation potential of agrochemical formulations. Cutan Ocul Toxcol. DOI: 10.1080/15569527.2021.1910291

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Apr 09, 2021
Registration Open for ICCVAM Public Forum May 27

ICCVAM will hold a virtual public forum Thursday, May 27 from 9:00 a.m. until about 4:30 p.m. EDT. This event is held annually to share information and facilitate direct communication of ideas and suggestions from stakeholders. NICEATM, ICCVAM, and a number of ICCVAM agencies will describe activities both to advance new approaches to safety testing of chemicals and medical products and to reduce the amount of testing required.

Registration is required to view the public forum webcast and will be open through the end of the meeting on May 27. Interested persons may also register to present oral public statements with associated slides on topics relevant to ICCVAM's mission. Requests to present oral statements during the meeting will be accepted on a first-come, first-served basis as time permits. The deadline for registering to present oral public statements is May 14.

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Apr 09, 2021
DOE Offers Funding to Develop Machine Learning Tools

The U.S. Department of Energy (DOE) will award $29 million in grants to develop new tools to analyze massive amounts of scientific information. Tools will use technologies such as artificial intelligence, machine learning, and advanced algorithms. DOE is offering two grants for research in the following areas:

DOE National Laboratories, universities, industry, and nonprofit research institutions may apply, with competitive funding awarded based on peer review.

Apr 16, 2021
Apr 09, 2021
Program Available for QSAR 2021: Register by May 8

The 19th International Workshop on (Quantitative) Structure-Activity Relationships in Environmental Health Sciences (QSAR 2021) will be held virtually from June 7-June 10, 2021. Each day of the meeting will feature two concurrent platform sessions and a keynote speaker each morning, with sponsored platform presentations followed by three concurrent poster sessions in the afternoons. The full program for QSAR 2021 is available on the program website.

To register for QSAR 2021, visit the meeting registration webpage. The deadline to register is May 8.

May 8, 2021
Apr 09, 2021
Workshop to Focus on Standardization of Organ on Chips

A free virtual workshop on April 28-29 will consider the topic “Putting Science into Standards - Organ on Chip: Towards Standardization”. The workshop is hosted by the Joint Research Centre of the European Commission, the European Committee for Standardization, and the European Committee for Electrotechnical Standardization. Registration is open.

Organ-on-chips, or more broadly microphysiological systems, are innovative devices that emulate human/animal biology and can reproduce one or more aspects of an organ’s functionality. Among other benefits, they can lead to better testing of drugs and adapted treatments to genetic diversity, ethnicity, sex and age; reduce the cost of clinical trials and replace animal testing for cosmetic products. The goal of this workshop is to facilitate the exchange of views on the future development of this technology, its application areas, and stakeholder needs in order to identify how European standardization can support safe, widescale deployment of these systems.

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Apr 08, 2021
Survey Seeks Information on Use of Animal-derived Reagents

A group of European research centers and nonprofits is conducting a survey to identify the most commonly used animal-derived materials and reagents (e.g., animal sera, antibodies, etc.) in in vitro experimentation, and characterize the current level of knowledge on available non-animal derived alternatives. Survey results will help create a framework to shape policy in science and education. The survey is being coordinated by Italian nonprofit “Oltre la Sperimentazione Animale” (OSA; English: “Beyond Animal Experimentation”).

The survey is directed to scientists at any level involved in human health or life science research. It takes about 15 minutes to complete. There is no deadline to respond. Survey organizers hope to compile responses from at least 500 researchers and share survey results in a presentation at the virtual 11th World Congress on Alternatives and Animal Use in the Life Sciences in August.

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Apr 08, 2021
April 27 Webinar to Consider Legal and Policy Considerations for NAM Use

ASCCT and the European Society of Toxicology In Vitro will host a webinar on “Legal and Policy Considerations for the Use of New Approach Methodologies in Chemical Risk Assessment.” The webinar will be presented on Tuesday, April 27, from 10:00-11:30 a.m. EDT.

  • The first presentation, "Legal and Policy Challenges in Agency Regulatory Use of NAMs," will be given by Gary Marchant of the Sandra Day O’Connor College of Law at Arizona State University and Kirk Hartley of ToxicoGenomica and LSP Group LLC. Marchant and Hartley will discuss the challenges of using NAMs in regulatory decision-making using case studies from EPA.
  • In the second presentation, "Case Studies of Actual Uses of NAMs in Civil Litigation Involving Diseases/Conditions," Hartley will discuss the use of NAM-based data in product liability and personal injury cases.
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Apr 08, 2021
Finalists Announced for EMGS Bioinformatics Challenge

EMGS has announced the four finalists in its 2021 Bioinformatics Challenge:

  • Predicting Molecular Initiating Events from High Throughput Transcriptomic Screening using Machine Learning (lead institution: EPA).
  • Leveraging Zebrafish High-throughput Screening Data and Conditional Generative Adversarial Networks to Advance Predictive Toxicology (lead institution: North Carolina State University).
  • Transcriptomic Meta-Analyses Reveal a Molecular Fingerprint Underlying Hepatic Cholestasis Response (lead institution: ScitoVation LLC).
  • Exposome Target Prediction with Coupled Matrix-Matrix Completion (lead institution: University of Michigan).

The second-round competition will be held as a series of webinars presented in conjunction with the EMGS annual meeting in September.

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Apr 08, 2021
FDA to Hold Science Forum May 26-27

The 2021 FDA Science Forum will be held virtually on Wednesday and Thursday, May 26-27. The event allows the public to view the research and collaboration ongoing at FDA, and how FDA researchers use novel science and technologies to inform FDA’s regulatory decision-making and drive innovation.

The theme of this year’s forum is “Science as the Foundation for Protecting and Promoting Public Health,” and one of the topic areas is “Tools to Effectively Use Big Data.” The forum will feature a keynote address by is National Institute of Allergy and Infectious Diseases Director Anthony Fauci.

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Apr 01, 2021
CPSC Issues Proposed Guidance on Use of Alternative Methods, Comments Due June 14

In a March 31 Federal Register notice, CPSC requested comment on its “Proposed Guidance for Industry and Test Method Developers: CPSC Staff Evaluation of Alternative Test Methods and Integrated Testing Approaches and Data Generated from Such Methods to Support FHSA Labeling Requirements.” CPSC has developed this guidance, building on its Animal Testing Policy, to assist stakeholders in determining what test methods are deemed reliable for determining compliance with the labeling requirements under the Federal Hazardous Substances Act. This includes clarification of CPSC informational requirements and process for evaluating new approach methodologies and integrated approaches to testing and assessment.

More information about the draft guidance and instructions on how to submit comments are available in the Federal Register notice (download notice as PDF). Comments are due June 14.

Jun 14, 2021
Apr 01, 2021
NIEHS Invites Participation in Development of a Harmonized Language for Environmental Health Research

NIEHS is leading a community-driven initiative to advance integrative environmental health research by developing and promoting adoption of a harmonized language. This initiative will facilitate answering large-scale complex research questions that require integration of multiple disparate data sources by developing standards for describing data and biomedical knowledge.

To begin the process of community development, NIEHS is hosting a session on “Enhancing Semantic Interoperability in Environmental Health Sciences Research” on Wednesday, April 21, from 11:00 a.m.-12:30 p.m. EDT (3:00-4:30 p.m. UTC). This is the first of several events that NIEHS will host related to this initiative.

The April 21 event is part of the upcoming Research Data Alliance Plenary Meeting, which will be held virtually from April 20-23. Research Data Alliance is an international collaboration with the goal of building the social and technical infrastructure to enable open sharing and re-use of data.

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Apr 01, 2021
Apply by June 30 for HESI Innovation Prize

HESI is accepting nominations for the 2021 HESI Innovation Prize. This prize recognizes scientists who share HESI’s commitment to synthesizing ideas, resources, and collaborators across scientific disciplines and sectors. The theme of this year’s prize is “health equity,” and nominees will be evaluated on their work to catalyze health equity progress in relation to HESI’s four focus areas: safe and effective medicines, food safety and security, chemical and consumer product safety, and environmental quality and sustainability.

Individual scientists who hold a master’s degree or higher may self-nominate or be nominated by colleagues; there are no geographic restrictions. Groups and institutions are not eligible. Nominations will be evaluated on the basis of work done by the nominee over the past five years. The winner will receive an unrestricted cash prize of $80,000 USD. Nominations are due by June 30; winners will be announced in August.

Jun 30, 2021
Apr 01, 2021
NICEATM Paper Describes Variability in Skin Irritation Data

To establish appropriate benchmarks for understanding the performance of new approach methodologies, the reference standard animal tests should be well characterized. To assess variability in the rabbit skin irritation test, NICEATM analyzed data from 990 substances tested at least twice each. The analysis found that chemicals classified as moderate irritants at least once were classified as mild or non-irritants at least 40% of the time when tested repeatedly. This analysis indicates that variability present in the rabbit skin irritation test should be considered when evaluating nonanimal alternative methods as potential replacements.

Rooney et al. 2021. Analysis of variability in the rabbit skin irritation assay. Reg Toxicol Pharmacol. https://doi.org/10.1016/j.yrtph.2021.104920.

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Mar 30, 2021
Nominations Due April 30 for Russell and Burch Award

HSUS has extended the deadline for nominations for the Russell and Burch Award to April 30. This award is named in honor of William Russell and Rex Burch, the scientists who formulated the three Rs approach of replacement, reduction and refinement and recognizes those who have played an important role in limiting the use and suffering of animals in laboratories. The 2021 award will be presented virtually at the 11th World Congress on Alternatives and Animal Use in the Life Sciences.

For this award, HSUS welcomes nominations of scientists who have made outstanding contributions to the advancement of alternative methods in the areas of research, testing, or higher education. Applicants may nominate themselves or others. Anyone who submitted a nomination last year will not need to resubmit the application. Nominations should include a cover letter explaining the nominee’s suitability for the award, the nominee’s curriculum vitae, and three published articles that represent their work in alternative testing methods. To apply email Mary Hilley at mhilley@humanesociety.org.

Apr 30, 2021
Mar 30, 2021
ARDF Offering Research Funding: Proposals Due April 30

ARDF is soliciting proposals for research projects that focus on significantly reducing or replacing laboratory animals in biomedical research, product testing, and education. Up to $40,000 U.S. will be awarded. Proposals will be accepted from non-profit, tax-exempt educational or research institutions from any country. Preference will be given to proposals from U.S. institutions and organizations describing in silico and in vitro methods with human cells or tissues using pathway-based approaches as exemplified by the 2007 National Academy of Sciences report, “Toxicity Testing in the Twenty-first Century: A Vision and A Strategy.” The deadline to apply for the funding opportunity is April 30.

Apr 30, 2021
Mar 30, 2021
OECD Presents Webinar on Physiologically Based Kinetic Modeling May 10

OECD is presenting a webinar on physiologically based kinetic modeling (PBK) titled “Gaining Acceptance in Next Generation PBK Modelling Approaches for Regulatory Assessments.” The webinar’s six speakers will describe a scientific workflow for characterizing and validating PBK models, a template for documenting PBK models in a systematic manner, and a checklist to support model evaluation. The webinar will be held on May 10 from 7:20-9:30 a.m. EDT.

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Mar 30, 2021
Webinar on QSAR Modeling of Skin Sensitization May 19

The SOT In Vitro and Alternative Methods and Computational Toxicology specialty sections are co-sponsoring a 75-minute webinar on May 19 at 11:00 a.m. titled “State of the Science: QSAR Modeling of Skin Sensitization.” The webinar will feature three speakers:

  1. Vinicius Alves, University of North Carolina at Chapel Hill: Pred-Skin: A Web Portal for Accurate Prediction of Human Skin Sensitizers
  2. Emily Golden, Center for Alternatives to Animal Testing, Johns Hopkins University: Evaluation of the Global Performance of Eight In Silico Skin Sensitization Models Using Human Data
  3. Glenn Myatt, Leadscope, Inc.: Skin Sensitization In Silico Protocol
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Mar 25, 2021
DNTP Postdoctoral Fellow Wins SOT Specialty Section Young Investigator Award

The SOT Computational Toxicology Specialty Section selected DNTP/NICEATM scientist Shagun Krishna as the recipient of this year’s Yves Alarie Diversity Award for Trainees and Young Investigators. This award recognizes a young investigator from an under-represented group who is working in the field of computational toxicology. The award was presented at the specialty section’s virtual reception on March 16.

Krishna is a postdoctoral fellow at the National Institute of Environmental Health Sciences. Her mentor is Acting NICEATM Director Nicole Kleinstreuer. The current focus of Krishna’s research is developing informatics approaches to identifying potentially cardiotoxic substances.

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Mar 25, 2021
NICEATM Paper Named Paper of the Year by SOT Specialty Section

Neepa Choksi, Principal Toxicologist at ILS (contractor supporting NICEATM), is first author of the 2021 SOT Ocular Toxicology Specialty Section Paper of the Year. The paper describes validation of OptiSafe, a non-animal method to assess eye irritation hazard. The award was presented at the specialty section’s virtual reception on March 15.

Choksi et al. 2020. Validation of the OptiSafe™ eye irritation test. Cutan Ocul Toxicol 39(3):180-192. https://doi.org/10.1080/15569527.2020.1787431

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Mar 25, 2021
Paper Describes Characteristics of Positive Controls for In Vitro Assays

Because specific positive control materials are often written into testing standards for in vitro assays, selection of appropriate positive control materials can aid in ensuring the long-term relevance and usability of these standards. A recent publication in the journal ALTEX describes characteristics that should be considered when selecting a positive control material for an in vitro assay. Authors of the paper include Acting NICEATM Director Nicole Kleinstreuer and ICCVAM members John Gordon. U.S. Consumer Product Safety Commission, and Elijah Petersen and John Elliott, both of the National Institute of Standards and Technology.

Petersen et al. 2021. Characteristics to consider when selecting a positive control material for an in vitro assay. ALTEX. https://doi.org/10.14573/altex.2102111

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Mar 25, 2021
Paper Evaluates Use of In Vitro Data Alone to Estimate Dermal Absorption

Estimates of dermal absorption used in dermal toxicity hazard assessments are currently derived using both in vitro and in vivo data. NICEATM and the U.S. Environmental Protection Agency retrospectively evaluated agrochemical formulations to assess the feasibility of using in vitro data alone for these estimates. The comparisons presented support potentially using in vitro data alone to derive these estimates for human health risk assessment of pesticides.

Allen et al. 2021. Retrospective analysis of dermal absorption triple pack data. ALTEX. https://doi.org/10.14573/altex.2101121

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Mar 25, 2021
Recent Meeting Reports
  • Acting NICEATM Director Kleinstreuer coauthored a summary of a symposium titled “Per- and Polyfluoroalkyl Substances (PFAS): Challenges and Opportunities,” hosted by the Yale School of Public Health. The meeting focused on the current state of the science on these chemicals, highlighted the challenges unique to PFAS, and explored promising opportunities for addressing them.
    Hagstrom et al. 2021. Yale School of Public Health Symposium: An overview of the challenges and opportunities associated with per- and polyfluoroalkyl substances (PFAS). Sci Total Environ. https://doi.org/10.1016/j.scitotenv.2021.146192
  • A report is now available of the November 2018 workshop “FutureTox IV: Predictive Toxicology for Healthy Children.” Report coauthors include Acting NICEATM Director Kleinstreuer; ICCVAM members Suzanne Fitzpatrick and Donna Mendrick, both of FDA; and K. Nadira De Abrew, current chair of SACATM.
    Knudsen et al. 2021. FutureTox IV Workshop Summary: Predictive Toxicology for Healthy Children. Toxicol Sci. https://doi.org/10.1093/toxsci/kfab013
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Mar 18, 2021
NICEATM and ICCVAM Activities: SOT Week 2

The following sessions during the second week of the virtual SOT meeting, March 22-26, feature presentations by NICEATM and ICCVAM scientists. Please consider adding them to your itinerary.

Monday March 22:

  • Poster Session - 1:00-2:45 p.m. EDT: Computational Toxicology I
  • Poster Session - 1:00-2:45 p.m. EDT: Risk Assessment
Tuesday March 23:
  • Symposium Session - 11:15 a.m.-2:00 p.m. EDT: Opportunities for Human Induced Pluripotent Stem Cell-Derived Neurons in In Vitro Neurotoxicity Safety Testing
  • Symposium Session - 11:30 a.m.-2:45 p.m. EDT: Mind the Gap: Finding Practical Ways to Fast-Track the Future of Animal-Free Toxicology Testing
  • Poster Session - 1:00-2:45 p.m. EDT: Computational Toxicology II
  • Poster Session - 1:00-2:45 p.m. EDT: Alternatives to Mammalian Models I
  • Poster Session - 1:00-2:45 p.m. EDT: DNA Damage and Repair
  • Platform Session - 2:45-4:00 p.m. EDT: Biological Models for In Vitro-In Vivo Extrapolation
Wednesday March 24:
  • Workshop Session - 11:45 a.m.-2:30 p.m. EDT: Applicability Domains and Future of Nonanimal Tests for Skin Sensitization
  • Poster Session - 11:00 a.m.-1:00 p.m. EDT: Alternatives to Mammalian Models II
Friday March 26:
  • Continuing Education Course 11 - 11:00 a.m.-2:45 p.m. EDT: Establishing Confidence in Organ-on-a-Chip Systems for Toxicity Testing: Lung-on-a-Chip as an Example
  • Continuing Education Course 14 - 11:00 a.m.-2:45 p.m. EDT: Understanding Tox21/ToxCast High-Throughput Screening Data and Applications to Modeling
Mar 26, 2021
Mar 18, 2021
Nominations Open for Awards at QSAR 2021

Scientists planning to attend QSAR 2021 are invited to nominate themselves or their colleagues for awards to be presented at the workshop. Nominations are due by April 30.

  • Students or postdocs who have submitted an abstract to QSAR 2021 are eligible for the Student/Post-Doc Best Abstract Awards. Three awards will be presented, one each to applicants from North America, Europe, and Japan. Winners will receive complementary registration to QSAR 2021 and the next international QSAR conference.
  • Scientists who have made substantial and seminal scientific contributions to the field of in silico non-animal testing methods are eligible for the International QSAR Lifetime Achievement Award. Nominees should be active scientists involved in relevant research and must have worked at least 30 years in the field after receiving their highest degree. The winner will be honored during the QSAR 2021 awards luncheon and recognized in the meeting program and website.
  • Scientists who have made significant scientific contributions to the field of in silico non-animal testing methods are eligible for the International QSAR Mid-career Achievement Award. Nominees should be active scientists involved in relevant research and must have worked 15-30 years in the field after receiving their highest degree. The winner will be honored during the QSAR 2021 awards luncheon and recognized in the meeting program and website.
  • Scientists who have made significant scientific contributions to the field of in silico non-animal testing methods and show promise in continuing to have a meaningful role in the field are eligible for the International QSAR Promising Early Career Award. Nominees should be active scientists involved in relevant research and must have worked 5-15 years in the field after receiving their highest degree. The winner will be honored during the QSAR 2021 awards luncheon and recognized in the meeting program and website. They will also receive a £250 monetary award, courtesy of the journal ATLA (Alternatives to Laboratory Animals).
Apr 30, 2021
Mar 18, 2021
Abstract Submission Reopened for 11th World Congress, Deadline April 1

The 11th World Congress on Alternatives and Animal Use in the Life Sciences will be held as a virtual meeting from August 23-September 2. Registration will open soon. Those who registered to attend World Congress in 2020 will not need to re-register to attend the virtual World Congress. Frequently Asked Questions about the virtual World Congress can be viewed on the meeting website.

World Congress organizers are accepting new abstracts. Abstracts previously submitted can be updated. The deadline for submitting, updating, or withdrawing abstracts is April 1. Abstracts should cover original work that may have been published recently; there is no abstract submission fee.

Apr 1, 2021
Mar 16, 2021
NICEATM Releases ICE 3.3

On March 12, NICEATM released the version 3.3 update of the Integrated Chemical Environment (ICE). ICE provides data and tools to help develop, assess, and interpret chemical safety tests. This release adds two new tools, new features including expanded activity visualization, and new datasets to existing ICE resources.

New tools:

  • Curve Surfer: allows users to view and interact with concentration-response curves from curated high-throughput screening data.
  • PBPK tool: this tool, based on the EPA httk package, allows users to generate predictions of tissue-specific chemical concentration profiles following a dosing event.

Updates to existing tools:

  • Search tool: users can get detailed visualization of query results.
  • IVIVE tool: users can now upload their own in vivo data to overlay on the results.
  • Chemical Characterization: new visualizations include bioactivity PCA plots and Consumer Use Explorer, which allows users to view chemical use categories from EPA's CPDat.

New data:

  • Cancer data from multiple sources, including detailed data from NTP two-year cancer bioassays and in vivo and in vitro genotoxicity studies.
  • DART in vivo bioassays from EPA’s ToxRefDB.
  • Updated in vivo human predictive patch test data set for skin sensitization characterization compiled by NICEATM and the German Federal Institute for Risk Assessment (BfR).

ICE is available at https://ice.ntp.niehs.nih.gov/.

 

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Mar 12, 2021
NICEATM and ICCVAM Activities: SOT Week 1

The following sessions during the first full week of the virtual SOT meeting, March 15-19, feature presentations by NICEATM and ICCVAM scientists. Please consider adding them to your itinerary.

Monday March 15:

  • Workshop Session - 11:15 a.m.-2:00 p.m. EDT: A Future Framework for Application of In Vitro Metabolism and QIVIVE Models to Inform Risk Assessment

Tuesday March 16:

  • Symposium Session - 11:15 a.m.-2:00 p.m. EDT: Developmental Toxicity Hazard Assessment without Animals: Pathways and Prospects

Thursday March 18:

  • Workshop Session - 11:15 a.m.-2:00 p.m. EDT: New Approach Methods for Cancer Risk Assessment
  • Poster Session - 1:00-2:45 p.m. EDT: Ecotoxicology
  • Poster Session - 1:00-2:45 p.m. EDT: Regulation/Policy
  • Roundtable Session - 2:45-4:05 p.m. EDT: The Future of Uncertainty Factors with In Vitro Studies Using Human Cells

We look forward to seeing you at SOT!

Mar 19, 2021
Mar 05, 2021
March 10 Webinar Highlights Computational and AOP-based Approaches to Predicting Carcinogenicity

The PETA Science Consortium International e.V. is co-organizing a webinar series with EPA and PCRM. The eighth webinar in the series, “Use of Computational and AOP-based Approaches to Inform Carcinogenicity Assessments,” will be Wednesday, March 10 at 11:00 a.m.

This webinar features two presenters:

  • Susanne Stalford from Lhasa Limited will present on the development of an adverse outcome pathway (AOP) framework being developed for carcinogenicity risk.
  • Martin Philips from the EPA Office of Pollution Prevention and Toxics will present an overview of OncoLogic® Version 9, a system for predicting carcinogenicity concerns.
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Mar 05, 2021
Abstracts Due March 31 for Birth Defects Research and Prevention Society Annual Meeting

The Birth Defects Research and Prevention Society annual meeting will be held virtually from June 24-July 1. The theme for this year’s meeting is “Building Bridges in Birth Defects Research and Prevention: From Innovation to Application”.

Abstract submissions are due March 31. More information about the annual meeting and abstract submission, including a list of topics for potential abstracts, visit the Society's website.

Mar 31, 2021
Mar 05, 2021
11th World Congress to be Held Virtually

The 11th World Congress on Animal Use and Alternatives in the Life Sciences will be held virtually in late August 2021. More information will be posted as it becomes available on the World Congress website.

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Feb 22, 2021
Apply by April 9 for Free Inhalation Tissue Models

PETA Science Consortium International e.V. (PETA-SCI) is teaming up with MatTek Life Sciences to offer EpiAlveolar™ and EpiAirway™ tissues that can be used to test chemicals, drugs, nanomaterials, and pathogens. EpiAlveolar models the lower respiratory tract and includes primary human alveolar epithelial cells, pulmonary endothelial cells, and fibroblasts, while EpiAirway models the upper respiratory tract and comprises normal, human-derived tracheal/bronchial epithelial cells.

The awardee will be selected based on their proposal’s scientific merit and impact on replacing animal tests, and will receive $10,000 U.S. redeemable for EpiAlveolar or EpiAirway tissues. Researchers from any sector are encouraged to apply, and the competition is open to applicants worldwide. More information is available on the PETA-SCI website; apply by April 9

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Apr 9, 2021
Feb 22, 2021
Germolec Elected to SOT Leadership Position

Dori Germolec, National Institute of Environmental Health Sciences, has been elected to serve as SOT Vice President-elect for 2021-2022. The Vice President-elect serves on the SOT governing council and transitions to the role of Vice President and then President in subsequent years. Germolec will begin her term on May 1. A blog post on the SOT website summarizes Germolec's work with SOT and her vision for the future of SOT.

For several years, Germolec has led or participated in NICEATM immunotoxicity projects. She coordinated testing in three in vitro assays of over 200 chemicals nominated by ICCVAM member agencies to expand the potential applicability of defined approaches to identification of skin sensitizers. Some of these data were used to support the use of non-animal defined approaches for skin sensitization hazard assessment of isothiazolinone compounds, the basis for a recent draft U.S. Environmental Protection Agency risk assessment for these substances. Germolec is a member of the ICCVAM Skin Sensitization Expert Group and the ICCVAM Developmental Immunotoxicity Expert Group.

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Feb 22, 2021
Slides and Video Available from ICCVAM January 26 Webinar

Slides and video are now available from the January 26 ICCVAM Communities of Practice Webinar on "Non-animal Approaches for Mixtures Assessment." The purpose of this webinar was to present key insights and ongoing activities in the area of mixtures toxicity testing. The webinar included presentations from staff of three ICCVAM agencies, including Cynthia Rider from the National Institute of Environmental Health Sciences, Patricia Ruiz from the Agency for Toxic Substances and Disease Registry, and Kristin Isaacs from the U.S. Environmental Protection Agency.

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Feb 22, 2021
Chemical Research in Toxicology Special Issue Focuses on Computational Toxicology

The discipline of computational toxicology encompasses the use of computational tools to support integrative approaches to toxicological research and chemical safety assessments. Computational approaches can be applied to predictive modeling, analyses of complex data sets, and extrapolation and translation among evidence streams, particularly those from new approach methodologies that rely upon alternatives to animal testing.

Chemical Research in Toxicology has published a special issue focusing on computational toxicology. The issue includes 38 contributions from experts in the field, as well as three reviews and perspectives, 34 research articles and one ToxWatch. Acting NICEATM Director Nicole Kleinstreuer is a co-editor of the special issue and co-author of three research articles. Other co-authors of articles appearing in the issue include Brian Berridge, principal representative to ICCVAM from the National Institute of Environmental Health Sciences, and Suzanne Fitzpatrick, principal representative to ICCVAM from the U.S. Food and Drug Administration.

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Feb 22, 2021
PETA-ISC Activities Now Being Conducted by PETA-SCI

In order to maintain full engagement with the European Union, the UK-based PETA International Science Consortium Ltd. announced that it will cease operations and that their activities will now be conducted as the Germany-based PETA Science Consortium International e.V. (PETA-SCI). PETA-SCI will continue to engage with NICEATM and other organizations to advance robust non-animal methods.

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Feb 22, 2021
Postdoctoral Opportunity at NCATS

NCATS is seeking an exceptional scientist to apply genomic tools to toxicology and pharmacology as a postdoctoral student in the Genomic Toxicology Lab. The Genomic Toxicology Lab participates in the U.S. federal Tox21 Consortium by developing methods to assess the effects of chemicals on human health.

The selected candidate will complete development and implement a novel high-throughput screening method that quantifies expression of selected genes in cultured mammalian cells. They will work with collaborators who have developed iPSC-derived endothelial cells, as well as 3-D endothelial cell models that incorporate shear flow and co-culture with vascular smooth muscle cells.

Applicants should be U.S. citizens and have a Ph.D. in a relevant field of molecular or medical biology, a strong publication record, molecular biology and mammalian cell culture skills and strong communication skills in written and spoken English. Familiarity with vascular biology, or high-throughput screening is an advantage.

To apply, please send a cover letter, that specifically addresses why you're interested in this position, a CV with bibliography, and names and contact information for three references to David Gerhold at NCATSGenomicTox@mail.nih.gov.

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Feb 16, 2021
Update Available: EPA List of Alternative Test Methods

EPA has updated the list of NAMs that the agency will consider for the purpose of satisfying information requirements under TSCA. Updates reflect changes made to OECD test guidelines. Other updates consider guidance on acute systemic toxicity testing waivers issued by the EPA Office of Pesticide Programs, and availability of a new expert system to predict carcinogenicity of organic chemicals, fibers, metals, and polymers.

A 2016 update of TSCA required EPA to issue a list of methods and approaches that do not use vertebrate animals to develop new data or information required under TSCA. EPA also developed the “Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program.” Information about the NAMs list and the Strategic Plan is available on the EPA website.

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Feb 16, 2021
Video Available from MPS Workgroup Meeting

Microphysiological systems (MPS) provide human cell-based platforms that enable the study both of normal organ function and effects on organ function by toxicants or pathogens. On January 29, NICEATM and the National Centre for the Replacement, Refinement, and Reduction of Animal Research (NC3Rs) co-hosted the first meeting of the Microphysiological Systems for COVID Research (MPSCoRe) working group.

Meeting attendees were individuals and organizations that represent MPS stakeholders as well as COVID researchers. The agenda included three presentations and a time for open discussion. To view a recording of the presentations and other materials from the meeting, visit the NICEATM MPS webpage.

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Feb 16, 2021
ICCVAM Member Honored by Chemical Research in Toxicology

ICCVAM Member Elijah Petersen, NIST, is recipient of the 2020 Young Investigator Award from Chemical Research in Toxicology. The journal has published an interview with Petersen about the award.

Petersen played a key role in NIST becoming an ICCVAM member agency in 2016 and has been NIST’s alternate principal agency representative since NIST joined ICCVAM. His work focuses on developing robust, reproducible standard methods, and he has a particular interest in the effect of nanomaterials contamination on living organisms. He is a lead investigator for an ongoing validation study of the electrophilic allergen screening assay that is being conducted by four ICCVAM member agencies.

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Feb 16, 2021
Deadline February 28 for EMGS Bioinformatics Challenge

EMGS is now accepting submissions for their 2021 Bioinformatics Challenge. Abstracts are solicited for following areas:

  • Novel computational approaches, including machine learning and artificial intelligence, on high-throughput, high-content, exposure-risk assessment, and/or clinical data classification.
  • Genetic/genomic toxicological applications of model organism databases, including EcoCyc E. coli database, Saccharomyces genome database, WormBase, wFleaBase, Xenbase, and ZFIN.
  • Predictive modeling with genomic/mutation/epimutation datasets, and/or toxicology databases, including Tox21/ToxCast, Drug Matrix, TG-Gates, Comparative Toxicogenomics Database, and SeqAPASS.

Submissions should include a 250-word abstract and a data visualization or conceptual workflow pipeline. Submissions are due by February 28 to bioinformatics@emgs-us.org. Selected participants will receive a $100 monetary award and present their work in the preliminary round of the competition, which will be held as a virtual symposium in Spring 2021. The finalist teams will be invited to present during the 2021 EMGS Virtual Annual Meeting and compete for the grand prize of $1000.

Feb 28, 2021
Feb 16, 2021
Workshop Report Available: Application of NAMs in Support of Read-across

Read-across is a computational technique that uses toxicity data from data-rich chemicals to predict toxicity for an untested or data-poor chemical. The use of NAMs in support of read-across approaches for regulatory purposes is a main goal of the European Union’s EU-ToxRisk project. At a 2019 workshop, scientists from regulatory agencies, industry, and academia met to discuss this issue and consider case studies in which read-across had been applied to specific regulatory problems. Grace Patlewicz, EPA, chair of the ICCVAM Read Across Workgroup, is a co-author of the workshop report.

Rovida et al. NAM-supported read-across: from case studies to regulatory guidance in safety assessment. ALTEX. https://doi.org/10.14573/altex.2010062

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Feb 09, 2021
EURL ECVAM Issues Status Report on Alternatives

EURL ECVAM has issued its 2020 “Status Report on the Development, Validation and Regulatory Acceptance of Alternative Methods and Approaches.”

The status report describes research, development, and validation activities, as well as initiatives that promote the regulatory and international adoption and use of alternative approaches and their dissemination. Activities described in the report include:

  • Developing guidance for moving from traditional animal tests to non-animal assays for vaccine quality control.
  • Validating methods to identify substances with the potential to affect the thyroid signaling pathway, damage DNA, induce skin and respiratory sensitization, or harm fish.
  • Exploring how to apply existing toxicity information to predicting different toxicity endpoints.
  • EURL ECVAM, which is part of the European Commission's Joint Research Centre, coordinates research and validation studies on alternatives to animal testing within the European Union. EURL ECVAM also shares knowledge about and promotes use of alternative methods.
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Feb 09, 2021
Special Issue of Frontiers in In Vitro Toxicology on New Approach Methodologies

Frontiers in In Vitro Toxicology has launched a new research topic, Chemical Testing Using New Approach Methodologies (NAMs). The journal is actively looking for research contributions on this topic for an upcoming special issue. Contributions should be related to the use of NAMs to meet or support regulatory requirements for chemical toxicity testing. Submissions will be put online as they are accepted and the journal will also put together a special e-book of the issue after the deadline.

The optional deadline to submit an abstract is March 31, 2021. Manuscripts are due by July 31, 2021. To submit your abstract or manuscript and for more information about this research topic visit the journal website.

Jul 31, 2021
Feb 09, 2021
Postdoctoral Opportunity at NIST

NIST has an opening for a postdoctoral position in their Biosystems and Biomaterials Division. This postdoctoral opportunity will feature comprehensive examination of in vitro or other assays relevant to the biocompatibility of dental materials to improve the repeatability, comparability and interlaboratory agreement of the assay results. The position is located in the Gaithersburg, MD office.

Applicants should be U.S. citizens and have Ph.D.s in engineering, biology, chemistry, physics, or a related field. Applicants should also have experience in cell and tissue culture, cell-assay development and execution, and using other biological laboratory assays.

Applications are being received now and will continue to be reviewed on a rolling basis until the position is filed. To apply, applicants should send an updated CV and contact information to Elijah Petersen elijah.petersen@nist.gov.

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Feb 09, 2021
Positions Available for Biologists at EPA; Apply by February 17

EPA has openings for experienced biologists in the Health Effects Division and the Environmental Fate and Effects Division within the Office of Pesticide Programs. Successful candidates for these positions will:

  • Interpret, evaluate, analyze, and synthesize scientific data and other information for the development of human health and/or environmental assessments on the effects of pesticides from both hazard/toxicology and exposure studies.
  • Determine the general approach necessary to accomplish the review and evaluation of data.
  • Prepare reports that include evaluation of available data and assessments of exposure, hazard, and/or risk from exposure to pesticides.
  • Review and make recommendations on the exposure analyses for pesticides in various environments concerning the retention or cancellation of pesticides.

Applicants should have at least a bachelor’s degree in biological sciences, agriculture, natural resource management, chemistry, or related area and at least one year of relevant experience. Applicants must be U.S. citizens, and a pre-employment background check will be required. All positions are currently located in Arlington, Virginia. Applications must be submitted by Wednesday, February 17. For more information, contact Chelsea Vaughn at 919-541-4215 or vaughn.chelsea@epa.gov.

Feb 17, 2021
Feb 09, 2021
New Toxicity Prediction Model Provides Broader and Improved Predictions

A publication coauthored by Acting NICEATM Director Nicole Kleinstreuer describes computational models that use a variety of multitask approaches to predict acute systemic toxicity. The accuracy of the new models improves upon previous models. The new models also provide toxicity predictions for species such as dog, chicken, and rabbit.

Jain et al. 2021. Large-scale modeling of multispecies acute toxicity end points using consensus of multitask deep learning models. J Chem Inf Model. https://doi.org/10.1021/acs.jcim.0c01164

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Feb 05, 2021
Video Available from January 2021 Microphysiological Systems Workshop

A video recording and other materials are now available from the workshop “Microphysiological Systems (MPS): Bridging Human and Animal Research,” presented by National Academies of Science, Engineering, and Medicine and the Institute for Laboratory Animal Research on January 19-20. Topics covered in the webinar included:

  • MPS for toxicology testing
  • Data and developmental tools
  • Public health and COVID-19
  • Commercialization
  • Integrated multi-organ systems
  • Animal cell and chip banks
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Feb 05, 2021
Materials Available from EPA's Second Annual NAMs Conference

Materials are now available from the second annual EPA conference on the “State of Science on Development and Use of NAMs for Chemical Safety Testing,” which was held October 19-20, 2020. The conference highlighted the state of the science on the development and use of NAMs for chemical safety testing. A summary of the conference including the agenda, presentations, conference recording, transcript, and conference summary report (which includes questions received during the conference and responses) can be found at the EPA’s NAMs website.

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Feb 05, 2021
Minutes Available from 2020 SACATM Meeting

Minutes from the September 2020 meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) are now available. SACATM, a federally chartered advisory group, meets annually to advise ICCVAM, NICEATM and the Director of NIEHS and NTP regarding the statutorily mandated duties of ICCVAM and NICEATM activities.

Recognizing the occasion of ICCVAM’s 20th anniversary, SACATM members and commenters praised ICCVAM’s work to advance alternatives to animal testing and identified opportunities for further progress. Specific areas mentioned included genotoxicity and carcinogenicity and replacement of animal use for antibody production. One day of the meeting was devoted to considering sources, management, and quality of data that are needed to evaluate new methods, as well as computational tools that can both support evaluation of new methods and predict toxicity. Presentations covered the variability in animal data, applications of machine learning, and in vitro human-based models that incorporate genetic diversity.

Feb 05, 2021
NIEHS Small Business Funding to Develop AI and Machine Learning Methods

NIEHS is offering grants to small businesses to support development of artificial intelligence (AI) and machine learning approaches to advance environmental health research and decisions. When further developed and validated, these approaches should improve the accuracy of toxicity prediction, help in prioritizing chemicals for more relevant or targeted testing, identify and/or fill data or knowledge gaps in toxicity assessment, and promote more comprehensive understanding of human exposure effects, susceptibility and adverse health outcomes.

Letters of intent to apply for the grants are due February 28, with applications due March 29. Only U.S. small businesses are eligible to apply. Applicant organizations may submit more than one application provided that each application is scientifically distinct. NIEHS intends to commit $2 million to this program in the 2021 fiscal year that will fund up to eight awards. More information is available on the National Institutes of Health website:

Mar 29, 2021
Feb 01, 2021
Opportunity at PETA-ISC for Scientist with Regulatory Experience

PETA-ISC is hiring a scientist for its Regulatory Testing Department. With the goal of replacing animal tests required by regulatory agencies, the successful candidate will conduct independent research, attend scientific conferences, collaborate with companies and regulatory agencies, review and write technical reports, and maintain expertise in non-animal testing approaches and international regulatory requirements.

Applicants should have at least three years of experience with FDA, EPA, USDA’s Center for Veterinary Biologics, or a chemical, pharmaceutical, or medical device company regulated by one of these agencies.

To apply for this position and see other available positions at PETA-ISC visit their website.

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Feb 01, 2021
Deadline Extended for SOT Trainee Award

The SOT Computational Toxicology Specialty Section is soliciting applications for the Yves Alarie Diversity Award, which recognizes a motivated trainee or young investigator from an under-represented group who is working in the field of computational toxicology. The award provides $2,500 to support professional development, including travel or registration to attend a scientific meeting or training.

Applications for the award have been extended to February 10, 2021. Applicants should be enrolled in a doctoral or postdoctoral program or have completed their training within the past five years. Only current SOT members are eligible, and preference will be given to Computational Toxicology Specialty Section members or applicants. Applicants should have had an abstract accepted and be planning to attend the SOT 2021 annual meeting.

To apply for this award, please send your abstract and all other required documents to David Szabo at DSzabo@ppg.com.

Feb 10, 2021
Feb 01, 2021
NICEATM and ICCVAM Activities at SOT 2021

A webpage summarizing NICEATM and ICCVAM activities at the March 12-26 virtual SOT annual meeting is now available. Please refer to this page as you plan your SOT itinerary.

NICEATM and ICCVAM will have a strong presence at SOT. NICEATM is presenting ten posters and four platform presentations. ICCVAM members are coauthors on seven posters and four talks. ICCVAM members Warren Casey (NIEHS) and Suzanne Fitzpatrick (FDA) will speak at a continuing education course on “Establishing Confidence in Organ-on-a-chip Systems for Toxicity Testing: Lung-on-a-chip as an Example”.

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Feb 01, 2021
Report Available for 2019 Acute Toxicity Workshop

A report is available from a 2019 workshop that reviewed developments in the prediction of acute oral lethality for chemicals and mixtures, as well as progress and needs in the understanding and modeling of mechanisms of acute lethality. The workshop was co-organized by NICEATM and the Physicians Committee for Responsible Medicine.

Workshop participants concluded that a variety of approaches will be needed to fully replace the use of animals for acute systemic toxicity testing. In the near term, non-testing approaches could be used for some assessments. These approaches, which include waiving tests, computational models for single chemicals, and calculating the acute lethality of mixtures based on the LD50 values of mixture components, may be particularly useful for chemicals in the very toxic or non-toxic classification ranges. Other needs identified in the workshop include development of agency policies indicating contexts under which mathematical approaches for mixtures assessment are acceptable; improved understanding of the variability of in vivo approaches; and mechanistically based in vitro or in silico models developed to support non-testing approaches.

Sullivan et al. 2021. Mind the gaps: Prioritizing activities to meet regulatory needs for acute systemic lethality. ALTEX. https://doi.org/10.14573/altex.2012121.

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Feb 01, 2021
EPA Finalizes Guidance to Waive Toxicity Tests on Animal Skin

On January 19, EPA published final guidance that will allow researchers to forego testing chemicals on animal skin in certain circumstances. The “Final Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Single-Active Ingredient and Supporting Retrospective Analysis” allows for data waivers for acute dermal studies for single active ingredients used to develop end-use products. The document includes a policy statement to waive all acute lethality dermal studies for single active ingredients.

The new final guidance supports EPA efforts to identify opportunities for test waivers that can reduce animal use for testing required for pesticide registration. It also supports the broader EPA goal of eliminating the use of mammals for chemical safety testing by 2035.

A link to the guidance and more information about EPA waivers of animal tests are available on the EPA website.

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Jan 21, 2021
Apply by January 29 for FDA Grants to Develop PBPK Models

The FDA Center for Drug Evaluation and Research is offering grants to support development of physiologically based pharmacokinetic (PBPK) models for bioequivalence studies for new generic drugs. Proposals should include scientifically justified in vitro to in vivo extrapolation strategies. They should also discuss how the models will address population variability and a plan for how to verify and validate models. Applications are being accepted now and are due by January 29. One or two awards will be made under this opportunity, with total funding of $600,000 over two years. FDA invites applications from a broad range of institutions for this opportunity, including U.S. and foreign for-profit and nonprofit organizations.

Jan 29, 2021
Jan 21, 2021
January 29 Webinar to Discuss Big Data and Toxicology

The SOT In Vitro and Alternatives Methods Specialty Section is presenting a webinar titled “Big Data and Toxicology – Future is Now” on January 29 at 11:00 a.m. EST.

The first speaker is Thomas Hartung from the Center for Alternatives to Animal Testing, Johns Hopkins University. His talk, titled “A.I. and Big Data-New Kids on the Toxicology Block,” will focus on how machine learning (A.I.) and big data have impacted developments in toxicology and chemical assessment over the last several years.

The second speaker is Thomas Luechtefeld from Insilica LLC. His talk, titled “Smart Chemistry – Algorithms for Chemical Classification and Clustering,” will discuss how transfer learning approaches leverage models that are trained on one task to accelerate learning on other tasks.

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Jan 21, 2021
European Conference on Replacement of Animals for Scientific Purposes

The European Commission is organizing a February 2-3 conference on “Towards Replacement of Animals for Scientific Purposes.” The conference aims to advance progress in reducing the use of animals in science and testing. It is open to a wide and diverse audience of those working with animal models or alternative approaches in any field of basic or applied science. The main objectives of the conference are to:

  • Provide an update on the Commission’s strategic work towards the ultimate goal of replacing animals in science by advancing non-animal alternatives.
  • Illustrate how increased transparency on current animal use can help speed up the transition to non-animal approaches.
  • Showcase the most recent scientific advances in replacing animal models.

Registration is free, and a draft program is available; please note that presentation times are Central European Time (subtract six hours for U.S. Eastern Time).

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Jan 21, 2021
SOT Trainee Webinar Series Begins February 5

The SOT Carcinogenesis Specialty Section will host a series of webinars titled “Fundamentals and Frontiers in Carcinogenesis” as part of a month-long trainee workshop. This workshop will introduce foundational aspects of carcinogenesis to SOT trainees including undergraduate students, graduate students, postdoctoral fellows, and those who may not directly work in the field of carcinogenesis but wish to expand their knowledgebase. The webinars will be presented every Friday in February 2021.

  • Molecular mechanism of carcinogenesisFebruary 5 from noon-1:00 p.m. EST. Speaker: Udayan Apte – Department of Pharmacology, Toxicology and Therapeutics, University of Kansas Medical Center.
  • Cancer risk assessmentFebruary 12 from noon-1:00 p.m. EST. Speaker: Bette Meek – McLaughlin Centre for Risk Science, University of Ottawa.
  • New tools for carcinogenicity assessmentFebruary 19 from noon-1:00 p.m. EST. Speaker: Scott Auerbach – Division of the NTP, National Institute of Environmental Health Sciences.
  • Cancer biomarkersFebruary 26 from noon-1:00 p.m. Speaker: Jia-Sheng Wang – Department of Environmental Health Science, College of Public Health, University of Georgia.
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Jan 21, 2021
February 25 Webinar to Discuss QIVIVE for Reproductive Endpoints

ASCCT and the European Society of Toxicology In Vitro are hosting a joint webinar on February 25, 10:00-11:30 a.m. EST. The first presentation, "Quantitative in Vitro to in Vivo Extrapolation (QIVIVE) for Predicting Reduced Anogenital Distance produced by Anti-Androgenic Pesticides in a Rodent Model for Male Reproductive Disorders," will be given by Martin Scholze, Centre for Pollution Research and Policy, Brunel University London, UK. The second presentation, "A Web-based Toolbox to Support Quantitative In Vitro-to-In Vivo extrapolations (QIVIVE)," will be given by Ans Punt, Wageningen Food Safety Research, The Netherlands.

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Jan 21, 2021
Apply by April 30 for IFER Graduate Fellowships

The International Foundation for Ethical Research (IFER) is accepting applications for graduate fellowships. These one-year grants of approximately $12,500 support projects by master’s and Ph.D. students in the sciences. Relevant projects address development, acceptance, and implementation of innovative methods that advance science and refine, reduce, or replace the use of animals in research, testing, or education. Grants are renewable for up to three years, depending on student progress and availability of funds. Special consideration may be given to proposals that are likely to replace the use of animals in research, and for projects that are likely to refine, reduce, or replace the use of nonhuman primates or dogs in research. Applicants must be beginning or beyond their second year of graduate school as of September 2021. Applications are due Friday, April 30.

Apr 30, 2021
Jan 12, 2021
NICEATM Research Featured in Special Issue of Chemical Research in Toxicology

Two papers describing NICEATM research are now available online from Chemical Research in Toxicology. Both papers will be included in a special issue of the journal co-edited by acting NICEATM Director Nicole Kleinstreuer.

  • A cardiotoxicity profile was developed for the Tox21 chemical library focusing on high-throughput screening assays having targets related to cardiovascular failure modes. The profile was able to identify drugs with known cardiotoxic effects. This approach may enable development of new hypotheses around environmental chemicals of potential interest for adverse cardiovascular outcomes using Tox21/ToxCast data. Krishna et al. 2020. High-throughput screening to identify chemical cardiotoxic potential. Chem Res Toxicol. https://doi.org/10.1021/acs.chemrestox.0c00382
  • Saagar is a novel set of extensible chemistry-aware substructures that support interpretable predictive models and read-across protocols. Saagar features are interpretable and efficiently characterize diverse chemical collections, making them a better choice for building interpretable predictive in silico models and read-across protocols. Sedykh et al. 2020. Saagar – a new, extensible set of molecular substructures for QSAR/QSPR and read-across predictions. Chem Res Toxicol. https://doi.org/10.1021/acs.chemrestox.0c00464
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Jan 12, 2021
Register by Friday for Environmental Health Perspectives Strategic Planning Summit

Environmental Health Perspectives (EHP) is seeking input from a diverse group of leaders in the field of environmental health science and scientific publishing. Participants in the upcoming EHP Strategic Planning Summit will explore the future of environmental health sciences and scholarly publishing, map a strategy for EHP, and cultivate a more connected and collaborative EHP community.

The summit will be held virtually on January 28, February 2, and February 5. Those interested in participating must register online. Registrants will be asked about their background and their perspectives on EHP and the field of environmental health sciences. Space in the summit is limited; participants will be notified about their selection by 6:00 p.m. EST this Friday, January 15.

EHP is a monthly journal of environmental health research and news published with support from the National Institute of Environmental Health Sciences. Since its launch in 1972, EHP has established itself as a high-impact, reliable, and trustworthy source of scientific information connecting the environment and human health.

Jan 15, 2021
Jan 11, 2021
ASCCT Webinar: 2020 Annual Meeting Award Winners

ASCCT and the European Society for Toxicology In Vitro will hold a webinar featuring presentations by authors of 2020 ASCCT award winning posters on Thursday, January 14, 10-11:15 a.m. EST.

The Ed Carney Predictive Toxicology Award recognizes the first author of an outstanding poster or platform presentation that will advance predictive toxicology. The 2020 award was presented to Eva C.M. Vitucci from the University of North Carolina at Chapel Hill for her presentation "Identifying the Molecular Mechanisms of Air Pollution-Induced Cardiovascular Disease".

The Ray Tice Tox21 Student Award recognizes the best student presentation during the ASCCT meeting. The 2020 winner was Sherri Bloch from Université de Montréal for her presentation "Using in Vitro Data to Derive Acceptable Exposure Levels: A Case Study on PBDE Developmental Neurotoxicity”.

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Jan 11, 2021
QSAR 2021 Abstracts Due January 30

Abstracts are now being accepted for the 19th International Workshop on (Quantitative) Structure-Activity Relationships in Environmental and Health Sciences (QSAR2021), which will take place on June 7-10, 2021 as a virtual event. The theme for this year’s workshop is “From QSAR to New Approach Methodologies (NAMs)”. This workshop aims to bring scientists from around the world together with developers and users of predictive models and their underlying data to foster discussion and debate around the practical implementation of NAMs.

Abstracts of original work must be submitted online by January 30. Presenters can indicate preference for an oral or poster presentation and up to two theme categories. Participants who submitted last year for QSAR2020 will need to update and resubmit their abstracts. User credentials for accessing the abstract submission system will still be valid. For more information and to register for QSAR2021 visit the workshop website or contact QSAR2021@icf.com.

Jan 30, 2021
Jan 11, 2021
New FDA Report Highlights Progress in Advancing Alternatives

A FDA report provides updates on activities to advance development of alternatives to animal use and their application to regulatory decision-making. The report, “Advancing New Alternative Methodologies at FDA,” is available on the FDA website.

This report was developed by the FDA Alternative Methods Working Group to highlight the progress FDA scientists have made in laying the groundwork to integrate alternatives to animal testing into FDA regulatory programs. The report describes activities within eight FDA offices and centers, as well as FDA working groups and interagency partnerships such as ICCVAM and Tox21. The report also summarizes FDA engagement to advance alternatives to animal testing in international venues such as the International Cooperation on Cosmetic Regulation and the Organisation for Economic Co-operation and Development.

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Jan 04, 2021
ICCVAM Communities of Practice Webinar on Mixtures Toxicity January 26

Registration is open for the ICCVAM Communities of Practice webinar “Non-animal Approaches for Mixtures Assessment.” The webinar is scheduled for Tuesday, January 26, at 9:00 a.m. EST. Information about the webinar and a link to register are available on the webinar information page.

While most available toxicity data are for single chemicals, humans are often exposed to chemicals as mixtures. Assessing the safety of a mixture is a complex process that requires consideration of both the toxicity of each chemical component of the mixture and the potential for interaction among the components to affect toxicity of the overall mixture. Additionally, most alternative methods and approaches used for assessing chemical safety are developed and evaluated using single chemicals. This can result in lack of clarity about whether a method is appropriate to use for assessing toxicity of a particular mixture.

This webinar will discuss new approach methodologies for assessing exposure to, and potential hazards associated with, chemical mixtures. Key insights and ongoing activities will be described in three presentations featuring speakers from U.S. federal research and regulatory agencies.

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Jan 04, 2021
ALTBIB Moves to NICEATM Webpage

NLM's ALTBIB literature search tool has moved to the NICEATM website.

ALTBIB is the Bibliography on Alternatives to the Use of Live Vertebrates in Biomedical Research and Testing. NLM developed ALTBIB to provide access to PubMed citations for users seeking information on alternatives to animal testing. Many citations provide access to free full text.

The search strategy on the new ALTBIB site has been updated to capture key topics of current interest such as microphysiological systems and quantitative structure activity relationship models. The content has been reorganized to provide additional user support, and more links have been added to the “Additional Resources” list. Users can still edit the ALTBIB search strategy to broaden or narrow searches. The list of keywords related to specific topics that was available on the NLM ALTBIB site is not yet available on the new NICEATM site. This list is being updated and revised and will be added to the NICEATM site in early 2021.

A link on the NLM site will temporarily redirect users looking for ALTBIB on the NLM site to its new home at NICEATM. However, ALTBIB users should update any bookmarks to reflect the new location.

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Dec 22, 2020
Materials Available From Webinar on Kinetically Derived Maximum Dose

Materials are now available from the September 30 webinar “Opportunities and Challenges in Using the Kinetically Derived Maximum Dose Concept to Refine Risk Assessment.” These include abstracts, slides, and video recordings of all presentations, as well as questions submitted to speakers and speakers’ responses.

The kinetically derived maximum dose (KMD) refers to the dose at which a departure from dose proportionality or linear pharmacokinetics is observed. Toxicity findings at doses above a KMD may not be relevant to human health risks when potential exposure levels are orders of magnitude lower. However, consideration of the KMD in the design or interpretation of animal toxicity studies for environmental chemicals is rare, and many technical and scientific issues hinder its proper use. The purpose of this symposium was to highlight these commonly raised issues and provide the background information needed to develop more consistent, transparent approaches to support broader KMD application in risk assessment. The symposium was organized by NICEATM, the U.S. Environmental Protection Agency Office of Pesticide Programs, and the Health and Environmental Sciences Institute

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Dec 22, 2020
Microphysiological Systems Workshop January 2021

The National Academies of Science, Engineering, and Medicine and the Institute for Laboratory Animal Research are hosting a virtual webinar “Microphysiological Systems (MPS): Bridging Human and Animal Research” on January 19-20. MPS are in vitro platforms comprised of 3D constructs from human or animal origin that mimic properties of organs or tissue function. They are developed with the goal of reducing the use of whole animal studies in research. The webinar will cover:

  • MPS for toxicology testing
  • Data and developmental tools
  • Public health and COVID-19
  • Commercialization
  • Integrated multi-organ systems
  • Animal cell and chip banks
Registration for this virtual event is free.
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Dec 22, 2020
Small Business Funding to Develop AI and Machine Learning Methods

NIEHS is offering grants to small businesses to support development of artificial intelligence (AI) and machine learning approaches to advance environmental health research and decisions. When further developed and validated, these approaches should improve the accuracy of toxicity prediction, help in prioritizing chemicals for more relevant or targeted testing, identify and/or fill data or knowledge gaps in toxicity assessment, and promote more comprehensive understanding of human exposure effects, susceptibility and adverse health outcomes.

Letters of intent to apply for the grants are due February 28, with applications due March 29. Only U.S. small businesses are eligible to apply. Applicant organizations may submit more than one application provided that each application is scientifically distinct. NIEHS intends to commit $2 million to this program in the 2021 fiscal year that will fund up to eight awards. More information is available on the National Institutes of Health website:

Mar 29, 2021
Dec 10, 2020
December 17 Webinar to Discuss Medical Device Assessment

A webinar organized by ASCCT and the European Society for Toxicology In Vitro will describe “Medical Device Assessment: Updates for Thrombogenicity and Skin Irritation”. The webinar will be presented Thursday, December 17, from 11:00 a.m. - 12 noon EST.

Interest is growing in the use of alternatives to animal testing for safety assessments of medical devices. In this webinar, two speakers from Medtronic will describe evaluations of in vitro tests for two endpoints. Michael Wolf will describe use of human blood to evaluate a device’s potential for thrombogenicity, the tendency of a material to induce blood clotting. Kelly Coleman will provide a progress update on the use of in vitro tests as alternatives to the rabbit skin irritation tests for medical devices. He will discuss the update of International Organization for Standardization standard 10993-23 on irritation testing for medical devices, which states that the use of reconstructed human epidermis test methods is preferable to animal use for this endpoint.

Previously recorded ASCCT webinars are available on their website.

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Dec 10, 2020
Deadline Extended to January 15 for SOT Award

The SOT Carcinogenesis Specialty Section has extended the deadline to January 15 for nominations for the James A. Swenberg Carcinogenesis Merit Award. This award has been established to encourage junior faculty members to conduct transformative mechanistic research in the field of carcinogenesis. The award will recognize outstanding individuals for their cumulative contribution to advancements in understanding the mechanisms of environmental agent-associated carcinogenesis.

Candidates can self-nominate or be nominated by their peers. They must be members of the Carcinogenesis Specialty Section, hold tenure- or research-track assistant professor positions in an academic institution, and have earned their highest degree within the last 15 years. Applications should be sent to Chris Corton at Corton.Chris@epa.gov by January 15.

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Dec 03, 2020
ICCVAM Member Honored at ASCCT Annual Meeting; Program Book Available

ASCCT's 9th annual meeting was held online on October 20-23. A summary of the meeting is available on the ASCCT website, and a link to a downloadable program, which includes all presentation abstracts, is also on this page.

During the meeting, Suzanne Fitzpatrick, FDA, was honored with the William and Eleanor Cave Award for her significant contributions to Tox21 and advancing alternative approaches. The award recognizes achievements in development and implementation of alternatives to the traditional use of animals in testing, research, or education. Fitzpatrick is the primary FDA representative to ICCVAM.

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Dec 03, 2020
Submissions Open for 2021 EMGS Bioinformatics Challenge

EMGS is now accepting submissions for their 2021 Bioinformatics Challenge. Abstracts are being solicited for following areas:

  • Novel computational approaches, including machine learning and artificial intelligence, on high-throughput, high-content, exposure-risk assessment, and/or clinical data classification.
  • Genetic/genomic toxicological applications of model organism databases, including EcoCyc E. coli database, Saccharomyces genome database, WormBase, wFleaBase, Xenbase, and ZFIN.
  • Predictive modeling with genomic/mutation/epimutation datasets, and/or toxicology databases, including Tox21/ToxCast, Drug Matrix, TG-Gates, Comparative Toxicogenomics Database, and SeqAPASS.

Abstracts should be 250 words and include a data visualization or conceptual workflow pipeline. Submissions are due by February 28th, 2021, to bioinformatics@emgs-us.org. Selected participants will receive a $100 monetary award and present their work in the preliminary round of the competition, which will be held as a virtual symposium in Spring 2021. The finalist teams will be invited to present at the 13th International Conference on Environmental Mutagens in Ottawa, Canada from August 28–September 2, 2021, and compete for the grand prize of $1000. For more information visit the EMGS Bioinformatics Challenge website.

Feb 28, 2021
Dec 03, 2020
FDA Launches Pilot Program to Support Novel Approaches to Drug Development

On November 30, FDA announced establishment of the Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program. This program is designed to encourage innovation of drug development tools (DDTs) that are out of scope for existing DDT qualification programs but may still be useful for drug development. DDTs are methods, materials, or measures that have the potential to facilitate drug development. Approaches that could be considered under ISTAND include using tissue chips (also known as microphysiological systems) to assess safety or efficacy questions; developing novel nonclinical pharmacology/toxicology assays; or using artificial intelligence-based algorithms to evaluate patients, develop novel endpoints, or inform study design.

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Nov 30, 2020
Apply by January 31 for CAAT 2021 Reduction and Refinement Award

CAAT is accepting proposals for the 2021 Reduction and Refinement Award. The grant is intended for scientists who conduct:

  • Systematic reviews, meta-analyses, or citation analyses of animal studies or similar work with the goal to reduce animal use in science.
  • Projects with the potential to improve animals’ living situation in the laboratory.

The 2021 award will provide a prize of up to $6,000. Preference will be given to studies that have broad applicability. Applications are due January 31, 2021. Applications should be submitted electronically to Kathrin Herrmann at kherrma1@jhu.edu.

Jan 31, 2021
Nov 30, 2020
Call for Papers on Integrated Strategy Approaches: Deadline February 15

Applied In Vitro Toxicology is calling for original research and review manuscripts that address the use of integrated strategy approaches to investigate and/or assess toxicological effects, to be published in its next special issue. Integrated approaches combine two or more information sources such as in vitro methodologies, computerized and in silico systems, artificial intelligence, exposure and/or kinetics modeling, systematic reviews, clinical data, etc. The integrated strategy approaches can represent a combination of existing and newly generated data, a sequential testing strategy, a parallel testing battery, or a defined approach leading to the prediction of a certain mechanism of action or toxicological effect. The deadline to submit manuscripts has been extended to February 15, 2021.

Feb 15, 2021
Nov 30, 2020
Virtual Workshop on Assessing Carcinogenicity December 7-10

The Toxicology Forum will present a virtual workshop on “Assessing Carcinogenicity: Hazard Identification, Classification, and Risk Assessment” on December 7-10. Interested persons are encouraged to register as soon as possible to allow time for review of premeeting materials. For more information and to register, visit the workshop webpage or contact Kevin Merritt at kevin@toxicology.org.

As understanding of chemical carcinogenesis has grown significantly over the last several decades, it is appropriate to look at whether long-standing test methods and risk assessment approaches should be updated based on new understanding. EPA is updating its guidelines for risk assessment, including the 2005 Guidelines for Carcinogen Risk Assessment, that are used by EPA and other federal and state agencies to aid regulatory decision-making and set research priorities. This workshop will provide an opportunity for national and international experts and stakeholders to exchange information regarding these revisions. Outcomes will guide next steps toward the modernization of carcinogenicity identification and risk assessment.

This virtual workshop is planned as two parts. Immediately upon registration, registrants will have access to recorded speaker presentations that provide background on the subject matter. During the scheduled virtual workshop in December, attendees will be able to ask questions and participate in the panel and group discussions on the day's topics. To accommodate registrants from across the world, each day’s live virtual workshop will last 3 hours.

Warren Casey, former NICEATM Director, and Suzanne Fitzpatrick, U.S. Food and Drug Administration principal representative to ICCVAM, are members of the workshop organizing committee; ICCVAM co-chair Anna Lowit, EPA, is a presenter.

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Nov 16, 2020
Presentations and Video Available from EPA NAMs Conference

EPA hosted the Second Annual “Conference on the State of the Science on Development and Use of New Approach Methods (NAMs) for Chemical Safety Testing” virtually on October 19-20. The virtual conference was presented in response to the September 2019 directive by EPA Administrator Andrew Wheeler to reduce the EPA’s use of mammalian studies. Conference topics included:

  • Implementation of animal testing reduction at EPA.
  • State of the science in development of NAMs.
  • Current limitations of NAMs.
  • Developing scientific confidence in NAMs.

To view the conference presentations and recordings, visit the conference website. If you attended the conference and would like to submit feedback on the EPA New Approach Methods Work Plan, email NAM@epa.gov.

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Nov 16, 2020
OECD Webinars to Consider AOP Training Needs and Resources

OECD will hold two interactive webinars to discuss opportunities for expanding the community of trainers to meet current needs for training on AOP-based approaches. Webinar participants will also discuss opportunities for engaging a broader range of communities who may benefit from such training. The webinars are particularly targeted to researchers who are engaged in developing innovative approaches based on mechanistic knowledge of toxicity pathways, have given or attended training on AOPs, or used AOP-based hypotheses for research, test development, or safety assessment purposes.

The same 90-minute webinar will be presented at two different times:

  • Monday, November 23, 11:00 a.m. EST (5:00 p.m. Central European Time).
  • Monday, November 30, 4:00 a.m. EST (10:00 a.m. Central European Time).
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Nov 16, 2020
FDA Partnership to Apply Lung Chips to Safety Evaluation of COVID-19 Vaccines and Therapies

FDA has entered into a Cooperative Research and Development Agreement (CRADA) with Emulate, Inc. to enable multiple studies using Emulate’s Organ-Chips across FDA offices in priority research areas. Organ-Chips are in vitro systems that recreate the natural physiology of specific human tissues and organs. Some projects will evaluate COVID-19 vaccines or investigate human immune response against SARS-CoV-2, the virus that causes COVID-19. Under the CRADA, FDA will use a range of Organ-Chips to study the safety, efficacy, and mechanisms of action of drugs regulated by the FDA. This new CRADA agreement follows the successful completion of the first Emulate CRADA with the FDA initiated in 2017 that focused on toxicity studies using Emulate's Liver-Chip. Details on the CRADA are provided in Emulate’s October 29 press release.

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Nov 16, 2020
November 30 Webinar to Discuss Predicting Fish Acute Toxicity

A webinar organized by ASCCT and the European Society for Toxicology In Vitro will describe “Development of a Bayesian Network Model for Predicting Fish Acute Toxicity from Fish Embryo Toxicity Data”. The webinar will be presented Monday, November 30, from 10:00-11:00 a.m. EST.

To reduce animal testing, the fish embryo toxicity test has been proposed as an alternative to the juvenile acute fish toxicity test. However, data from the fish embryo toxicity test are not yet accepted as a replacement to the juvenile acute fish toxicity test for certain regulatory purposes such as REACH. Adam Lillicrap of the Norwegian Institute for Water Research will describe a Bayesian network model for predicting toxicity of substances to juvenile fish from embryo toxicity data in combination with other relevant information. The goal is to use the model in a weight-of-evidence approach to support replacing juvenile fish toxicity testing with embryo toxicity testing.

Previously recorded ASCCT webinars are available on their website.

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Oct 28, 2020
OSHA, PHMSA Request Public Input in Advance of International Meetings

OSHA and the Department of Transportation Pipeline and Hazardous Materials Safety Administration (PHMSA) will hold virtual public meetings on Thursday, November 19. The purpose of the November 19 meetings is to consider public comments and gather information in advance of:

  • The 57th session of the United Nations Sub-Committee of Experts on the Transport of Dangerous Goods (UNSCETDG) on November 30-December 8.
  • The 39th session of the United Nations Sub-Committee of Experts on the Globally Harmonized System of Classification and Labelling of Chemicals (UNSCEGHS) on December 9-11.

The PHMSA public meeting will be held on November 19 from 9:00 a.m. to 12:00 p.m. EST. The OSHA public meeting will be held November 19 from 1:00 p.m. to 4:00 p.m. EST. General information about the OSHA meeting can be found in an October 22 Federal Register notice. Specific information regarding each meeting will be available on the OSHA website as it becomes available.

These meetings will be open to the public on a first-come, first served basis. Attendees must pre-register for all meetings; links to registration will be available on the PHMSA website.

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Oct 28, 2020
OECD Seeking Input on Training on AOPs; Respond by October 30

The Extended Advisory Group on Molecular Screening and Toxicogenomics of OECD is seeking information on currently available training courses on AOPs. Those involved in developing or conducting training courses that focus on or incorporate AOPs are invited to complete a brief survey. Completion of the survey will allow OECD to:

  • Understand the current training courses available, including the different materials, formats, and target audiences.
  • Enable better support of existing activities
  • Identify gaps where new content is needed.

The survey has 18 questions and should take 10 minutes or less to complete. Please respond by Friday, October 30.

Oct 30, 2020
Oct 28, 2020
Nominations Due December 11 for SOT Carcinogenesis Merit Award

The Carcinogenesis Specialty Section of SOT is accepting nominations for the James A. Swenberg Carcinogenesis Merit Award. This award has been established to encourage junior faculty members to conduct transformative mechanistic research in the field of carcinogenesis. The award will recognize outstanding individuals for their cumulative contribution to advancements in understanding the mechanisms of environmental agent-associated carcinogenesis.

Candidates can self-nominate or be nominated by their peers. They must be members of the Carcinogenesis Specialty Section, hold tenure- or research-track assistant professor positions in an academic institution, and have earned their highest degree within the last 15 years. Applications are due December 11.

Dec 11, 2020
Oct 28, 2020
Science Adviser Position Available at HSUS

HSUS is seeking a Science Adviser for its Animal Research Issues department. The Science Adviser offers scientific advice to HSUS on programs that seek to replace the use of animals in testing and research through regulatory, legislative, and corporate reforms. Duties include researching and analyzing areas of testing and research that involve the use of animals, staying up to date on scientific advances and technologies that seek to replace the use of animals, and contributing scientific expertise to legislative and regulatory efforts. The applicant must have at least a master's and preferably a Ph.D. in a relevant field, at least two years' experience related to the use of animals in laboratories and alternatives to animal testing, and excellent communication and interpersonal skills. The position will be based in Gaithersburg, MD, or Washington, DC, and applicants should be willing and able to travel. 

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Oct 26, 2020
ICE Version 3.2 Now Available

On October 20, NICEATM released an update of the Integrated Chemical Environment (ICE). ICE provides data and tools to help develop, assess, and interpret chemical safety tests. This update adds the following features to these ICE tools.

  • In Vitro to In Vivo Extrapolation (IVIVE): a new inhalation model from the EPA httk package is available that allows estimation of an equivalent administered dose based on a gas exposure. The IVIVE tool also now allows the user to specify whether experimental or predicted data are used for ADME parameters.
  • Chemical Characterization: query results are now displayed using two principal component analysis plots: a static plot that compares query chemicals to a background of a larger chemical set and a dynamic plot that compares query chemicals to one another based on physicochemical properties or molecular descriptors.

Other new resources in ICE 3.2 include:

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Oct 16, 2020
Molecular Virologist Position at National Institute of Allergy and Infectious Diseases

Laulima Government Solutions, LLC, is looking for a qualified molecular virologist to support the National Institute of Allergy and Infectious Diseases at Fort Detrick, MD. Duties will include:

  • Designing and implementing in vivo, ex vivo, in situ, and in vitro test systems to address molecular virology objectives.
  • Advising program leadership on important advances in molecular virology theories and practices.
  • Managing and coordinating molecular virology support for ongoing studies.

Applicants must have a PhD in molecular virology or related field and at least five years’ specialized training and research experience. They should be proficient in techniques including reverse genetics and genomics, organs/organoids-on-a-chip, mechanism of action, viral life cycle surrogate systems, protein-protein interactions, gene knock in/knock out, and enzymatic assays. They must also be U.S. citizens, eligible for Centers for Disease Control Select Agent Program approval, and willing to work under BSL-2, BSL-3, and BSL-4 conditions.

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Oct 16, 2020
EPA PFAS Postdoctoral Research Positions

EPA has several openings for postdoctoral fellows at their Office of Research and Development laboratory in Duluth, MN. Projects are focused on applications of NAMs for characterization of PFAS. Successful candidates will have interest or experience working with PFAS chemicals. For information about each of the openings, visit the linked webpages or contact the principal investigators listed below. Application deadlines begin October 26.

Oak Ridge Institute for Science and Education Postdoctoral Positions:

University of Wisconsin-Madison Postdoctoral Position:

Oct 26, 2020
Oct 16, 2020
Opportunity at FDA for Early-career Cell Biologist

FDA has an opening for an early career scientist with cell and molecular biology lab experience. The successful candidate will support current projects including investigating microphysiological systems and the potential of human cells to model different tissues for predicting clinical drug adverse effects. Specific duties will include:

  • Culturing human cells and induced pluripotent stem cells and participating in their differentiation.
  • Assembling, operating and cleaning microphysiological systems.
  • Performing experiments with the microphysiological systems.
  • Maintaining the laboratory for work with the microphysiological systems.
  • Properly documenting data and results from experiments, assays, and analysis following established guidelines.

Applicants should have an undergraduate or master’s degree in engineering, microphysiology, cell biology, biology, or a related field, and at least one year’s laboratory experience in academia or industry. The application has no closing date. Additional details are in the attached PDF. For more information please contact Alexandre Ribeiro at 301-796-0126 or Alexandre.Ribeiro@fda.hhs.gov.

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Oct 16, 2020
Safer Alternatives Symposium and NAMs Short Courses

Registration is open for the “International Symposium on Alternatives Assessment: Current Practices and Future Prospects.” This meeting will be held virtually on October 27-29. It is organized by the Association for the Advancement of Alternatives Assessment (A4), a professional association dedicated to advancing the science, practice, and policy of alternatives assessment and informed substitution. The vision of A4 is that every essential function performed by a chemical, material, process, or product is achieved with safe and sustainable solutions.

In conjunction with the symposium, A4 is partnering with the Physicians Committee for Responsible Medicine to offer two short courses on “New Approach Methodology (NAM) Use for Regulatory Application.” The session on Monday, October 26, will introduce applied approaches to incorporate and customize read-across strategies for chemical assessments. The session on Friday, October 30, will be a deep dive into case-study illustrations of in vitro tools and next-generation risk assessment. Registration for the short courses and other symposium sessions is free.

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Oct 09, 2020
EMGS Bioinformatics Challenge Winners Announced; Challenge to Continue in 2021

Winners have been announced for EMGS Bioinformatics Challenge 2020. The Challenge encouraged EMGS members and bioinformatics/data science experts to work together to develop novel tools and approaches that harness publicly available data resources such as Tox21 and DrugMatrix to identify signatures of genotoxic hazards and provide insight into their mechanisms of action.

The first place award went to Maximillian Soltysiak for the project “Machine learning-based analysis of genome sequences for studying the impact of extreme environments on genomic signatures.” Second place went to David Chen for the project “SomaticSim: a somatic mutational signature simulator for benchmarking alignment-free machine learning analyses.” Both projects were conducted by teams with members from the University of Western Ontario and the University of Waterloo in Canada.

The Bioinformatics Challenge will be conducted again next year, with winners to be announced at the International Conference on Environmental Mutagens in August-September 2021.

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Oct 09, 2020
Lush Prize Conference and Awards Ceremony November 11-12

Lush Cosmetics sponsors a global prize fund to support initiatives to end or replace animal testing. The 2020 Lush Prize Conference and Awards Ceremony will be held as a free virtual event November 11-12. The Conference theme is “Can Big Data Replace Animal Testing?” and will include discussions on “Paving the way from big data to regulatory acceptance” and “The role of big data in next-generation risk assessment”. Speakers will include winners from this year and previous years. Acting NICEATM Director Nicole Kleinstreuer, who won a Lush Young Researcher–North America Prize in 2016, will deliver a keynote address titled “From the 3Rs to the 4Cs: communication, collaboration, commitment, and confidence.”

The Conference will be presented both days from 8:00-11:00 a.m. EDT (1:00-4:00 p.m. GMT), and the Awards Ceremony will be held November 11 from 11:00 a.m-noon EDT (4:00-5:00 p.m. GMT).

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Oct 09, 2020
OECD Releases Eight IATA Case Studies

OECD supports the development of integrated approaches to testing and assessment (IATA). IATA provide a means by which all relevant and reliable information about a chemical is used to answer a defined hazard characterization question. Information considered can include toxicity data, exposure routes, use cases, and production volumes.

The OECD IATA Case Studies Project allows countries to share and explore the use of novel methodologies in IATA for chemical hazard characterization within a regulatory context. Eight new case studies illustrate the use of NAMs for predicting systemic toxicity, developmental and reproductive toxicity, and neurotoxicity from chemicals such as caffeine, p-alkylphenols, and carboxylic acids. Information about the Case Studies Project and links to the new case studies are available on the OECD website.

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Oct 09, 2020
EPA Announces Guidance to Waive Toxicity Tests on Animal Skin, New Webpages on Metrics and NAMs

On October 7, EPA requested public comment on draft guidance that would allow researchers to forego testing chemicals on animal skin in certain circumstances. Based on a retrospective analysis conducted by EPA, which concluded that such studies provide little to no added value in regulatory decision-making, the proposed guidance would allow waivers for studies on single active ingredients used in pesticides. This guidance, when finalized, is expected to save up to 750 test animals annually from unnecessary testing, as well as EPA, industry, and laboratory resources.

A page on the EPA website summarizes its strategic vision for adopting NAMs. Three webpages linked from this page have details of EPA activities in this area.

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Oct 01, 2020
Animal-free Antibody Webinar Series Continues October 15

NICEATM, PETA-ISC, and the European Union Reference Laboratory for Alternatives to Animal Testing are presenting a series of free webinars in which experts will address the application and benefits of recombinant antibodies. Registration for the next two webinars is available. You need only register once to attend both webinars. Both webinars are at 10:00-11:00 a.m. EDT.

  • Webinar 3, “Application of Animal-free Antibodies,” is Thursday, October 15. Giulio Russo of Abcalis will discuss replacement of animal serum-derived secondary antibodies with animal-free multiclonal antibodies. Charu Chandrasekara, Canadian Centre for Alternatives to Animal Methods, will describe her experience with replacement of animal-derived affinity reagents.
  • Webinar 4, “Accessibility of Recombinant Antibodies,” is Thursday, November 12. Pierre Cosson, University of Geneva, and Michael Fiebig, Absolute Antibody, will describe their institutions’ antibody production activities.

Recordings and slides from past webinars are available on the PETA-ISC website. Information about future webinars will be posted on this page when it is available.

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Oct 01, 2020
October Symposia Focus on Artificial Intelligence, Open Science

Carnegie Mellon University is hosting two free virtual symposia in October that will be of interest to data scientists. Registration is available; you need only register once to attend both events.

  • The “Artificial Intelligence for Data Discovery and Reuse” symposium will be Monday, October 19. This meeting will allow participants to explore innovative solutions to accelerate the dissemination and reuse of scientific data. The program will feature invited speakers and panel discussions from a variety of disciplines, including a focused session on COVID-19 data. Poster submissions will be accepted through October 11.
  • The “Open Science Symposium” will be Tuesday, October 20. The symposium will build awareness and support for the adoption of open research practices and encourage innovative ideas about data sharing. The full day program will feature talks from researchers, tool developers, and publishers; panel discussions; and networking opportunities.
Oct 11, 2020
Oct 01, 2020
NIH Hosting Seminar on Grants Process October 27-30

NIH will present a “Virtual Seminar on Program Funding and Grants Administration” on October 27-30, beginning at 1:00 p.m. EDT each day. This seminar will provide attendees an opportunity to learn about the NIH grants processes, programs, and policies, and will include information specific to small business programs. It is primarily aimed at persons new to the NIH grants process but also includes sessions focused on more in-depth polices and processes for more advanced participants. The event is free.

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Sep 25, 2020
Webinar on Addition of New Approach Methodologies to TSCA

The PETA International Science Consortium is co-organizing a webinar series with EPA and PCRM. The seventh webinar in the series, “Identification of New Approach Methodologies (NAMs) for Placement on the TSCA Section 4(h)(2)(C) List: A Proposed NAM Nomination Form,” will be Wednesday, September 30 at 10:00 a.m. EDT.

The webinar features presenter Steve Simmons of the EPA Office of Research and Development with panelists Pam Spencer, ANGUS Chemical Company; Lauren Heine, ChemFORWARD; Kristie Sullivan, PCRM; and Patrick McMullen, ScitoVation. They will discuss the initial criteria for considering scientific reliability and relevance of NAMs to be placed on the TSCA Section 4(h)2(C) list and review a proposed nomination form.

A list of previous webinars in this series can be found on the PETA International Science Consortium website.

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Sep 25, 2020
Presentations Available from September 2-3 SACATM Meeting

Presentation slides are available from the September 2-3 SACATM meeting. To view the presentations, visit the Past SACATM Meetings page on the NTP website and click on “Presentations” in the far right column of the first row. Minutes from the meeting will be posted here when they have been reviewed and approved by the committee.

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Sep 21, 2020
Paper Provides Update on EU-ToxRisk Project

In 2016, the European Commission launched the EU-ToxRisk research project to develop and promote animal-free approaches in toxicology. An editorial in Archives of Toxicology summarizes the scientific and regulatory learnings from this project. Future chemical safety science projects can draw from this experience to implement systems toxicology-guided, animal-free next-generation risk assessment.

Mone et al. 2020. Setting the stage for next-generation risk assessment with non-animal approaches: the EU-ToxRisk project experience. https://doi.org/10.1007/s00204-020-02866-4.

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Sep 21, 2020
Studies Support Use of In Vitro Models for Skin Irritation Testing of Medical Devices

A new paper in Toxicology In Vitro summarizes validation studies of reconstructed human epidermis as alternatives for in vivo irritation testing of medical device extracts. It concludes that these models are acceptable replacements for the rabbit intracutaneous irritation test for evaluating the irritant potential of medical devices. The senior author of the paper is SACATM member Kelly Coleman, Medtronic PLC.

DeJong et al. 2020. The suitability of reconstructed human epidermis models for medical device irritation assessment: A comparison of in vitro and in vivo testing results. Toxicology In Vitro. https://doi.org/10.1016/j.tiv.2020.104995.

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Sep 21, 2020
FDA and Global Partners to Study Coronaviruses Using In Vitro Models

FDA has awarded over $5 million to a global collaboration to inform the development of treatments and vaccines for coronavirus infections. The collaboration, led by the University of Liverpool, will sequence and analyze samples from humans and animals to create profiles of various coronaviruses, including SARS-CoV-2, which causes COVID-19.

As part of this three-year project, investigators will evaluate how in vitro models of coronavirus infection, including human organs-on-chips, compare to in vivo responses in animal models and humans. Ultimately, these in vitro models may be employed in the development of biologics, drugs, or devices to treat COVID-19.

For more information about the project, visit:

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Sep 21, 2020
NICEATM Activities at ASCCT Annual Meeting

The 9th annual meeting of ASCCT will be held virtually on October 20-22 free of charge. The conference will focus on the science and policy considerations needed to enable the EPA to eliminate reliance on mammalian tests in regulatory decision making by 2035. The program will feature plenary speakers, panel discussions, oral and poster presentations drawn from submitted abstracts, and opportunities for early-career scientists through a mentoring session and poster awards. Registration and program are available on the ASCCT website.

At this year’s ASCCT annual meeting, NICEATM’s work will be featured with talks on “Providing Insight into Chemical Activity Through Data Curation and Assay Annotation” and compilation of a “Human Reference Database for Skin Sensitization.” NICEATM scientists will also present six posters, one of which will be featured in a flash presentation, a format that enables poster presenters to share their work in a 3-minute oral presentation to a broader audience.

View full list of NICEATM’s activities at ASCCT >>

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Sep 17, 2020
NIEHS Scientist Featured in Webinar on Biomarkers for Kidney Toxicity

HESI is co-organizing a webinar series with the American Association of Pharmaceutical Scientists. The first webinar in the series, “Development of Next-Generation Biomarkers for Detecting Kidney Toxicity” is Thursday, September 24, at 12:30 p.m. EDT.

In this webinar, NIEHS scientist Alison Harrill will discuss current research to identify biomarkers for kidney toxicity. While noninvasive monitoring of nephrotoxicity is challenging, there is promise in utilizing urinary biomarkers such as clusterin and renal papillary antigen-1 as indicators of nephron toxicity. Harrill is leading efforts toward developing models that incorporate host genetic susceptibility into risk assessment.

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Sep 17, 2020
Cell Culture Practitioners Invited to Serve on Scientific Advisory Committee

Scientists experienced in cell culture are invited to join the Scientific Advisory Committee for Good Cell Culture Practice (SAC GCCP). The SAC GCCP will evaluate and propose revisions to a recently published update to a 2005 Good Cell Culture Practice guidance document (GCCP 2.0). The review is being coordinated by the Center for Alternatives for Animal Testing. To apply, please email CAAT@jhu.edu.

The SAC GCCP will review and revise the GCCP 2.0 document through November 2020. Members will review and vote on suggested revisions in December and review a final revision in early 2021. The goal of this public consultation is an open and scientifically intense review of GCCP 2.0 across cell culture experts in various fields of research, in vitro testing, biotechnology development, and industry. More details of the review process are available in a recent publication in ALTEX.

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Sep 17, 2020
Thailand Joins OECD Mutual Acceptance of Data Agreement

On September 7, OECD announced that Thailand has joined the system for the Mutual Acceptance of Data (MAD). MAD, which sets regulatory standards for chemical toxicity testing, allows participating countries to share data results from non-clinical safety tests from chemicals and chemical products. By creating standards that all the countries involved agree on, MAD reduces the number of animals tested by minimizing duplicate testing on chemicals such as industry chemicals and pesticides. Thailand joins the 37 OECD countries as well as Argentina, Brazil, India, Malaysia, Singapore, and South Africa in this initiative that creates international standards and communication for nonclinical toxicity testing.

Visit the OECD website to:

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Sep 17, 2020
Positions Available for Biologists at EPA; Apply by September 23

EPA has openings for experienced biologists in the Health Effects Division and the Environmental Fate and Effects Division within the Office of Pesticide Programs. Successful candidates will:

  • Interpret, evaluate, analyze, and synthesize scientific data and other information for the development of human health and/or environmental assessments on the effects of pesticides from both hazard/toxicology and exposure studies.
  • Determine the general approach necessary to accomplish the review and evaluation of data.
  • Prepare reports that include evaluation of available data and assessments of exposure, hazard, and/or risk from exposure to pesticides
  • Review and make recommendations on the exposure analyses for pesticides in various environments concerning the retention or cancellation of pesticides.

Applicants should have at least a bachelor’s degree in biological sciences, agriculture, natural resource management, chemistry, or related area and at least one year of relevant experience. Applicants must be U.S. citizens, and a pre-employment background check will be required. All positions are currently located in Arlington, Virginia. Applications must be submitted by Wednesday, September 23. For more information, contact Chelsea Vaughn at 919-541-4215 or vaughn.chelsea@epa.gov.

Sep 23, 2020
Sep 14, 2020
Animal-free Antibody Webinar Series Continues September 16

NICEATM, PETA-ISC, and EURL ECVAM will present a free webinar providing an overview of the scientific and economic benefits of animal-free antibodies. The webinar will be on Wednesday, September 16 from 10:00-11:00 a.m. EDT.

In this webinar, Alison Gray of Afability will discuss how animal-free antibodies are developed, how they mimic the mechanistic principles evolved by nature, and the challenges that have slowed their replacement. In a second presentation, João Borroso of EURL ECVAM will share a summary of the findings from a 2018 EURL ECVAM Scientific Advisory Committee meeting that included a review of the validity and benefits of using animal-free technology to produce affinity reagents and the subsequent EURL ECVAM recommendation.

This is the second of a series of free webinars in which experts will address the application and benefits of recombinant antibodies. Information about upcoming webinars is available on the PETA-ISC website. Registration for two upcoming webinars is now open; both webinars are at 10:00-11:00 a.m. EDT.

  • Webinar 3, “Application of Animal-free Antibodies,” is Thursday, October 15. Giulio Russo of Abcalis will discuss replacement of animal serum-derived secondary antibodies with animal-free multiclonal antibodies. Charu Chandrasekara, Canadian Centre for Alternatives to Animal Methods, will describe her experience with replacement of animal-derived affinity reagents.
  • Webinar 4, “Accessibility of Recombinant Antibodies,” is Thursday, November 12. Pierre Cosson, University of Geneva, and Michael Fiebig, Absolute Antibody, will describe their institutions’ antibody production activities.
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Sep 14, 2020
International FAIR Convergence Symposium to be Held Nov. 30-Dec. 4

A virtual International FAIR Convergence Symposium will be held November 30-December 4. The symposium is a forum for advancing international and cross-domain convergence around FAIR principles of digital assets. The event will bring together a global data community with a common interest of combining data across domains for a host of research issues. Topics will include Sustainable Development Goals and the COVID-19 pandemic. The sessions will be a mix of discussions, collaborative workshops, and plenary sessions. The symposium is being organized by CODATA and GO FAIR.

Registration for the event is free. Proposals for sessions, posters, and lightning talks are being accepted now; submit session proposals by September 30, and abstracts for posters or lightning talks by October 31. Proposals can be submitted on the CODATA website; you will need to create a free CODATA account. For more information about the event, visit the GO FAIR website.

Session proposals: Sep 30

Abstracts: Oct 31

Sep 14, 2020
EPA Holds Second Conference on NAMs for Chemical Safety Testing

EPA will hold its 2nd annual conference on the “State of Science on Development and Use of NAMs for Chemical Safety Testing” on October 19-20. The virtual conference is being presented in response to the September 2019 directive by EPA Administrator Andrew Wheeler to reduce the EPA’s use of mammalian studies. Conference topics will include implementation of animal testing reduction at EPA, state of the science in development of NAMs, current limitations of NAMs, and developing scientific confidence in NAMs.

Registrants who would like to submit questions or comments for consideration at the conference may use the form on the EPA website or email Dayna Gibbons.

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Sep 14, 2020
Virtual SACATM Meeting Considers ICCVAM’s Future Directions

SACATM met virtually in a public webcast on September 2-3. Over 200 people viewed or participated in the webcast, making it one of the most broadly viewed SACATM meetings ever. SACATM meets annually to advise NICEATM, ICCVAM, and the director of the National Institute of Environmental Health Sciences regarding statutorily mandated duties of ICCVAM and activities of NICEATM.

Recognizing the occasion of ICCVAM’s 20th anniversary, SACATM members and commenters praised ICCVAM’s work to advance alternatives to animal testing and identified opportunities for further progress. Specific areas mentioned included genotoxicity and carcinogenicity and replacement of animal use for antibody production.

An entire day of the meeting was devoted to considering the data that are needed to evaluate new methods and tools that can put data to use. Presentations discussed variability in animal data, applications of machine learning, and in vitro human-based models that incorporate genetic diversity. NICEATM scientists showcased computational tools for exploring toxicity data and making toxicity predictions. Presentations from the meeting will be available soon on the NTP website, and minutes will be posted following their review by the committee.

Save the date for the next ICCVAM public event: the annual ICCVAM Communities of Practice webinar is planned for Tuesday, January 26, 2021. Information will be posted on the NICEATM events webpage as it becomes available.

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Aug 27, 2020
Cell Culture Practitioners Invited to Serve on Scientific Advisory Committee

Scientists experienced in cell culture are invited to join the Scientific Advisory Committee for Good Cell Culture Practice (SAC GCCP). The SAC GCCP will evaluate and propose revisions to a recently published update to a 2005 Good Cell Culture Practice guidance document (GCCP 2.0). The review is being coordinated by the Center for Alternatives for Animal Testing. To apply, please email CAAT@jhu.edu.

The SAC GCCP will review and revise the GCCP 2.0 document from September through November 2020. Members will review and vote on suggested revisions in December and review a final revision in early 2021. The goal of this public consultation is an open and scientifically intense review of GCCP 2.0 across cell culture experts in various fields of research, in vitro testing, biotechnology development, and industry. More details of the review process are available in a recent publication in ALTEX.

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Aug 27, 2020
September 16 Webinar Presents eChemPortal Case Studies

A webinar on “eChemPortal: the Global Portal to Information on Chemical Substances” will be presented by OECD and the European Chemicals Agency on Wednesday, September 16, at 9:00 a.m. EDT (3:00 p.m. CEST).

OECD’s eChemPortal provides direct access to critical scientific information on chemical substances of regulatory relevance with over 800,000 substance records from over 34 databases. The portal allows countries and companies to share work, ensure resource efficiencies, and reduce animal testing. In this webinar, Gerlinde Knetsch of the German Environment Agency and Jake Sanderson of Environment Canada will describe how their agencies used eChemPortal to support improvements in chemical safety.

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Aug 27, 2020
September 24 Webinar to Discuss EPA Phenotypic Profiling Approach

A webinar organized by ASCCT and the European Society for Toxicology In Vitro will describe “Phenotypic Profiling for High-throughput Chemical Screening at the U.S. EPA”. The webinar will be presented Thursday, September 24, from 10:00-11:00 a.m. EDT.

The Center for Computational Toxicology & Exposure at EPA has been an integral part of developing new approach methodologies in computational toxicology. The tiered in vitro approach to toxicity testing relies on high-throughput assays to derive a potency estimate for chemical bioactivity and to gain information about putative mechanisms of action. In this webinar, Johanna Nyffeler, EPA, will outline how image-based high-throughput phenotypic profiling (HTPP) assays can provide both types of data required for tiered in vitro testing. She will describe a study that demonstrated that the HTPP assay can be used to derive potency estimates and some mechanistic features that can be used for the prioritization of chemicals.

Previously recorded ASCCT webinars are available on their website.

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Aug 27, 2020
Paper Describes Minimal Assay Set for Androgen Activity Screening

A paper co-authored by Acting NICEATM Director Nicole Kleinstreuer and NICEATM computational chemist Kamel Mansouri (ILS, contractor supporting NICEATM) describes a minimal set of assays that can identify chemicals with androgen receptor activity in initial screening. Agonist batteries of as few as six assays and antagonist batteries of as few as five assays were shown to yield balanced accuracies of 95% or better relative to a previously described set of 11 assays.

Judson et al. 2020. Selecting a minimal set of androgen receptor assays for screening chemicals. Reg Toxicol Pharmacol. https://doi.org/10.1016/j.yrtph.2020.104764.

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Aug 27, 2020
NTP Update Newsletter

The August NTP Update newsletter is now available. In addition to summaries of NICEATM activities, the issue includes an article about Global Environmental Health Day, at which an international audience of experts discussed social-environmental tradeoffs, climate change, and more. The newsletter also features a profile of NIEHS health scientist Brandy Beverly, whose experiences growing up in small town of Oklahoma shaped her passion for research and outreach to minority students. In addition, the issue features a review of the NIEHS Biomedical career symposium, which attracted a national audience of early-career scientists who gained insights to industry, government and academic sectors of research.

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Aug 19, 2020
Symposium Webinar September 30 on Kinetically Derived Maximum Dose

A symposium webinar on “Use of the Kinetically Derived Maximum Dose in Toxicity Testing” will be held Wednesday, September 30, from 8:00 a.m. to 1:00 p.m. EDT. The symposium is organized by NICEATM, the EPA Office of Pesticide Programs, and the Health and Environmental Sciences Institute.

The kinetically derived maximum dose (KMD) refers to the dose at which a departure from linear pharmacokinetics is observed. In contrast to its routine use in pharmaceutical development, consideration of the KMD in the design or interpretation of animal toxicity studies for environmental chemicals is rare. Interest is growing in use of the KMD to interpret animal dose-response data or set top dose in chronic toxicity studies of these chemicals, but many technical and scientific issues hinder its proper use. The purpose of this symposium is to highlight these commonly raised issues and provide the background information needed to develop more consistent, transparent approaches to support broader KMD application in risk assessment.

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Aug 19, 2020
Submit Comments for SACATM Meeting by August 26

SACATM will meet September 2-3. This meeting will be conducted as a public webcast. An agenda and other materials, a link to register to view the webcast, and information about submitting comments are available on the NTP website. Registration to view the webcast will be open until the conclusion of the meeting.

Interested individuals are invited to submit written and oral public comments on agenda topics. The preliminary agenda allows for several public comment periods, each allowing up to three commenters a maximum of five minutes per speaker. The deadline to submit comments is Wednesday, August 26.

SACATM is a federally chartered external advisory group of scientists from the public and private sectors, including representatives of regulated industry and national animal protection organizations. SACATM advises ICCVAM, NICEATM, and the Director of the National Institute of Environmental Health Sciences and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM.

Aug 26, 2020
Aug 19, 2020
FIFRA SAP to Meet in September; Pre-meeting August 25 Open to Public

EPA will convene a public peer review meeting of the FIFRA Scientific Advisory Panel (SAP) on September 15-18. Panelists will consider and review the use of new approach methodologies (NAMs) to derive extrapolation factors and evaluate developmental neurotoxicity for human health risk assessment.

On Tuesday, August 25, there will be a virtual public preparatory meeting to consider the scope and clarity of the draft charge questions for this peer review. More information about both meetings is available in a June 17 Federal Register notice.

The FIFRA SAP provides independent scientific advice, information and recommendations to the EPA Administrator on pesticides and pesticide-related issues as to the impact of regulatory actions on human health and the environment. At this meeting, EPA is seeking advice and recommendations from the FIFRA SAP on scientific issues associated with:

  • The evaluation and utility of NAMs as part of a weight of evidence evaluation of developmental neurotoxicity potential.
  • The use of in vitro acetylcholinesterase inhibition data to develop interspecies and/or intraspecies data-derived extrapolation factors for organophosphate pesticides.
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Aug 19, 2020
EPA Seeks Nominees for TSCA Scientific Advisory Committee on Chemicals

EPA is seeking nominations of scientific experts to be considered for appointment to the TSCA Science Advisory Committee on Chemicals. The committee provides independent advice and expert consultation on the scientific and technical aspects of implementing TSCA.

Nominations should be received by September 1. This announcement was originally issued in March 2020 with an April deadline, but subsequent legal decisions have affected the criteria used to evaluate nominees. All nominations and comments submitted in response to the March notice will be considered by EPA and do not need to be resubmitted.

Nominees should have expertise in one or more of the following subject areas: human health and ecological risk assessment, biostatistics, epidemiology, pediatrics, physiologically based pharmacokinetics, toxicology and pathology, and chemical exposures of sensitive populations. An August 17 Federal Register notice [85 FR 50020] has details on the call for nominations, including instructions for submitting nominations.

Sep 1, 2020
Aug 13, 2020
FDA Accepting Proposals for Alternative Methods Webinar Series

The FDA Office of the Chief Scientist is launching a webinar series on alternative methods. The webinar series supports FDA’s commitment to promote novel technologies and potentially incorporate them into its regulatory review, as applicable.

Test method developers who participate in this webinar series will have the opportunity to introduce their new technology to FDA and give individual FDA programs the option to contact them for further information. Please note, however, that participation in FDA’s webinar series does not constitute FDA’s endorsement of a new method or oblige FDA to assist the developer in qualifying a new method for regulatory use.

To be considered for the webinar series, please submit the following information to alternatives@fda.gov:

  • A description of your new method, including origin of cells or species of animal if appropriate.
  • A description of the proposed context of use of your new method.
  • A description of the regulatory issue/gap where the new method could have an impact.
  • Data from use of your method, including any publications.

FDA will respond within 60 days to your webinar submission.

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Aug 13, 2020
Webinar Will Describe a Literature Informatics Tool for Chemical Research

A webinar organized by ASCCT and ESTIV will describe “PubMed Abstract Sifter: A Literature Informatics Tool for Chemical Research.” The webinar will be presented Thursday, August 20, from 10:00-11:00 a.m. EDT.

Assessing and understanding chemical effects requires assembling information from a wide variety of sources, including millions of articles in the biomedical literature. Literature informatics approaches can help researchers make use of this information in more effective ways. In the webinar, Nancy Baker, Leidos, Inc., will describe the PubMed Abstract Sifter, a freely available literature tool from EPA. With the Abstract Sifter, researchers can easily retrieve and triage citations from PubMed and visualize the literature landscape for a set of chemicals. The tool is supplied with template queries that facilitate the exploration of mechanistic information by using the language of adverse outcome pathways and key characteristics of carcinogens.

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Aug 13, 2020
Papers Due August 30 for Special Issue of Chemical Research in Toxicology

Papers are being accepted for a special issue of the journal Chemical Research in Toxicology that will focus on computational toxicology. The deadline for submission has been extended to August 30. This special issue will bring together recent developments in computational toxicology, with equal emphasis given to methodological developments, such as statistical approaches, modeling advances, and computational resources, as well as applications and case studies demonstrating the use of existing and novel methods. In particular, the focus will be on online and freely available tools and open source software, databases, and recent studies that exemplify success or limitations of the currently used methods. The issue will be edited by Acting NICEATM Director Nicole Kleinstreuer and Weida Tong of the FDA’s National Center for Toxicological Research.

Submissions are invited on, but are not limited to, the topics of:

  • Curated data sets and models to predict human and environmental toxicity.
  • Physiologically based pharmacokinetic modeling.
  • Advanced approaches for in vitro to in vivo extrapolation.
  • Combining in silico predictions with in vitro and in vivo data.
  • Multiscale and agent-based models.
  • Harvesting and processing of big, heterogeneous, and nonstandard data (e.g., literature and patent mining, pathway information).
  • Toxicogenomics.
  • Systems toxicology.
Aug 30, 2020
Aug 13, 2020
EMGS Bioinformatics Challenge Finalists Announced; Presentations September 16

EMGS has announced the finalists of the EMGS Bioinformatics Challenge 2020. This competition encouraged EMGS members and bioinformatics/data science experts to work together to develop novel tools and approaches that harness publicly available data resources such as Tox21 and DrugMatrix to identify signatures of genotoxic hazards and provide insight into their mechanisms of action. The list of finalists is available on the EMGS website. NTP Associate Director Brian Berridge is a member of one of the finalist teams; Berridge is NIEHS principal representative to ICCVAM.

The final round of the EMGS Bioinformatics Challenge will be held on Wednesday, September 16 at 1:30 p.m. CDT (2:30 p.m. EDT). Five competing teams will present their work and take questions from the audience. The Bioinformatics Challenge presentations are part of the EMGS Virtual Meeting, which will be held September 12-16. Attendance is free but registration is required. A full meeting program is available on the EMGS website.

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Aug 13, 2020
Virtual Workshop on Assessing Carcinogenicity December 7-10

The Toxicology Forum will present a virtual workshop on “Assessing Carcinogenicity: Hazard Identification, Classification, and Risk Assessment” on December 7-10. This virtual workshop is planned as two parts. Beginning in mid-November, registrants will have access to recorded speaker presentations, allowing ample time for registrants to become familiar with the diverse subject matter. During the scheduled dates of the virtual workshop in December, attendees will have the opportunity to ask questions and participate in the panel and group discussions pertaining to the day's subject matter. To accommodate registrants from across the world, the live virtual workshop will last 3 hours per day.

As understanding of chemical carcinogenesis has grown significantly over the last several decades, it is appropriate to look at whether long-standing test methods and risk assessment approaches should be updated based on new understandings. EPA is updating its guidelines for risk assessment, including the 2005 Guidelines for Carcinogen Risk Assessment, that are used by EPA and other federal and state agencies to aid regulatory decision-making and set research priorities. This workshop will provide an opportunity for national and international experts and stakeholders to exchange information regarding these revisions, which will be of great value to guide next steps towards the modernization of carcinogenicity identification and risk assessment.

Warren Casey, former NICEATM Director, and Suzanne Fitzpatrick, FDA principal representative to ICCVAM, are members of the workshop organizing committee; ICCVAM co-chair Anna Lowit, EPA, is a presenter.

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Aug 03, 2020
OECD Survey on Confidential Information in Proposed Test Guidelines: Respond by August 31

OECD is collecting stakeholder input on handling of confidential information in candidate test guidelines. A short survey is available and takes approximately 10 minutes to complete. Responses are requested by August 31.

The OECD Test Guidelines Programme regularly receives proposals for new and innovative test methods for chemical safety testing. These methods may contain elements protected by intellectual property. As the goal of the Test Guidelines Programme is to develop and standardize relevant and reliable methods, transparency is important from a regulatory perspective. Therefore, the Test Guidelines Programme is developing a policy to deal with confidentiality claims so that it remains an attractive program for innovative methods, while ensuring that developers identify other means to protect their assets. Input received via the current survey will help evaluate of the impact of this policy on developers, regulators, and the broader community.

Aug 31, 2020
Aug 03, 2020
Paper Describes Web Tool for Predicting Human Skin Sensitizers

A paper co-authored by Acting NICEATM Director Nicole Kleinstreuer describes Pred-Skin, a web tool that integrates multiple quantitative structure-activity relationship models to predict whether chemicals might be skin sensitizers with the potential to cause allergic contact dermatitis. Pred-Skin was developed by NICEATM in collaboration with scientists at the University of North Carolina at Chapel Hill and the Universidade Federal de Goiás.

Borba et al. 2020. Pred-Skin: a web portal for accurate prediction of human skin sensitizers. Chem Res Toxicol. https://doi.org/10.1021/acs.chemrestox.0c00186.

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Jul 31, 2020
ICE Version 3.1 Now Available

On July 24, NICEATM released an update of the Integrated Chemical Environment (ICE). ICE provides data and tools to help develop, assess, and interpret chemical safety tests. This update adds the following features to these ICE tools:

  • Search: query results can now be sent directly to the EPA CompTox Chemicals Dashboard.
  • In Vitro to In Vivo Extrapolation (IVIVE): assays can be selected based on mode of action; results can be filtered by mode of action or toxicity endpoint annotation.
  • Chemical Characterization: principal component analysis plots provide an additional option for visualization of chemical properties.

Other new resources in ICE 3.1 include:

  • New Chemical Quick Lists: EPA List of Active Ingredients and EPA List of Inert Ingredients Food and Nonfood Use.
  • Additional metadata provided in results downloads.
  • New tooltips and information buttons to help users set up queries.
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Jul 31, 2020
Small Business Grants Available for Test Method Development

The Department of Health and Human Services (HHS) has released the 2020 SBIR and STTR Omnibus Grant Solicitations. These solicitations will be used by the National Institutes of Health and other offices within HHS to fund researcher-initiated projects in health, medicine, and life sciences.

Projects being funded by NIEHS under this solicitation include development of toxicity screening, testing, and modeling approaches that support Tox21 and other NTP goals. Areas of high priority include development of:

  • Metabolically competent in vitro assay systems for various tissue types.
  • Computational approaches for predictive toxicology.

The first deadline for applications under this announcement is September 8. More information is available on the NICEATM website.

NIEHS has also reissued the Funding Opportunity Announcement for its Commercialization Readiness Pilot program. These grants support commercialization of previously funded SBIR and STTR Phase II and Phase IIB projects by funding activities not typically supported through Phase II or Phase IIB grants or contracts. Small businesses that have had an active National Institutes of Health SBIR or STTR Phase II or Phase IIB award within the last 36 months are eligible to apply. Awardees will receive up to $300,000. Standard SBIR/STTR application deadlines apply for these grants; the next deadline is September 8.

Sep 8, 2020
Jul 31, 2020
September 16 Webinar Will Discuss Animal-free Antibody Benefits

NICEATM, PETA-ISC, and EURL ECVAM will present a free webinar providing an overview of the scientific and economic benefits of animal-free antibodies. The webinar will be on Wednesday, September 16 from 10:00-11:00 a.m. EDT. In this webinar, João Borroso of EURL ECVAM will share a summary of the findings from a 2018 EURL ECVAM Scientific Advisory Committee meeting that reviewed the validity and benefits of using animal-free technology to produce affinity reagents and the subsequent EURL ECVAM recommendation.

This is the second of a series of free webinars in which experts will address the application and benefits of recombinant antibodies. Topics and some tentative dates for upcoming webinars are available on the PETA-ISC website.

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Jul 27, 2020
ICCVAM 2018-2019 Biennial Report Now Available

The ICCVAM Biennial Progress Report 2018-2019 is now available. The ICCVAM Authorization Act of 2000 directed ICCVAM to prepare a progress report on its first anniversary and every other year thereafter. The latest ICCVAM Biennial Progress Report describes ICCVAM and ICCVAM agency activities from January 2018 through December 2019. Key ICCVAM, ICCVAM agency, and NICEATM accomplishments summarized in the report include:

  • Publication of A Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States.
  • Development of the Collaborative Acute Toxicity Modeling Suite, in silico models of acute oral systemic toxicity that predict five specific endpoints needed by regulatory agencies.
  • Expansion of the Integrated Chemical Environment.
  • Development of plans to replace, reduce, or refine animal use for testing by DoD, EPA and FDA.

This edition of the Biennial Report has been reorganized to make it easier for users to find content of interest. Menu items allow users to view articles by agency or find articles relevant to topics such as in vitro to in vivo extrapolation, cardiotoxicity, or mixtures toxicity. Reference pages list publications of interest as well as providing glossary terms and acronyms relevant to ICCVAM agencies and activities.

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Jul 27, 2020
EU Launches COVID-19 AOP-focused Modeling Project; Kickoff Webinar July 28

The European Union is launching a project on “Modelling the Pathogenesis of COVID-19 Using the Adverse Outcome Pathway Framework” (CIAO). CIAO will use crowdsourcing and the AOP framework to make sense of emerging COVID-19 data and relate this knowledge to what is known about similar diseases. CIAO is recruiting policy makers, health professionals, and scientists to contribute skills and knowledge to this effort. Participants will analyze relevant published knowledge and use what is learned to create or edit key events and key event relationships in COVID-19-related AOPs.

CIAO kickoff webinars will be on Tuesday, July 28 and Tuesday, August 4; both webinars will be at 7:30 a.m. EDT (1:30 Central European Time). You may register for one or both webinars. Please answer a few questions on the webinar registration page to help organizers plan the webinars.

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Jul 27, 2020
Applications Due August 1 for CAAT Award

The Center for Alternatives to Animal Testing (CAAT) at the Johns Hopkins Bloomberg School of Public Health sponsors the Next Generation Humane Science Award to acknowledge and encourage early-career researchers who focus on replacing animal experiments. The 2020 award will provide a prize of up to $5,000 recognizing the work of one scientist, or may be shared among two or more scientists. Factors considered in the evaluation of applications include the potential of the work to replace animal experiments and be used in a regulatory context. Candidates must be U.S. citizens or permanent residents working at U.S.-based institutions and have received Ph.D. or equivalent degrees no earlier than 2012. Applications are due August 1.

Aug 1, 2020
Jul 27, 2020
Online Conference to Consider Roadmap to Human Relevant Research

Cruelty Free Europe will present “Building Back Better: A Roadmap to Human Relevant Research in a Post COVID-19 World” on September 10 at 4:00-10 a.m. EDT (10:00 a.m.-4:00 p.m. Central European Time). The European Union’s plans to build back better after the coronavirus crisis include ambitious proposals to reinforce research and innovation and kick-start the economy. This online conference will bring together a broad range of stakeholders from the European Union and the U.S. to talk about:

  • The contribution new approach methodologies can make to delivering the European Union Green Deal and to building back better all over the world.
  • Initiatives underway in Europe and North America to replace animal testing.
  • What programs like Horizon Europe can do to bring about a paradigm shift.
  • How applying the logic of targets to the replacement of animal testing could be the important next step.

ICCVAM Administrative Director Warren Casey is one of the speakers.

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Jul 27, 2020
Global Summit on Regulatory Science to be Held Virtually September 28-30

The Global Summit on Regulatory Science will be held virtually September 28-30 with the theme of “Emerging Technologies and Their Application to Regulatory Science.” The meeting will feature emerging technologies from global regulatory, research, and standards communities. Topics include:

  • Emerging Technologies for the Safety Assessment of Food, Drugs, and Personal Care Products.
  • Approaches to Standardize and Validate Emerging Technologies for Regulatory Application.
  • Challenges and Opportunities of Emerging Technologies and Alternate Methods for Decision Making.

Registration for the meeting is required but there is no fee to attend. The meeting is being co-hosted by the Global Coalition for Regulatory Science Research and the National Center for Advancing Translational Sciences.

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Jul 21, 2020
OECD Issues Updated Test Guidelines; Webinar September 16

The Organisation for Economic Co-operation and Development (OECD) issued eight updated Test Guidelines on June 26. Included among the updated documents are tests relevant to replacing or reducing animal use for common acute toxicity endpoints.

  • Test Guidelines 437 and 491 describe the bovine corneal opacity and permeability test and the short time exposure test, respectively. Both in vitro tests are used to assess a chemical’s potential to cause eye irritation. The update to Test Guideline 437 expands the type of equipment that can be used to measure corneal opacity and revises the list of proficiency substances. The update to Test Guideline 491 revises the list of proficiency substances, addresses the testing of highly volatile substances, and provides guidance on how to use test results within the context of integrated approaches to testing and assessment.
  • Test Guideline 458 describes transcriptional activation assays for detecting androgenic activity of chemicals. The update adds two new validated methods to the test guideline and increases the sensitivity of a previously described method.
  • Test Guideline 439 describes reconstructed human epidermis models for assessing a chemical’s potential to cause skin irritation. The update represents a minor correction.

NICEATM and ICCVAM member agencies participate in the development and national review of documents issued by the OECD Test Guidelines Programme. OECD Test Guidelines are used by government, industry, and independent laboratories in the 36 member countries of the OECD to assess chemical safety. The OECD Mutual Acceptance of Data clause entails that safety data generated using an OECD test guideline will be accepted by all the member countries, avoiding redundant testing.

Acting NICEATM Director Nicole Kleinstreuer and ICCVAM member Wanda Hall, U.S. Environmental Protection Agency, participated in the April meeting of the Working Group of National Coordinators of the Test Guidelines Programme, which evaluated and recommended OECD adoption of the updated Test Guidelines.

An upcoming webinar will describe how Test Guidelines are developed through OECD, with a focus on nanomaterials. The webinar is scheduled for September 16 at 8:00 a.m. EDT (2:00 p.m. Central European Time).

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Jul 21, 2020
ECHA Issues Report on Animal and Alternatives Use

The European Chemicals Agency (ECHA) has issued its fourth report on the use of alternatives to animals for testing required under the REACH regulation. Data on more than 12,000 substances show that registrants are sharing data, using adaptations to avoid animal testing, and employing alternatives to animal testing. Examples include:

  • Registrants used at least one adaptation to avoid animal testing for about 70% of substances. Read-across is the most commonly used adaptation.
  • Use of non-animal tests for evaluating potential for skin and eye irritation and skin sensitization has increased greatly since 2016.
  • Companies are reducing the numbers of animals used for repeat dose toxicity tests and reproductive screening by using the combined test described in OECD Test Guideline 422.
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Jul 21, 2020
July 23 Webinar Describes Use of Recombinant Antibodies in COVID-19 and Other Infections

NICEATM, the PETA International Science Consortium Ltd. (PETA-ISC), and the European Union Reference Laboratory for Alternatives to Animal Testing will present a free webinar describing how animal-free recombinant antibodies are being used to fight diseases such as COVID-19. The webinar will be on Thursday, July 23 from 10:00-11:00 a.m. EDT.

In this webinar, Stefan Dübel, Technische Universität Braunschweig, will describe his work developing fully human antibodies against infections such as COVID-19 and diphtheria. Sachdev Sidhu will describe his successes at the Toronto Recombinant Antibody Centre in developing non-animal antibodies against the coronavirus SARS-CoV-2.

This is the first of a series of free webinars in which experts will address the application and benefits of recombinant antibodies. Topics and some tentative dates for upcoming webinars are available on the PETA-ISC website.

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Jul 15, 2020
Report Recommends Alternatives to Laboratory Dog Use by VA

A new report presents the findings of a National Academies of Sciences, Engineering, and Medicine study to evaluate the use of dogs in biomedical research. Conducted at the request of the U.S. Department of Veterans Affairs (VA), the study assessed whether laboratory dogs are or will continue to be necessary for biomedical research related to the VA’s mission. Former NICEATM Director Warren Casey is a coauthor of the report.

The report concludes that using laboratory dogs in research at the VA is scientifically necessary for only a few areas of current biomedical research. The report recommends that the VA adopt an expanded set of criteria for determining when it is scientifically necessary to use laboratory dogs in VA biomedical research and promote the development and use of alternatives to laboratory dogs. It also highlights opportunities for the VA to enhance the welfare of laboratory dogs that are being used in necessary biomedical research areas.

News articles about the report were published July 1 in the Military Times and the Washington Post.

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Jul 15, 2020
ASCCT Annual Meeting October 20-22; Abstracts Due August 7

Mark your calendars for the 9th Annual Meeting of ASCCT. The meeting will be held virtually on October 20-22 and no registration fee will be charged. The program will feature plenary speakers, panel discussions, oral and poster presentations drawn from submitted abstracts, and opportunities for early-career scientists through a mentoring session and poster awards. A draft program is available on the ASCCT website; a link to registration will be on this page in early fall.

Abstracts are being accepted for oral and poster presentations and are due August 7. Abstracts should be 250 words or less and can address any topic of interest to the society’s membership.

Aug 7, 2020
Jul 15, 2020
World Congress Webinars on COVID-19 Research August 25 and 26

The 11th World Congress on Alternatives and Animal Use in the Life Sciences will present two 90-minute webinars on replacing, reducing, and refining animal use in COVID-19 research on August 25 and 26. Both webinars will begin at 9:00 a.m. EDT (3:00 p.m. Central European Time). They will feature presentations highlighting innovative model systems to study COVID-19 as well as discuss new strategies for the development of vaccines, therapeutics, and diagnostics.

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Jul 15, 2020
Article Describes Updates to ICE

A new article in Toxicology In Vitro provides an overview of and summarizes recent updates to the NICEATM Integrated Chemical Environment (ICE). ICE provides tools and curated data centered around chemical safety assessment. This article describes updates to ICE, including improved accessibility and interpretability of in vitro data via mechanistic target mapping and enhanced interactive tools for in vitro to in vivo extrapolation (IVIVE).

Bell et al. 2020. An integrated chemical environment with tools for chemical safety testing. Toxicology In Vitro. https://doi.org/10.1016/j.tiv.2020.104916.

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Jul 09, 2020
NIEHS Scientific Information Officer Recruitment

NIEHS is seeking an outstanding leader with expertise in scientific computing and scientific information technology to join the Division of Intramural Research. Applications for this position will be accepted through August 1, 2020. The ideal candidate will:

  • Have an advanced degree (Ph.D., M.D., or equivalent) with a record of accomplishment in information technology support to a scientific enterprise as well as application to basic and clinical research.
  • Be highly collaborative and comfortable tackling information technology interests in a scientifically diverse environment.
  • Have strong oral and written communication skills and can build and manage a team.
  • Keep abreast of the most current technological advances in support of both scientific and enterprise information technology strategy.

Knowledge of the following areas is highly desired: academic and federal scientific culture, information technology solution development in the research and research administration space, government information technology security principles, clinical and basic research data management strategies, high-performance computing systems, scientific- and data-driven computational approaches, and content management systems.

This individual will head the Office of Scientific Computing and will lead a team that is directly focused on scientific information technology. Responsibilities include strategic planning and management, scientific and high-performance computing, training, and functioning as a liaison with NIH offices and institutes, other federal agencies, and with other organizations. The successful candidate will work with scientific and technology leaders within NIEHS to establish and maintain an information technology infrastructure that supports a vast variety of biomedical computing priorities ensuring that NIEHS remains a leader in applying technology to scientific collaboration and discovery.

Aug 1, 2020
Jul 02, 2020
NICEATM Staff Scientist Recruitment

NIEHS is seeking a scientist with expertise in computational chemistry to join the NICEATM group. Review of applications will begin on July 22. Candidates must have:

  • Ph.D., D.V.M., Sc.D., M.D., or equivalent in cheminformatics, biomedical, or related fields, with at least 5 years of research experience after receiving the final degree.
  • Strong background in cheminformatics and best practices in quantitative structure-activity relationship modeling and chemical curation.
  • Experience in performing and directing computational chemistry research, in particular to support regulatory decision-making.
  • Demonstrated expertise with the integration of in silico computational approaches with in vitro toxicology and in vivo reference data for chemical prioritization and hazard characterization.

The successful candidate will lead, develop, manage, and coordinate scientific and operational activities related to the development, validation, and use of proposed computational testing methods; develop strategies with appropriate programmatic, interagency, and international committees and organizations; and represent the NIEHS Division of NTP and ICCVAM at national and international scientific workshops and meetings.

Jul 22, 2020
Jul 02, 2020
July 23 Webinar Describes Use of Recombinant Antibodies in COVID-19 and Other Infections

NICEATM, PETA-ISC, and EURL ECVAM will present a free webinar describing how animal-free recombinant antibodies are being used to fight diseases such as COVID-19. The webinar will be on July 23 from 10:00-11:00 a.m. EDT.

In this webinar, Stefan Dübel, Technische Universität Braunschweig, will describe his work developing fully human antibodies against infections such as COVID-19 and diphtheria. Sachdev Sidhu will describe his successes at the Toronto Recombinant Antibody Centre in developing non-animal antibodies against the coronavirus SARS-CoV-2.

This is the first of a series of free webinars in which experts will address the application and benefits of recombinant antibodies. Topics and some tentative dates for upcoming webinars are available on the PETA-ISC website.

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Jul 02, 2020
July 8 Webinar Describes Human Biology-based Approaches for COVID-19 Therapeutics

ASCCT and the European Society for Toxicology In Vitro will present a free webinar describing the application of human biology-based in vitro testing platforms to study the SARS-CoV-2 virus and develop therapies for the prevention and treatment of COVID-19. The webinar will be July 8 from 11:00 a.m.-12:30 p.m. EDT.

  • Malcolm Wilkinson of Kirkstall will discuss applications of the Quasi Vivo® Systems, which introduce air and media flow over in vitro cell cultures and can be used to create multi-cell or multi-organoid models for the study of disease. Current studies relevant to COVID-19 include gaining a better understanding of viral entry and cellular response, as well as the impact of obesity and cigarette smoking on SARS-CoV-2 susceptibility.
  • Samuel Constant of Epithelix will describe application of the MucilAir and SmallAir systems, which closely mimic the morphology and function of nasal/bronchial and small-airway tissues, respectively. Current studies are focused on the SARS-CoV-2 infection process and how to apply these models to preclinical evaluation of antiviral candidates.
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Jul 02, 2020
EPA Releases New Approach Methods Work Plan

On June 23, EPA released its New Approach Methods Work Plan, which was created in response to the EPA Administrator’s 2019 directive to prioritize activities that will reduce the use of animal testing while continuing to protect human health and the environment. The work plan was developed by experts across the agency to set the objectives and strategies for using new approach methods to meet the ambitious goals set out in the Administrator's directive.

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Jul 02, 2020
SACATM to Meet September 2-3; Registration Open

SACATM will meet September 2-3. This meeting will be conducted as a public webcast. Information and registration to view the webcast and submit comments is available on the NTP website. The deadline to submit comments is August 26; registration to view the webcast will be open until the conclusion of the meeting.

SACATM is a federally chartered external advisory group of scientists from the public and private sectors, including representatives of regulated industry and national animal protection organizations. SACATM advises ICCVAM, NICEATM, and the Director of NIEHS and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM.

Aug 26, 2020
Jun 24, 2020
Woychik Named Director of NIEHS

National Institutes of Health Director Francis S. Collins, M.D., Ph.D., has appointed Richard (Rick) P. Woychik, Ph.D., as director of NIEHS. Initially joining NIEHS in 2011 as deputy director, Woychik has served as acting director of the NIEHS since October 2019 and began his new role as the NIEHS director on June 7. He will also serve as director of the interagency National Toxicology Program.

Woychik is highly respected for his accomplishments in mammalian genetics and environmental epigenetics. His laboratory was the first to identify a gene associated with polycystic kidney disease, the first to connect a protocadherin gene ultimately linked to hearing loss in Cushing’s disease patients, and the first to clone an obesity-related gene called agouti. He earned his Ph.D. in molecular biology in 1984 from Case Western Reserve University and moved into the field of molecular genetics during his postdoctoral training at Harvard Medical School.

A June 11 NIEHS press release has additional details about Woychik’s career and vision for NIEHS.

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Jun 24, 2020
NTP Postdoc Opportunity

Recruitment is underway for a postdoctoral fellow with training and experience in statistics and/or bioinformatics to join the newly formed, interdisciplinary Spatiotemporal Health Analytics Group in the Division of the NTP at NIEHS. This group is also affiliated with the National Institute on Minority Health and Health Disparities. The successful candidate will gain research training and experience in spatiotemporal methods and applications that bridge human health exposure science, epidemiology, and toxicology. Fellows will have the opportunity to propose related research for internal or external funding. The initial appointment is for two years.

Candidates should have doctoral degrees in statistics, bioinformatics, toxicology, or epidemiology. Other relevant experience includes scientific writing and oral communication, spatial analysis, big data, data visualization, analyzing toxicity assays and -omic data sets, and using software such as R, MATLAB, GitHub, and LaTeX.

For more information or to apply, contact Dr. Kyle Messier at kyle.messier@nih.gov.

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Jun 24, 2020
New Tool Maps Chemical Effects on the Human Body

Acting NICEATM Director Nicole Kleinstreuer is coauthor of a new publication in the journal Nucleic Acids Research that describes the Tox21BodyMap tool. Tox21BodyMap is an intuitive webtool allowing a user to identify target organs in the human body where a substance is estimated to be more likely to produce effects.

Borrel et al. 2020. Tox21BodyMap: a webtool to map chemical effects on the human body. Nucleic Acids Research. https://doi.org/10.1093/nar/gkaa433.

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Jun 17, 2020
Slides and Video Available from ICCVAM Public Forum

Slides and a video recording are available for the May 21 ICCVAM Public Forum. At the public forum, representatives of eight ICCVAM member agencies described work both to advance new approaches to safety testing of chemicals and medical products and to reduce the amount of testing required. Commenters at the forum commended the agencies’ progress and noted the importance of federal agencies taking leadership roles in reducing animal testing.

The annual public forum, usually an in-person event, was presented this year as a webinar that was attended by over 400 viewers. In addition to government agencies, viewers represented pharmaceutical and chemical companies, animal welfare organizations, and test method developers.

Please mark your calendars for the upcoming public meeting of ICCVAM’s scientific advisory committee, the Scientific Advisory Committee on Alternative Toxicological Methods. This meeting will be held online on Wednesday, September 2, and Thursday, September 3. Materials for the meeting will posted on the NTP website as they become available.

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Jun 17, 2020
Registration Open: Society for Birth Defects Research and Prevention Annual Meeting

Registration is open for the 60th Annual Meeting of the Society for Birth Defects Research and Prevention (formerly the Teratology Society). This year’s meeting will be held virtually from June 25-July 2. Society members and nonmembers may register to attend the entire meeting or a single day.

Acting NICEATM Director Nicole Kleinstreuer will give a presentation on “Automated applications of ontologies to standardize developmental toxicology study extraction” at a platform session beginning at 2:30 p.m. EDT on Wednesday, July 1. She will also present a poster on application of in vitro to in vivo extrapolation to developmental toxicity.

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Jun 17, 2020
Paper Examines Variability of In Vivo Data

A new publication in the journal Computational Toxicology describes the U.S. Environmental Protection Agency’s studies to quantify the variance in data from systemic in vivo toxicology studies. Data from these studies are often used as a reference for evaluating new approach methodologies (NAMs). However, variability in animal study data limits NAM accuracy. The findings from this study suggest quantitative considerations for building scientific confidence in NAM-based systemic toxicity predictions.

Pham et al. 2020. Variability in in vivo studies: defining the upper limit of performance for predictions of systemic effect levels. Computational Toxicology. https://doi.org/10.1016/j.comtox.2020.100126.

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Jun 09, 2020
Virtual Workshop on COVID-19 Modeling Begins June 11

The Biocomplexity Institute at Indiana University is presenting the two-part virtual workshop “Open-Source CompuCell3D Multiscale, Virtual-Tissue Spatio-Temporal Simulations of COVID-19 Infection, Viral Spread and Immune Response and Treatment Regimes.” The workshop will describe CompuCell3D, an open-source tool to simulate biological processes within a cell. Attendees will learn how to use CompuCell3D to model basic patterns of infection dynamics and antiviral treatment.

  • Part I will present an overview of CompuCell3D and describe how to run it and to change model parameters for generating new biologically meaningful simulations. It will be presented twice, first on Thursday, June 11, 2:00-5:00 p.m. EST and again on Friday, June 12, 9:00 a.m.-noon EST.
  • Part II will describe how to extend the model with additional images, graphics and file outputs, additional cell types, diffusive fields, cell behaviors and interactions and improved subcellular and immune-system models. It will be presented twice, first on Thursday, June 18, 2:00-5:00 p.m. EST and again on Friday, June 19, 9:00 a.m.-noon EST.

The workshop is intended for a broad audience with interest in COVID-19 modeling; no programming experience or advanced mathematical knowledge is required.

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Jun 09, 2020
OSHA and DOT Request Public Input in Advance of International Meetings

OSHA and the DOT Pipeline and Hazardous Materials Safety Administration plan to hold public meetings on Wednesday, June 24, in advance of July meetings of:

  • The United Nations Sub-committee of Experts on the Globally Harmonized System of Classification and Labelling of Chemicals (OSHA)
  • The United Nations Subcommittee of Experts on the Transport of Dangerous Goods (DOT)

The purpose of the June 24 public meetings is to discuss proposals and receive input for the July meetings. Both June 24 meetings will be convened virtually and are open to the public. Interested parties may submit comments by June 11.

Jun 11, 2020
Jun 03, 2020
HSI Publishes Roadmap for Elimination of Vaccine Tests

HSI has published “Global Harmonization of Vaccine Testing Requirements: Roadmap for Elimination of the ATT, TABST, & LABST.” This document outlines steps that could facilitate deletion of the Abnormal Toxicity Test (ATT), Target Animal Batch Safety Test (TABST), and Laboratory Animal Batch Safety Test (LABST) from global regulations and pharmacopeias for human and veterinary batch-release testing. The roadmap also aims to foster a more harmonized regulatory environment that both recognizes and encourages alternative methods. The document has been reviewed and approved by experts and representatives from Argentina, Brazil, China, Europe, India, Russia, South Africa, and the United States.

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Jun 03, 2020
Apply by June 10 for Summer School on Innovative Approaches to Science

The Summer School on Innovative Approaches to Science will be held June 22-26 as a free virtual meeting. This event will focus on cutting-edge methods to reduce and replace animal tests in toxicology and biomedical science and is targeted to students and early-career scientists. The program will feature lectures, in-depth training, virtual laboratory tours, e-poster presentations, and virtual engagement with speakers and attendees. ICCVAM Administrative Director Warren Casey will give the keynote address and Acting NICEATM Director Nicole Kleinstreuer will present an “Overview of Evidence Integration in Toxicology.”

Apply to participate by June 10. Attendees may choose to register for one or more training or lecture sessions. Alternatively, those who register to participate in the full program will be eligible for participation awards and receive a certificate for their involvement.

Jun 10, 2020
Jun 03, 2020
Webinar June 9 to Discuss Machine Learning and Artificial Intelligence in Toxicology

A webinar organized by ASCCT and ESTIV will consider “The Use of Machine Learning and Artificial Intelligence in Toxicology and Risk Assessment.” The webinar will be presented Tuesday, June 9, from 11:00 a.m.-12 noon EDT.

Artificial intelligence and machine learning algorithms are gaining visibility in toxicology. These algorithms can identify new patterns in data and make predictions in a way and on a scale that human scientists cannot. What are they and how do they work? How do they “learn” and help make decisions? And where do they fit into the science of toxicology? In this webinar, Timothy Allen of the Toxicology Unit of the Medical Research Council at the University of Cambridge will answer these questions and address how artificial intelligence and machine learning can be used in safety science.

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May 28, 2020
Positions Available for Biologists at EPA; Apply by June 1

EPA has openings for experienced biologists in the Health Effects Division and Environmental Fate Effects Division within the Office of Pesticide Programs. Successful candidates will:

  • Interpret, evaluate, analyze, and synthesize scientific data and other information for the development of human health and/or environmental assessments on the effects of pesticides from both toxicology and exposure studies;
  • Determine the general approach necessary to accomplish the review and evaluation of data;
  • Prepare reports that includes evaluation of available data and assessments of exposure, hazard and/or risk from exposure to pesticides;
  • Review and make recommendations on the exposure analyses for pesticides in various environments concerning the retention or cancellation of pesticides.

Applicants should have at least a bachelor’s degree in biological sciences, natural resource management, chemistry, or related area and at least one year of relevant experience. Applicants must be U.S. citizens, and a pre-employment background check will be required. All positions are currently located in Arlington, Virginia, with eventual relocation likely to Washington, DC. Applications must be submitted by Monday, June 1. For more information, contact Chelsea Vaughn at 919-541-4215 or vaughn.chelsea@epa.gov.

Jun 1, 2020
May 21, 2020
Publication Describes Tool to Predict Chemical-assay Interference

A paper in the journal Nucleic Acids Research describes InterPred, an online tool that combines 17 quantitative structure activity relationship models to allow users to predict the probability that a new chemical will interfere with different combinations of cellular and technology conditions used in high-throughput screening applications. The paper was coauthored by Acting NICEATM Director Nicole Kleinstreuer and computational chemist Kamel Mansouri (ILS, contractor supporting NICEATM).

Borrel et al. 2020. InterPred: a webtool to predict chemical autofluorescence and luminescence interference. Nucleic Acids Research. https://doi.org/10.1093/nar/gkaa378.

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May 21, 2020
Summer School on Innovative Approaches to Science Moves Online

The Summer School on Innovative Approaches to Science will now take place as a free virtual meeting. The June 22-26 meeting will feature lectures, in-depth training, virtual laboratory tours, e-poster presentations, and virtual engagement with speakers and attendees. Content will focus on cutting-edge methods to reduce and replace animal tests in toxicology and biomedical science and is targeted to students and early-career scientists. Attendees may choose to register for one or more training or lecture sessions. Alternatively, those who register to participate in the full program will be eligible for poster and participation awards and will receive a certificate for their involvement.

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May 21, 2020
HESI to Support Development of Cardiac Safety Assays; Letters of Intent Due June 8

The Health and Safety Environmental Institute (HESI) is seeking proposals for studies to develop human-relevant, mechanism-based assays evaluating cardiac safety liabilities. Assays should focus on any of six failure modes:

  • Changes in blood pressure or heart rate
  • Changes in contractility and ejection fraction
  • Electrophysiology
  • Cardiac cell injury
  • Valvular injury or proliferation
  • Hemorrhage and coagulation

Awards of up to $50,000 will be awarded for 12-month projects. Awardees must be based in the United States. Letters of intent are due June 8.

Jun 8, 2020
May 21, 2020
Webinar Discusses Computational Collaborations for Predictive Toxicology

A webinar presented by the American Society for Cellular and Computational Toxicology and the European Society for Toxicology In Vitro will discuss “International Computational Collaborations for Predictive Toxicology.” The webinar is scheduled for Tuesday, May 26, from 11:00 a.m.-12 noon EDT.

Computational chemist Kamel Mansouri (ILS, contractor supporting NICEATM) will describe three projects involving over 100 scientists from governmental agencies, academia, and industry that collaboratively developed in silico tools for predicting chemical toxicity. These projects—the Collaborative Estrogen Receptor Activity Prediction Project (CERAPP), the Collaborative Modeling Project for Androgen Receptor Activity (CoMPARA), and the Collaborative Acute Toxicity Modeling Suite (CATMoS)—used data from both the published literature and the ToxCast/Tox21 programs. The consensus models developed through these projects have been used to screen hundreds of thousands of chemicals and are freely available for further use though open-source applications.

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May 21, 2020
EPA Requests Public Comment on Draft Risk Assessment for Antimicrobial Chemicals

In a May 14 Federal Register notice, EPA requested comment on draft human health and ecological risk assessments for registration review of a group of antimicrobial chemicals known as isothiazolinones. EPA specifically requests comment on the use of an in vitro and artificial neural network-based defined approach to determine points of departure used in the isothiazolinone draft risk assessments instead of using laboratory animal data to evaluate risks for dermal sensitization. Comments are due by July 13. The Federal Register notice includes instructions on how to submit comments.

The draft risk assessments rely heavily on work done by NTP, NICEATM, and ICCVAM. The in vitro testing was conducted by the NTP Toxicology Branch. NICEATM analyzed the in vitro data and ran the artificial neural network-based defined approach to provide quantitative potency predictions used to determine points of departure. The ICCVAM Skin Sensitization Expert Group reviewed the NTP testing report and the NICEATM analyses before data were provided to EPA for development of the risk assessments. The use of in vitro and in chemico assays and neural network-based defined approaches is the first use of such information in regulatory risk assessment.

Jul 13, 2020
May 20, 2020
NTP 2019 Annual Report Now Available

The NTP Annual Report for fiscal year 2019 is now available. In fiscal year 2019, NTP continued to advance toxicology and inform public health policy by providing information to decision makers and the public about substances in our environment. NTP, of which NICEATM is a part, also participated in activities to advance alternatives to animal testing. Among over 250 peer-reviewed research studies and articles published by NTP during fiscal year 2019 are articles describing NICEATM activities in promoting alternatives to animal testing, as well as Tox21 projects that explored toxicity mechanisms and developed new tools for toxicity testing.

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May 20, 2020
Presentations Available from Webinar on Small Business Funding

Presentations are now available from the April 17 town hall webinar on “Development of New Approach Methodologies to Reduce Animal Use in Toxicity Testing.” The webinar was presented by the NIEHS SBIR and STTR program in coordination with NICEATM. The presentations are available on the NTP website. A video of the webinar is available on the NIEHS website.

A key component of the Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States is early interaction between developers of NAMs and end-users, to ensure that the proposed NAMs will meet testing requirements for agency and industry stakeholders. The goal of this webinar was to facilitate improved communication between method developers, including SBIR/STTR applicants, and end-users. The webinar provided an opportunity for assay developers to hear from ICCVAM stakeholders on the desired characteristics and requirements for NAMs. Presenters included representatives from NICEATM, the U.S. Environmental Protection Agency, the U.S. Food and Drug Administration, the U.S. Department of Defense, 3M Corporation, and Novartis.

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May 20, 2020
ICCVAM Public Forum This Thursday, May 21: Registration Still Open

Registration is still open for the ICCVAM Public Forum, which will be webcast Thursday, May 21, from 9:00 a.m.-4:00 p.m. Registration is required to view the webcast and will be open through the end of the meeting. Representatives from eight ICCVAM member agencies will give presentations on current activities related to the development and validation of alternative test methods and approaches, including activities relevant to implementation of the strategic roadmap for establishing new approaches to evaluate the safety of chemicals and medical products in the United States.

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May 20, 2020
EURL ECVAM Recommends Use of Nonanimal-derived Antibodies

EURL ECVAM has issued a recommendation urging end-users and other stakeholders to recognize the scientific validity of nonanimal-derived antibodies and to stop using animals for antibody development and production. The recommendation is based on the opinion of EURL ECVAM’s scientific advisory committee. It states that animals should no longer be used for the development and production of antibodies for research, regulatory, diagnostic and therapeutic applications. It also challenges misconceptions about nonanimal-derived antibodies and highlights the scientific and economic benefits of their use. The report is available on the European Joint Research Centre website; a news release summarizing the report’s recommendations is also available on the website.

Use of nonanimal-derived antibodies was the topic of the 2020 ICCVAM Communities of Practice webinar, presented in January. One of the webinar presenters, Rebecca Clewell, served on the scientific advisory committee on whose opinion the EURL ECVAM recommendation was based.

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May 07, 2020
FDA Webinar to Discuss Artificial Intelligence in Regulatory Science

A webinar on “Artificial Intelligence for Regulatory Science Research” will be presented on Thursday, May 14, at 12 noon EDT. Weida Tong of the FDA National Center for Toxicological Research will review the center’s current thinking and ongoing efforts in the area of artificial intelligence. The webinar is free and open to the public.

Artificial intelligence (AI) is a broad concept of training machines to think and behave like humans. It consists of a wide range of statistical and machine learning approaches to learn from existing data/information to predict future outcomes. This webinar will present examples of AI implementation in drug and food safety, natural language processing of regulatory documents, and biomarker discovery and development. The guiding principles and best practice of applying AI in regulatory science research will also be discussed with respect to the context of use and fit-for-purpose application.

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May 07, 2020
Workshop Report Available on Read-across for Regulatory Toxicology

NICEATM Acting Director Nicole Kleinstreuer, ICCVAM FDA Principal Representative Suzanne Fitzpatrick, and ICCVAM Read Across Workgroup Chair Grace Patlewicz co-authored a report from a workshop that considered read-across as a new approach methodology for regulatory toxicology. The report concludes that read-across is potentially a major tool for risk assessment. Currently used primarily to justify waiving in vivo tests, there is a future opportunity for read-across to be applied in combination with other new approach methodologies to increase predictivity and reliability of toxicological assessment.

Rovida et al. Internationalization of read-across as a validation new approach method (NAM) for regulatory toxicology. ALTEX. https://doi.org/10.14573/altex.1912181.

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May 05, 2020
ICCVAM Public Forum May 21: Register to Present Oral Statements by Friday May 8

ICCVAM will hold a public forum on Thursday, May 21 from 9:00 a.m.-4:00 p.m. EDT. This event is held annually to share information and facilitate direct communication of ideas and suggestions from stakeholders. This year the public forum will be presented via webcast only. NICEATM staff and ICCVAM members will give presentations on current activities related to the development and validation of alternative test methods and approaches, including activities relevant to implementation of the strategic roadmap for establishing new approaches to evaluate the safety of chemicals and medical products in the United States. More information and a draft agenda are available on the NICEATM website.

Interested persons may register to present oral public statements with associated slides on topics relevant to ICCVAM's mission. Requests to present oral statements during the meeting will be accepted on a first-come, first-served basis as time permits. The deadline for registering to present oral public statements is this Friday, May 8. Registration is required to view the public forum webcast and will be open through the end of the meeting on May 21.

May 8, 2020
May 05, 2020
Webinar to Discuss Use of Non-animal Skin Sensitization Test Methods

A webinar on “Use of Non-animal Skin Sensitization Test Methods” will be presented on Wednesday, May 27, at 10:00 a.m. EDT. Louis Scarano of EPA Office of Pollution Prevention and Toxics will discuss their recent review of non-animal skin sensitization tests. Hans Raabe, Institute for In Vitro Sciences, will discuss the use of non-animal skin sensitization test methods for EPA hazard classification and will provide an overview of three currently accepted regulatory test methods. The webinar is being presented by PETA-ISC, EPA, and PCRM. It is free and open to the public.

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May 05, 2020
World Congress on Alternatives and Animal Use in the Life Sciences Postponed to August 2021

The 11th World Congress on Alternatives and Animal Use in the Life Sciences, originally scheduled for August 2020, has been postponed to August 22-26, 2021. The meeting will still be held in Maastricht, the Netherlands. More information about the meeting is available on the meeting website.

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May 05, 2020
Publication Discusses FDA Perspective on Use of NAMs in Drug Development

A paper coauthored by Paul Brown, ICCVAM representative from the FDA Center for Drug Evaluation and Research, discusses the center’s view on the opportunities and challenges of using NAMs in drug development, especially for regulatory purposes. The paper includes examples where NAMs are currently being used in nonclinical safety assessments and where they may supplement and/or enhance current testing methods.

Avila et al. 2020. An FDA/CDER perspective on nonclinical testing strategies: Classical toxicology approaches and new approach methodologies (NAMs). Regulatory Toxicology and Pharmacology. https://doi.org/10.1016/j.yrtph.2020.104662.

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May 04, 2020
SOT FDA Colloquium to Discuss Integrated Approaches to Testing and Assessment

SOT and the FDA will hold a colloquium on “Integrated Approaches to Testing and Assessment: The Future of Regulatory Toxicology Assessment” on Thursday, May 28, from 8:30 a.m.-12:35 p.m. This event is the latest in the series, “SOT FDA Colloquia on Emerging Toxicological Science: Challenges in Food and Ingredient Safety.” Suzanne Fitzpatrick, FDA principal representative to ICCVAM, is event co-chair. The colloquium will be webcast and is open to the public.

Integrated approaches to testing and assessment (IATAs) are pragmatic, science-based frameworks for chemical hazard or risk characterization. IATAs follow an iterative, integrative approach to answer a defined question with a pre-determined level of certainty in a specific regulatory context. This colloquium will introduce the concept, process, and components that comprise an IATA and present several case studies demonstrating different applications of this decision tool. Issues, challenges, and prospects of adopting IATAs in regulatory risk assessment will be discussed.

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May 04, 2020
New FDA Webpage Highlights Alternative Methods Working Group

FDA has a long-standing commitment to promote the development and use of new technologies to better predict human and animal responses to substances relevant to its regulatory mission. To strengthen that commitment, FDA launched its Alternative Methods Working Group. This group facilitates interactions with global regulatory bodies interested in implementing alternative methods in toxicology. Additionally, the group examines opportunities and viable ways by which emerging methods and new technologies can support regulatory review of risk, safety, and efficacy of FDA-regulated products.

The Alternative Methods Working Group recently launched its webpage, which will highlight FDA’s work in this area. A link to this page and to other ICCVAM agency webpages focused on alternative methods is available on the NICEATM website.

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Apr 22, 2020
NCATS Funding Use of Tissue Chips to Support COVID-19 Research

NCATS has issued two Notices of Special Interest to support research in collecting and examining data on the risks and outcomes for COVID-19 infections using MPS or tissue chips. Such work is expected to advance the translation of research findings into diagnostics, therapeutics, and vaccines. Applications for both opportunities will be accepted on a rolling basis from May 15, 2020, through January 25, 2022.

  • NOT-TR-20-016 announces the availability of one-year administrative supplements for investigators and institutions funded through existing grants of the NCATS MPS program. Proposals should address how the work will contribute to advancing translational research for COVID-19.
  • NOT-TR-20-017 announces the availability of competitive revisions for investigators and institutions funded through existing grants of the NCATS MPS program. Proposals should address development of MPS models for COVID-19, the use of MPS for rapid detection of COVID-19 infection, or the use of MPS to evaluate potential therapeutics for COVID-19.
Jan 25, 2022
Apr 22, 2020
FDA Guidance on Immunotoxicity Testing Supports Use of Alternatives

In February, FDA issued draft guidance on “Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics.” This guidance supplements previously issued recommendations on nonclinical evaluations of immunotoxic potential and is intended to assist sponsors in such evaluations. The guidance includes several specific recommendations on assessing potential for dermal sensitization:

  • FDA no longer recommends that sponsors conduct the murine local lymph node assay to assess the sensitization potential of topical drug products due to the limitations of the assay.
  • As an alternative to accepted guinea pig tests, FDA will consider a battery of in silico, in chemico, and in vitro studies that have been shown to adequately predict human skin sensitization with an accuracy similar to existing in vivo methods.
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Apr 22, 2020
REACH Chemical Data Available Through IUCLID Database

The European Union’s REACH regulation requires companies to identify and manage risks of chemicals. Data required under REACH are submitted to the European Chemicals Agency (ECHA).

On April 17, ECHA updated data from REACH studies available through the IUCLID data resource. The data contain results from studies that relate to physical-chemical properties, environmental fate and pathways, and ecotoxicology and toxicological information. These data may be helpful in the development and use of alternatives to animal testing.

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Apr 16, 2020
ICCVAM Public Forum May 21: Registration Open

ICCVAM will hold a public forum on Thursday, May 21 from 9:00 a.m.-4:00 p.m. EDT. This event is held annually to share information and facilitate direct communication of ideas and suggestions from stakeholders. This year the public forum will be presented via webcast only due to restrictions on in-person gatherings amid ongoing public health concerns. NICEATM staff and ICCVAM members will give presentations on current activities related to the development and validation of alternative test methods and approaches, including activities relevant to implementation of the strategic roadmap for establishing new approaches to evaluate the safety of chemicals and medical products in the United States.

Registration is required to view the public forum webcast and will be open through the end of the meeting on May 21. Interested persons may also register to present oral public statements with associated slides on topics relevant to ICCVAM's mission. Requests to present oral statements during the meeting will be accepted on a first-come, first-served basis as time permits. The deadline for registering to present oral public statements is May 8.

May 8, 2020
Apr 16, 2020
Call for Abstracts for ASCCT Annual Meeting: Deadline July 31

Abstracts are being accepted for oral and poster presentations for the 9th Annual Meeting of the ASCCT. The meeting will be held in Durham, North Carolina, on October 21-22. The conference’s theme will address the EPA goal to eliminate reliance on mammalian tests for regulatory decisions by 2035, and the science and policy considerations related to meeting this goal. An optional training session on the EPA Chemistry Dashboard and related tools will be held October 23. Abstracts of 250 words or less are welcome on any topic of interest to the society’s membership and are due July 31.

Jul 31, 2020
Apr 16, 2020
ASCCT Webinar April 30; Call for Webinar Topics and Speakers

A webinar presented by ASCCT and ESTIV will consider “Use of New Approach Methodologies for Cosmetics Safety Assessment Without Animal Testing.” The webinar is scheduled for Thursday, April 30, from 11:00 a.m.-12 noon EDT.

With the cancellation or postponement of in-person conferences, ASCCT webinars offer scientists an opportunity to present their work to a worldwide virtual audience of ASCCT and ESTIV colleagues and other regulators and industry and academic toxicologists. Webinars are typically scheduled once per month, but more frequent events can be scheduled based on the level of interest. To suggest a webinar topic or speaker, please contact ASCCT Secretary Kristie Sullivan at info@ascctox.org; self-nominations are welcome.

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Apr 09, 2020
Deadline Extended for EMGS Bioinformatics Challenge

The Environmental Mutagenesis and Genomics Society (EMGS) has extended the application deadline for the EMGS Bioinformatics Challenge 2020, to be held at the EMGS annual meeting in September. This competition encourages EMGS members and bioinformatics/data science experts to work together to develop novel tools and approaches that harness publicly available data resources such as Tox21 and DrugMatrix to identify signatures of genotoxic hazards and provide insight into their mechanisms of action.

To participate, submit a 250-word abstract with a data visualization by Wednesday, April 15. Abstracts will be evaluated in part on model performance in classifying/predicting carcinogens and ability to identify novel genotoxic modes of action. Those selected to participate in the final challenge will receive a $300 monetary award for academic participants and a membership waiver for non-member participants. The overall challenge winner will receive a grand prize of $1200.

Apr 15, 2020
Apr 09, 2020
Fast-track Grants Support In Vitro Models for COVID-19

The Johns Hopkins Center for Alternatives to Animal Testing (CAAT) is redirecting funds in the Alan and Helene Goldberg In Vitro Toxicology Grants program (formerly CAAT Grants Program) to help accelerate the discovery of mechanisms, medicines, and vaccines for COVID-19. These grants of up to $40,000 each will support development of non-animal, human biology-based models to accelerate the response to current and emerging pandemics. Applications for this grant will be screened by an advisory committee and will be funded as soon as possible. The application deadline is April 30.

CAAT is accepting financial donations to support this program; for more information, contact Camila Januario.

Apr 30, 2020
Apr 09, 2020
In Vitro Methods Support EPA Prioritization for TSCA Testing

In February, EPA announced the designation of 20 chemical substances as low priority under the Toxic Substances Control Act (TSCA). The designation is the third and final step in the prioritization process for reviewing chemical substances under the Frank R. Lautenberg Chemical Safety for the 21st Century Act amendments to TSCA. A low-priority designation means that risk evaluation for these substances is not warranted at this time.

For each chemical substance designated as low priority, EPA published a document describing the information, analysis, and basis for the designation. Information used to support the designation for each chemical included 3Rs approaches:

  • Data from in vitro high-throughput screening assays used in the EPA ToxCast program
  • Predictions of toxicity generated using quantitative structure-activity relationship models
  • Predictions of toxicity generated using read-across, a computational technique that uses toxicity data from a tested chemical to predict toxicity for an untested chemical

NICEATM has compiled a summary of 3Rs approaches used to designate these substances as low priority. In addition to the reduction of animal use realized by the approaches described above, designation of each substance as low priority reduces the likelihood that animals will be required for future testing of these substances.

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Mar 27, 2020
World Congress Abstract Deadline Extended to March 31

WC11 has extended its deadline for submitting abstracts for poster or platform presentations to Tuesday, March 31. Abstracts should describe original work not previously published relevant to interests and goals of WC11. There is no fee charged for abstract submission.

WC11 will be held on August 23-27 in Maastricht, The Netherlands. This meeting will explore the latest in alternative methods research and development, providing a multidisciplinary program covering both traditional themes and the latest issues and novel developments in the field of alternatives to animal testing in the life sciences. The preliminary program for WC11 is available. Registration is open; discounted early registration is available through May 15.

Abstracts: Mar 31

Early Registration: May 15

Mar 27, 2020
Preproposals Due April 20 for In Vitro Toxicology Grants

CAAT is accepting preproposals for the Alan and Helene Goldberg In Vitro Toxicology Grants program (formerly CAAT Grants Program). These grants of up to $40,000 each will support projects with the potential to significantly reduce or replace the use of laboratory animals. Examples of acceptable projects include providing mechanistic understanding of in vitro responses to toxicants in human cells, development of adverse outcome pathways, or conducting systematic reviews. Consideration should be given to the translation of new methods to evaluate/predict health outcomes. Preproposals for the grants are due Monday, April 20.

Apr 20, 2020
Mar 27, 2020
Webinar April 30 to Discuss NAMs for Cosmetic Safety Assessment

A webinar presented by ASCCT and the European Society for Toxicology In Vitro will consider “Use of New Approach Methodologies for Cosmetics Safety Assessment Without Animal Testing.” The webinar will be presented Thursday, April 30, from 11:00 a.m.-12 noon EDT.

Recent advances in chemical safety assessment now allow the complete evaluation of personal care products without the use of animals. The safety assessment approach begins with problem formulation and evaluation of existing information before considering development of a targeted testing approaches. Assessment tools, often described as new approach methodologies (NAMs), can include computational models and human relevant in vitro assays which are applied in combination to provide information on ingredient hazard and risk assessment. These disparate types of information are integrated and weighted in a transparent assessment that captures uncertainty. Each presentation in this webinar will cover different aspects of this decision process.

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Mar 27, 2020
ASCCT Webinar Series Available Online

ASCCT is now making its library of past webinars available to the public at no cost. The ASCCT webinar library includes over 40 expert presentations highlighting innovation in science and policy related to in vitro and computational toxicology. Speakers represent a variety of professional backgrounds including federal and state agencies, private industry, and academia. Topics include advancing predictive toxicology, moving away from animal studies, regulatory application, organs-on-chips and 3D bioprinting.

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Mar 27, 2020
Papers Due July 31 for Special Issue of Chemical Research in Toxicology

Papers are being accepted for a special issue of the journal Chemical Research in Toxicology that will focus on computational toxicology. The goal of this special issue is to bring together recent developments in computational toxicology, with equal emphasis given to methodological developments, such as statistical approaches, modeling advances, and computational resources, as well as applications and case studies demonstrating the use of existing and novel methods. In particular, the focus will be on online and freely available tools and open source software, databases, and recent studies that exemplify success or limitations of the currently used methods. The issue will be edited by Acting NICEATM Director Nicole Kleinstreuer and Weida Tong of the U.S. Food and Drug Administration’s National Center for Toxicological Research.

Submissions are invited in, but are not limited to: curated data sets and models to predict human and environmental toxicity; physiologically based pharmacokinetic modeling; advanced approaches for in vitro to in vivo extrapolation; combining in silico predictions with in vitro and in vivo data; multiscale and agent-based models; harvesting and processing of big, heterogeneous, and nonstandard data (e.g., literature and patent mining, pathway information); toxicogenomics; and systems toxicology. Submissions are due July 31.

Jul 31, 2020
Mar 25, 2020
Slides Available from ICCVAM Webinar on Animal-free Affinity Reagents

Slides from the January 21 ICCVAM Communities of Practice webinar on “Use of Animal-free Affinity Reagents” are available on the NTP website. In this webinar, Alejandra Solache of Abcam presented an overview of production, use, and characteristics of monoclonal and polyclonal antibodies. Rebecca Clewell of 21st Century Tox Consulting summarized a recent review by a working group of the Scientific Advisory Committee of the European Union Reference Laboratory for Alternatives to Animal Testing on the scientific validity and benefits of animal-free technologies to produce affinity reagents.

Save the following dates for ICCVAM public events later this year:

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Mar 25, 2020
EPA Seeks Nominees for TSCA Scientific Advisory Committee on Chemicals

EPA invites nominations of scientific experts to be considered for appointment to the TSCA Science Advisory Committee on Chemicals (SACC). The purpose of the SACC is to provide independent advice and expert consultation on the scientific and technical aspects of implementing TSCA.

Nominations should be received by April 20. Nominees should have expertise in one or more of the following subject areas: human health and ecological risk assessment, biostatistics, epidemiology, pediatrics, physiologically based pharmacokinetics, toxicology and pathology, and chemical exposures of sensitive populations. A March 20 Federal Register notice [85 FR 16094] has details on the call for nominations.

Apr 20, 2020
Mar 25, 2020
NICEATM and ICCVAM Scientists Featured in SOT Virtual Meeting Webinars

Over the next few months, SOT will present scientific sessions and CE courses as live webinars. These events were originally planned for presentation at SOT’s annual meeting in Anaheim. Visit the SOT website for the complete schedule. This web page will be updated regularly as webinars are confirmed and registration details become available.

Registration is available for three CE courses that feature topics of potential interest to ICCVAM stakeholders. Please note that all CE courses require a paid registration. Those persons who registered to attend a CE course in Anaheim are registered for the webinar course. Registration has now reopened for those not previously registered.

  • Introduction to Open Access Computational Toxicology Tools: Friday, April 3, noon-3:30 p.m. EDT
    This CE course offers an introductory-level foundation for leveraging some widely accepted computational toxicology approaches, and demonstrates how to use open-source tools and resources to make use of these methods. Agnes Karmaus, ILS (contractor supporting NICEATM), and NICEATM Acting Director Nicole Kleinstreuer are course co-chairs; Shannon Bell, ILS (contractor supporting NICEATM), is a presenter.
  • An Introduction to New Approach Methodologies (NAMs) and Understanding Their Potential to Support Regulatory Decisions: Friday, May 15, noon-3:30 p.m. EDT
    This CE course will provide an overview of NAMs along with case studies where they are being used or could potentially be used for regulatory risk assessment. Suzanne Fitzpatrick, U.S. Food and Drug Administration principal representative to ICCVAM, is a course co-chair.
  • In Vitro Approaches to Assess the Toxicity of Inhaled Substances: Friday, May 15, noon-3:30 p.m. EDT
    In this course, speakers from government, contract research organizations, academia, NGOs, and method developers will discuss progress and challenges associated with various approaches for inhalation toxicity testing. ICCVAM Co-chair Emily Reinke, U.S. Department of Defense, is a course co-chair; David Allen, ILS (contractor supporting NICEATM), is a presenter.
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Mar 18, 2020
ICE Version 3.0 Now Available

On March 11, NICEATM released an update of the Integrated Chemical Environment (ICE). ICE provides data and tools to help develop, assess, and interpret chemical safety tests. The update introduces a new user interface to simplify searches and new tools that will let users explore chemical properties and toxicity in more detail.

The ICE 3.0 update features improvements to the in vitro to in vivo extrapolation (IVIVE) tool. In response to customer requests, ICE now allows users to upload their own data for IVIVE analyses. A new physiologically based toxicokinetic model has been added, and the output graphics have been improved.

Other new resources in ICE 3.0 include:

  • User interface improvements
  • Organization of Tox21 assays in query setup menus based on modes of action
  • Availability of data from in vitro dermal irritation assays
  • Updated property predictions for over 800,000 chemicals from OPERA (Open Structure-activity/property Relationship App)
  • Mapping of Tox21 assays to controlled terms from the NCI Metathesaurus
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Mar 17, 2020
NIEHS to Present Webinar on Grant Opportunities for NAM Development

The NIEHS SBIR/STTRM program, in coordination with NICEATM, will host a webinar-based town hall meeting on “Development of New Approach Methodologies to Reduce Animal Use in Toxicity Testing.” The webinar will be held on April 17 from 1:00-3:00 p.m. EDT.

A key component of the Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States is early interaction between developers of NAMs and end-users, to ensure that the proposed NAMs will meet testing requirements for agency and industry stakeholders. This webinar will facilitate improved communication between method developers, including small business (SBIR/STTR) applicants, and end-users, providing an opportunity for assay developers to hear from ICCVAM stakeholders on the desired characteristics and requirements for NAMs. The agenda will include short presentations from experts from U.S. federal agencies and industries, including pharmaceutical developers, with time allowed for questions from method developers. Presenters include representatives from NICEATM, the U.S. Environmental Protection Agency, the U.S. Food and Drug Administration, the U.S. Department of Defense, 3M Corporation, and Novartis.

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Mar 16, 2020
SOT Presentations Available on NICEATM Webpage; Save the Date for ICCVAM Public Forum May 21

SOT announced Monday March 9 that its 2020 annual meeting was cancelled. A list of planned presentations from NICEATM and ICCVAM is available on the NTP website. Posters and other presentations planned for SOT will be made available on this page in the near future. Please visit this page occasionally to check for availability of materials of interest to you.

Updates on ICCVAM activities will be presented at the ICCVAM Public Forum scheduled for May 21. The meeting and presentations will be available for remote viewing. Additional meeting details will be shared as they become available.

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Mar 16, 2020
EURL ECVAM Issues Status Report on Alternatives

EURL ECVAM has issued its 2019 “Status Report on the Development, Validation and Regulatory Acceptance of Alternative Methods and Approaches.” The status report describes research, development, and validation activities, as well as initiatives that promote the regulatory and international adoption and use of alternative approaches and their dissemination. Activities described in the report include:

  • Research initiatives to foster mechanistic-based toxicity testing to support risk assessment of chemicals, with a primary focus on repeated dose, developmental and reproductive toxicity
  • Exploration of the relationship between chemical exposure and public and environmental health, with particular attention being given to the area of carcinogenicity
  • Validation of methods to identify substances with the potential to affect the thyroid signaling pathway, damage DNA, or induce skin sensitization

EURL ECVAM, which is part of the European Commission's Joint Research Centre, coordinates research and validation studies on alternatives to animal testing within the European Union. EURL ECVAM also shares knowledge about and promotes use of alternative methods.

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Mar 11, 2020
FDA Seeking Public Input in Advance of International Meeting

FDA will hold a public meeting titled ‘‘Health Canada and United States Food and Drug Administration Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Human Use (ICH).’’ This meeting will allow stakeholders to receive information and comment on the current activities of ICH in advance of its upcoming meetings in Vancouver, Canada, in May 2020, which include revision of the guideline on rodent carcinogenicity studies for human pharmaceuticals.

The FDA meeting will be held Friday, April 3, from 10:00 a.m.-1:00 p.m. at FDA in Silver Spring, Maryland, and will also be webcast. Registrations may be limited, so early registration is recommended. Information about the May ICH meeting is available on the ICH website.

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Mar 11, 2020
NLM ICCVAM Representative to Speak in Webinar on Toxicology Information Resources

NLM’s TOXNET resource was retired in December 2019. Most of TOXNET’s databases have been incorporated into existing resources provided by NLM and other institutions. An upcoming webinar on “Finding Toxicology-related Information in 2020 Using PubChem and Other NLM Resources,” presented by the American Chemical Society, will describe where former users of TOXNET can now go for information.

Two NLM scientists will be speaking at the webinar: Evan Bolton, Head of the Chemistry Program of the National Center for Biotechnology Information, and Pertti (Bert) Hakkinen, NLM Senior Toxicologist and Toxicology and Environmental Health Science Advisor. Hakkinen is also the NLM’s principal representative to ICCVAM. The webinar will be presented Tuesday, March 17, at 1:00 p.m. EDT.

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Mar 11, 2020
QSAR 2020: Late-breaking Abstract and Registration Deadlines

The 19th International Workshop on (Quantitative) Structure-Activity Relationships in Environmental Health Sciences (QSAR 2020) will take place June 8-11 in Durham, North Carolina. The workshop’s theme - “From QSAR to New Approach Methodologies” - will bring scientists together with users and developers of predictive models and their underlying data to discuss the practical implementation of non-animal approaches to inform chemical hazard and risk assessment.

The deadline for discount early registration has been extended to April 15. Sponsorship opportunities for the conference are still available. Late-breaking abstracts are currently being accepted for a limited number of poster presentation slots; abstracts will be accepted until April 8 or until all slots are filled.

Abstracts: Apr 8

Early registration: Apr 15

Mar 04, 2020
WC11 Program, Travel Grants Available; Abstract Deadline March 15

The preliminary daily program is available for the 11th World Congress on Alternatives and Animal Use in the Life Sciences (WC11). The program lists the dates and times of platform sessions throughout the meeting. The program will be updated as additional details become available. Applications are also being accepted for WC11 travel grants and awards.

The deadline for submitting abstracts for WC11 poster or platform presentations is March 15. Abstracts should describe original work not previously published relevant to interests and goals of WC11. There is no fee charged for abstract submission.

Mar 15, 2020
Mar 04, 2020
EPA Issues Challenge to Develop Ecotoxicity Gene Expression Assay

EPA and government and industry partners are sponsoring the EcoTox TARGET innovation challenge. A prize of $300,000 will be awarded to the applicant who successfully develops a low-cost high-throughput technology for measuring global gene expression in samples from four common aquatic toxicity test organisms. Participants must register by March 16.

Mar 16, 2020
Mar 04, 2020
Applications Being Accepted to Attend In Vitro Summer School

The Physicians Committee for Responsible Medicine, the European Commission Joint Research Centre, and the Johns Hopkins University Center for Alternatives to Animal Testing are hosting the Summer School on Innovative Approaches in Science on June 22-25 in Baltimore. This free course will focus on innovative non-animal testing approaches, such as in vitro and computational methods. The program includes lectures by experts, networking events, and laboratory visits.

Applications for the course will be accepted on a rolling basis until open slots are filled and will be evaluated in the order they are received; no applications will be accepted after May 22. Though the course is tuition-free, participants will need to cover the costs of their travel, accommodation, and daily subsistence. Applicants can apply for travel awards to help offset these costs. Applications for the Early Career Researchers Advancing 21st Century Science program award are due March 20, and applications for the PETA International Science Consortium Ltd. Early Career Science Award are due March 23.

Apply by: May 22

Travel awards: Mar 20 and Mar 23

Feb 21, 2020
European Union Publishes Report on Animal Use

The EU has published the “2019 Report on the Statistics on the Use of Animals for Scientific Purposes in the Member States of the European Union in 2015-2017.” Publication of the report is in response to EU Directive 2010/63/EU, which updated existing rules governing the use of animals for experimental and other scientific purposes and addressed disparities among EU member states. Henceforth, this report will be published annually with the objective to structure collected data for an improved understanding of when and how animals are still used in science today. It is hoped that, in line with the Directive aims, these reports will facilitate the identification of animal use areas on which efforts for the development and validation of alternative approaches can be focused.

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Feb 21, 2020
Paper Describes Predictive Model for Androgenic Activity

A paper now available online from Environmental Health Perspectives describes a worldwide consortium led by EPA to develop models to virtually screen chemicals for their potential androgenic activity. The paper was coauthored by Acting NICEATM Director Nicole Kleinstreuer; the first author is Kamel Mansouri, ILS (contractor supporting NICEATM). Predictions generated by the consensus model developed for the project are available in the NICEATM Integrated Chemical Environment.

Mansouri et al. 2020. CoMPARA: Collaborative Modeling Project for Androgen Receptor Activity. Environ Health Perspect. https://doi.org/10.1289/EHP5580.

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Feb 21, 2020
ECHA Newsletter Article Focuses on Data Resources and Collaborations

An article in the February ECHA newsletter focuses on chemical data resources. Data submitted to ECHA on chemicals available in the European market are made available through the IUCLID web resource. The newsletter article, “Working towards one global IUCLID,” summarizes features that have been added to IUCLID and the vision for future improvements. It also describes a collaboration between ECHA and ICCVAM on acute oral toxicity as a case study on the utility of these data for development of alternative methods.

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Feb 10, 2020
Submissions Due February 15 for the EMGS Bioinformatics Challenge

EMGS is accepting applications for the EMGS Bioinformatics Challenge 2020, to be held at the EMGS annual meeting in September 2020. This competition encourages EMGS members and bioinformatics/data science experts to work together to develop novel tools and approaches that harness publicly available data resources such as Tox21 and DrugMatrix to identify signatures of genotoxic hazards and provide insight into their mechanisms of action.

To participate, submit a 250-word abstract with a data visualization by Saturday, February 15. Abstracts will be evaluated in part on model performance in classifying/predicting carcinogens and ability to identify novel genotoxic modes of action. Those selected to participate in the final challenge will receive a $300 monetary award for academic participants and a membership waiver for non-member participants. The overall challenge winner will receive a grand prize of $1200.

Feb 15, 2020
Feb 10, 2020
February 19 Webinar Will Discuss Cancer Risk Assessment

The Carcinogenesis Specialty Section of the Society of Toxicology and the PETA International Science Consortium Ltd. will present a webinar on “Modernization of Cancer Risk Assessment” on Wednesday, February 19 at 11:00 a.m. EST. Acting NTP Biomolecular Screening Branch Chief Warren Casey will discuss “Advances in Carcinogenicity Assessment at NTP,” and Sabitha Papineni of Corteva Agriscience will present on “ReCAAP: Carcinogenicity Case Study Waivers for Food-use Pesticide Registration.”

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Feb 10, 2020
New FDA Guidance Available for In Vitro Drug Interaction Studies

FDA published “In Vitro Drug Interaction Studies – Cytochrome P450 Enzyme- and Transporter-mediated Drug Interactions Guidance for Industry” in January. This guidance is intended to help drug developers plan and evaluate studies to determine the drug-drug interaction (DDI) potential of an investigational drug product. It focuses on in vitro approaches to evaluate the interaction potential between investigational drugs with cytochrome P450 enzymes and transporters, as well as how in vitro results can inform future clinical DDI studies. The appendices of this guidance include factors to consider when choosing in vitro experimental systems, key issues regarding in vitro experimental conditions, and more detailed explanations regarding model-based DDI prediction strategies.

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Feb 10, 2020
New Version of OECD’s eChemPortal Now Available

OECD has released eChemPortal v3.0. The new version includes a modernized user interface architecture, a refreshed design, improved navigation, and the alignment of eChemPortal to OECD Harmonised Template 2018. The user experience is now more fluid, and the user can search for chemical information more efficiently. New features include quick search functionality from the homepage, filtering and sorting on results tables, and a preliminary indication of the number of results expected in a search by chemical properties.

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Feb 10, 2020
NIEHS Data Center Outage Will Affect NICEATM Resources

NIEHS will be upgrading computing equipment Sunday, February 16 and Monday, February 17. The upgrade process will require a data center outage that will impact many NIEHS resources including the NTP website, the NICEATM website, and the NICEATM Integrated Chemical Environment web tool. Please be aware that these resources may not be available during this time and plan accordingly.

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Feb 10, 2020
Paper Describes Framework for Evaluation of NAMs

Former NICEATM Director Warren Casey and NICEATM Acting Director Nicole Kleinstreuer are co-authors on a paper that describes a framework for evaluating new approach methodologies (NAMs). The goal of this framework, developed by a multi-stakeholder group of industry, academic, and regulatory experts, is to provide a structure to collect relevant information to build confidence that will accelerate, facilitate and encourage development of NAMs that can be used within appropriate regulatory contexts.

Parish et al. 2020. An evaluation framework for new approach methodologies for human health safety assessment. Reg Toxicol Pharmacol. https://doi.org/10.1016/j.yrtph.2020.104592.

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Feb 10, 2020
Study Examines Reproducibility of Life Sciences Research

A news article in the January 22 issue of Nature describes an analysis of reproducibility of over one million freely available life sciences papers. While reproducibility has increased over time, the analysis supports recent concerns about ambiguous characterization of antibodies hampering reproducibility of research. This issue was discussed in a recent ICCVAM webinar.

Chawla. 2020. Software searches out reproducibility issues in scientific papers. Nature.

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Feb 10, 2020
Postdoctoral Position Available at EPA

The Human Studies Facility at the EPA Clinical Research Branch is seeking a new postdoctoral fellow to develop and utilize organotypic in vitro models for cellular and molecular toxicology. This position will involve the development and application of novel organotypic primary cell-based models of the human respiratory tract to identify and characterize the dynamics of molecular mechanisms involved in the response of both airway epithelial and stromal cells in response to chemical exposures in multiple airway cell types. Candidates should have a strong understanding of, and experience with, basic cell and molecular biology concepts and techniques, and experience with advanced cell and molecular biology is preferred. Contact Shaun McCullough at mccullough.shaun@epa.gov for more information.

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Feb 10, 2020
Save the Date for Birnbaum Research Symposium April 6

NIEHS will hold a research symposium Monday, April 6 in honor of former director Linda Birnbaum, who retired last fall. The symposium will pay tribute to Dr. Birnbaum’s own research and to the impact her career has had on shaping science, protecting exposed communities, impacting global health, and mentoring leaders. It will be held in the Rodbell Auditorium at NIEHS in Research Triangle Park, NC. An agenda and registration webpage will be available soon on the NIEHS website.

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Feb 06, 2020
Video Available from Webinar on Acute Toxicity Modeling Tool

A video recording and slides are available from a January 22 webinar titled “CATMoS: Development and Use of the Collaborative Acute Toxicity Modeling Suite,” presented by the PETA International Science Consortium (PETA-ISC). Links to recordings of all webinars in the PETA-ISC series on “Use of New Approach Methodologies in Risk Assessment” are available on the PISC-ISC website.

In this webinar, NICEATM Acting Director Nicole Kleinstreuer and Kamel Mansouri, ILS (contractor supporting NICEATM), discussed development of CATMoS, a free resource for screening organic chemicals for acute oral toxicity. Predictions generated by CATMoS compare favorably with performance characteristics of the in vivo acute oral toxicity test. Kleinstreuer and Mansouri also demonstrated how to use the modeling suite to generate acute oral toxicity predictions.

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Feb 06, 2020
ARDF Grants Available, Apply by May 1

The Alternatives Research and Development Foundation (ARDF) awards grants to support research projects that develop alternative methods to advance science and replace or reduce animal use. ARDF is currently accepting applications for this year’s grants, with proposals due May 1.

The maximum grant is $40,000. While preference will be given to U.S. applications, proposals are welcome from any nonprofit educational or research institution worldwide. Expert reviews of each proposal will evaluate scientific merit and feasibility and the potential to reduce or replace the use of animals in the near future. Proposals in the fields of research, testing, or education will be considered. Projects may not use intact non-human vertebrate or invertebrate animals. Preference will be given to projects that use:

  • In silico and in vitro methods with human cells or tissues.
  • Pathway-based approaches as exemplified by the 2007 National Academy of Sciences report, Toxicity Testing in the Twenty-first Century: A Vision and A Strategy.
May 1, 2020
Jan 30, 2020
Paper Describes Animal-free Alternative to Produce Diphtheria Antitoxin

A paper published last week in Scientific Reports describes an animal-free alternative for production of diphtheria antitoxin, the most effective treatment for the respiratory disease diphtheria. Antitoxin is produced in horses, but this paper describes an approach that uses lab-grown cells to make human antibodies.

Wenzel et al. 2020. Human antibodies neutralizing diphtheria toxin in vitro and in vivo. Sci Rep 10:571.

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Jan 30, 2020
SOT Award Winner Helped Start ICCVAM, Served on SACATM

Sidney Green, Adjunct Associate Professor of pharmacology at Howard University, will receive the 2020 SOT Founders Award for outstanding leadership in toxicology. Green’s career in toxicology and pharmacology has spanned over 50 years, during which time he worked at FDA, EPA, and Covance before joining Howard University in 1998. While at FDA, where he served as Director of the Division of Toxicological Research, his efforts as the Agency’s chief spokesperson in the area of alternative tests contributed to the establishment of the Interagency Regulatory Alternatives Group, a predecessor of ICCVAM. Green also served on SACATM, ICCVAM’s advisory committee.

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Jan 30, 2020
FDA Colloquium on Route-to-route Extrapolation February 19

SOT and the FDA Center for Food Safety and Applied Nutrition announce the latest colloquium in their series, “Emerging Toxicological Science: Challenges in Food and Ingredient Safety.” “Route-to-route Extrapolation in the 21st Century” will be held Wednesday, February 19, at the FDA Wiley Auditorium in College Park, Maryland. The colloquium is free and open to the public, but in-person attendees who are not federal employees must register by February 11. The meeting will also be webcast.

The toxicity and pharmacokinetic profiles of substances may vary with the exposure route. If adequate data based on the relevant route of exposure are not available, a route-to-route extrapolation methodology may be employed to predict toxicity and estimate point-of-departure for risk assessment. Route-to-route extrapolation-based approaches use physiologically based pharmacokinetic models to estimate equivalent internal dose for predicting effects. This colloquium will present considerations for conducting route-to-route extrapolations and discuss the possibility of developing consistent methods for utilizing such extrapolations for risk assessment.

Feb 11, 2020
Jan 30, 2020
February 5 Webinar Describes FDA Experience with QSAR Modeling

The SOT Computational Toxicology Specialty Section is hosting a webinar on “U.S. FDA Experience in the Regulatory Application of (Q)SAR Modeling” on Wednesday, February 5 at 11:00 a.m. EST. The webinar is free and open to the public.

Naomi Kruhlak of the FDA Center for Drug Evaluation and Research will provide an in-depth look at current regulatory practice and expectations for the use of QSAR models to evaluate mutagenic potential of drug impurities. She will also highlight emerging applications of the methodology to chemical entities of regulatory importance to FDA, as well as endpoints such as carcinogenicity and endocrine disruption.

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Jan 23, 2020
Kleinstreuer Assumes Leadership of NICEATM

As of January 1, Nicole Kleinstreuer has assumed the role of Acting NICEATM Director. Kleinstreuer has been NICEATM Deputy Director since 2016. Before that she worked for ILS, the NICEATM support contractor. In both roles, she has contributed significantly to the development of NICEATM’s capabilities in computational toxicology.

Kleinstreuer received her Ph.D. in bioengineering from the University of Canterbury in Christchurch, New Zealand, and B.S. degrees in mathematics and biomedical engineering from the University of North Carolina at Chapel Hill (UNC-CH). Prior to joining ILS, she completed postdoctoral training at the U.S. Environmental Protection Agency’s National Center for Computational Toxicology. In addition to her work with NICEATM, Kleinstreuer holds a secondary appointment in the Biostatistics and Computational Biology Branch at the National Institute of Environmental Health Sciences (NIEHS) and adjunct faculty appointments at Yale University School of Public Health and Eshelman School of Pharmacy at UNC-CH. Her research focuses on mathematical and computational modeling of biological systems and their susceptibility to perturbations that result in adverse health outcomes. Her achievements have been recognized with awards from a number of organizations, including the Society of Toxicology, Society for Birth Defects Research and Prevention, Australian Mathematical Society, and American Society for Cellular and Computational Toxicology.

The NICEATM leadership change occurs as former Director Warren Casey has accepted the position of Acting Chief of the Biomolecular Screening Branch in the National Toxicology Program Division at NIEHS. Casey will continue as ICCVAM Executive Director, where his responsibilities will focus primarily on administrative and strategic duties.

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Jan 17, 2020
Presentations Available from EPA Conference on NAMs

Presentation slides are available from the First Annual Conference on the State of the Science on Development and Use of New Approach Methods (NAMs) for Chemical Safety Testing, presented by EPA on December 17. This conference was one of EPA’s commitments in the "Directive to Prioritize Efforts to Reduce Animal Testing" signed by Administrator Andrew Wheeler on September 10, 2019, calling for EPA to reduce use of mammalian studies. Presentations discuss both animal and non-animal tests used to satisfy testing requirements and establishing baselines for animal use. Presenters included Acting NTP Biomolecular Screening Branch Chief Warren Casey, Acting NICEATM Director Nicole Kleinstreuer, and ICCVAM Co-chair Anna Lowit, EPA.

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Jan 17, 2020
Publication Summarizes December Meeting on Animal-Free Antibodies

A paper now available online from ALTEX summarizes discussions on the status of development and use of animal-free recombinant antibodies and their potential to replace antibodies derived from animals from a December meeting organized by NICEATM and the PETA International Science Consortium, Ltd. Co-authors of the paper include Acting NTP Biomolecular Screening Branch Chief Warren Casey and David Allen, ILS (contractor supporting NICEATM).

Groff et al. 2020. Increasing the use of animal-free recombinant antibodies. ALTEX.

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Jan 17, 2020
March 11 Webinar Features Presentations on Mechanistic Frameworks and Cell Line Characterization

A webinar presented by ASCCT and ESTIV will feature presentations by recent ASCCT award winners. The webinar is Tuesday, March 11, at 11:00 a.m. EST.

  • Ignacio Tripodi of the University of Colorado – Boulder will present “Toxicological mechanistic inference: Generating mechanistic explanations of adverse outcomes.” Tripodi will describe a mechanistic inference framework that can generate hypotheses of the most likely mechanisms of toxicity for a specific chemical and cell type, using gene expression time series on human tissue and a semantically interconnected knowledge graph.
  • Vy Tran of the Center for Alternatives to Animal Testing at Johns Hopkins University will present “Co-expression network analysis to identify heterogeneity between the breast cancer cell line MCF-7 and human breast cancer tissues.” Tran’s study used weighted gene correlation network analysis to explore key similarities and differences in gene expression networks of MCF-7 cell lines and human breast cancer tissues. Study results indicate that results from MCF-7 cells have to be used with caution as a proxy for human breast cancer physiology.

ASCCT also has webinars scheduled for January 21 and February 25. Live viewing of ASCCT webinars is free and open to the public; recorded webinars are only available to ASCCT members.

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Jan 17, 2020
Graduate Fellowships Available from IFER

The International Foundation for Ethical Research (IFER) is accepting applications for graduate fellowships. These one-year grants of approximately $12,500 support projects by master’s and Ph.D. students in the sciences. Relevant projects address development, acceptance, and implementation of innovative methods that advance science and refine, reduce, or replace the use of animals in research, testing, or education. Grants are renewable for up to three years, depending on student progress and availability of funds. Special consideration may be given to proposals that are likely to replace the use of animals in research, and for projects that are likely to refine, reduce, or replace the use of nonhuman primates in research. Applications are due Thursday, April 30.

Apr 30, 2020
Jan 17, 2020
EPA Seeks Rapid Assay Development Branch Chief; Apply by January 22

The EPA Center for Computational Toxicology and Exposure within the Office of Research and Development is seeking an experienced scientist to lead the Rapid Assay Development Branch. Applicants should have degrees in biology, toxicology, physical sciences, or chemistry, and at least one year of experience in a relevant leadership position. Candidates will be evaluated on their skills in leading a scientific program, developing high-throughput assays for toxicity screening analysis, and interpretation of scientific data, as well as their ability to perform supervisory duties and communicate scientific and technical information to a diverse audience. The position is located at EPA in Research Triangle Park, North Carolina. Applications must be received by January 22. For more information, visit USAJobs.gov or contact Brooke Holmes.

Jan 22, 2020
Jan 16, 2020
Publication Describes In Vitro Method for Eye Irritation Testing

NICEATM Acting Director Nicole Kleinstreuer is a co-author of a recent paper describing an in vitro method for eye irritation testing. A multilaboratory validation study indicated that the Vitrigel-Eye Irritancy Test could be a useful alternative to animal testing for distinguishing test chemicals that are ocular non-irritants from irritants.

Kojima et al. 2019. Multi-laboratory validation study of the Vitrigel-Eye Irritancy Test method as an alternative to in vivo eye irritation testing. Altern Lab Anim 47(3-4):140-157.

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Jan 16, 2020
Travel Awards Available for QSAR 2020

The International Council of Chemical Associations Long-range Research Initiative (ICCA-LRI) invites undergraduate or graduate students and postdoctoral fellows to apply for Student/Post-Doc Travel Awards to present a platform talk or poster at the 19th International Workshop on (Q)SAR in Environmental and Health Sciences (QSAR 2020). Three awards will be given, one each for North America, Europe, and Japan. Awards will be used to reimburse awardees for travel, hotel accommodations, meal expenses, and poster printing costs. Apply by February 7.

QSAR 2020 will take place June 8-11 in Durham, North Carolina. The workshop’s theme - “From QSAR to New Approach Methodologies” - will bring scientists together with users and developers of predictive models and their underlying data to discuss the practical implementation of non-animal approaches to inform chemical hazard and risk assessment. Discounted registration is available through April 1. The workshop is being organized by the U.S. Environmental Protection Agency, the ICCA-LRI, and the American Society for Cellular and Computational Toxicology.

Travel award: Feb 7

Early registration: Apr 1

Jan 16, 2020
Webinar to Present Overview of New Approach Methodologies

The Association for Advancement of Alternatives Assessment will present a free webinar on “How to Get Safer Alternatives Using Non-Animal Testing Methods” on Wednesday, January 29 at 12:00 noon EST.

Interest is growing around the application of NAMs, which use non-animal approaches as an effective means to fill data gaps on new chemicals. Over the last decade, significant investments have been made in the development of NAMs. Speakers Amy Clippinger, PETA International Science Consortium, Ltd., and Pamela Spencer, ANGUS Chemical, will explore the status of these methods, the endpoints they are being used for, and the strategies being used to incorporate NAMs into chemical hazard assessments.

The Association for the Advancement of Alternatives Assessment is a professional association dedicated to advancing the science, practice, and policy of assessment and informed substitution to accelerate the transition to the use of safer chemicals, materials, processes, and products.

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Jan 16, 2020
Upcoming Webinars on Carcinogenicity Assessment

The Carcinogenesis Specialty Section of the Society of Toxicology and the PETA International Science Consortium, Ltd., will present webinars in January and February on new tools and approaches for carcinogenicity assessment.

  • The “Mechanistic Assessment of Carcinogenicity” webinar will feature Mirjam Luijen of RIVM (Dutch National Institute for Public Health and the Environment) speaking on “Early Mechanistic Key Events for the Prediction of Carcinogenic Potential” and Chris Corton of the U.S. Environmental Protection Agency speaking on “Transcriptomic Thresholds from Short-Term Assays Predict Rat Liver Tumorigens.” This webinar is Friday, January 24 at 10:00 a.m. EST.
  • The “Modernization of Cancer Risk Assessment” webinar will feature acting NTP Biomolecular Screening Branch Chief Warren Casey speaking on “Advances in Carcinogenicity Assessment at NTP” and Sabitha Papineni of Corteva Agriscience speaking on “ReCAAP: Carcinogenicity Case Study Waivers for Food-use Pesticide Registration.” This webinar is Wednesday, February 19 at 11:00 a.m. EST.
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Jan 16, 2020
ICCVAM Communities of Practice Webinar to Discuss Animal-free Affinity Reagents

Registration is open for the ICCVAM Communities of Practice webinar “Use of Animal-free Affinity Reagents.” The webinar is scheduled for Tuesday, January 21, at 11:00 a.m. EST.

Traditional methods for producing affinity reagents such as antibodies require immunization of laboratory animals. Therefore, even when applied to nonanimal test methods, their use is inconsistent with the spirit of replacing, reducing, or refining animal use. This webinar will present a review of the usefulness and limitations of nonanimal-derived affinity reagents and their potential to replace animal-derived reagents.

Alejandra Solache of Abcam will present an overview of production, use, and characteristics of monoclonal and polyclonal antibodies. Rebecca Clewell of 21st Century Tox Consulting will summarize a recent review by a working group of the Scientific Advisory Committee of EURL ECVAM on the scientific validity and benefits of animal-free technologies to produce affinity reagents .

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Jan 13, 2020
January 22 Webinar to Demonstrate Tool for Predicting Acute Oral Toxicity

PETA-ISC will present a webinar titled “CATMoS: Development and Use of the Collaborative Acute Toxicity Modeling Suite.” The webinar is Wednesday, January 22, at 1:00 p.m. EST. It is free and open to the public. NICEATM Acting Director Nicole Kleinstreuer and Kamel Mansouri, ILS (contractor supporting NICEATM), will discuss development of CATMoS, a free resource for screening organic chemicals for acute oral toxicity. Predictions generated by CATMoS compare favorably with performance characteristics of the in vivo acute oral toxicity test. Kleinstreuer and Mansouri will also demonstrate how to use the modeling suite to generate acute oral toxicity predictions.

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Jan 13, 2020
February 25 Webinar to Describe In Vitro Model for Inhalation Toxicity

A webinar presented by ASCCT and ESTIV will describe an in vitro method for acute inhalation toxicity. The webinar is Tuesday, February 25, at 10:00 a.m. EST. Emilie Da Silva of Technical University of Denmark/National Research Center for the Working Environment will describe the test method, which is based on the monitoring of lung surfactant function. The lung surfactant layer in the alveoli is the first barrier that inhaled compounds encounter in the lungs. Inhibition of lung surfactant function in the in vitro method correlates with decreased tidal volume in mice for a variety of compounds, including drug formulation excipients and impregnation spray products.

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Jan 13, 2020
PETA-ISC Offers Award to Attend In Vitro Summer School

PCRM and the Johns Hopkins University Center for Alternatives to Animal Testing are hosting the Summer School on Innovative Approaches in Science on June 22-25 in Baltimore. This free course will focus on innovative non-animal testing approaches, such as in vitro and computational methods. The program includes lectures by experts, networking events, and laboratory visits. Applications are due January 31.

PETA-ISC is offering a travel award to attend the summer school to an early-career scientist. The winner of this award will be reimbursed for hotel accommodation and airfare. Those eligible include students working towards their master’s or PhD who have completed one year of study, postdoctoral fellows, or scientists who have completed training within the past five years. The summer school is divided into toxicology and biomedical sciences tracks, and this award is available only to attendees of the toxicology track. The deadline to apply for the award is March 23.

Register: Jan 31

Travel award: Mar 23

Jan 13, 2020
New California Law Bans Sale of Cosmetics Tested on Animals

The California Cruelty-Free Cosmetics Act, which took effect January 1, will ban sales in California of cosmetics that have been tested on animals. The law follows an international trend, with Europe, China, and other countries having enacted similar bans or reducing requirements for animal testing for imported cosmetic products. PCRM, a frequent NICEATM collaborator, helped develop the California law.

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Jan 13, 2020
Javelin Biotech Seeking Scientist to Lead Development of Novel Testing Systems

Javelin Biotech is seeking an experienced scientist to lead development of in vitro liver tissue pharmacology testing tools for preclinical drug discovery. The scientist will work with pharmacologists and computational/data scientists to develop state-of-the-art pathophysiological hepatic tissue models. Candidates must have PhD or equivalent degrees in biological engineering, chemical engineering, biological sciences or similar disciplines and at least three years of post-graduate experience developing and using advanced tissue culture systems, including microphysiological systems, tissue chips, organ-on-chips, and 3D cultures.

Javelin Biotech is an outgrowth of the Translational Center of Tissue Chip Technologies at the Massachusetts Institute of Technology. Javelin Biotech’s vision is to bring model-informed drug discovery workflows using human microphysiological systems and computational biology/machine learning to preclinical drug discovery to support mechanistic and comprehensive understanding of how drugs affect human physiology.

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Dec 18, 2019
Free Online Course on 3Rs and Animal Use in Science

Young scientists are needed to help meet the European Union’s commitment to replace animal use in science. The European Commission's Joint Research Centre is funding a Massive Open Online Course (MOOC) on the 3Rs (replacement, reduction, and refinement of animal use in science) to provide ideas and examples on how to address the 3Rs in the classroom and develop students’ critical thinking and understanding of science. The course begins on January 13, 2020, and lasts for five weeks with an estimated workload of four hours per week. It is tailored to secondary school teachers but anyone can register.

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Dec 18, 2019
Abstract Submission and Registration Open for Global Summit on Regulatory Science

The Global Summit on Regulatory Science will be held September 28-30, 2020, in Bethesda, Maryland, with the theme of “Emerging Technologies and Their Application to Regulatory Science.” The meeting will feature emerging technologies from global regulatory, research, and standards communities. Topics include:

  • Emerging Technologies for the Safety Assessment of Food, Drugs, and Personal Care Products.
  • Approaches to Standardize and Validate Emerging Technologies for Regulatory Application.
  • Challenges and Opportunities of Emerging Technologies and Alternate Methods for Decision Making.

Registration for the meeting is open; there is no fee to attend. Abstracts are being accepted for poster presentations; abstracts must be 300 words are less and be submitted by July 15. The meeting is being co-hosted by the Global Coalition for Regulatory Science Research and the National Center for Advancing Translational Sciences.

Jul 15, 2020
Dec 18, 2019
Abstract Submission Open for World Congress, Abstracts Due March 15

Abstracts are being accepted for the 11th World Congress on Alternatives and Animal Use in the Life Sciences (WC11). Abstracts should describe recent original work and reflect one of the four conference topics, “Safety”, “Innovative Technologies”, “Ethics, Welfare and Regulation”, and “Disease.” There is no abstract submission fee and registration is not required to submit an abstract, although the designated presenting author is expected to attend. Abstracts must be 300 words or less, written in English, and submitted by March 15, 2020.

WC11 will be held August 23-27, 2020, in Maastricht, The Netherlands. The theme of the meeting is “3Rs in Transition: From Development to Application.” Registration to attend the meeting is open, with advance registration discounts available until May 15. More information, including a preliminary program, is available on the conference website.

Abstract submission: Mar 15
Early registration: May 15
Dec 18, 2019
Job Opportunities for Biologists at EPA; Apply by December 26

The EPA Office of Pesticide Programs is seeking candidates for multiple biologist positions in Arlington, Virginia. Successful candidates will:

  • Evaluate and assess the validity of data from microorganisms, laboratory animals, and other study types to identify possible adverse effects to animals and/or humans.
  • Attend and participate in meetings with other organizations to prepare recommendations and/or advice.
  • Assist with the preparation of reports that provide recommendations concerning either the registration and/or testing of pesticides.

Applications must be received by December 26. Applicants must be U.S. citizens with at least a bachelor’s degree in biological sciences, chemistry, or a related discipline and at least one year of relevant experience that includes analyzing scientific data, preparing reports, and providing recommendations.

Dec 26, 2019
Dec 16, 2019
Summary of ICATM Workshop Available on JRC Website

The European Union Joint Research Centre (JRC) hosted a workshop on October 22 to celebrate the tenth anniversary of ICATM. The workshop was attended by former National Institute of Environmental Health Sciences and NTP Director Linda Birnbaum, NTP Associate Director Brian Berridge, and NICEATM Director Warren Casey. A summary of the workshop is available on the JRC website.

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Dec 16, 2019
Nature Medicine Article Discusses Chronic Inflammation in Common Diseases

NICEATM Deputy Director Nicole Kleinstreuer is a co-author of a “Perspective” article in the December issue of Nature Medicine that examines the role of environmental factors in systemic chronic inflammation. The article discusses mechanisms and risk factors, and proposes strategies for advancing early diagnosis, prevention, and treatment.

Furman et al. 2019. Chronic inflammation in the etiology of disease across the life span. Nat Med 25(12):1822-1832. https://www.doi.org/10.1038/s41591-019-0675-0

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Dec 16, 2019
Webinar to Discuss Assessment of Endocrine Activity and Developmental Toxicity

A webinar presented by the American Society for Cellular and Computational Toxicology and the European Society for Toxicology In Vitro (ESTIV) will feature two recipients of 2019 ESTIV awards. The webinar is January 21 at 10:00 a.m. EST.

  • Laura Escrivá of the University of Valencia will discuss the “Role of in vitro mechanistic data for the assessment of endocrine disruptors in the regulatory context.” Escrivá will review steps for endocrine disruptor identification according to European Union regulatory guidance and illustrate the essential role of in vitro data for endocrine disruptor assessment.
  • Lenny Kamelia of Wageningen University will describe “A battery of animal-free in vitro assays for evaluating prenatal developmental toxicity potency of highly complex petroleum substances.” A study using three in vitro methods to characterize nine petroleum substances representing five product categories demonstrated that combining data from the in vitro methods with property data produced ranking and clustering outcomes that reflected in vivo prenatal developmental toxicity potency.
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Dec 16, 2019
OECD Webinar to Provide Perspectives on AOP Development

A webinar presented by OECD will focus on assembling and evaluating weight of evidence and quantitative understanding of relationships in developing AOPs. Speakers include Bette Meek of the University of Ottawa, Kristie Sullivan of the Physicians Committee for Responsible Medicine, and Dan Villeneuve of EPA. The webinar is January 15 at 7 a.m. EST. More information about the OECD AOP framework is available in a OECD webinar presented in April 2019.

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Dec 16, 2019
EPA Updates List of Alternative Test Methods and Strategies

On December 5, EPA released an update of its “List of Alternative Test Methods and Strategies (or New Approach Methodologies [NAMs])”. Creation and maintenance of this list was required by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, passed in 2016 to update TSCA. The list includes tests for human health effects, tests for effects on biotic systems, NAM-related EPA policies that may be relevant to TSCA, and other NAMs that may be used for TSCA.

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Dec 09, 2019
NIH to Provide Small Business Funding for Genetically Diverse Toxicity Tests

NIH announces the availability of Small Business Innovation Research grants to support the development of chemical testing resources and approaches that better reflect the genetic diversity among human populations. The resources and approaches might include panels of human cells or cell lines, panels of cell lines generated from genetically diverse rodent strains, lower organism strains with well-characterized genetic backgrounds, or in silico approaches to enhance the ability to characterize the effects of genetic variation in toxicity testing. These grants are available only to U.S. small businesses. Letters of intent are due January 19, 2020, with applications due February 19.

Feb 19, 2020
Dec 09, 2019
Abstract Deadline Extended for QSAR 2020

The abstract deadline for the 19th International Workshop on (Quantitative) Structure-Activity Relationships in Environmental Health Sciences (QSAR 2020) has been extended to January 24. The workshop will take place June 8-11, 2020, in Durham, North Carolina. Abstracts may be submitted for oral or poster presentations and should address one or more of the 12 topics listed on the abstract information page. Proceedings of the workshop will be published in a special issue of Computational Toxicology, and all presenters will be invited to submit manuscripts.

The workshop’s theme - “From QSAR to New Approach Methodologies” - will bring scientists together with users and developers of predictive models and their underlying data to discuss the practical implementation of non-animal approaches to inform chemical hazard and risk assessment. Discounted registration is available through April 1, 2020.

QSAR 2020 is being organized by the U.S. Environmental Protection Agency, the International Council of Chemical Associations' Long-Range Research Initiative, and the American Society for Cellular and Computational Toxicology.

Jan 24, 2020
Dec 09, 2019
Applications Open for SOT Trainee Award

The SOT Computational Toxicology Specialty Section is soliciting applications for the Yves Alarie Diversity Award, which recognizes a motivated trainee or young investigator from an under-represented group who is working in the field of computational toxicology. The award provides $2,500 to support professional development, including travel or registration to attend a scientific meeting or training.

Applications for the award are due January 10, 2020. Applicants should be enrolled in a doctoral or postdoctoral program or have completed their training within the past five years. Only current SOT members are eligible, and preference will be given to Computational Toxicology Specialty Section members or applicants. Applicants should have had an abstract accepted and be planning to attend the SOT 2020 annual meeting.

Jan 10, 2020
Dec 02, 2019
ICCVAM Communities of Practice Webinar to Discuss Use of Animal-free Affinity Reagents

Registration is open for the ICCVAM Communities of Practice webinar, which will discuss “Use of Animal-free Affinity Reagents.” The webinar will be presented on Tuesday, January 21, at 11:00 a.m. EST.

Affinity reagents such as antibodies are used in a range of research, diagnostic, and regulatory applications. However, traditional methods for producing such reagents require immunization of laboratory animals. Therefore, even when applied to nonanimal test methods, their use is inconsistent with the spirit of replacing, reducing, or refining animal use. This webinar will present a review of the usefulness and limitations of nonanimal-derived affinity reagents and their potential to replace animal-derived reagents.

Dec 5, 2019
Dec 02, 2019
Nominations of Experts Requested by December 5 for National Academies Workshop

The National Academies of Sciences, Engineering, and Medicine request nominations of experts to organize a June 2020 workshop to explore how experience with developing biomarkers can be applied to understanding the consequences of environmental exposures and improve environmental health decisions. The workshop will bring together scientists and public policy experts to discuss the promise and limitations of using biomarkers from model systems and clinical studies to make predictions about human health effects from environmental exposures. Workshop presentations will focus on approaches to developing early and predictive biomarkers, recent advances in imaging technologies for detecting disease onset caused by environmental exposures, validation and utility of a biomarker for medical and public health decisions, and other relevant topics.

Nominees for the workshop organizing committee should have expertise in biomarkers, biomarker validation strategies, biological mechanisms, data science, computational toxicology, precision medicine, environmental health policy, or risk assessment. Nominations should be received by December 5.

Dec 5, 2019
Dec 02, 2019
Upcoming Webinars on Carcinogenicity Assessment

The Carcinogenesis Specialty Section of the Society of Toxicology and the PETA International Science Consortium will present webinars in January and February on new tools and approaches for carcinogenicity assessment.

  • The “Mechanistic Assessment of Carcinogenicity” webinar will feature Mirjam Luijen of RIVM (Dutch National Institute for Public Health and the Environment) speaking on “Early Mechanistic Key Events for the Prediction of Carcinogenic Potential,” and Chris Corton of the U.S. Environmental Protection Agency speaking on “Transcriptomic Thresholds from Short-Term Assays Predict Rat Liver Tumorigens.” This webinar is Friday, January 24 at 10:00 a.m. EST.
  • The “Modernization of Cancer Risk Assessment” webinar will feature NICEATM Director Warren Casey speaking on “Advances in Carcinogenicity Assessment at NTP,” and Sabitha Papineni of Corteva Agriscience speaking on “ReCAAP: Carcinogenicity Case Study Waivers for Food-use Pesticide Registration.” This webinar is Wednesday, February 19 at 11:00 a.m. EST.
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Dec 02, 2019
Nominations Due December 6 for Lush Prize

Nominations are being accepted through December 6 for the 2020 Lush Prize, which recognizes advancement toward animal-free testing. A total of £250,000 will be awarded in the categories of Lobbying, Public Awareness, Science, Training, and Young Researcher. Alternatively, the entire £250,000 may be awarded as a Black Box Prize, to recognize a major advancement likely to lead to practical non-animal tests that could be accepted by regulators.

Candidates must self-nominate for the Lush Prize; candidates and projects from anywhere in the world are eligible. Requirements of the recipients include attending an awards ceremony and preparing an explanation of the winning project for the ceremony and the Lush Prize website.

Dec 6, 2019
Dec 02, 2019
PCRM Seeks Regulatory Testing Analyst

The Physicians Committee for Responsible Medicine (PCRM) is seeking candidates for a regulatory testing analyst position. The analyst will implement human-relevant test methods to replace and reduce the use of animals in domestic and international chemical and pharmaceutical testing policies and guidelines. They will work with PCRM staff and external collaborators to promote the funding and acceptance of nonanimal test methods by:

  • Training and engaging toxicologists
  • Devising strategies to make favorable changes to policies and regulations
  • Writing peer-reviewed papers as well as blogs, public comments, and web copy
  • Meeting with government, NGO, and industry stakeholders
  • Organizing topical workshops
  • Facilitating collaborative research projects

The ideal candidate for this position will have a degree in toxicology, pharmacology, environmental health, risk assessment, industrial hygiene, chemistry, or a related field; at least two years of experience related to toxicological assessment or regulations; and familiarity with in vitro and in silico test methods and national and international test guidelines and regulatory requirements. This is a full-time position located at PCRM headquarters in Washington, DC, although a remote working arrangement is possible.

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Nov 27, 2019
Free Workshop on New Approach Methodologies December 11-12

The Physicians Committee for Responsible Medicine will provide training on “New Approach Methodology (NAM) Use for Regulatory Application (NURA): Integrating Modern Science Approaches” on December 11-12. The free event will be held at the Hilton Americas in Houston, Texas, and presentations will also be webcast.

Attendees will hear expert presentations from leaders in NAMs representing test method developers, industry, and government. NICEATM Deputy Director Nicole Kleinstreuer will discuss “International Approaches for Integrated Approaches to Testing and Assessment.” Attendees will also participate in hands-on demonstrations of in silico and in vitro predictive tools for endpoints like acute toxicity, skin sensitization, and developmental neurotoxicity. This workshop will be of particular interest to cosmetic, pharmaceutical, and chemical company staff, toxicology consultants, and regulators.

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Nov 27, 2019
EPA Public Meeting Will Discuss Implementation of TSCA New Chemicals Program

The EPA Office of Chemical Safety and Pollution Prevention will hold a public meeting on December 10 to engage stakeholders on implementation of the TSCA New Chemicals program. Specific topics for discussion include:

  • Update of the document “New Chemicals Decision-Making Framework: Working Approach to Making Determinations Under Section 5 of TSCA”
  • Case studies of how EPA uses key concepts in the Working Approach
  • Updates on confidential business information process improvements and clarifications
  • EPA’s ongoing efforts and progress to increase transparency

The meeting will be held at EPA’s William Jefferson Clinton East Building in Washington DC. It is open to the public free of charge and will also be webcast.

EPA is setting aside one hour during the meeting for the public to share their views on the topics under discussion. Online requests to speak at the meeting must be received by December 6. A November 20 Federal Register notice has details about the meeting.

Dec 6, 2019
Nov 21, 2019
NIH to Fund Studies to Improve iPSC Reproducibility, Apply by January 6

NIH is offering Small Business Innovation Research grants to develop methods that improve the reproducibility of human induced pluripotent stem cell (iPSC) derivation, growth, and differentiation. Eligible projects should seek to address the significant variability currently observed in human iPSCs in reprogramming efficiency, differentiation potential, and cell growth and stability, which is limiting the full application of these tools to research and clinical practice. Eleven NIH Institutes and centers, including the National Institute of Environmental Health Sciences, intend to commit funds to this effort. An estimated 25 grants will be awarded to U.S. small businesses. Applications will be accepted from December 6, 2019 through January 6, 2020.

Jan 6, 2020
Nov 21, 2019
Postdoctoral Opportunity to Develop Organ-on-chip Models

A postdoctoral position is available immediately within the NIH TissueChip consortium to study antigen sampling across gastrointestinal barriers in the Department of Microbiology and Immunology at Montana State University. Project leaders are seeking a Ph.D. graduate with a background in mucosal immunology or developmental biology. The ideal candidate should have a strong publication record and demonstrated expertise with organoid models or other primary epithelial cell models, antigen-presenting-cells, and/or confocal microscopy. This cross-disciplinary project offers a unique opportunity to work with a dynamic team of researchers at the interface of immunology, microbiology, and biological engineering. The successful candidate will gain experience with state-or-the-art organ-on-a-chip models, human gastrointestinal organoids, primary human antigen-presenting cells, and milli- and microfluidics technologies. Screening of applicants will begin December 15.

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Nov 21, 2019
Science Adviser Position Available at HSUS

The Humane Society of the United States (HSUS) is seeking a Science Adviser for the Animal Research Issues department. The Science Adviser offers scientific advice to HSUS on programs that seek to replace the use of animals in testing and research through regulatory, legislative, and corporate reforms. Duties include researching and analyzing areas of testing and research that involve the use of animals, staying up to date on scientific advances and technologies that seek to replace the use of animals, and contributing scientific expertise to legislative and regulatory efforts. The applicant should have at least a master’s and preferably a Ph.D. in a relevant field, two to four years’ experience related to the use of animals in laboratories and alternatives to animal testing, and excellent communication and interpersonal skills. The position will be based in Gaithersburg, MD, or Washington, DC, and applicants should be willing and able to travel.

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Nov 21, 2019
Publication Describes Identification of Developmental Regulation Pathway Disruptors

A paper co-authored by NICEATM Deputy Director Nicole Kleinstreuer describes use of quantitative high-throughput screening to identify compounds in the Tox21 10K library with the potential to disrupt transforming growth factor beta signaling, which could affect embryonic development. The approach represents a robust and efficient means to identify compounds for mechanistic evaluation in other assays relevant to developmental signaling to prioritize testing of putative developmental toxicants.

Wei et al. 2019. Identification and profiling of environmental chemicals that inhibit the TGFβ/SMAD signaling pathway. Chem Res Toxicol.

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Nov 01, 2019
Presentations Available from September 19-20 SACATM Meeting

Presentations from the recent SACATM meeting are available on the NTP website (click “Presentations” in far right column under “Meetings”).

SACATM met September 19-20 in Arlington, Virginia. In presentations at the meeting, scientists from NICEATM, ICCVAM member agencies, and collaborators described advances in alternatives to animal use. SACATM members expressed support for the current activities and direction of ICCVAM and noted the progress that has been made in advancing alternatives to animal testing.

Discussions on the use of computational methods focused on the limitations and applications of machine learning models in predicting toxicology. Considering the potential uses of microphysiological systems (also known as “tissue chips”) in predicting human toxicity, committee members suggested these might be most useful for early-stage toxicity screening, evaluating effects on diverse populations, and providing models for applications lacking established animal models. They cautioned, however, that the context of use for these platforms need to be clearly defined, and expressed support for developing a roadmap to build confidence in specific applications.

SACATM meets annually to advise NICEATM, ICCVAM, and the director of the National Institute of Environmental Health Sciences regarding statutorily mandated duties of ICCVAM and activities of NICEATM.

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Nov 01, 2019
Free Workshop on New Approach Methodologies

The Physicians Committee for Responsible Medicine will present training on “New Approach Methodology (NAM) Use for Regulatory Application (NURA): Integrating Modern Science Approaches” on December 11-12. The free event will be held at the Hilton Americas in Houston, Texas, and presentations will also be webcast.

Attendees will hear expert presentations from leaders in NAMs and participate in hands-on demonstrations of in silico and in vitro predictive tools for endpoints like acute toxicity, skin sensitization, and developmental neurotoxicity. This workshop will be of particular interest to cosmetic, pharmaceutical, and chemical company staff; toxicology consultants; and regulators.

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Oct 24, 2019
NIEHS Providing Funding to Develop In Vitro Models

NIEHS will provide funding for U.S. small businesses to develop novel, engineered 3D or organotypic in vitro systems using cells from experimental animal models typically used for toxicology testing. When developed and validated, these animal-derived in vitro systems will help predict toxicity of chemical and drug candidates, enable comparisons with existing in vivo animal toxicity data, and potentially reduce the numbers of animals used in toxicology testing.

The funding opportunity is open only to U.S. small businesses. NIEHS intends to fund six to eight awards totaling up to $4 million. Applications for renewals of existing grants are eligible. While this project is intended to facilitate comparisons to in vivo animal data, applicants should not include new in vivo animal studies in their research plan for initial development of these models. Letters of intent are due December 3, with applications due January 3, 2020.

Letters of intent: Dec 3
Applications: Jan 3
Oct 24, 2019
FDA Requests Input for International Meeting on Drug Development

FDA will hold a joint public meeting with Health Canada on November 4 in advance of an international meeting later in the month. The November 4 meeting will provide information and solicit public input on activities of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

ICH brings together regulators and industry to increase efficiency of development and registration of new medical products without compromising safety or effectiveness. Several items currently under consideration by ICH have potential to reduce or replace animal use. These include revisions of guidance documents “S1: Rodent Carcinogenicity Studies for Human Pharmaceuticals” and “S5: Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals,” which explicitly mention opportunities for potential reduction of animal use.

The November 4 meeting will be held at the Sir Frederick Banting Research Centre in Ottawa, Canada and will also be webcast. An October 18 Federal Register notice announcing the meeting provides instructions for submitting comments to FDA. Those planning to attend the November 4 meeting should register by October 28. Comments relevant to the meeting should be submitted to FDA by November 8.

Meeting registration: Oct 28
Comments: Nov 8
Oct 24, 2019
Postdoctoral Position Available at CAAT

The Center for Alternatives to Animal Testing (CAAT) at Johns Hopkins University has a three-year opening available for a postdoctoral fellow. The successful candidate will develop a new approach methodology for developmental neurotoxicity testing based on an iPSC-derived 3D organotypic brain model. They will design several CRISPR/Cas9-modified iPSC lines, generate 3D brain organoids, and perform screening of chemicals using high-content imaging. They will also collaborate with a bioengineering group in developing an electrophysiology recording platform.

Candidates should have PhDs in molecular or cell biology; a background in neuroscience is preferred. Training in toxicology is desired but not required. Candidates should have experience with gene editing using CRISPR/Cas9 technology and culturing iPSCs, embryonic stem cells, and neuronal cells. The position offers the opportunity to develop high-impact publications, present at conferences, and prepare for a career in academia or industry in a rich intellectual environment. To apply, send a CV and motivation letter to Lena Smirnova at lena.smirnova@jhu.edu.

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Oct 10, 2019
Workshop to Discuss Key Activities Needed to Predict Acute Toxicity

NICEATM and the Physicians Committee for Responsible Medicine will hold a workshop titled “Mind the Gaps: Prioritizing Activities to Meet Regulatory Needs for Acute Systemic Toxicity” on October 30-31 at the National Institutes of Health in Bethesda, Maryland. The workshop is free and open to the public but attendees must preregister by October 24.

Acute systemic toxicity tests are the most commonly performed type of safety test worldwide. Participants in this workshop will consider approaches available to assess acute lethality associated with chemicals and chemical mixtures, with the purpose of designing comprehensive strategies to predict toxicity while avoiding animal tests. The envisioned specific areas for discussion will include:

  • Defining how to calculate the LD50 of a chemical mixture/formulated product
  • Identifying gaps where model (or assay) development or optimization is needed
  • Understanding regulatory needs for model (or assay) outputs
  • Pinpointing the types of mechanistic information that would be useful
  • Establishing the feasibility of using artificial intelligence in model development
Oct 24, 2019
Oct 10, 2019
Submissions Open for EMGS Bioinformatics Challenge

EMGS is accepting applications for the EMGS Bioinformatics Challenge 2020, to be held at the EMGS annual meeting in September 2020. This competition encourages EMGS members and bioinformatics/data science experts to work together to develop novel tools and approaches that harness publicly available data resources such as Tox21 and DrugMatrix to identify signatures of genotoxic hazards and provide insight into their mechanisms of action.

To participate, submit a 250-word abstract with a data visualization by February 15, 2020. Abstracts will be evaluated in part on model performance in classifying/predicting carcinogens and ability to identify novel genotoxic modes of action. Those selected to participate in the final challenge will receive a $300 monetary award for academic participants and a membership waiver for non-member participants. The overall challenge winner will receive a grand prize of $1200.

Feb 15, 2020
Oct 10, 2019
Workshop to Consider Use of Tissue Chips for Biomaterials Testing

The National Institute of Environmental Health Sciences is partnering with three other institutes within the National Institutes of Health to hold an October 24-25 workshop on the use of tissue chips for biomaterials testing. The workshop will be held at the Washington Hilton in Washington DC. Attendees must register by Monday, October 14.

The “Workshop on Tissue Chip Platforms as Tools for Testing Biocompatibility and Biotoxicity of Biomaterials” will guide research into use of human tissue chip platforms for assessing biocompatibility, immunogenicity, and biotoxicity of biomaterials for research and clinical application in tissue engineering, regenerative medicine, oncology, dentistry, cardiology, drug screening, and other areas. Among the priority discussion topics will be the design and validation of tissue chips platforms for assessing biomaterial properties, and application of tissue chips platforms in predicting in vivo responses of tissues and organs to biomaterials.

Oct 14, 2019
Oct 10, 2019
Travel Award Available for In Vitro Methods Workshop; Apply by October 14

The PETA International Science Consortium is offering an award for an early-career scientist to attend a workshop on Practical Methods for In Vitro Toxicology Workshop on January 13-16, 2020. The workshop will be presented by The Institute for In Vitro Sciences at its facility in Gaithersburg, Maryland. The award will provide up to $1,000 to fund workshop registration, airfare, and hotel accommodations. Those eligible for the award include (1) students working towards a master’s or PhD who have completed their first year of study; (2) postdoctoral fellows; or (3) scientists less than three years out of a master’s, PhD, or postdoctoral program. The awardee must attend all four days of the workshop. The deadline to apply is October 14.

Oct 14, 2019
Oct 07, 2019
EPA Council Achieves Cost and Animal Savings for Required Testing

An article in Regulatory Toxicology and Pharmacology co-authored by ICCVAM co-chair Anna Lowit summarizes the activities of EPA's Hazard and Science Policy Council (HASPOC). HASPOC was established in 2012 by the EPA Office of Pesticide Programs to consider requests for waiving animal study requirements for human health risk assessments. Since its inception, HASPOC has evaluated over 1,000 requests to waive animal studies and granted waivers in response to nearly 90% of requests. These waivers have saved over 200,000 animals, $300 million in study costs, and $6 million in study review costs.

Craig et al. 2019. Reducing the need for animal testing while increasing efficiency in a pesticide regulatory setting: lessons from the EPA Office of Pesticide Programs’ Hazard and Science Policy Council. Regulatory Toxicology and Pharmacology.

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Oct 07, 2019
NTP Web Update Changes Location of NICEATM Webpages

An October 2 update to the NTP website implemented a new navigation structure that affects the location and addresses of NICEATM webpages.

Please contact the NICEATM webmaster if you need any help finding specific content within the NICEATM webpages.

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Oct 07, 2019
Upcoming Webinars Focus on Organ Toxicity Models

Two upcoming webinars by ASCCT and the European Society for Toxicology In Vitro will focus on in vitro models for toxicity to specific organs.

  • “Translational challenges in in vitro nephrotoxicity models” will be presented on Tuesday, October 22 at 10:00 a.m. EDT. Roos Masereeuw of the Utrecht Institute for Pharmaceutical Sciences at Utrecht University will present an overview of advances in 3D cultures of human renal cells and organoids. These microphysiological systems provide novel strategies for the prediction of renal drug disposition and safety assessment, but knowledge gaps in quantitative translation of renal drug disposition from microphysiological systems still exist and will be discussed.
  • “The pros and cons of 3D in vitro culture models of liver fibrosis” will be presented on Monday, November 4 at 10:00 a.m. EDT. Leo van Grunsven of Vrije Universiteit Brussels will describe the mechanisms involved in liver fibrosis development. He will discuss progress achieved and challenges encountered by his group in developing an in vitro liver fibrosis model, and also summarize ongoing work by his and other groups to develop more complex co-culture models.

Register for both webinars on the ASCCT website. Links to past ASCCT webinars, available to ASCCT members only, are also on this page.

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Oct 07, 2019
Webinar Reviews Alternatives for Fish Toxicity Testing

A webinar on Wednesday, November 13 at 11:30 a.m. EST will consider “New approaches to fish toxicity testing.” David Volz, University of California – Riverside, will discuss alternatives to the fish early life-stage test and efforts to discover and annotate adverse outcome pathways for early fish development. Michelle Embry, Health and Environmental Sciences Institute, will provide an overview of recent advances toward replacing or reducing the use of traditional fish acute toxicity tests, including in silico, in vitro, and modified in vivo approaches.

This webinar is the latest in a series co-organized by the PISC, EPA, and PCRM. Recordings of past webinars are available on the PISC website.

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Oct 07, 2019
Society of Toxicology of Canada to Hold Symposium in December

The Society of Toxicology of Canada (STC) supports continuing education and excellence in research through its Annual Symposium, which provides a venue for members and international experts to present the latest advances in experimental and regulatory toxicology. This year’s symposium, December 2-4 in Ottawa, Canada, focuses on the theme “Optimizing Testing Strategies and Exploring Novel Mechanisms of Human and Environmental Toxicants.”

Registration for the symposium is open and discounted registration is available until November 8; the deadline for discounted hotel rooms is October 19. STC welcomes submission of abstracts describing original research for poster or short platform presentations; abstracts are due October 21.

Early registration: Nov 8
Abstract submission: Oct 21
Oct 07, 2019
EPA to Present Training on NAMs at SRA Meeting

The Society for Risk Analysis (SRA) will hold its annual meeting on the theme of “Risk Analysis in the Data Analytics Era” on December 8-12 in Arlington, Virginia. Registration for the meeting is open and discounted registration is available until October 30; the deadline for discounted hotel rooms is November 15. SRA is still accepting late-breaking abstracts, which are due November 1.

EPA will present a workshop at the SRA meeting on Sunday, December 8 titled, “Practical Applications of New Approach Methodologies (NAM) in Chemical Safety Assessment: Applying US EPA Tools/Approaches in Practice.” This workshop will demonstrate application of the CompTox Chemicals Dashboard to evaluating chemicals for potential human health or ecological risks. Workshop instructors include Grace Patlewicz, co-chair of the ICCVAM Acute Toxicity Workgroup and chair of the ICCVAM Read Across Workgroup. Register for the workshop by November 1.

Oct 30, 2019
Sep 24, 2019
EPA Releases Draft Guidance for Waiving In Vivo Avian Toxicity Studies

In a September 17 news release, EPA announced a draft science policy to reduce testing of pesticides on birds when registering conventional outdoor pesticides. The draft policy is open for public comment until November 1; email comments to OPPeco@epa.gov.

This document describes the results and implications of a retrospective study conducted by EPA and People for the Ethical Treatment of Animals. The study explored the quantitative and qualitative contributions of risk assessment methods using single oral dose and subacute dietary toxicity endpoints to the overall conclusions of acute avian risk. The analysis indicated that, in most cases, the subacute dietary results had little impact on risk conclusions arrived upon by use of acute oral data alone. This finding is expected to reduce the number of animals tested by a total of 60 birds per test, for a total projected animal savings of over 700 animals per year.

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Sep 24, 2019
OECD Webinar on Alternatives to In Vivo Eye Irritation Testing September 27

OECD will present a webinar on “OECD Alternatives to In Vivo Eye Irritation Testing” on Friday, September 27, at 7:00 a.m. EDT (1:00 p.m. CEST). This webinar will present an overview of alternative test methods developed as OECD Test Guidelines and relevant guidance material to address eye irritation and serious eye damage for hazard classification of chemicals. Presenters include:

  • Anne Gourmelon, OECD Environment Directorate
  • Chantra Eskes, Swiss Centre for 3Rs, a lead author of the OECD guidance document on integrated approaches to testing and assessment for eye irritation
  • Bertrand Desprez, Cosmetics Europe, who will describe a project to develop defined approaches to determine eye irritation potential
  • David Allen, Integrated Laboratory Systems, Inc. (contractor supporting NICEATM), who will discuss applicability and limitations of the current alternative methods

This is the latest in a series of OECD webinars on testing and assessment methodologies; links to previous webinars on the adverse outcome pathway framework and defined approaches to skin sensitization are available on the OECD website.

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Sep 11, 2019
Preregistration for ASCCT Meeting Closes September 13

Preregistration closes Friday, September 13, for the annual meeting of ASCCT scheduled for September 24-26 at the Hilton Washington DC North in Gaithersburg, Maryland. The theme of the meeting is “Computational Toxicology: Peeking into the Clouds While Keeping Our Feet on Solid Ground.” Program highlights include a mentoring event, poster session, and computational toxicology software showcase.

NICEATM Deputy Director Nicole Kleinstreuer is a featured speaker at the meeting, with a presentation on “The March Toward Big Data in Toxicology: Striking a Balance Between Machine Learning and Mechanistic Modeling.” Shannon Bell, ILS (contractor supporting NICEATM) will give an oral presentation titled “Good Decisions Require Good Data: Creating Curated and Structured Resources for Toxicology.” NICEATM will also have two presentations at the poster session. More about NICEATM activities at ASCCT>>

Sep 13, 2019
Sep 11, 2019
September 20 Webinar to Present Introduction to In Silico Toxicology

The Computational Toxicology Specialty Section of the Society of Toxicology will present a free webinar titled “An Introduction to In Silico Toxicology” on Friday, September 20, at 11:00 a.m. EDT.

In silico models are built from existing knowledge or automatically derived from training sets of historical toxicity data. This webinar will outline the process of developing and using in silico methods to predict toxicity. Two commonly used in silico methodologies, expert rule-based (or structural alerts) and statistical-based (or QSAR models), will be described. The webinar will describe construction of these models as well as how these models could be used to make a prediction and support an expert review. This process will be illustrated with a series of case studies using first principles and commercial software.

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Sep 11, 2019
EPA Announces Directive, Funding to Reduce Animal Testing

In a September 10 press release, EPA announced a directive to prioritize efforts to reduce animal testing. The directive, issued by EPA Administrator Andrew Wheeler, calls for reducing mammal study requests and funding 30% by 2025 and completely eliminating them by 2035.

Wheeler also announced $4.25 million in funding to five universities to research the development and use of alternative test methods and strategies that reduce, refine, and/or replace vertebrate animal testing. Studies funded include in vitro models to test for developmental and reproductive toxicants, neurotoxins, and toxicity of complex environmental mixtures.

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Sep 09, 2019
Preregistration for SACATM Meeting Closes September 12

SACATM will meet on September 19-20 at the Crowne Plaza Crystal City in Arlington, Virginia. SACATM meets annually to advise NICEATM, ICCVAM, and the director of NIEHS regarding statutorily mandated duties of ICCVAM and activities of NICEATM. Preliminary agenda items for the upcoming meeting include:

  • New approaches to the principles and practice of validation
  • Developing a next generation data infrastructure to support the development and implementation of new approach methodologies (NAMs) for complex endpoints
  • Translational impact and human relevance of NAMs

The SACATM meeting is open to the public and attendance is free. Those wishing to attend in person and/or submit public comments should register to do so by September 12. Registration to view the webcast will be open until the meeting ends.

Sep 12, 2019
Sep 09, 2019
September 17 Webinar to Highlight Chip Model for Neuropathy

A free webinar titled “Nerve-on-a-Chip Platform for Assessing Chemotherapy-induced Peripheral Neuropathy” will be presented on Tuesday, September 17, at 11:00 a.m. EDT. Lowry Curley of AxoSim, Inc., will describe a study in which a novel 3D microphysiological cell-based model of the peripheral nerve was used to investigate the in vitro manifestation of neuropathy induced by chemotherapeutic agents. Results suggest that this system can be used as a clinically relevant model to study neurotoxicity, as well as a potential screen for agents that can counteract those effects.

The webinar is being presented by ASCCT and the European Society for Toxicology In Vitro. Videos of past ASCCT webinars are available for viewing by society members.

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Sep 09, 2019
Teratology Society Presents Webinar on September 24

The Teratology Society is hosting a webinar on “Computational and Biotechnology Approaches to Predict Developmental Toxicity” on Tuesday, September 24, at 11:00 a.m. EDT. The speaker is George Daston of Procter & Gamble. The webinar is free.

Techniques like cheminformatics, global gene expression analysis, and high-throughput screening are producing a large volume of information on how chemicals interact with their endogenous targets and the initial biological responses that emanate from these interactions. This webinar will consider strategies for using these new techniques to predict the toxicity of new chemicals while continuing to leverage existing toxicology data.

The webinar is being presented by the Teratology Society in collaboration with the American College of Toxicology, the Developmental Neurotoxicity Society, and the Society of Toxicology’s Reproductive and Developmental Toxicology Specialty Section.

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Sep 09, 2019
Free Training on Computational Toxicology Tools September 26

PCRM will hold a free training session on New Approach Methodology Use for Regulatory Application (NURA): Tools for Computational Toxicology on September 26 from 1:00-5:30 p.m. The training session will follow immediately after the ASCCT annual meeting in the same venue, the Hilton Washington DC North in Gaithersburg, MD. Registration to attend the training session is separate from ASCCT, those interested in attending the training must register by September 25. Lunch will be served.

The training session will feature expert presentations from computational leaders and customizable demonstrations on predictive tools like OPERA, ICE, UL Cheminformatics Toolkit, DEREK, and QSARs to support regulatory guidelines. This training will be of particular interest to pharmaceutical and chemical company staff, toxicology consultants, and regulators.

Sep 25, 2019
Sep 09, 2019
Abstract Submission Open for QSAR2020 Workshop

Abstracts are being accepted for the 19th International Workshop on (Quantitative) Structure-Activity Relationships in Environmental and Health Sciences (QSAR2020). The workshop will be held June 8-11, 2020, in Durham, North Carolina. It will bring together scientists along with developers and users of predictive models and their underlying data to discuss the practical implementation of non-animal approaches to inform chemical hazard and risk assessment. The workshop is being organized by the EPA, the International Council of Chemical Associations' Long-Range Research Initiative, and ASCCT.

Abstracts may be submitted for oral or poster presentations and should address one or more of the 12 themes listed on the abstract information page. Abstracts are due December 15. Proceedings of the workshop will be published in a special issue of Computational Toxicology, and all presenters will be invited to submit manuscripts.

Dec 15, 2019
Sep 09, 2019
NURA Modern Science Portal Launched

PCRM and IIVS have launched the NURA Modern Science portal. From the portal, users can download presentations and other materials from the May 2019 workshop, New Approach Methodology Use for Regulatory Application (NURA): Evaluating Toxicological Information Using Modern Science. Other resources available include journal articles, government publications, and other documents relevant to development of new approach methodologies.

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Sep 09, 2019
EPA CompTox Dashboard Updated

A new version of EPA’s Comptox Chemicals Dashboard was released on August 9. Included in this release are updates to the hazard data in the ToxVal database and an update to the ToxCast in vitro database. The release also addresses a number of minor bugs. The CompTox Chemicals Dashboard includes data and information on over 875,000 chemicals.

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Aug 27, 2019
FDA to Present Update on Predictive Toxicology Roadmap September 18

On Wednesday, September 18, FDA will host a free public meeting to provide updates on implementation of its Predictive Toxicology Roadmap. Speakers from seven FDA centers will describe how predictive toxicology methods are being advanced towards application to safety and risk assessments. An announcement about the meeting was published in the August 20 Federal Register.

The meeting, to be held at FDA’s White Oak campus in Silver Spring, Maryland, will also be webcast. Information about registration and a preliminary agenda are available on the FDA website. Those interested in attending or viewing the webcast should register by Monday, September 16.

Sep 16, 2019
Aug 27, 2019
EPA to Fund Toxicokinetics Studies, Apply by September 24

EPA is seeking applications for a new funding opportunity, Advancing Toxicokinetics for Efficient and Robust Chemical Evaluations. Toxicokinetics describes the absorption, distribution, metabolism, and excretion of chemicals and their metabolites by the body. The research activities to be funded under this announcement are intended to improve the development of chemical toxicokinetic tools and approaches for broader applicability during chemical evaluations. Of particular interest are projects that will increase throughput and predictivity of current in vitro to in vivo extrapolation approaches while reducing the uncertainty of these approaches.

Eligibility for this funding is limited to U.S.-based public and private non-profit institutions and government entities. Applications will be accepted through September 24.

Sep 24, 2019
Aug 27, 2019
Registration Open for In Vitro Methods Workshop; Travel Award Available

Registration is open for a Practical Methods for In Vitro Toxicology Workshop on January 13-16, 2020. Presented by The Institute for In Vitro Sciences at its facility in Gaithersburg, Maryland, this intensive workshop will allow participants an opportunity to gain hands-on experience with non-animal methods in a small-group setting. A $200 discount is available for registrations received by September 30.

The PETA International Science Consortium is offering an award for an early-career scientist to attend the workshop. The award will provide up to $1,000 to fund workshop registration, airfare, and hotel accommodations. Those eligible for the award include (1) students working towards a master’s or PhD who have completed their first year of study; (2) postdoctoral fellows; or (3) scientists less than three years out of a master’s, PhD, or postdoctoral program. The awardee must attend all four days of the workshop. The deadline to apply is October 14.

Discount registration: Sep 30
Travel award: Oct 14
Aug 27, 2019
Review Describes Identification of Endocrine Disrupting Chemicals Using Gene Expression Biomarkers

A review article coauthored by NICEATM Deputy Director Nicole Kleinstreuer and EPA collaborators describes the use of gene expression biomarkers to identify endocrine-disrupting chemicals. This approach can identify both androgen and estrogen receptor agonists and antagonists with over 90% accuracy in microarray data derived from human breast or prostate cancer cell lines. Predictions generated with this approach can help prioritize chemicals with the greatest risk of potential adverse outcomes in the endocrine systems of animals and people.

Corton et al. 2019. Identification of potential endocrine disrupting chemicals using gene expression biomarkers. Toxicol Appl Pharmacol. https://doi.org/10.1016/j.taap.2019.114683

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Aug 19, 2019
Agenda, Registration Available for ASCCT Annual Meeting

ASCCT will hold its annual meeting on September 24-26 at the Hilton Washington DC North in Gaithersburg, MD. The theme of the meeting is “Computational Toxicology: Peeking into the Clouds While Keeping Our Feet on Solid Ground.” Program highlights include a mentoring event, poster session, and computational toxicology software showcase. The online registration deadline is September 13.

NICEATM Deputy Director Nicole Kleinstreuer is a featured speaker at the meeting, with a presentation on “The March Toward Big Data in Toxicology: Striking a Balance Between Machine Learning and Mechanistic Modeling.” Shannon Bell, ILS (contractor supporting NICEATM) will give an oral presentation titled “Good Decisions Require Good Data: Creating Curated and Structured Resources for Toxicology.” NICEATM will also have two presentations at the poster session. More information about NICEATM activities at ASCCT >>

Sep 13, 2019
Aug 19, 2019
OECD Publishes New AOPs

OECD has published seven new AOPs. An AOP is a framework that identifies the sequence of biochemical events required to produce a toxic effect. AOPs can help outline evidence and evidence gaps about a particular toxicological pathway, aid interpretation of mechanistic data for regulatory decision-making, and facilitate development and use of in vitro and in silico approaches for toxicity testing. Three of the new AOPs are relevant to neurotoxicity; others describe perturbations of the aryl hydrocarbon and PPAR-alpha receptor pathways. Information about the OECD AOP Development Programme is available on the OECD website.

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Aug 19, 2019
NIH Small Business Opportunities

NIH is accepting applications to two SBIR/STTR programs to assist small businesses with commercialization of their technologies.

  • The NIH Commercialization Accelerator Program is a competitive program designed to help small businesses with meeting their commercialization objectives. Participants selected for the program will receive help with establishing market and customer relevance, building commercial relationships, and identifying revenue opportunities. Small businesses whose NIH SBIR and STTR Phase II, Phase IIB, or Phase II portion of a fast-track award is current or was active in the past five fiscal years are eligible to apply. The application deadline is August 22.
  • The NIH Commercialization Readiness Pilot program facilitates the commercialization of previously funded SBIR and STTR Phase II and Phase IIB projects by funding activities not typically supported through Phase II or Phase IIB grants or contracts. Small businesses that have had an active NIH SBIR or STTR Phase II or Phase IIB award within the last 36 months are eligible to apply. Awardees will receive up to $300,000. Standard SBIR/STTR application deadlines apply for these grants; the next deadline is September 5.

CAP: Aug 22
CRP: Sep 5

Aug 19, 2019
Postdoctoral Position Available at CAAT

CAAT at Johns Hopkins University has a three-year opening available for a postdoctoral fellow. The successful candidate will develop a new approach methodology for developmental neurotoxicity testing based on an iPSC-derived 3D organotypic brain model. They will design several CRISPR/Cas9-modified iPSC lines, generate 3D brain organoids, and perform screening of chemicals using high-content imaging. They will also collaborate with a bioengineering group in developing an electrophysiology recording platform.

Candidates should have PhDs in molecular or cell biology; a background in neuroscience is preferred. Training in toxicology is desired but not required. Candidates should have experience with gene editing using CRISPR/Cas9 technology and culturing iPSCs, embryonic stem cells, and neuronal cells. The position offers the opportunity to develop high-impact publications, present at conferences, and prepare for a career in academia or industry in a rich intellectual environment. To apply for the position, send a CV and motivation letter to Lena Smirnova at lena.smirnova@jhu.edu.

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Aug 15, 2019
SACATM to Meet September 19-20; Registration Open and Agenda Available

The Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) will meet on September 19-20 at the Crowne Plaza Crystal City in Arlington, Virginia. SACATM meets annually to advise NICEATM, ICCVAM, and the director of the National Institute of Environmental Health Sciences regarding statutorily mandated duties of ICCVAM and activities of NICEATM. Preliminary agenda items for the upcoming meeting include:

  • New approaches to the principles and practice of validation
  • Developing a next generation data infrastructure to support the development and implementation of new approach methodologies (NAMs) for complex endpoints
  • Translational impact and human relevance of NAMs

The SACATM meeting is open to the public and attendance is free. Registration is open to attend the meeting in person or view the webcast. Those wishing to attend in person and/or submit public comments should register to do so by September 12.

Sep 12, 2019
Aug 05, 2019
Grants Available to Support Alternative Methods for Vaccine Testing

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is offering $1.5 million in grants to develop and implement innovative technologies for vaccine and biological manufacturing. A major area of interest is development of alternative in vitro assays to reduce the reliance on animal testing required for lot release.

Those interested in applying for these grants must submit a four-page concept paper by September 10. This paper should present an overview of the proposed project; no teaming, detailed budget, or cost share information is required. Following submission of concept papers, invitations will be issued to participate in the Project Call 3.1 Summit in October. At this event, proposers will have opportunities to network and discuss their project. This phase will conclude with invitations issued to submit a full proposal in Stage 2 of the process.

More information about the funding opportunity, including slides from a July 23 webinar, is available on the NIIMBL website. This funding opportunity is supported by the NIIMBL Global Health Fund, a collaboration between NIIMBL and the Bill & Melinda Gates Foundation.

Sep 10, 2019
Aug 05, 2019
PCRM Offers Student Travel Award

The Physicians Committee for Responsible Medicine (PCRM) is offering $1000 to support attendance of an outstanding undergraduate or graduate student at the Annual Biomedical Research Conference for Minority Students (ABRCMS) in November.

Applicants for the PCRM travel award must be attending an accredited U.S. higher learning institution. They must have had an abstract accepted at ABRCMS that describes human-relevant research using microphysiological systems, bioengineering, computational modeling, organoids, or other non-animal approaches. Projects using or suggesting future use of animals are not eligible. Applications will be evaluated in part on the student’s demonstrated interest in ethical sciences and commitment to pursue a career using non-animal methods. Applications are due September 6.

Sep 6, 2019
Jul 31, 2019
ICE Update Launched July 30

On July 30, NICEATM released the latest version of the Integrated Chemical Environment (ICE). ICE now includes:

  • Updates to Tox21 data
  • Predictions of endocrine activity using in silico models
  • Improved performance and output standardization for the In Vitro to In Vivo Extrapolation tool
  • Simplified outputs for the Machine Learning tool
  • Revised and improved user instructions

ICE is a publicly available, web-based resource that provides curated data and tools to facilitate safety assessment of chemicals.

The recent updates will be among ICE features highlighted in a webinar to be presented July 31 at 11:00 a.m. Eastern Daylight Time. The webinar, “The Integrated Chemical Environment: Tools and Data to Support Toxicity Assessments,” is hosted by the PETA International Science Consortium (PISC). The webinar will be recorded and made available on the PISC website after presentation.

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Jul 31, 2019
NIH to Fund Studies to Improve iPSC Reproducibility

The National Institutes of Health (NIH) is offering Small Business Innovation Research grants to develop methods that improve the reproducibility of human induced pluripotent stem cell (iPSC) derivation, growth, and differentiation. Eligible projects should seek to address the significant variability currently observed in human iPSCs in reprogramming efficiency, differentiation potential, and cell growth and stability, which is limiting the full potential of these tools for research and clinical practice. Eleven NIH Institutes and centers, including the National Institute of Environmental Health Sciences, intend to commit funds to this effort, with an estimated 25 awards to be awarded to U.S. small businesses. Applications will be accepted from December 6, 2019 through January 6, 2020.

Jan 6, 2020
Jul 31, 2019
Report Available from Workshop on Developmental Toxicity

NICEATM Deputy Director Nicole Kleinstreuer is a coauthor of the report on the Ninth Berlin Workshop on Developmental Toxicity held in September 2018. Attendees at this workshop considered the future of in vitro methods for developmental and reproductive toxicology, the potential relevance of alternative species in testing of developmental effects, and risk and hazard assessment of developmental and endocrine effects. Recommendations included the need for a harmonized terminology for classification of anomalies in laboratory animals in developmental toxicity studies for human health risk assessment.

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Jul 18, 2019
July 31 Webinar to Highlight Updates to ICE

A webinar titled “The Integrated Chemical Environment: Tools and Data to Support Toxicity Assessments” will be presented Wednesday, July 31 at 11:00 a.m. Eastern Daylight Time. Shannon Bell, ILS (contractor supporting NICEATM), will provide an overview of the updated Integrated Chemical Environment (ICE), a publicly available, web-based resource that provides curated data and tools to facilitate safety assessment of chemicals. Attendees will view a live demonstration of ICE and learn about newly added features. The webinar is hosted by the PETA International Science Consortium.

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Jul 18, 2019
FDA to Present Update on Predictive Toxicology Roadmap September 18

On Wednesday, September 18, FDA will host a free public meeting to provide updates on implementation of its Predictive Toxicology Roadmap. Speakers from seven FDA centers will describe how predictive toxicology methods are being advanced towards application to safety and risk assessments. The meeting, to be held at FDA’s White Oak campus in Silver Spring, MD, will also be webcast. Information about registration and a preliminary agenda are available on the FDA website. Those interested in attending or viewing the webcast should register by Monday, September 16.

Sep 16, 2019
Jul 18, 2019
Report Available from Rabies Vaccine Workshop

A report is available from the October 2018 workshop “Implementing Nonanimal Approaches to Human and Veterinary Vaccine Testing: Achieving Scientific and Regulatory Success for Rabies and Beyond.” NICEATM Director Warren Casey and David Allen, ILS (contractor supporting NICEATM), workshop participants, coauthored the report.

This workshop, co-sponsored by NICEATM and the International Alliance for Biological Standardization-North America, explored how to advance alternative methods for human and veterinary rabies virus vaccine potency testing. The workshop attendees agreed that a more suitable, scientifically based in vitro assay is needed as an alternative to the current in vivo challenge potency test. ELISA assays specific for rabies virus glycoprotein were identified as the most appropriate in vitro alternative test candidates for further development.

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Jul 18, 2019
Report Available from Artificial Intelligence Summit

A report is available from the “Summit on Artificial Intelligence in Environmental Health Science and Decision Making,” held in October 2018. The goal of the summit was to identify and prioritize environmental health sciences (EHS) research questions that might be investigated with artificial intelligence and machine learning (AI/ML) techniques. The summit described some early opportunities for the application of AI/ML in EHS. Participants also identified action items for advancing the field in the three areas of (1) data, research, and practice; (2) education and training; and (3) community and field development. NICEATM Deputy Director Nicole Kleinstreuer and Lyle Burgoon, U.S. Department of Defense, co-chair of the ICCVAM Ecotoxicology Workgroup, were among the presenters at the summit.

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Jul 07, 2019
OECD Issues New and Updated Test Guidelines

The Organisation for Economic Co-operation and Development (OECD) issued three new and six updated Test Guidelines on June 18. Included among the new documents are tests relevant to replacing or reducing animal use for common acute toxicity endpoints.

  • Test Guideline 494 (new) describes the in vitro Vitrigel-Eye Irritancy Test (EIT) to identify chemicals not requiring classification and labelling for eye irritation or serious eye damage. The Japanese Center for the Validation of Alternative Methods coordinated validation of the EIT. NICEATM staff served on the management team for the validation study, and an ICCVAM member participated in the peer review.
  • Test Guideline 442C (updated) describes in chemico assays that measure covalent binding of a test chemical to skin proteins, a key event in the adverse outcome pathway for skin sensitization. The previous TG 442C described the direct peptide reactivity assay. The updated Test Guideline also describes a similar method, the amino acid derivative reactivity assay (ADRA), and discusses how in chemico protein binding assays could be used within integrated approaches to testing and assessment for skin sensitization. NICEATM staff served on the validation management team for the ADRA and participated on the OECD Expert Group that reviewed the methods included in the test guideline.
  • Test Guideline 492 (updated) describes in vitro reconstructed human corneal epithelium test methods to identify chemicals not requiring classification and labelling for eye irritation or serious eye damage. The Test Guideline is based on four commercial methods of this type. It includes descriptions of essential test method components and a list of chemicals to be used to demonstrate proficiency with the assays. NICEATM staff participated on the OECD Expert Group that reviewed the methods included in the test guideline.
  • Test Guidelines 431 and 439 (updated) describe in vitro reconstructed human epidermis test methods to identify chemicals that may cause skin corrosion (TG 431) or irritation (TG 439). The test guidelines were revised to include a greater number of commercial methods of this type. Both Test Guidelines include lists of chemicals to be used to demonstrate proficiency with the assays. NICEATM staff participated on the OECD Expert Group that reviewed the methods included in the Test Guidelines.

NICEATM and ICCVAM member agencies participate in the development and national review of documents issued by the OECD Test Guidelines Programme. OECD Test Guidelines are used by government, industry, and independent laboratories in the 36 member countries of the OECD to assess chemical safety. The OECD Mutual Acceptance of Data clause entails that safety data generated using an OECD test guideline will be accepted by all the member countries, avoiding redundant testing.

NICEATM Director Warren Casey and ICCVAM member Wanda Hall, U.S. Environmental Protection Agency and U.S. National Coordinator, participated in the April meeting of the Working Group of National Coordinators of the Test Guidelines Programme, which evaluated and recommended OECD adoption of the new and updated Test Guidelines.

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Jul 01, 2019
World Congress Session Proposal Deadline Extended to July 7

The deadline for session proposals for the 11th World Congress on Alternatives and Animal Use in the Life Sciences has been extended through July 7. Proposals for symposia, workshops, roundtables, or other session types should reflect any of the four themes “Safety,” “Disease,” “Innovative Technologies,” and “Ethics, Welfare, and Regulatory Affairs.” To submit a proposal, you will be asked to create a World Congress account, provide a working title and short description of the proposed session, and identify possible funding sources. Proposals should support the integration of submitted abstracts and the participation of speakers from a diversity of sectors.

The 11th World Congress will be held August 23-27, 2020, in Maastricht, The Netherlands. NICEATM Deputy Director Nicole Kleinstreuer is on the scientific committee for World Congress, which will focus on “3Rs in Transition from Development to Application.” Pages within the meeting website allow you to submit session proposals, subscribe to the meeting newsletter, and get details on the location, venues, sponsorship, and travel to Maastricht.

Jul 7, 2019
Jul 01, 2019
September 17 Webinar to Highlight Chip Model for Neuropathy

A free webinar titled “Nerve-on-a-Chip Platform for Assessing Chemotherapy-induced Peripheral Neuropathy” will be presented on Tuesday, September 17, at 11:00 a.m. Eastern Daylight Time. Lowry Curley of AxoSim, Inc., will describe a study in which a novel 3D microphysiological cell-based model of the peripheral nerve was used to investigate the in vitro manifestation of neuropathy induced by chemotherapeutic agents. Results suggest that this system can be used as a clinically relevant in vitro model to study neurotoxicity, as well as a potential screen for agents that can counteract those effects.

The webinar is being presented by the American Society for Cellular and Computational Toxicology (ASCCT) and the European Society for Toxicology In Vitro. Videos of past ASCCT webinars are available for viewing by society members; information is available on the ASCCT website.

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Jul 01, 2019
NAS Graduate Fellowships Available, Apply by September 6

Applications are being accepted through September 6 for the Christine Mirzayan Science and Technology Policy Graduate Fellowship Program, a full-time educational program for early career individuals. Fellows will spend 12 weeks in early 2020 at the National Academies of Sciences, Engineering, and Medicine (NAS) in Washington, DC, learning about science and technology policy and the role that scientists and engineers play in advising the nation. The fellowship offers a unique opportunity to obtain the essential skills and knowledge needed to work in science policy at the federal, state, or local levels.

Applicants should be current graduate or professional school students, or have received degrees within the last five years. Applicants need not be U.S. citizens but must be legal residents of the U.S.; NAS does not sponsor visas for the fellowship program. Applicants must provide two references relevant to their academic or professional experience before applications will be accepted.

Sep 6, 2019