NICEATM News Archive

The next ICCVAM Communities of Practice webinar will be Wednesday, January 29, 2025, from 10:00 a.m.-12 noon ET and will focus on the topic of “Evolution of Complex In Vitro Models.” Ongoing efforts and key insights will be described in three presentations by speakers from the U.S. government, academia, and the private sector focusing on regulatory application of these models. Registration is not required to view the webinar. More information is available.

ICCVAM promotes the development and validation of toxicity testing methods that protect human health and the environment while replacing, reducing, or refining animal use. ICCVAM also provides guidance to test method developers and facilitates collaborations that promote the development of new test methods. To address these goals, ICCVAM presents Communities of Practice webinars focused on current topics relevant to development and evaluation of new test methods. Materials from past webinars are available.

The next webinar in the U.S. Environmental Protection Agency (EPA), PETA Science Consortium International, Institute for In Vitro Sciences, and the California Department of Pesticide Regulation (EPIC) series on the use of new approach methodologies (NAMs) in risk assessment will cover “NAM-based strategies for systemic toxicity assessment.” The webinar will be held on Wednesday, January 29, 2025, at 11:00 a.m. ET. More information and registration is available.

The webinar will feature presentations by Katie Paul Friedman, EPA, and Elisabet Berggren, European Commission Joint Research Centre. Paul Friedman will describe PODNAM, a NAMs-based point-of-departure for systemic toxicity, and summarize international activities to characterize the concordance between a PODNAM and a traditional systemic toxicity point-of-departure. Berggren’s presentation will consider challenges and possible ways to progress towards a system of chemical safety assessment not relying on animal testing based on the knowledge and experience of today.

The EPIC series covers timely topics on the use of NAMs for risk assessment within the EPA and the California Department of Pesticide Regulation (CDPR). The series began in August 2023 and continues quarterly; links to past webinars are available. The webinar series is co-organized by EPA, PETA Science Consortium International, the Institute for In Vitro Sciences, and CPDR.

The National Institutes of Health (NIH) Common Fund, along with the Office of the NIH Director, Office of Strategic Coordination has published a Notice of Funding Opportunity to support the Complement Animal Research in Experimentation (Complement-ARIE) Program. The funding opportunity will be administered by the National Center for Advancing Translational Sciences on behalf of NIH. Complement-ARIE will accelerate the development, standardization, validation, and use of human-based NAMs.

Investigators with expertise and insights into the area of NAMs are encouraged to consider applying for these funding opportunities. Funding will support technology development centers that will stimulate the development of combinatorial NAMs to support scientific areas of need, with emphasis on increased biological complexity and throughput, innovative combinatorial approaches, and data sharing according to findability, accessibility, interoperability, and reusability (FAIR) principles. Developing these NAMs will require multi-disciplinary expertise in disease research, personalized medicine, screening therapeutics for safety and efficacy, and regulatory science. The NIH Common Fund intends to commit approximately $18M per year to fund 4-5 awards. Letters of intent are due January 24, 2025. Applications will be accepted starting January 28 and will be due February 28.

Complement-ARIE program goals include:

• To better model and understand human health and disease outcomes across diverse populations.
• To develop NAMs that provide insight into specific biological processes or disease states.
• To validate mature NAMs to support regulatory use and standardization.
• To complement traditional models and make biomedical research more efficient and effective.

Eligibility, award information, and an application are available.

• A report is available from the November 2023 workshop, “State of the Science on Assessing Developmental Neurotoxicity Using New Approach Methods.” This event convened experts from international organizations, governmental agencies, industry, and academia to explore the transition from traditional in vivo tests to innovative NAMs in developmental neurotoxicity (DNT) testing. Presentations and panel discussions considered the state of the science, assessed the capabilities and limitations of current DNT NAMs, and outlined critical next steps in advancing the field of DNT testing. NICEATM scientist Helena Hogberg, ICCVAM co-chair Suzanne Fitzpatrick (U.S. Food and Drug Administration [FDA]) and ICCVAM members Omari Bandele (FDA), Kelly Carstens (EPA), and Monique Perron (EPA) are co-authors on the report.
  
  Debad et al. 2024. State of the science on assessing developmental neurotoxicity using new approach methods. ALTEX. https://doi.org/10.14573/altex.2410231.
   
• A new paper describes the Skin Allergy Risk Assessment – Integrated Chemical Environment (SARA-ICE) Bayesian statistical model for derivation of a point-of-departure for quantitative risk assessment for skin sensitization. The SARA-ICE model was developed in a collaboration between NICEATM and the consumer products company Unilever. NICEATM scientists Emily Reinke (Inotiv, contractor supporting NICEATM) and Dori Germolec (National Institute of Environmental Health Sciences) and NICEATM Director Nicole Kleinstreuer are co-authors on the paper.
  
  Reinke et al. 2024. The skin allergy risk assessment-integrated chemical environment (SARA-ICE) defined approach to derive points of departure for skin sensitization. Current Research in Toxicology. https://doi.org/10.1016/j.crtox.2024.100205.

A scientific review is being organized for an adverse outcome pathway (AOP) for activation of the Ah receptor (AhR) leading to metastatic breast cancer. This review will be conducted in accordance with principles for the scientific review of AOPs established by the Organisation for Economic Co-operation and Development. Scientists with expertise relevant to the AOP are needed for the review panel. Those interested should contact Markus Hecker at [email protected] by Friday, December 27. Hecker will establish the panel based on the applications received. The scientific review is planned for January and February of 2025.

The Physicians Committee for Responsible Medicine (PCRM) ERA21 travel awards are designed to support the next generation of life sciences researchers using human-based nonanimal methods. The monetary value of each award will be determined on a case-by-case basis depending on the conference. Recipients must be dedicated to promoting the replacement of animals in science and must have been accepted to present animal-free research at the conference in which the travel award will assist.

Applicants may apply for more than one award but is eligible to receive only one ERA21 award within a one-year period. Priority will be given to applicants who apply prior to two months from the date of the event.

A list of current travel award opportunities and dates, requirements, and the application form is available.

Additional travel awards are available on a case-by-case basis for early career researchers who are dedicated to using nonanimal methods and who can demonstrate financial need. Please send a letter of intent briefly describing your presentation, the conference, a statement of need, and how your research advances nonanimal science (250 words maximum) to Mikalah Singer at [email protected].

A review by NICEATM and EPA scientists discusses how toxicokinetic models can incorporate variability and complex exposure scenarios. A state-of-the-science update describes emerging strategies for population and life-stage variability, including the application of in vitro to in vivo extrapolation (IVIVE) in pharmaceutical and chemical safety research. Case study examples demonstrate novel applications of physiologically based toxicokinetic modeling, and the review concludes with an update on applications for regulatory decision-making.

Kreutz et al. 2024. Advancing understanding of human variability through toxicokinetic modeling, in vitro-in vivo extrapolation, and new approach methodologies. Human Genomics. https://doi.org/10.1186/s40246-024-00691-9.

On November 5, the EPA released Version 2.5 of the CompTox Chemicals Dashboard. Updated tools include SeqAPASS and ToxCast. Some featured updates are:

• A new default option, “Formula Contains,” for the Advanced Search > Molecular Formula Search.
• Addition of a “Reply” column to the Comments page.
• Updates of Hazard and high-throughput phenotypic profiling (HTPP) data and assay descriptions, respectively, to accordions to be more widely accessible.
• Inclusion of the MS-Ready mass and MS-Ready formulae in the downloaded Batch Search file after MS-Ready SMILES are selected.

More information about EPA’s Version 2.5 updates, including resolved issues and the data sources used for release of the Dashboard, is available.

The Triangle Centers of Excellence in Regulatory Science and Innovation (CERSI) and the U.S. Food and Drug Administration (FDA) are hosting a hybrid workshop February 27-28, 2025, on “Pediatric Developmental Safety Assessment and Novel Alternative Methods.” The on-site location is FDA White Oak Campus in Silver Spring, MD. In-person attendance is capped at 150. Registration is available until 5 p.m. ET on February 26. Nicole Kleinstreuer, NICEATM Director, will present on “NAMs Across Agencies.”

Workshop objectives include:

• To understand the current programs in federal agencies related to novel alternative methods and pediatric developmental biology.
• To discuss the identification and utilization of secondary targets in pediatric developmental safety assessment.
• To review the use of juvenile animal studies and in vitro tools to assess pediatric developmental safety assessment.
• To explore the use of model-informed drug development techniques such as quantitative systems pharmacology and the use of artificial intelligence and machine learning in pediatric developmental safety assessment.

Registration is free of charge and required for in-person and virtual attendance.

The U.S. Environmental Protection Agency (EPA) will host a webinar, “Computational Toxicology and Exposure Communities of Practice: Updates to the Web-based Interspecies Correlation Estimation (Web-ICE) Application,” on December 12 at 11 a.m. ET. Registration for the webinar is available.

The webinar will present an overview of the Web-ICE application and its use within EPA. Web-ICE is a new approach methodology developed and applied by EPA to predict acute toxicity for diverse species from limited surrogate species data. Web-ICE was developed to address data gaps in species sensitivity and reduce reliance on uncertainty factors in ecological risk assessment. Web-ICE uses least squares regression of species sensitivity to predict acute toxicity to taxa for chemicals with limited measured toxicity data from the known toxicity of a surrogate species. The newly released Web-ICE v4.0 has over 4,700 models representing 478 aquatic animal species, over 100 models representing 69 algae species, and over 850 models for 156 species of terrestrial birds and mammals. A new feature of Web-ICE v4.0 is the Bulk ICE module, which provides predictions from all available surrogates to maximize the taxonomic diversity of modelled output.

The Physicians Committee for Responsible Medicine (PCRM) NAMs Use for Regulatory Application (NURA) program is a continuing education resource to provide toxicology professionals with specialized resources and basic hands-on training in nonanimal new approach methodologies (NAMs). NURA now provides a learning portal which users can navigate via its long-form content at their own pace.

Course topics include training on NICEATM’s Integrated Chemical Environment resource, a series on available replacement options for the “six-pack” of regulatory acute toxicity tests, and approaches for reducing animal use for pyrogen and carcinogenicity testing. Users can view one presentation at a time and can find, skip, and replay presentations, with the platform keeping track of progress. The platform provides certificates upon course completion that may be submitted for continuing education credits. The platform also features English and Spanish subtitle options.

Users who create new accounts by November 30 will be entered into a drawing to win one of three $100 Amazon gift cards. An audience survey is also available to let PCRM know what other features and trainings would be helpful, and a signup to their mailing list.

The next webinar in the Environmental Protection Agency, PETA Science Consortium International, Institute for In Vitro Sciences, and the California Department of Pesticide Regulation (EPIC) series on the use of new approach methodologies (NAMs) in risk assessment will cover “Regulatory tools for assessing the skin sensitization potential of chemicals and a case study using the SARA-ICE model.” The webinar will be held on Wednesday, December 11 at 11:00 a.m. EDT. Registration is now available.

The webinar will feature presentations by Donna Macmillan, International Collaboration on Cosmetics Safety, and NICEATM scientist Emily Reinke, Inotiv (contractor supporting NICEATM). Macmillan will describe the development of an internationally accepted guideline for defined approaches to skin sensitization, and how to apply the defined approaches published in the guideline. Reinke will discuss the Skin Allergy Risk Assessment – Integrated Chemical Environment (SARA-ICE) Bayesian statistical model for derivation of a point-of-departure for quantitative risk assessment for skin sensitization.

The EPIC series covers timely topics on the use of NAMs for risk assessment within the U.S. Environmental Protection Agency (EPA) and the California Department of Pesticide Regulation (CDPR). The series began in August 2023 and continues quarterly; links to past webinars are available. The webinar series is co-organized by EPA, PETA Science Consortium International, the Institute for In Vitro Sciences, and CPDR.

A new article in the journal Toxics describes HuSSPred, an in silico tool based on the human predictive patch test (HPPT) for assessing skin sensitization potential of chemicals. HuSSPred was trained on an extensive curated HPPT database. It aims to enhance the reliability of predicting human skin sensitization effects for chemical agents to support their regulatory assessment. The web tool offers a user-friendly interface for predicting skin sensitization based on chemical structure. NICEATM Director Nicole Kleinstreuer and NICEATM scientist Jose Teofilo Moreira-Filho are coauthors on the paper.

Tieghi RS et al. 2024. A novel machine learning model and a web portal for predicting the human skin sensitization effects of chemical agents. Toxics 12(11):803. https://doi.org/10.3390/toxics12110803.

Registration is now open for upcoming webinars presented by ASCCT and the European Society for Toxicology In Vitro (ESTIV).

• A webinar to be held Friday, November 22 from 10:00–11:30 a.m. EST will feature presentations from award winners at this year’s ESTIV and Eurotox meetings. “Ontology-Based AI-driven Innovative Approach Using DNT NAMs for NGRA” will be presented by Eliska Kuchovska, IUF - Leibniz Research Institute for Environmental Medicine, winner of the Japanese Society for Alternatives to Animal Experiments (JSAAE) Best Oral Presentation award at ESTIV 2024. “Using a Machine Learning Framework to Improve the Efficiency of Mitochondrial Toxicity Screening by Guiding Compound Selection” will be presented by Tiago Marques Pedro, University of Cambridge, winner of the ESTIV Best Oral Presentation award at Eurotox 2024.
• A webinar on “Prediction of Skin Sensitization Using Machine Learning” will be held Wednesday, December 4 at 8:00 a.m. EST. The speaker will be Kaori Ambi, Nagoya City University. This webinar is a joint presentation of JSAAE and ASCCT-ESTIV.

A colloquium on “Emerging Concepts in Hazard Identification and Exposure Assessment of Per- and Polyfluoroalkyl Substances” will be held Tuesday, December 3 from 9:00-12:45 p.m. Speakers from federal agencies, academia, and testing laboratories will discuss dietary sources of PFAS and methods for assessing and communicating their health risks. The webcast is open to the public at no charge; registration is available now.

This is the latest event in a series organized by the Society of Toxicology and the U.S. Food and Drug Administration (FDA) Human Foods Program (formerly the Center for Food Safety and Applied Nutrition). The colloquia present scientific information that is high-quality, cutting-edge, future-oriented toxicological science to provide a well-grounded foundation to inform the work of FDA employees. Materials from previous colloquia are available as well.

Videos are now available from presentations from the 11th Annual 3Rs Symposium held September 4-5. Topics discussed included microphysiological systems, animal/organ sharing, optimizing animal breeding, and research design and statistical strategies. Videos are available on the National Agricultural Library, Animal Welfare Information Center’s website.

The 3Rs Symposium is an annual event organized by:

• Center for Alternatives to Animal Testing, Johns Hopkins University Bloomberg School of Public Health
• Department of Molecular and Comparative Pathobiology, Johns Hopkins University School of Medicine
• U.S. Department of Agriculture’s Animal Welfare Information Center at the National Agricultural Library
• Office of Laboratory Animal Welfare, National Institutes of Health

  Materials from previous 3Rs Symposiums are also available.

A new article in the journal ALTEX discusses challenges in implementing biomarker-based approaches, including standardization, demonstration of relevance, regulatory acceptance, and addressing biological complexity. Case studies demonstrate successful applications of biomarkers in preclinical safety, while future perspectives explore emerging trends like multi-omics integration, microphysiological systems, and artificial intelligence. NICEATM Director Nicole Kleinstreuer is a coauthor on the paper.

Hartung T. 2024. Leveraging biomarkers and translational medicine for preclinical safety - Lessons for advancing the validation of alternatives to animal testing. ALTEX 41(4):545–566. https://doi.org/10.14573/altex.2410011.

The National Eye Institute is leading an NIH collaboration to incentivize the creation, development, and validation of a quantitative data sharing index. The Data Sharing Index (S-index) Challenge aims to incentivize and reward effective data sharing practices by assessing how effective a researcher is in sharing their data in a way that has utility for future study. This metric will incorporate factors such as adherence to findable, accessible, interoperable, and reusable (FAIR) standards; data timeliness; completeness of annotation; frequency of utilization in other studies; and related publications and patents. This metric seeks to recognize and incentivize the efforts of individuals and teams in sharing data, rather than just the value of the data itself.

Phase 1 of the Challenge will open in April 2025; the deadline to register to participate is March 3, 2025. In Phase 1, participants will engage in brainstorming and idea generation, culminating in the submission of a proof-of-concept proposal. These proposals will compete in the first round, with up to six finalists selected to receive a $15,000 prize and advance to Phase 2. The Challenge will award up to $1M to support development of winning submissions. Detailed information and timeline are available.

Abstracts are being accepted for the 2024 MPS World Summit to be held June 9-13, 2025 in Brussels. Abstracts are invited on the topic of new developments in microphysiological systems (MPS) and applications of MPS. Abstracts will be evaluated for their alignment with the four meeting tracks:

• Track 1: MPS Development and Results Processing.
• Track 2: MPS for Biomedical Research and Disease Modelling.
• Track 3: MPS for Efficacy, ADME, and Toxicity Testing.
• Track 4: MPS for Industrial and Regulatory Testing.

Submit abstracts by January 15, 2025. Abstracts must be in English and no more than 350 words. Submitters should indicate their preferred track. More details on abstract submission are available.

The MPS World Summit is organized by the International MPS Society, which facilitates connection, exchange, and education within the community of MPS developers and users.

Presentation slides and videos from the webcast of the September 21-22 meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) are now available. Meeting minutes are in preparation and will be posted on that page when they are available.

Next year’s SACATM meeting will be held on September 11-12, 2025, at the National Institute of Environmental Health Sciences in Research Triangle Park, NC. Meeting information will be posted as it becomes available. Information about other upcoming and recent NICEATM and ICCVAM events are also available.

The Physicians Committee for Responsible Medicine’s NAM Use for Regulatory Application (NURA) program announces two webinars in its DyNAMic Discussions series. NURA is a continuing education program to provide toxicology professionals with specialized resources and basic hands-on training in nonanimal new approach methodologies (NAMs). The DyNAMic Discussions series invites speakers to share candid perspectives on how they’ve overcome barriers to apply NAMs in their fields and discuss how we can learn from these examples to increase NAM use together. Information about the series and links to register for the upcoming webinars are available.

• “Next Steps Toward the Implementation of Next Generation Risk Assessment” will be presented Thursday, November 14 from 10:00-11:30 a.m. EST. Mirijam Luijten of the Netherlands National Institute for Public Health and the Environment and Matthias Herzler of the German Federal Institute for Risk Assessment will discuss frameworks for next-generation risk assessment.
• “Using ‘Omics for In Vitro Toxicology and Drug Discovery” will be presented Thursday, November 21 from 10:00-11:30 a.m. EST. David Rouquie of Bayer will discuss “OASIS: a multi-stakeholder collaboration leveraging robust ‘omics data to evaluate liver toxicity.” Jessica Ewald of The Broad Institute will present on “Cell Painting as an emerging ‘omics tool for toxicology and drug discovery’.

The International Collaboration on Cosmetics Safety (ICCS) is hiring a Project Manager to lead key initiatives in animal-free cosmetics testing and safety, driving collaboration and innovation in the industry. ICCS is a global non-profit dedicated to advancing animal-free testing approaches for cosmetics safety.

The Project Manager will oversee scientific projects, coordinate with key industry stakeholders, and support research and education initiatives aimed at safeguarding human health and the environment.

This virtual webinar, Microphysiological Systems (MPS) for Chemical Risk Assessment, is scheduled for October 28 from 10:00 a.m.-12:00 p.m. (ET), and is cohosted by the Johns Hopkins Center for Alternatives to Animal Testing, FDA Human Foods Program, and the International MPS Society. Read more and register as well as view the attachments for an agenda and scannable QR code for registration.

The focus of the webinar is on advancing applications of microphysiological systems (MPS) in chemical risk assessment and safety testing. The event will bring together regulators and researchers to explore the role of MPS in various research and regulatory settings, offering attendees the opportunity to engage with practical experiences and technical knowledge that drive innovation in this field. The webinar will be the first in a series aimed at fostering collaboration between leading investigators and regulators, providing a platform for exploring both established and potential applications of in vitro methods in chemical safety.

Only one month left to submit your session proposal for the 13th World Congress on Alternatives and Animal Use in the Life Sciences (WC13) due on Friday, November 15. General guidelines, a proposal preparation checklist, a proposal submission link, and more information are available on the WC13 website.

WC13 will be held August 31-September 4, 2025, in Rio de Janiero, Brazil. Session proposals will be accepted under four main congress themes (human health, animal health, environmental health, and education) and two formats:

• Symposium: an information-rich session designed for a diverse, multisectoral audience that follows a conventional presentation format.
• Workshop: a more interactive session that addresses new discoveries, challenges, and emerging needs, and may include hands-on exposure to technology.

  Submitters should select the most relevant track for their content and the best format for delivery. All sessions within the WC13 program will be up to 90 minutes long. Submitters should diversify proposals by including interdisciplinary content and including multisectoral content and speaker suggestions for diverse perspectives.

Pistoia Alliance and Elsevier announce a webinar, “Rapid Biomedical Insight Discovery with AI: New Approaches (and New Lessons)”, on Monday, November 4 from 10:00-11:00 a.m. (ET). Speakers are Ivana Kotevic, VP of Product for Corporate Life Sciences at Elsevier; and Guy Kingham, Sr. Director and leading strategist for Elsevier’s Life Sciences.

Pharma Research and Development (R&D) is increasingly costly and the industry looks to Artificial Intelligence (AI) for productivity and return on investment (ROI) improvements. A critical bottleneck in early-stage R&D is insight discovery. Huge amounts of researcher time are spent interrogating the literature to find biological connections and uncover new insights, Elsevier has a history of deploying AI to transform these tasks. The webinar speakers will take you through recent innovations in this space as well as some of the key lessons we have learned. Registration for the webinar is available.

NIEHS and NICEATM have entered into a public-private partnership with the International Collaboration on Cosmetics Safety (ICCS) to conduct a landscape analysis on the current state of non-animal, human-relevant methods and approaches for assessing systemic toxicity. The analysis will focus on describing existing efforts, and will highlight gaps, challenges, and opportunities associated with human-relevant models of systemic toxicity. The intent is to provide sufficient coverage of the landscape both to address pragmatic near-term needs and to shape the future of how safety assessments are performed. This work will use a generative artificial intelligence approach to drastically decrease the time and improve efficiency of completing the analysis, which is expected to be completed in Spring 2025. More information about the project is available on the ICCS webpage.

The Coalition to Illuminate and Address Animal Methods Bias (COLAAB) presents “Addressing Reviewers’ Preference for Animal-Based Methods” in a webinar on Wednesday, December 18 from 1:00-2:30 p.m. ET. Registration and webinar information are already available.

COLAAB is an international collaboration of researchers and advocates gathering information evidence of animal methods bias and mitigating its detrimental effects on biomedical research. Animal methods bias is the preference for animal-based research methods or the lack of expertise to adequately evaluate nonanimal methods. A recent COLAAB study found that half of researchers surveyed had been asked by reviewers to add an animal experiment to their otherwise animal-free study. These requests and other forms of animal methods bias can affect the quality or fairness of nonanimal research assessments, including peer reviews of manuscripts and grant applications, potentially causing delays in publication, lower-impact papers, or rejected grants. In this webinar, Catherine Krebs of the Physicians Committee for Responsible Medicine will provide an overview of animal methods bias and ongoing work of the COLAAB, including the latest evidence and a new online tool authors can use to help prevent and address animal methods bias when publishing studies.

The Animal Protection Commissioner of Berlin, the Johns Hopkins University Center for Alternatives to Animal Testing (CAAT), and the Physicians Committee for Responsible Medicine (PCRM) are launching a new workshop series focused on animal-free NAMs in biomedical research. The first two-hour online workshop will take place on Tuesday, November 19, at 10 a.m. ET (4 p.m. CET) via Zoom. Registration and more information are available.

The November 19 event will feature two presentations:

• Jarrod Bailey, PCRM, will explain how human-focused research provides greater clinical benefits. Due to significant biological differences, animal models often fail to translate effectively to human biology, leading to poor clinical outcomes in areas like drug testing and research on diseases such as Alzheimer’s, Parkinson’s, HIV/AIDS, and cancer.
• Angela Hvitved, Alternatives Research & Development Foundation, will discuss writing successful grant applications for funding non-animal methods research. She will address two key topics, funding sources and writing competitive applications.

Presentation slides and video are available from the August 21-22 ICCVAM Method Developers Forum, which focused on NAMs for carcinogenicity testing. The webinar featured presentations by selected method developers describing their methods and proposing how they may be useful for regulatory and/or industry stakeholders. Stakeholders representing potential government and industry users of the NAMs or the data they generate also participated in the webinar. Slides, video, and more information about the webinar are available.

The next ICCVAM Method Developers Forum will focus on NAMs for cardiovascular toxicity testing. Development of videos summarizing regulatory and industry stakeholders’ information requirements and/or decision frameworks relevant to cardiovascular toxicity is in progress, with a webinar planned for spring 2025. More information will be posted on the website mentioned above as it becomes available.

The Physicians Committee for Responsible Medicine (PCRM) has the following career opportunities available at the Research and Regulatory Affairs Office in Washington, D.C.

• Science Policy Specialist: may be performed remotely from any location in the United States. Apply by November 27.
• Research Policy Lead: on-site in Washington, D.C. Position will remain open until filled.

The Physicians Committee for Responsible Medicine is dedicated to saving and improving human and animal lives through plant-based diets and ethical and effective scientific research. Their vision is to create a healthier world in which health and compassion are central values in science and medicine.

The U.S. Environmental Protection Agency (EPA) released a detailed review of major environmental statutes that summarizes which EPA laws or regulations require vertebrate animal testing, such as laboratory testing done on rats, mice, or rabbits. The report concludes that many statutes and regulations guiding EPA’s authority are broadly written and do not preclude the use of scientific information from NAMs, which 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.

Sharma et al. 2024. Minimum information for reporting on the TEER (trans-epithelial/endothelial electrical resistance) assay (MIRTA). Arch Toxicol. https://doi.org/10.1007/s00204-024-03879-z.

The U.S. Environmental Protection Agency (EPA) released a detailed review of major environmental statutes that summarizes which EPA laws or regulations require vertebrate animal testing, such as laboratory testing done on rats, mice, or rabbits. The report concludes that many statutes and regulations guiding EPA’s authority are broadly written and do not preclude the use of scientific information from NAMs, which 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.

This report is a deliverable in EPA’s NAMs Work Plan, which was originally released in June 2020 and updated in November 2021. The Work Plan outlines the Agency’s strategies and objectives for increasing the rigor and sophistication of Agency assessments while reducing the reliance on vertebrate animals to test chemicals in regulatory, compliance, enforcement, and research activities through the use of NAMs. The assessments will remain fully protective of human health and the environment. The first objective in the Work Plan was to evaluate regulatory flexibility for accommodating NAMs, and the report accomplishes that objective.

The National Institutes of Health (NIH) Common Fund, along with its partner NIH Institutes, Centers, and Offices has published two Notices of Funding Opportunity (NOFOs) to support the Completement Animal Research in Experimentation (Complement-ARIE) Program. Complement-ARIE will accelerate the development, standardization, validation, and use of human-based New Approach Methodologies (NAMs).

Investigators with expertise and insights into the area of NAMs are encouraged to consider applying for these funding opportunities, which will support Technology Development Centers and a Data Hub and Coordinating Center. NIH also encourages collaborative investigations combining expertise in in vitro, in silico, and in chemico NAMs. NIH expects to offer four or five awards with funding of approximately $18M per year.

• First estimated application due date for the Technology Development Centers (UM1 Clinical Trial Option) is February 28, 2025.
• First estimated application due date for the Data Hub and Coordinating Center (U24 Clinical Trial Option) is March 10, 2025.

Complement-ARIE program goals include:

• To better model and understand human health and disease outcomes across diverse populations.
• To develop NAMs that provide insight into specific biological processes or disease states.
• To validate mature NAMs to support regulatory use and standardization.
• To complement traditional models and make biomedical research more efficient and effective.

More information about Complement-ARIE is available.

• An analysis by Brazilian scientists collaborating with NICEATM suggests potentially significant human health risk from exposure to triazole fungicides used in coffee production. In vitro human cell-based data and computational modeling predicted effects observed in human biomonitoring, supporting the utility of computational tools in evaluating potential human health risk.
  
  Marciano et al. 2024. A novel approach to triazole fungicides risk characterization: Bridging human biomonitoring and computational toxicology. Sci Total Environ 953:176003. https://doi.org/10.1016/j.scitotenv.2024.176003.
   
• NICEATM director Nicole Kleinstreuer and staff scientist Kamel Mansouri are coauthors on a paper on chemical grouping, where chemicals with common characteristics are categorized into distinct groups based on physicochemical properties, use, biological activity, or a combination. This work presents a novel, comprehensive chemical grouping workflow in KNIME, enhancing accessibility by integrating a user-friendly graphical interface that eliminates the need for extensive programming skills.
  
  Moreira-Filho et al. 2024. Democratizing cheminformatics: interpretable chemical grouping using an automated KNIME workflow. J Cheminform 16:101. https://doi.org/10.1186/s13321-024-00894-1.

The Coalition to Illuminate and Address Animal Methods Bias (COLAAB) has launched a new website. This site provides guidance and resources aimed at helping researchers successfully publish nonanimal biomedical studies by overcoming the preference some peer reviewers have for animal-based research methods. The site houses the COLAAB’s Author Guide for Addressing Animal Methods Bias in Publishing, which has several sections researchers can use when designing studies, preparing and submitting manuscripts, and responding to reviews. It includes a database of animal-free experimental platforms and tools, a database of journals with a track record of publishing nonanimal studies, and a comprehensive library of more than 800 papers and other references relevant to nonanimal research.

The deadline for submitting session proposals for the 13th World Congress on Alternatives and Animal Use in the Life Sciences (WC13) has been extended to Friday, November 15. General guidelines, a proposal preparation checklist, and more information are available on the WC13 website.

WC13 will be held August 31-September 4, 2025, in Rio de Janiero, Brazil. Session proposals will be accepted under four main congress tracks (academia, industry, government, and not-for-profit) and two formats:

• Symposium: an information-rich session designed for a diverse, multisectoral audience that follows a conventional presentation format.
• Workshop: a more interactive session that addresses new discoveries, challenges, and emerging needs, and may include hands-on exposure to technology.

Submitters should select the most relevant track for their content and the best format for delivery. All sessions within the WC13 program will be 90 minutes long. Submitters should diversify proposals by including interdisciplinary content and including multisectoral content and speaker suggestions for diverse perspectives.

The UK National Centre for the Replacement Refinement & Reduction of Animals in Research (NC3Rs) and collaborators are funding a consortium for novel human in vitro models of complex disease with the aim to:

• Improve understanding of human disease mechanisms and better support therapeutic development for disease intervention.
• Overcome limitations of current in vivo and in vitro models to represent human (patho) physiology and disease heterogeneity.
• Accelerate the development, validation and uptake of technologies and methods to accurately and reproducibly model human physiology and disease and reduce the reliance on animal models.

This initiative anticipates funding interdisciplinary research clusters for four years with a total fund of £10M. A webinar about the initiative will be presented Wednesday, October 16, at 9:00 a.m. EDT. More information and a link to register are available.

• The U.S. Environmental Protection Agency’s (EPA’s) next Computational Toxicology and Exposure Communities of Practice webinar will focus on “Using Environmental RNA to Understand the Effects of Pollution on Aquatic Ecosystems.” The webinar is on Thursday, September 26, at 11:00 a.m. EDT. Marissa Geroux of the Center for Environmental Measurement and Modeling will explain what environmental RNA (eRNA) is and how is it used in environmental science, and discuss use of eRNA metabarcoding to assess the impacts of emerging contaminants on aquatic communities. Information about the Communities of Practice webinar series and a link to register for this webinar are available.
• EPA is hosting its fourth “Conference on the State of Science on Development and Use of NAMs for Chemical Safety Testing” on November 5-6. This will be a hybrid meeting with in-person participation on EPA’s campus at Research Triangle Park, NC. Registration to attend in person is open until October 22 or until the venue capacity is reached. Information and a link to register are available.
• EPA has released updates of the Sequence Alignment to Predict Across Species Susceptibility (SeqAPASS) and Generalized Read-Across (GenRA) tools. These and other EPA CompTox tools are available on the EPA CompTox website.

The 2022-2023 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 twelfth progress report describes ICCVAM activities and accomplishments from January 2022 through December 2023.

Key ICCVAM, ICCVAM agency, and NICEATM accomplishments summarized in the report include:

• Development of an updated document on “Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies,” by the ICCVAM Validation Workgroup.
• Publication of articles describing U.S. and international information needs and testing requirements for nanomaterials, ecotoxicity, and acute systemic toxicity. An ICCVAM workgroup also published an award-winning article describing federal agency application of in vitro to in vivo extrapolation.
• Curation and publication of a human skin sensitization database, the largest existing database of human reference data for skin sensitization.
• Broadening applicability of defined approaches for skin sensitization.
• Establishment of an ICCVAM workgroup to provide expertise in identifying and evaluating new approach methodologies to predict toxicity of per- and polyfluoroalkyl substances (PFAS).
• Development, updates, and training on web tools and data resources for chemical exploration and toxicity prediction. The report describes tools provided by NIEHS, the U.S. Environmental Protection Agency, and others, as well as training that has been provided to support their use.

Discussion of the report is an agenda item for the September 17-18 SACATM meeting.

An agenda and presentation abstracts are available for the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) meeting on Tuesday and Wednesday, September 17-18 at the National Institutes of Health (NIH) in Bethesda, MD. The registration deadline to attend the meeting in person and to present an oral statement in-person or remotely is Wednesday, September 11. Registration to view the webcast will remain open through the end of the meeting on September 18. Materials, links to register, and more information are available.

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 (NIEHS) and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM. Preliminary agenda items for the upcoming meeting include: (1) a review of the 2022-2023 ICCVAM Biennial Progress Report with a focus on activity gaps and future directions, (2) updates on validation and consideration of the new approach methodologies pipeline, (3) ICCVAM agency activities in developmental neurotoxicity, and (4) an update on NICEATM computational resources.

A new review in Cutaneous and Ocular Toxicology compares and contrasts the extent to which available models used in skin irritation testing mimic the anatomy and physiology of human skin, and how each aligns with the known key events leading to chemically induced adverse skin irritation and corrosion. The review supports use of human-relevant in vitro methods for skin irritation and corrosion classification of pesticides and pesticide formulations. ICCVAM member Anna Lowit (U.S. Environmental Protection Agency) is an author of the report.

Raabe et al. 2024. Human relevance of in vivo and in vitro skin irritation tests for hazard classification of pesticides. Cut Ocular Toxicol. https://doi.org/10.1080/15569527.2024.2387596.

The Society for Neuroscience (SfN) will present a symposium on “Advancing Organoids: Synergizing Tissue Engineering and Neurotechnology Development,” on Sunday, October 6, 2:00-4:30 p.m. at McCormick Place in Chicago. The symposium is in-person only and is part of the larger Neuroscience 2024 meeting on October 5–9. Information about Neuroscience 2024, including the meeting’s virtual component, is available.

Microphysiological systems (MPS) have garnered substantial interest in understanding human-specific brain biology and increasing the translatability of preclinical work. 3D organoids hold great promise as models that can provide insights into the development of the human nervous system and the emergence and progression of nervous system disorders. This symposium will highlight advances in MPS, novel technologies to interface organoids, and potential applications of organoid engraftment in model organisms. Session chair is Duygu Kuzum, University of California San Diego; co-chair is Grace Hwang, National Institutes of Health.

The Physicians Committee for Responsible Medicine’s NAM Use for Regulatory Application (NURA) program announces three upcoming webinars. NURA is a continuing education program designed to provide toxicology professionals with specialized resources and basic hands-on training in nonanimal NAMs. NURA offers trainings, seminars, and other events to encourage the use of nonanimal approaches within various regulatory frameworks.

Two webinars in September and October will describe case studies of NAMs use in U.S. Food and Drug Administration submissions.

• “Case Study #1: The Utilization of Human-on-a-chip Systems for Regulatory Submissions for Neurological Conditions,” is Tuesday, September 10 at 1:00 p.m. EDT. James Hickman, Hesperos, Inc., will describe functional in vitro systems to create organs and subsystems to model motor control, muscle function, myelination and cognitive function, as well as cardiac and liver subsystems.
• “Case Study #2: Vanda Pharmaceuticals, Inc. Uses NAMs in Lieu of Animal Study,” is Thursday, October 10 at 1:00 p.m. EDT. Sandra Smieszek, Vanda Pharmaceuticals, Inc., will discuss their use of NAMs in lieu of animal studies in translational research and development. More information on the case study series and registration are available.

A New Approach Spotlight webinar, “RosetteArray® Platform for Quantitative High-throughput Screening of Human Developmental Neurotoxicity,” will be Wednesday, September 25 at 10:00 a.m. EDT. Randolph Ashton will describe a platform that enables quantitative high-throughput screening of human developmental neurotoxicity (DNT) for chemical risk assessment. More information and registration are available.

A virtual workshop on “Status of Global Implementation of MAT for Biologicals. Product Specific Approaches and Regulatory Alignment” will be held Wednesday, September 25, 6:00-10:45 a.m. EDT. Global experts will share their insights on implementing the monocyte activation test (MAT) for vaccines and blood-derived products. Registration and more information on the virtual workshop are available.

Attendees are invited to fill out a pre-workshop survey. Feedback will provide information to the workshop's organizers and speakers about the experience and challenges on the implementation of the MAT and will be used to define the topics to discuss during the final roundtable discussion. The survey data are collected anonymously.

RTI International is presenting a webinar, “How to Characterize and Validate AI and In Vitro NAMs for Toxicity Testing,” on September 11 at 12:00 noon EDT. During this free webinar, attendees will hear from experts at the National Institute of Environmental Health Sciences and RTI International regarding:

• Critical considerations for the development, characterization, and validation of artificial intelligence (AI)/machine learning-based new approach methodologies (NAMs).
• Challenges and opportunities associated with regulatory acceptance of these innovative methods.
• Importance of integrating primary multicellular in vitro models into toxicity testing.
• Impact of test article delivery method on in vitro test system physiology.
• Value of characterizing the parameters for in vivo physiology-relevant endpoint assays for interpreting data within and across studies.

Information and registration are available on the RTI website.

The National Institutes of Health (NIH) has published its landscape analysis for the Complement Animal Research in Experimentation (Complement-ARIE) program.

Complement-ARIE will accelerate the development, standardization, validation, and use of human-based NAMs that more accurately model human biology, and complement, or in some cases, replace traditional research models. To ensure the Complement-ARIE program focused on the best opportunities and areas of greatest need for human-based model development, a comprehensive landscape analysis was conducted to collect information on ongoing efforts in the NAMs space. The analysis described existing efforts, and highlighted gaps, challenges, and opportunities in the areas of human-based models of health and disease including:

• In vitro models
• In silico models
• In chemico cell-free models
• FAIRness of data needed to train, interpret, and use NAMs (FAIR = findable, accessible, interoperable, reusable)

NICEATM scientists were key contributors to the landscape analysis. In addition to NICEATM Director Nicole Kleinstreuer, seven members of the Inotiv contract support team are acknowledged as authors of the landscape analysis report.

ICCVAM co-chair Natalia Garcia-Reyero (U.S. Department of Defense) is guest editor for a planned special issue of the journal Toxics that will focus on promoting the use of NAMs to predict hazards. Articles in this issue will aim to enhance innovative human and environmental health-based approaches that will allow progress towards more predictive hazard assessments while embracing replacement, reduction, and refinement. Contributors may submit research articles, reviews, and short communications related to any aspect of NAMs including in vitro, in silico, and computational and artificial intelligence approaches, as well as gaps, challenges, and regulatory acceptance.

Manuscripts can be submitted until the October 31 deadline. Accepted papers will be published immediately and will be listed together on the special issue website. Research articles, review articles, and short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on the Toxics website.

Registration is open for the “Building Confidence in New Approach Methodologies for Regulatory Use” workshop to be held October 4 in Washington, DC. This public workshop will bring together regulators, industry, and nongovernmental organizations to provide their perspective on building confidence in new approach methodologies (NAMs) for regulatory use, especially moving beyond their use for the “6-pack” battery of tests used to evaluate acute toxicity. The agenda includes EPA, Health Canada, PETA International Science Consortium e.V., and others giving short presentations followed by a moderated panel discussion. NICEATM Director Nicole Kleinstreuer and ICCVAM member Alison Harrill (EPA) are among the presenters. Workshop participants will also consider two case studies, one on NAM-augmented read-across and one on ab initio assessment.

The workshop is being presented by the International Collaboration on Cosmetics Safety and is being held in conjunction with their inaugural meeting on October 3 in Washington, DC. This meeting will feature speakers and scientific sessions that stimulate dialogue on animal-free safety assessments for human and environmental health.

The U.S. Environmental Protection Agency (EPA) Office of Research and Development, in conjunction with NICEATM, is convening a workshop to facilitate discussion of probabilistic methods in human health risk assessment. This workshop will provide examples of the application of probabilistic methods in chemical risk assessments, highlight ongoing research, and discuss the needs and challenges for the regular use of these methods. The workshop will be held in person at EPA in Research Triangle Park, NC and also webcast. In-person attendees should register by Tuesday, September 24.

Those planning to attend in person are invited to submit abstracts for a poster session. Abstracts should describe projects or activities relevant to workshop agenda topics. Abstracts will be accepted until Friday, September 13 or until 40 abstracts are received. Organizers will contact submitters to confirm poster acceptance and provide logistical details about the presentation.

The National Academies of Sciences, Engineering, and Medicine recently recommended consideration of how and when traditional deterministic approaches for human health risk assessment (i.e., toxicity value point estimates) can be transitioned towards probabilistic methods for deriving risk-specific doses. This workshop will highlight past examples where probabilistic methods were implemented to derive chemical-specific toxicity values, provide insight into the current state of the research surrounding probabilistic methods in chemical risk assessments, and discuss the future directions for implementing these probabilistic methods in human health assessments. The agenda will feature sessions on four subtopics:

• Probabilistic exposure
• Toxicokinetics
• Benchmark dose modeling
• Toxicity value determination

Throughout these sessions interdisciplinary panels comprising subject matter experts from government, industry, academia, and nongovernmental organizations will conduct panel discussions to evaluate the proposed methods and provide suggestions for how the transition might be implemented. Workshop participants should gain a greater understanding of probabilistic methods within the context of human health assessments and learn how these methods may ultimately be implemented.

As a followup to publication of the report on Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies, ICCVAM and NICEATM will host a series of Method Developers’ Forums (MDFs). Each forum will focus on a specific endpoint/toxicity and provide an opportunity for NAMs developers to discuss their methods and regulatory issues with relevant stakeholders.

The first MDF is on new approach methodologies (NAMs) for carcinogenicity testing and will be held virtually August 21-22 from 9:00 a.m.-noon EDT. At this interactive forum, selected method developers will describe how their NAM is appropriate for addressing the carcinogenicity information requirements of one or more federal agencies and engage in scientific discussion about the NAM.

The agenda with details of the 10 featured presentations is available. Those interested in viewing the forum can visit this page to access the webinar shortly before it begins. Registration is not required to view the webinar.

NICEATM scientist Kamel Mansouri is the lead author on a commentary in Environmental Health Perspectives that discusses how class-based methods, such as clustering and classification, can aid the understanding of hazard and risk concerns associated with groups of chemicals without the need for conducting laboratory experiments. This commentary provides insights into the significance of chemical similarity and its role in supervised classification and unsupervised clustering approaches. The commentary is discussed in a post on the Tox Navigation blog.

Mansouri et al. 2024. Unlocking the potential of clustering and classification approaches: navigating supervised and unsupervised chemical similarity. Environ Health Perspect 132(8):085002. https://doi.org/10.1289/EHP14001.

Registration is open to attend or view the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) meeting on Tuesday and Wednesday, September 17-18 at NIH in Bethesda, MD. The registration deadline to attend the meeting in person and to present an oral statement is Wednesday, September 11. Registration to view the webcast will be open through the end of the meeting on September 18.

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 Preliminary agenda items for the upcoming meeting include (1) a review of the 2022-2023 ICCVAM Biennial Progress Report with a focus on activity gaps and future directions, (2) updates on validation and consideration of the new approach methodologies pipeline, (3) ICCVAM agency activities in developmental neurotoxicity, and (4) an update on NICEATM computational resources.

The National Institutes of Health (NIH) Common Fund has announced a Notice of Intent to Publish a Funding Opportunity for the Complement Animal Research in Experimentation (Complement-ARIE) program. Complement-ARIE will accelerate the development, standardization, validation, and use of human-based new approach methodologies (NAMs) that more accurately model human biology, and complement, or in some cases, replace traditional research models.

Complement-ARIE program goals include:

• To better model and understand human health and disease outcomes across diverse populations.
• To develop NAMs that provide insight into specific biological processes or disease states.
• To validate mature NAMs to support regulatory use and standardization.
• To complement traditional models and make biomedical research more efficient and effective.

The Complement-ARIE program plans to issue a Notice of Funding Opportunity to support the Complement-ARIE Comprehensive NAMs Technology Development Centers. The goal/intent of these Centers is to stimulate the development of combinatorial NAMs in the areas of greatest need.

Publication of the funding opportunity is anticipated on October 18. The Notice of Intent to Publish a Funding Opportunity is available now. More information about the Complement-ARIE Program is also available and interested persons can keep up to date with future announcements by signing up for the Complement-ARIE listserv.

The Alaka`ina Foundation Family of Companies (FOCs) is looking for a Molecular Virology Associate Study Director to support their government customer located in Ft Detrick, Maryland. Interested candidates should have a minimum of a doctorate (PhD, DVM, or MD) in Virology or a related field from an accredited college or university, work in a biosafety level 4 (BSL-4) setting. Required skills include hands-on laboratory experience with a working knowledge of microphysiological systems must be documented by a strong publication record in conducting virus experiments using organ-chips and/or organoid models, excellent communication skills with team members and rapport with leadership.

A complete list of requirements, responsibilities, qualifications, and application are available.

C-Path’s Global Impact Conference will be held in Washington, DC September 9-11 at the Washington Marriott at Metro Center. The conference will provide a unique opportunity to integrate key learning initiatives within C-Path’s expanding portfolio, dedicated to accelerating drug development for conditions in neurology, rare diseases, pediatrics, and more. Featured highlights are C-Path’s Core Competencies including Data Management and Standards, Biomarkers, Modeling and Analytics, Clinical Outcome Assessments, and Regulatory/Development Science to lead collaborations that expedite drug development and advance better treatments for people worldwide.

A full conference agenda including featured speakers is forthcoming. A limited agenda and registration are now available.

Critical Path Institute’s (C-Path) Predictive Safety Testing Consortium (PSTC) presents the second public workshop on regulatory assessment and qualification of complex in vitro models (CIVMs). The workshop will be held September 26-27, 2024, in Bethesda, Maryland at the Bethesdan Hotel (8120 Wisconsin Avenue). The goal of the workshop is to achieve a consensus on the model standards and features to improve the performance of CIVMs as a tool for drug development and regulatory assessment.

Building upon outputs from the first workshop held in September 2023, anticipated attendees are individuals from health authorities, academia, model developers, and the pharmaceutical industry. The meeting will include sessions from key opinion leaders on general considerations for qualification, as well as interactive breakout sessions focusing on different organ systems and disease models. Access a full agenda (available closer to the workshop date) and register now. If you are unable to attend, the workshop can be accessed virtually by contacting Laura Lummus.

As a followup to publication of the report on Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies, ICCVAM and NICEATM will host a series of Method Developers’ Forums (MDFs). Each forum will focus on a specific endpoint/toxicity and provide an opportunity for NAMs developers to discuss their methods and regulatory issues with relevant stakeholders.

The first MDF is on new approach methodologies (NAMs) for carcinogenicity testing and will be held virtually August 21-22. This forum will be interactive and offer selected method developers an opportunity to describe how their NAM is appropriate for addressing the carcinogenicity information requirements of one or more federal agencies and answer questions from ICCVAM-agency representatives about the NAM. Developers will be selected to participate in the forum based on proposals submitted to the MDF steering committee, which includes scientists from federal research and regulatory agencies with an interest in this endpoint.

The deadline for proposals has been extended to August 9. Proposals should represent the presentation planned for the forum including provide an overview of the NAM and its relevance to carcinogenicity testing. The proposal should provide sufficient technical detail and data on the NAM’s performance for regulatory and industry stakeholders to understand how the NAM may meet their needs. Proposals should be submitted as a PowerPoint presentation exported to PDF format with the resulting PDF being no larger than 100 MB. Details on how to prepare proposals and resources available include:

• Instructions for submitting your proposal and important dates.
• Video presentations from federal agencies explaining their information requirements and decision frameworks for carcinogenicity testing.
• Guidance for developing proposals, including specific questions that should be addressed in your proposal.
• A template you may use for developing your PowerPoint presentation.

The National Institutes of Health (NIH) National Institute on Aging 3-D In Vitro Tissue Systems Workshop will be held July 29, 9:00 a.m. – 5:00 p.m., and July 30, 9:00 a.m. – 3:00 p.m. (EDT). The workshop aims to examine how complex mammalian 3-D in vitro tissue platforms can be developed, validated, and leveraged to study aging. The goals are to assess the status of the field and critical needs, to define future directions, and to outline opportunities and priorities to better support the development of novel in vitro platforms for research on aging. Researchers at all career stages interested in modeling aging in vitro are invited to attend.

An agenda with a list of presentations, speakers, and times, and registration are now available. Contact Tiziana Cogliati with any questions about the workshop.

The 11th Annual 3Rs Symposium: Practical Approaches to Each of the 3Rs, a virtual webinar, will be held September 4-5 and 11-12, 10:00 a.m. – 1:30 p.m. (ET). The symposium is jointly organized by Center for Alternatives to Animal Testing, Johns Hopkins University Bloomberg School of Public Health, the Department of Molecular and Comparative Pathobiology, Johns Hopkins University School of Medicine, the USDA’s Animal Welfare Information Center (AWIC) at the National Agricultural Library, and the Office of Laboratory Animal Welfare, National Institutes of Health.

The goal of the symposium is to bring together experts and practitioners to share information and discuss new and practical approaches to the 3Rs. Sessions are designed for investigators, laboratory animal veterinarians, care staff, and IACUC members and staff. Residents, students, and postdocs are also welcome. There will be opportunities built into the program for attendees to ask questions, comment, or offer suggestions. More information, including a full agenda, and ticket information are now available.

The Publications Office of the European Union issues Report of the European Commission workshop on “The Roadmap Towards Phasing Out Animal Testing for Chemical Safety Assessments”. The report summarises the main findings and discussion from the European Commission (EC) workshop” (Brussels, 11-12 December 2023). The aim of the workshop was to identify the major challenges in moving towards animal-free chemical safety assessment and to inform the roadmap to achieve this goal. Over 500 delegates attended the workshop, either in person or on-line, representing relevant stakeholders.

Nicole Kleinstreuer, Director, NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), contributed comments on the U.S. position on New Approach Methodologies (NAMs).

European Commission, Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, Cronin, M., Report of the European Commission workshop on “The Roadmap Towards Phasing Out Animal Testing for Chemical Safety Assessments” – Brussels, 11-12 December 2023, Publications Office of the European Union, 2024, https://data.europa.eu/doi/10.2873/34576.

The National Center for Advancing Translational Sciences (NCATS) Assay Guidance Manual (AGM) program is hosting a two-day workshop, Wednesday, October 23, 11:00 a.m. – Thursday, October 24, 5:15 p.m. (EDT) covering a broad range of critical concepts. This workshop is offered virtual and free to attend, and is jointly organized by NCATS, Biomedical Advanced Research and Development Authority (BARDA), University of California San Diego (UCSD), and The University of North Carolina at Chapel Hill (UNC). More information including a full agenda and registration are now available.

The workshop goal is to provide scientists with best practices and standards for rigor in the field of computational drug discovery to enable accurate and reproducible results. This workshop will also cover case studies for AI-driven drug discovery campaigns as well as an overview of new trends and gaps in the field.

Specific goals and objectives:

• Provide participants with data sources and best practices in building and maintaining databases used for developing robust and rigorous AI-based drug discovery models/methods.
• Introduce participants to the available computational methodologies utilized in drug discovery and discuss their utility and limitations.
• Provide case studies for digital drug discovery and an overview of new trends in the field.
• Provide guidelines and considerations for developing robust and reproducible in silico models.
• Discuss challenges in data quality and data sharing as well as affordability, accessibility, transferability, accuracy, and reproducibility of AI-driven computational techniques.
• Identify gaps in translation of these in silico models to therapies and seed discussions around best practices to help bridge the gaps in the field.

The New Approach Methodology (NAM) Use for Regulatory Application (NURA) program’s recorded content is moving to a new platform that offers easier access to NURA resources. You can now navigate NURA content at your own pace, one presentation at a time; the platform will keep track of your progress. Find, skip, or replay presentations easily, and earn certifications upon course completion that may be submitted for continuing education credits. The new NURA platform also features English and Spanish subtitle options.

The National Institutes of Health (NIH) Office of Strategic Coordination (OSC) Community Engagement Workshop will be held July 24-25 from 9:00 a.m. – 4:30 p.m. Day 1, and 9:00 a.m. – 12:30 p.m. Day 2. This workshop brings together differing perspectives from an array of individuals that represent their communities to gather their thoughts and opinions about challenges and opportunities regarding NIH Common Fund data science resources.

The NIH Common Fund cultivates large publicly available biomedical and behavioral datasets. This data may be used by the research and medical community to make new discoveries or generate new hypotheses. During this workshop, NIH would like to identify barriers that currently exist to using data and learn what outreach, training, and support can be provided to the biomedical community.

Douglas Sheeley, Acting Director of OSC will give the welcome and introduction. Krystal Tsosie, Assistant Professor in the School of Life Sciences and Associate Director of Biodiversity Knowledge Integration at Arizona State University is the keynote speaker. More information regarding speakers, a full agenda and workshop registration are now available.

Merck & Co. is seeking scientists with expertise in computational biology and advanced data science approaches to fill positions within its Nonclinical Drug Safety positions. These are both hybrid positions with the option to be based in locations in Pennsylvania, California, or Massachusetts. Candidates should have at least a master’s degree in a relevant field. For more information visit the following webpages:

• Computational Biologist/Toxicologist
• Senior AI/ML Data Scientist

The U.S. Environmental Protection Agency (EPA) conducted a value of information (VOI) analysis to weigh the public health and economic trade-offs associated with the timeliness, uncertainty, and costs of conducting the EPA Transcriptomics Assessment Product compared to traditional human health assessment processes. EPA’s VOI framework and a report on a case study applying the framework are now available.

Fewer than a quarter of the tens of thousands of chemicals in commerce--as well as those found in the environment, various waste streams, and the human body--have traditional toxicity or epidemiological data that can inform human health risk assessments. VOI analysis is a systematic approach to determine the “value of information” in economic terms. It allows comparison of “what we already know” and “what we will know” to determine which data generation methodologies are most valuable for decision-making. While the potential application of value-of-information analysis for toxicology has been discussed for a number of years, practical applications of such an analysis in toxicology to real-world problems are lacking.

A novel feature of the EPA framework was the inclusion of a time dimension that permits incorporation of the cost of delay in incorporating additional information. The case study described in the report applied this framework to compare a short-term in vivo transcriptomic assay approach to developing protective reference doses with the traditional chronic rodent bioassay and human health assessment process. A panel of the EPA Board of Scientific Counselors was convened to assess the scientific rigor of this case study and the resulting conclusions.

The United Kingdom National Centre for the 3Rs (NC3Rs) is offering £4M in grants to develop infrastructure to accelerate the use of approaches that replace the use of animals in research and testing. This funding call is exclusively for non-research proposals that will increase the capacity and capabilities of the UK research base to use non-animal methods. Funding could be used to purchase equipment and associated consumables, develop platforms for data sharing, fund access to demonstrator labs to facilitate scale-up and training, or create hubs and networks to facilitate the collation and distribution of resources that support the use of non-animal methods. More information is available; apply by July 30th.

NC3Rs is also offering £1M to support projects seeking to characterize and validate the use of non-animal derived reagents and products for use in in vitro research. Despite their documented benefits, the widespread use of animal-free reagents and products in in vitro research has been hindered by the lack of dedicated support for the characterization and validation studies that are required to build the experience and confidence necessary to shift practice. This funding call is meant to address this need with the aim to build further confidence in these alternative approaches and demonstrate that they are fit-for-purpose. More information is available; apply by July 30th.

As a follow-up to the publication of the report on Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies, ICCVAM and NICEATM will host a series of Method Developers’ Forums (MDFs), each focused on a specific endpoint/toxicity, that provide an opportunity for NAMs developers to discuss their methods and regulatory issues with relevant stakeholders.

The first MDF will focus on new approach methodologies (NAMs) for carcinogenicity testing and will be held virtually August 21-22. This will be an interactive forum at which method developers will have an opportunity to describe how the NAM is appropriate for addressing the carcinogenicity information requirements of one or more federal agencies and answer questions from agency representatives about the NAM. Developers will be selected to participate in the forum on the basis of proposals submitted to the MDF steering committee, which includes scientists from federal research and regulatory agencies with an interest in this endpoint.

Submit proposals by Friday, July 26. Your proposal should be in the form of the presentation you plan to give at the forum. It should provide an overview of the NAM and its relevance to carcinogenicity testing. Provide enough technical detail and data on the performance of the NAM for regulatory and industry stakeholders to understand how your NAM may meet their needs. Proposals should be in the form of a PowerPoint presentation exported to PDF format. The resulting file should be no larger than 100 MB. Details on how to prepare proposals and resources available on this page include:

• Instructions for submitting your proposal and important dates.
• Video presentations from federal agencies explaining their information requirements and decision frameworks for carcinogenicity testing.
• Guidance for developing proposals, including specific questions that should be addressed in your proposal.
• A template you may use for developing your PowerPoint presentation.

The next webinar in the EPIC series on the use of new approach methodologies (NAMs) in risk assessment will cover “The CATMoS model for acute oral toxicity and evaluation of its potential use in a regulatory context for pesticide hazard and risk assessment.” The webinar will be held on Wednesday, August 28 at 11:00 a.m. EDT. Registration and more information are now available.

The webinar will feature presentations by NICEATM scientist Kamel Mansouri, National Institute of Environmental Health Sciences (NIEHS), and Michael Lowit, U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs. Mansouri will discuss the Collaborative Acute Toxicity Modeling Suite (CATMoS), a global project to develop predictive in silico models for assessing chemical safety. These models cover five endpoints relevant to regulatory frameworks and are now being evaluated for use by the EPA. Lowit will describe a collaboration between EPA, NICEATM, and the Humane Society of the United States to apply CATMoS to predicting acute toxicity of technical grade active ingredients for pesticides registered by the EPA.

The EPIC series covers timely topics on the use of NAMs for risk assessment within EPA and the California Department of Pesticide Regulation (CDPR). The series began in August 2023 and continues quarterly; links to past webinars are available. The webinar series is co-organized by EPA, PETA Science Consortium International, the Institute for In Vitro Sciences, and CPDR.

The journal Environmental and Molecular Mutagenesis is planning an upcoming special issue on “New Approach Methods in Genetic Toxicology.” Editors are soliciting manuscripts to be included in this issue. The issue will have three main areas of focus:

Details on the special issue are now available. Potential contributors should contact the editors by August 30 with article proposals, which should include a draft title and potential author list. Manuscripts will be due by the end of 2024. General information about the journal is available at https://onlinelibrary.wiley.com/journal/10982280.

• Introducing the concept of NAMs with regulatory emphasis.
• Highlighting current NAMs that are applicable to the genetox field by way of case studies and within the context of deriving health-based guidance values.
• Shedding light on how different industries are presently using NAMs for hazard identification and risk assessment.

Details on the special issue are now available. Potential contributors should contact the editors by August 30 with article proposals, which should include a draft title and potential author list. Manuscripts will be due by the end of 2024. General information about the journal is available at https://onlinelibrary.wiley.com/journal/10982280.

Session proposals are due September 30 for the 13th World Congress (WC13) to be held August 31 – September 4, 2025, in Rio de Janeiro, Brazil. General guidelines, a proposal preparation checklist, and more information are now available.

Session proposals will be accepted under four main congress tracks (academia, industry, government, and not-for-profit) and two formats (symposium or workshop). Submitters should select the most relevant track for their content and the best format for its delivery. All sessions within the WC13 program will be 60 minutes long. Each session organizer may allocate 40 minutes of the 60-minute session to speakers. The remaining 20 minutes within the session will be filled later with submitted abstracts.

After receiving session proposals, the Scientific Committee will review the session based on quality, innovation, and inclusivity. Submitters should diversify proposals by including interdisciplinary content such as refinement, reduction, replacement, toxicology, regulatory testing, biomedical research, disease models, technologies, regulatory acceptance, global harmonization, education, and bioethics.

• A recent article by NICEATM scientists and collaborators has been designated the cover article for the current issue of the journal Toxics. The article describes an integrated approach to testing and assessment (IATA) for developmental neurotoxicity of organophosphorus flame retardants (OPFRs) using chemical data from the literature and from NICEATM’s Integrated Chemical Environment. This IATA case study indicates that human exposure to some OPFRs could lead to a plasma concentration similar to those exerting in vitro activities, indicating potential concern for human health.
  
  Kreutz et al. 2024. Integrated approach for testing and assessment for developmental neurotoxicity (DNT) to prioritize aromatic organophosphorus flame retardants. Toxics 12(6):437. https://doi.org/10.3390/toxics12060437
   
• A study by NICEATM and Duke University explores how disruptions in the vascular endothelial growth factor (VEGF) contribute to atherosclerosis. The study describes an adverse outcome pathway that links the effects of chemicals such as bisphenols and DDT to VEGF activity and subsequent atherosclerosis. It proposes a data-driven approach to evaluating environmental cardiotoxicity that could eventually supplement and reduce the need for animal testing in toxicological assessments.
  
  Ehrlich et al. 2024. Data-driven derivation of an adverse outcome pathway linking vascular endothelial growth factor receptor (VEGFR), endocrine disruption, and atherosclerosis. ALTEX. https://doi.org/10.14573/altex.2403211

EPA is hosting its fourth “Conference on the State of Science on Development and Use of NAMs for Chemical Safety Testing” on November 5-6. This will be a hybrid meeting with in-person participation on EPA’s campus at Research Triangle Park, NC. Registration to attend in person is open until October 22 or until the venue capacity is reached. Register to attend either in person or virtually.

At the conference, attendees will hear from representatives from EPA, other federal agencies, industry, universities, and international organizations on the state of the science on the development and use of NAMs for chemical safety testing. General information about the conference is already accessible; an agenda will be posted when available.

The Department of Health and Human Services has released the 2024-25 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. Complete program descriptions and research topic information are available at https://seed.nih.gov/sites/default/files/HHS_Program_Descriptions.pdf.

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:

• Informatics tools and platforms to organize, store, retrieve, extract, and integrate information on exposures and health effects data.
• Application of machine learning methods and natural language processing for extracting and integrating diverse data types and for generating causal networks from experimental data and public knowledgebases.
• Adapting or developing new methods and tools for automating environmental health-related literature and systematic reviews, including article selection and prioritization, data extraction, study quality evaluation, and summarization of environmental health impacts.
• Mid- to high-throughput and high-content assays using in vitro or tissue chip technologies to screen and rank toxicity of emerging engineered nanomaterials for cytotoxicity, genotoxicity, and metabolic toxicity.
• Human and rodent organotypic culture models and microphysiological systems.
• Approaches to characterize and integrate key molecular and cellular changes related to effects of toxicant exposures in carcinogenicity, developmental neurotoxicity, or cardiotoxicity.
• Screening systems that incorporate genetic diversity into toxicology testing.

Short-term tests, assays, or systems designed specifically to reduce or replace existing regulatory animal studies for acute toxicity (oral or inhalation), reproductive or developmental toxicity, carcinogenicity, or ocular toxicity.

The first deadline for applications under this announcement is September 5. Complete information about eligibility, applying, and deadlines is available at:

• PA-24-245, SBIR opportunities, clinical trial not allowed.
• PA-24-246, SBIR opportunities, clinical trial required.
• PA-24-247, STTR opportunities, clinical trial not allowed.
• PA-24-248, STTR opportunities, clinical trial required.

More information about the program is available on the NIEHS SBIR/STTR webpage.

A new report, “In Silico Technologies: A Strategic Imperative for Accelerating Breakthroughs and Market Leadership for FDA-regulated Products,” has been published by the Reagan-Udall Foundation for the FDA.

The report urges the adoption of in silico technologies such as artificial intelligence and machine learning for development and safety evaluation of products that influence human health. This report strives to bridge the gap between technical and business teams in the ecosystem of products regulated by the U.S. Food and Drug Administration (FDA) and the nation’s food supply by building the business case for industry investment in in silico technologies as a strategic imperative for accelerating breakthroughs and market leadership in FDA-regulated products. NICEATM Director Nicole Kleinstreuer was a contributor to the report.

Texas A&M University will present its annual Regulatory Science Symposium on Wednesday, August 21, from 3:30-6:30 p.m. EDT (2:30-5:30 U.S. Central Time). The symposium will be held in person in College Station, TX, and will also be webcast. An agenda and a link to register to view the webcast are available.

The theme of this year’s symposium is “Innovating Drug Safety Evaluation with Artificial Intelligence: Where Does Toxicology Fit?” NICEATM collaborator Weida Tong, FDA, will be joined by representatives of the pharmaceutical industry for a program of presentations followed by a panel discussion.

Registration for Indiana University’s 19th Annual Multicell Virtual-Tissue Modeling Online Summer School and Hackathon has been extended to July 5. More information on CompuCell3D is available on the website.

The Summer School will take place July 28-August 4 and will focus on the basics of building virtual tissue models using CompuCell3D, as well as exploration of more advanced modeling topics using the many features and capabilities of the CompuCell3D software. The first day of the Summer School will be an optional Python Bootcamp.

The August 9-11 Hackathon will be hosted on the weekend following the workshop. Attendees will work in teams to building a functioning model of the problem of interest. First-time attendees are required to attend the workshop for Hackathon participation. Returning participants may request admission into the Hackathon only.

For more information, see announcements on the website or view this flyer. Orientation sessions for the Summer School and Hackathon will be held in advance of the workshop on Thursday, July 18 at 9 a.m., 12 p.m., and 5 p.m. (to allow for time zone differences). You only need to attend one of the one-hour sessions. If you are unable to attend, you can view the recordings via YouTube and download the slides.

On June 25, the Organisation for Economic Co-operation and Development (OECD) published three new test guidelines. Three other test guidelines were updated, and an additional seven test guidelines were corrected or clarified.

One of the updated test guidelines was Test Guideline 496, which was revised to include the OptiSafe in vitro eye irritation test method, for which NICEATM coordinated a validation study. Test Guideline 442D for in vitro skin sensitization was revised to include the EpiSensA test method. NICEATM scientists participated in a peer review of the EpiSensA method, which is considered to improve upon existing in vitro skin sensitization test methods assessing the same key event in the development of skin sensitization.

ICCVAM member Charles Kovatch, U.S. Environmental Protection Agency, presented an overview of recent and ongoing OECD activities, including approval of these documents, at the May 20-21 ICCVAM Public Forum.

Presentation slides and video are available from the May 20-21 Public Forum organized by NICEATM on behalf of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM).

At this meeting, representatives of seven ICCVAM member agencies described their agencies’ activities both to advance new approaches to safety testing of chemicals and medical products, and to reduce the amount of testing required. Registered participants asked clarifying or follow-up questions of the ICCVAM members about their presentations during the meeting, and representatives of 12 organizations presented public statements relevant to ICCVAM activities.

Please mark your calendars and visit the NTP website for information about these upcoming ICCVAM events:

• Method Developers Forum webinar on New Approaches for Carcinogenicity Testing, August 21-22: proposals from method developers are being accepted now and are due Friday, July 26.
• Scientific Advisory Committee on Alternative Toxicological Methods, September 17-18: information is available now and the meeting will be in-person at the National Institutes of Health in Bethesda and will also be webcast.

Registration is now open for the 13th Annual Meeting of the American Society for Cellular and Computational Toxicology (ASCCT) October 28-30 to be held at RTI International, Research Triangle Park, NC. The meeting will feature presentations, panel discussions, and activities designed to support and engage members, students, and scientists in the practice and advancement of in vitro and computational toxicology. Information about the meeting and a draft program are available. Discounted early registration is available through September 15.

The deadline for submission of abstracts to be considered for oral, flash poster, or regular poster presentations is June 30. Abstracts may address all aspects of in vitro and in silico toxicology, including research, validation, policy, education, and regulatory science. Late-breaking abstracts for poster-only presentations will be accepted through September 1.

This year, ASCCT is offering two travel awards in advance of the meeting to assist with travel costs. The awards will cover meeting registration costs, travel, lodging, and food expenses. Applicants should provide a statement of interest with their submitted abstract and a verification of student or trainee status, if applicable, from their advisor. Submit materials by July 21 to [email protected].

As a follow-up to the publication of the report on Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies, ICCVAM and NICEATM will create a platform for highlighting the report’s recommendations by organizing a series of Method Developers’ Forums (MDFs), each focused on a specific endpoint/toxicity, that provide an opportunity for NAMs developers to discuss their methods and regulatory issues with relevant stakeholders.

The first MDF will focus on new approach methodologies (NAMs) for carcinogenicity testing and will be held virtually August 21-22. This will be an interactive forum at which method developers will have an opportunity to describe how the NAM is appropriate for addressing the carcinogenicity information requirements of one or more federal agencies and answer questions from agency representatives about the NAM. Developers will be selected to participate in the forum on the basis of proposals submitted to the MDF steering committee, which includes scientists from federal research and regulatory agencies with an interest in this endpoint.

Submit proposals by Friday, July 26. Your proposal should be in the form of the presentation you plan to give at the forum. It should provide an overview of the NAM and its relevance to carcinogenicity testing. Provide enough technical detail and data on the performance of the NAM for regulatory and industry stakeholders to understand how your NAM may meet their needs. Proposals should be in the form of a PowerPoint presentation exported to PDF format. The resulting file should be no larger than 100 MB. Details on how to prepare proposals are now available.

Registration is now open for an upcoming webinar, “Progress in in vitro thyroid disruption approaches.” The webinar will be held Tuesday, July 16 from 10:00–11:30 a.m. EDT. The webinar is being presented by ASCCT and the European Society for Toxicology In Vitro (ESTIV). Information about all ASCCT-ESTIV webinars and other ASCCT events is available on the ASCCT calendar page.

The July 16 webinar will feature two presentations on approaches being developed to identify potential thyroid disruptors. Chad Deisenroth, U.S. Environmental Protection Agency, will describe an ongoing validation study of a 3D human thyroid microtissue assay. Kostja Renko, German Federal Institute for Risk Assessment, will discuss identification of potential thyroid hormone disruptors using the Sandell-Kolthoff reaction as a technology platform.

Join the Institute for In Vitro Sciences and guest speakers August 15-16 for an interactive 1.5-day practical workshop focused on the ToxTracker Assay, a unique stem-cell based assay that uses six engineered green fluorescent protein-receptor cell lines to investigate genotoxic potential and toxicological mode of action. Lectures will focus on the science behind the assay and how the data can be applied in testing programs. Participants will have the opportunity to view and participate in the conduct of the assay in the laboratory, from cell exposure to data analysis, in small groups.

• NICEATM Director Nicole Kleinstreuer is an author on a paper describing development and validation of a high-throughput screening assay to identify CYP26A1 inhibitors. CYP26 enzymes degrade all-trans retinoic acid (atRA), which regulates cell growth and differentiation in many tissues. Given the importance of atRA as a morphogenetic signal and the localized expression of CYP26A1 in embryonic tissues, a validated CYP26A1 assay has important implications for evaluating the potential developmental toxicity of chemicals.
  Sakamuru et al. 2024. Development and validation of CYP26A1 inhibition assay for high-throughput screening. Biotechnology Journal 19(6):2300659. https://doi.org/10.1002/biot.202300659
• NICEATM scientists and collaborators have published an article describing an integrated approach to testing and assessment (IATA) for developmental neurotoxicity of organophosphorus flame retardants (OPFRs) using chemical data from the literature and from NICEATM’s Integrated Chemical Environment. This IATA case study indicates that human exposure to some OPFRs could lead to a plasma concentration similar to those exerting in vitro activities, indicating potential concern for human health.
  Kreutz et al. 2024. Integrated approach for testing and assessment for developmental neurotoxicity (DNT) to prioritize aromatic organophosphorus flame retardants. Toxics 12(6):437. https://doi.org/10.3390/toxics12060437
• ICCVAM member Jueichuan Kang and colleagues at the U.S. Food and Drug Administration Center for Tobacco Products have published an analysis using chemoinformatic computational models of chemicals present in electronic nicotine delivery systems. The analysis found structural similarities to neuroactive compounds and predicted that the majority of the chemicals could potentially cross the blood-brain barrier. This approach enabled prioritization of the chemicals for further study and potential early identification of chemicals that could cause central nervous system toxicity.
  Stratford et al. 2024. Investigative analysis of blood-brain barrier penetrating potential of electronic nicotine delivery systems (e-cigarettes) chemicals using predictive computational models. Expert Opin Drug Metab Toxicol. https://doi.org/10.1080/17425255.2024.2366385

ASTM International Committee E56: Nanotechnology is seeking subject matter experts to support review of work items on existing in vitro methods for assessing toxicity of nanomaterials. Scientists with in vitro methods expertise for a variety of endpoints are needed to review draft standards that focus on in vitro toxicology and to propose and develop new standards. Examples of ongoing projects include development of standards for “Assessing the Activation of the Complement System in Human Plasma Through Quantification of iC3b Concentration by ELISA” and “Quantitative Measurement of the Chemoattractant Capacity of a Nanoparticulate Material In Vitro.” The committee has subcommittees focusing on areas such as immunology, molecular and cellular biology, drug delivery, gene delivery, in vitro toxicology, use in medical products, and use in consumer products. Participants will contribute to projects lasting several months to 1-2 years, with attendance at occasional hybrid meetings (no travel required). Subject matter experts do not need to be members of ASTM International to be involved in review or development of a standard. For more information, please contact Aleks Stefaniak, National Institute for Occupational Safety and Health.

The National Institute of Environmental Health Sciences (NIEHS) seeks candidates for the position of Senior Scientist and chief of the Systems Toxicology Branch (STB) in the Division of Translational Toxicology (DTT). The mission of the DTT is to evaluate environmental substances of public health concern by developing and applying tools of modern toxicology and molecular biology. The STB chief oversees all major functions of the DTT organizational unit principally responsible for design, oversight, interpretation, and reporting of traditional toxicology and carcinogenesis studies. The STB chief is also responsible for continuous improvement and innovation in how STB addresses contemporary and human-relevant public health challenges.

The ideal candidate will have a research-based professional degree in the life sciences, with extensive experience in in vivo toxicology and carcinogenesis studies carried out according to national and international guidelines. In addition, the successful candidate will have a working knowledge of carcinogenesis, genomics, molecular biology, molecular genetics, cellular biology, systems biology, pathology, and statistics. The applicant should be recognized for their scientific expertise within the national and international scientific community. The branch chief should reside within the local commuting area of Research Triangle Park, North Carolina. This position is not eligible for remote work. Applications for this position will be accepted from Monday, June 10 through Wednesday, July 10. 

An upcoming webinar will describe an approach to replacing animal components within in vitro studies to address scientific and ethical concerns. This webinar, presented by Ahmed Samir Mohamed Ali from the Technical University (TU) of Berlin, Germany, will take place on Monday, June 24 at 1:00 p.m. EDT. Ali will report on how the TU bioprinting group is overcoming the current limitations to having a xeno-free liver model with good physiological relevance to the human body. Ali is pursuing his Ph.D. within the Institute of Biotechnology at TU Berlin. His research focuses on non-animal alternative methods, with a particular emphasis on 3D bioprinting.

A unique webinar, hosted by the Hispanic Organization of Toxicologists Special Interest Group of the Society of Toxicology and the Postdoctoral Assembly, will be held Friday, June 14 at 12 noon EDT. The webinar will focus on publishing, providing a step-by-step process for turning research data into publications. Participants will learn how to plan, structure, and organize a paper; prepare a manuscript for a peer-reviewed journal; and identify target journals to submit their research. The webinar is designed for scientists at all levels who wish to advance their careers. Particular emphasis will be placed on the needs of non-native English speakers. The speakers are Ofelia A. Olivero and Lester Hoffman, both certified coaches with the International Coaching Federation.

A new NTP webpage will allow users to easily search PubMed for information on specific topics related to alternatives to animal testing. NICEATM and the U.S. Department of Agriculture (USDA) National Agricultural Library’s Animal Welfare Information Center (AWIC) collaborated to develop search strategies, known as “hedges,” for topics specific to alternatives. Hedges are now available for the following topics:

• Alternatives to animal use for assessing acute inhalation toxicity.
• Alternatives to animal use for assessing developmental neurotoxicity.
• In vitro to in vivo extrapolation.
• Microphysiological systems.

Additional hedges are under development; please contact Catherine Sprankle with suggestions of additional topics.

AWIC has developed search hedges for a number of animal welfare topics, and offers guidance and assistance for literature searches on animal use alternatives. For more information and to access these resources, visit the USDA website.

• NICEATM staff and ICCVAM members from the U.S. Environmental Protection Agency are coauthors on a paper exploring the anatomy and physiology of the human and rat respiratory tracts and considering the impact of these on toxicological assessments. Key differences in the two species support an opportunity to harness modern toxicology tools and a detailed understanding of the human respiratory tract to develop testing approaches grounded in human biology.
  Stucki et al. 2024. Differences in the anatomy and physiology of the human and rat respiratory tracts and impact on toxicological assessments. Reg Toxicol Pharmacol 150:105648. https://doi.org/10.1016/j.yrtph.2024.105648
• NICEATM staff scientist Helena Hogberg and ICCVAM cochair Natalia Garcia-Reyero (U.S. Department of Defense) are coauthors on a systematic scoping review of COVID-19 and its related neurological symptoms. Information extracted from the scoping review may be useful in developing or supporting existing adverse outcome pathways linking COVID-19 and its neurological key events and adverse outcomes.
  Hogberg et al. 2024. A systematic scoping review of the neurological effects of COVID-19. Neurotoxicology. https://doi.org/10.1016/j.neuro.2024.05.003
• Hogberg is also a coauthor of a “Food for Thought” article in the journal ALTEX describing progress in the application of NAMs to developmental neurotoxicity testing. Innovations in this field can contribute to safer chemical management and better protection of human health, especially during the vulnerable stages of brain development.
  Smirnova et al. 2024. Revolutionizing developmental neurotoxicity testing – a journey from animal models to advanced in vitro systems. ALTEX 41(2):152-178. https://doi.org/10.14573/altex.2403281

The journal Environmental Toxicology and Chemistry is accepting submissions for a planned special issue on “New Approach Methods in Ecotoxicology.” Submissions are due August 31. For more information, refer to this flyer or contact Guest Editor Nil Basu.

This special issue will showcase the state of science of NAMs in ecotoxicology. Articles submitted should take the form of case studies that help increase scientific confidence of a given NAM. Case studies must be scientifically sound while also providing essential details on: (1) technical methods and performance; (2) biological and/or ecological relevance; and (3) fit for purpose detailing the context(s) in which the NAM is intended for use. The case studies must illustrate how the data, approaches, and conclusions derived from the NAM compare with those derived from traditional approaches. In addition to case studies, the editors welcome reviews, perspectives, and points of reference on the topic. Articles should focus on opportunities and barriers to the design, validation, and adoption of NAMs in ecotoxicological applications.

The Evidence-Based Toxicology Collaboration (EBTC) will present a webinar on “Methods-Sharing Platforms for Reproducible Results” on Wednesday, June 12 at 11:00 a.m. EDT. This webinar will demonstrate new approaches and technology for supporting the sharing of high-quality, reproducible study methods. It will present the protocols.io platform for recording, sharing, and improving study methods, and show an EBTC-led case study of how the platform can be used for automating standards compliance in research.

The NIEHS Division of Extramural Research and Training (DERT) has several openings for Health Science Administrator, Program Officer, and Scientific Review Officer positions. Positions are available in the following DERT branches: Genes, Environment, and Health; Exposure, Response, and Technology; Hazardous Substance Research; Population Health; and Scientific Review. These positions are included in a broader set of announcements issued by the National Institutes of Health. Openings were announced May 13; interested candidates should be aware that the announcement will close on May 22 or after the first 200 applications are received for these positions.

Applicants must be U.S. citizens and meet a basic education requirement of a bachelor's or graduate/higher level degree with major study in an academic field related to the medical field, health sciences, or allied sciences appropriate to the work of the position. Positions are located at NIH locations in Research Triangle Park, NC; Frederick, MD; and Montgomery County, MD. Some positions may be eligible for remote work as specified in the individual announcements. To apply, please visit the following sites:

• Health Science Administrator, GS 12-GS 14 level
• Health Science Administrator, GS 15 level
• Supervisory Health Science Administrator, GS 15 level

This notice corrects an error in NICEATM News Issue 21. The deadline for response to the RFI is June 7.

The Occupational and Inhalation Exposures Research Program within the Division of Translational Toxicology at the National Institute of Environmental Health Sciences (NIEHS) recently released a “Request for Information (RFI) on the Use of In Vitro Lung Models in Inhalation Toxicology Research with Potential Application to Regulatory Decision-Making.” Responses to this RFI will guide the Division’s research in this area and align it with the needs of the broader research and regulatory communities. Respondents are specifically asked to respond by June 7 and provide information about:

• Applications for which in vitro lung models have been used.
• The most important scientific knowledge gaps underlying the assessment of the effects of inhaled substances on human health.
• Current technical challenges and limitations related to using in vitro lung models in research.
• Ongoing concerted efforts by individuals or groups to utilize in vitro lung models in routine hazard or risk assessment.

Registration is now open for Indiana University’s 19th Annual Multicell Virtual-Tissue Modeling Online Summer School and Hackathon. Please register by June 1.

The Summer School will take place July 28-August 4 and will focus on the basics of building virtual tissue models using CompuCell3D, as well as exploration of more advanced modeling topics using the many features and capabilities of the CompuCell3D software. The first day of the Summer School will be an optional Python Bootcamp.

The August 9-11 Hackathon will be hosted on the weekend following the workshop. Attendees will work in teams to building a functioning model of the problem of interest. First-time attendees are required to attend the workshop for Hackathon participation. Returning participants may request admission into the Hackathon only.

For more information, see the announcements on the website and on the attached flyer. Orientation meetings for the Summer School and Hackathon will be held in June and July (dates to be determined). If you are unable to attend, you can view the recordings via YouTube and download the slides.

A webinar describing “Machine-Learning Aided Multi-Scale Modelling Framework for Toxicological Endpoint Predictions in the Dog” is scheduled for Wednesday, May 29 from 9:00-10:00 a.m. This webinar will highlight advances in computational approaches and machine learning to develop a “Virtual Dog” to ultimately replace their use for chronic toxicity studies. Stephan Schaller and Mark Davies from EsQlabs GmbH will give the project overview.

The project is funded via the National Centre for the Replacement, Refinement, and Reduction of Animals in Research (NC3Rs) CRACK IT Mega Challenge: Virtual Second Species, and co-sponsored by the Health and Environmental Sciences Institute and NC3Rs.

A training webinar presented by the Physicians Committee for Responsible Medicine (PCRM) will discuss “Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies: An ICCVAM Report.” NICEATM Director Nicole Kleinstreuer will present an overview of the report after which the webinar will be opened for a 30-minute Q&A session. The webinar is on Thursday, May 23 at 12 noon EDT.

This webinar is part of PCRM’s New Approach Methodology (NAM) Use for Regulatory Application continuing education program designed to provide professionals in the field of toxicology with specialized resources and basic hands-on training in non-animal NAMs.

A draft agenda is available for the ICCVAM Public Forum, which will be Monday, May 20 from 1:00-5:00 p.m. and Tuesday, May 21 from 9:00 a.m.-4:30 p.m. at the Natcher Conference Center, National Institutes of Health, Bethesda, MD. The meeting is in person with an option to view remotely. Registration to attend in person is encouraged and will be open through Friday, May 17. Registration to view the webcast is required 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 Wednesday, May 15.

The public forum 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.

In conjunction with the Public Forum, NICEATM will offer a hands-on training session on data and tools available in the Integrated Chemical Environment (ICE) on Wednesday, May 22 at the Natcher Conference Center. This training will provide a general overview of ICE and its data and curated chemical lists, as well as live demonstrations of different ICE tools. This session is in-person only and space is very limited. Register by Friday, May 17.

The fourth webinar in the EPIC series on the use of new approach methodologies (NAMs) in risk assessment will cover “Advancing eye irritation assessment with non-animal methods for industrial chemicals and agrochemicals: progress at the U.S. EPA.” The webinar will be held Wednesday, May 29 from 11:00 a.m.–12:30 p.m. EDT. The speakers include Lindsay O’Dell, U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs, and Renee Beardslee, EPA Office of Pollution Prevention and Toxics.

The EPIC series covers timely topics on the use of NAMs for risk assessment within EPA and the California Department of Pesticide Regulation (CDPR). The series began in August 2023 and continues quarterly. Links to past webinars are available at the link above. The webinar series is co-organized by EPA, PETA Science Consortium International (PSCI), the Institute for In Vitro Sciences, and CPDR.

Registration is now open for the ASCCT-ESTIV May 2024 webinar, “From physiological maps to ontology maps using a systems biology approach.” The webinar will be held Tuesday, May 14 from 10:00–11:00 a.m. EDT.

Physiological maps provide comprehensive graphic representations of biological processes and molecular interactions. They facilitate description of physiological processes and lay the groundwork for ontology maps, which are mode-of-action frameworks that integrate and structure qualitatively and quantitatively relevant biology, toxicological, chemical, and kinetic data ultimately designed to support chemical risk assessment. In the webinar, Luiz Ladeira, University of Liège (Belgium), will discuss five organ-specific physiological maps.

More information is available under “Upcoming Events” on the ASCCT calendar page.

Early-career scientists who are interested in non-animal testing are invited to apply for an award to attend the Applied In Vitro Toxicology Training Course organized by the European Society of Toxicology In Vitro. The course will be held at the Luxembourg Institute of Science and Technology in Belvaux, Luxembourg, from November 24-29.

This award, presented by PSCI, offers an early-career scientist the opportunity to learn about and gain hands-on experience with in vitro and in silico methods. The award is open to postdoctoral fellows and scientists who have been out of school or a postdoctoral program less than 10 years, 18 years of age or older, residents of any country. The deadline to apply is June 30. The winner will be notified in August.

The late-breaking abstract submission deadline for the 2024 MPS World Summit is Friday, May 10. Late-breaking abstract submissions will not be sent for reviews and will only be accepted as poster presentations. Abstracts are invited on the topic of new developments in Microphysiological Systems (MPS) and applications of MPS. Abstracts will be evaluated for their alignment with four meeting tracks:

• Track 1: MPS for (patho)physiology
• Track 2: Modeling, fabrication, and manufacturing of MPS
• Track 3: Validation, qualification, meet regulatory requirements
• Track 4: MPS in toxicology and drug development

Abstracts must be in English and no more than 350 words. Submitters should indicate their preferred track. The 2024 MPS World Summit will be held June 10-14 in Seattle.

The Collaborative Acute Toxicity Modeling Suite (CATMoS) is an in silico quantitative structure–activity relationship predictive tool to screen chemicals for acute oral toxicity based on two-dimensional molecular structures. The U.S. Environmental Protection Agency, NICEATM, and collaborators applied CATMoS to predict toxicity of pesticide active ingredients. For less toxic substances, CATMoS predictions aligned well with experimental data, supporting the tool’s potential use in place of animal studies for these substances.

Bishop et al. 2024. Evaluation of in silico model predictions for mammalian acute oral toxicity and regulatory application in pesticide hazard and risk assessment. Reg Toxicol Pharmacol 149:105614. https://doi.org/10.1016/j.yrtph.2024.105614

The California Environmental Protection Agency Office of Environmental Health Hazard Assessment and the Texas A&M Superfund Research Center will present a workshop exploring the use of new approach methodologies in inhalation toxicology and air toxics risk assessment. “New Tools and Approaches to Support Decision-Making in Inhalation Toxicology” will be held Thursday, May 23, from 12:00 noon-7:00 p.m. EDT (9:00 a.m.-4:00 p.m. U.S. Pacific Time). The workshop will focus on read-across methods and high-throughput tests to support decision-making for air toxics that lack traditional assessments. Xiaoqing Chang, Inotiv (contractor supporting NICEATM) is among the presenters.

The Keystone Symposium Virtual Conference, “AI in Biomedicine” will be held May 1-3. The conference is sponsored by the Cystic Fibrosis Foundation, DCVC Bio, and Moderna. Organizers are Thomas Hartung, Johns Hopkins University Center for Alternatives to Animal Testing; Weida Tong, U.S. Food and Drug Administration; and Yvonne Will, Crinetics Pharmaceuticals. NICEATM Director Nicole Kleinstreuer is among the presenters.

Artificial intelligence (AI) and machine learning are rapidly advancing biomedicine by enabling novel insights into disease mechanisms, earlier diagnosis, improved prognostics, and enhanced precision medicine. This meeting will showcase cutting-edge applications of AI across diverse areas of biomedicine including oncology, neurology, cardiology, immunology, and genetics. Talks will focus on the near-term translatability of AI technologies and practical hurdles that must still be overcome. Discussions will also address responsible and ethical implementation of AI in biomedicine. Speakers represent leading researchers across academia, industry, clinical medicine, and government. Collectively, they will provide a comprehensive overview of the current state and future directions of AI in transforming biomedicine to improve human health.

The National Institute of Environmental Health Sciences (NIEHS) is convening a two-day virtual workshop on horizon scanning to proactively identify and improve responses to emerging contaminants, emergencies, and issues of concern. Horizon scanning activities engage experts in conversations to predict responses or capabilities that may be needed. This workshop will establish a network or community of practice for sharing information about horizon scanning in the context of environmental health. Participants will produce one or more publications summarizing existing tools, research gaps, guidance, or strategies for proactively identifying emerging contaminants or issues of concern and best practices for communicating hazard information to affected communities. The workshop will be held in two sessions on Tuesday, April 30 and Tuesday, May 7.

ICCVAM will hold a public forum Monday, May 20 from 1:00-5:00 p.m., and Tuesday, May 21 from 9:00 a.m.-4:30 p.m. at the Natcher Conference Center, National Institutes of Health, Bethesda, MD. The meeting is in person with an option to view remotely. Registration to attend in person is encouraged and will be open through Friday, May 17. Registration to view the webcast is required 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 Wednesday, May 15.

The public forum 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.

EPA is seeking qualified individuals for a deputy director position in the Office of Resource Management (ORM) within the Office of Research and Development (ORD). ORM provides resource management support in areas such as budgeting, extramural management, human capital and travel management, program accountability, enterprise risk management, policy, and compliance. Applicants for this Senior Executive Service position must be U.S. citizens; applications must address core qualifications for leading change, leading people, driving results, business acumen, and building coalitions. Apply by May 7.

EURL ECVAM has issued its 2023 Status Report, “Non-animal Methods in Science and Regulation.” The report describes research, dissemination and promotion activities undertaken by EURL ECVAM to further the uptake and use of non-animal methods and approaches in science and regulation.

Specific activities described in the report include:.

• New in vitro methods under consideration for regulatory application.
• A virtual reality application for education in schools.
• Enhancing collaboration to promote innovative non-animal approaches.

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. NICEATM and ICCVAM collaborate with EURL ECVAM via the International Cooperation on Alternative Test Methods (ICATM).

Small Business Programs of the National Institutes of Health, including the National Institute of Environmental Health Sciences (NIEHS), provide an Applicant Assistance Program (AAP). This free, 10-week program is designed to assist small businesses in preparing a Small Business Innovation Research or Small Business Technology Transfer grant application. 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.

AAP will accept applications beginning April 25 from participants preparing grants for the September 5 deadline. Two webinars are being presented to provide information about the program and answer questions from potential participants:.

• Informational webinar, Thursday, April 25, 2:00-3:30 p.m. EDT
• Q&A webinar: Tuesday, May 14, 2:00-3:30 p.m. EDT

A complete schedule of AAP events is available with links to register for the webinars. AAP applications are due Tuesday, May 21. More information is also available about the NIEHS Small Business Program.

The National Science Foundation, the National Institutes of Health, and the U.S. Food and Drug Administration have established the Foundations for Digital Twins as Catalyzers of Biomedical Technological Innovation (FDT-BioTech) program to accelerate innovations in biomedical technologies through development of principled mathematical, statistical, and engineering foundations for digital twins and synthetic human models in healthcare applications. The program is offering six to ten awards totaling $4-5M to support interdisciplinary research projects, including projects to develop and use digital twins and synthetic data in biomedical and healthcare applications, with a particular focus on digital, in silico models used in the evaluation of medical devices.

A webinar providing an overview of FDT-BioTech will be presented on Monday, April 22, at 1:30 p.m. EDT. Registration for the webinar is available, as is information about the webinar and the detailed funding announcement. This is a multiyear program; the first deadline for funding proposals is Friday, June 21.

The Science Task Force of the European Regulation and Development Forum will meet on Thursday, April 18, from 10:00-11:30 a.m. EDT (4:00-5:30 p.m. Central European Time) to hear two expert presentations on current issues in regulatory toxicology.

• The first presentation, “Fostering trust in science and technologies,” will focus on nanotechnology and nanosafety. Monique Groenewold, from the Dutch Institute for Public Health and Environment (Dutch acronym RIVM) and the Organisation for Economic Co-operation and Development (OECD) will discuss the importance of good governance to overcome distrust and social concern and promote a shared commitment and confidence. Lennart Gisselsson, Lund University, Sweden, will outline a case study collaborative initiative between Lund University, Tetra Pak, and other companies, drawing wider lessons for impactful partnerships between academia and the private sector.
• The second part of the meeting will focus on the use of advanced techniques, including new approach methodologies (NAMs), in regulatory science. Alison Harrill, U.S. Environmental Protection Agency (EPA), will provide a brief assessment of the U.S. experience with NAMs, focusing on the forward and robust approach taken by EPA.

North Carolina State University (NCSU) presents a symposium on Data Science and Environmental Health Research on Friday, April 5 on the NCSU campus in Raleigh, NC. Speakers from NIEHS, the U.S. Environmental Protection Agency, and several universities will discuss current research activities in population genomics, genomic-driven new approach methodologies and environmental health disparities and address approaches to handling “big data.” This all-day meeting aims to foster collaborative discussions through an interdisciplinary forum and advance the application of new methods in environmental health science research. Registration is free and lunch is included; relevant posters may be submitted for the lunchtime poster session. 

NIVA’s Section for Ecotoxicology is seeking two highly motivated postdocs to contribute to establishing next-generation chemical risk assessment tools in two projects.

• Postdoc 1 will work on parametrization and modeling of qualitative and quantitative aggregate exposure pathways.
• Postdoc 2 will parametrize and model qualitative and quantitative adverse outcome pathways.

Candidates should have PhDs in relevant fields and experience in programming using R and python, mathematical modeling, chemometrics and/or bioinformatics. Applicants must have excellent verbal and written communication skills in English. The postdoc positions are full-time and have a duration of 2 years. Candidates should specify in applications the position for which they are applying. Apply by April 14.

The 13th World Congress on Alternatives and Animal Use in the Life Sciences (WC13) will be held August 31-September 4, 2025, in Rio de Janeiro, Brazil. No webpage is available yet; email [email protected] for more information. The main theme of WC13 is: 3Rs Integrating 3 Worlds: Human, Animal, and Environmental Health.

WC13 will showcase advancements in both academic and industrial sectors of life sciences, particularly focusing on sustainable alternatives to animal testing. The congress will feature focus sessions on the following topics:

• Reduction
• Refinement and Animal Welfare
• Replacement
• Toxicology
• Biomedical Research
• Regulatory Testing
• 3Rs Education
• Bioethics
• New Technologies
• 21st Century Vision Implementation

Stay tuned for exciting developments as the organizing committee prepares insightful scientific sessions and adventurous social programs.

The 13th annual meeting of the American Society for Cellular and Computational Toxicology (ASCCT) will be held October 28-30 at the Research Triangle Institute International campus in Research Triangle Park, NC. 

ASCCT is accepting proposals for continuing education (CE) courses and, for the first time this year, session proposals. Submit proposals by April 10. Proposals should follow these guidelines:

• Unlike regular oral sessions, CE sessions should address or provide guidance on relatively established science or practice and have specific takeaways or learning objectives.
• All proposals should fit within the mission of the ASCCT to further the use of in vitro or computational toxicology methodologies.
• Topics that will promote discussion of scientific and regulatory policy elements and cross-sector collaboration are welcomed.
• Sessions will be two hours long. We suggest three to four speakers plus time for Q&A.
• Computational hands-on learning, data evaluation exercises, and participatory elements are welcomed; there may be support from the conference organizers available for participatory elements.

ASCCT is also accepting abstracts for oral and poster presentations with the following deadlines:

• June 30: regular deadline; submitted abstracts will be considered for oral, flash poster, or poster presentations.
• September 1: late breaking deadline: posters only, submissions will open over the summer.

  Abstracts addressing all areas of in vitro, in silico, and other non-animal investigational and applied toxicology, as well as policy and engagement activities, are welcome. The meeting will again aim to emphasize the challenging topics of regulatory use and application of new tools, gaining confidence in new approaches, and advancing next-generation frameworks for risk and safety assessment. Ecological assessment topics are also encouraged.

The Physicians Committee for Responsible Medicine (PCRM) will present a webinar Monday, April 8 at 10:00 a.m. EDT on “Gaining Confidence in NGRA Approaches Together.” This is the latest webinar in the NAMs Use for Regulatory Applications series, "DyNAMic Discussions: The Future is Already Here." Materials from the previous webinars in the series, including presenter’s slides, session recordings, and supplementary publications, are available on the PCRM website.

The EPA Center for Computational and Exposure (CCTE) and Unilever’s Safety and Environmental Assurance Centre have established a cooperative research and development agreement (CRADA) to develop and evaluate new approach methodologies (NAMs) for use in next-generation risk assessment. The CRADA has been exploring the utility of a battery of NAMs for evaluating the safety and potential hazard(s) of a set of case study chemicals. Research topics in this project include (1) exploring the use of combinations of approaches for determining molecular points-of-departure, (2) comparing molecular points-of-departure to hazardous and non-hazardous human exposure scenarios, (3) evaluating the impact of in vitro metabolism on bioactivity assay readouts, and (4) assessing methods for metabolite determination. Sophie Cable, Unilever, and Joshua Harrill, EPA CCTE, will highlight recent findings from this collaboration; a Q&A and panel discussion after the presentation will feature the speakers and additional EPA and Unilever participants.

The Physicians Committee for Responsible Medicine (PCRM) is accepting applications through Friday, April 5 for its Summer Immersion on Innovative Approaches in Science, to be held May 30-June 1 in Washington DC. This workshop is designed to educate the next generation of scientists committed to advancing science ethically using nonanimal methods for research and testing. The program provides an overview of in vitro, in silico, and in chemico approaches and their many applications in basic, translational, and regulatory science to replace animals. Attendees will participate in scientific talks, career development workshops, poster presentations, technology demonstrations, case studies, networking opportunities, and more. Steering committee members include ICCVAM members Warren Casey, National Institute of Environmental Health Sciences; and Suzanne Fitzpatrick, U.S. Food and Drug Administration; speakers include Casey, NICEATM Director Nicole Kleinstreuer, and ICCVAM member Anna Lowit, U.S. Environmental Protection Agency (EPA).

The Summer Immersion welcomes undergraduate and graduate students, post-docs and early-career scientists interested or engaged in academic, industry, or government research in biomedical sciences.

A new paper by scientists at the German Federal Institute of Risk Assessment and NICEATM and ICCVAM agency collaborators describes detailed analysis of the value of human skin sensitization data for classification of chemicals as skin sensitizers under the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals (GHS). This project builds on a data set reported in Strickland et al. 2023. The analysis found that while such data are often not sufficient on their own for deriving unambiguous classifications, in cases where they are, the resulting classifications are reliable and reproducible and can be integrated well with those from other skin sensitization data.

Herzler et al. 2024. Use of human predictive patch test (HPPT) data for the classification of skin sensitization hazard and potency. Arch Toxicol. https://www.doi.org/10.1007/s00204-023-03656-4.

The United Kingdom National Centre for the Replacement Refinement and Reduction of Animals in Research (NC3Rs) has developed “Reporting In Vitro Experiments Responsibly” (RIVER), a set of six recommendations to help ensure that in vitro experiments are reported accurately and reproducibility. Implementation of such standards will enable reviewers to assess the reliability of published results and facilitate reproduction of in vitro methods.

NC3Rs is seeking participants for a study to gather feedback on the RIVER recommendations. Researchers currently preparing a manuscript that includes in vitro models are invited to apply the RIVER recommendations to their draft manuscript and provide feedback on whether the recommendations and their explanations are clear, well understood, and useful in practice. Findings from the user testing will be used to revise the recommendations. Participants in this study will have the opportunity to receive expert feedback on their manuscript from members of the working group, with the potential to improve the transparency and reliability of their work and its subsequent chances of successful publication. Participants will receive a £50 Amazon voucher for completing the study. To find out more, visit the NC3Rs website or email [email protected].

The AWIC within the USDA National Agricultural Library of the U.S. Department of Agriculture has updated the online version of its popular workshop on “Meeting the Requirements of the Animal Welfare Act.” The online workshop is available on demand year-round and can be completed on the user’s own schedule. Topics covered include the Animal Welfare Act, 3Rs alternatives and resources, and how to conduct a literature search for animal use alternatives. The online workshop is hosted on the website of Oregon State University.

AWIC also offers live workshops throughout the year; the next one is scheduled for May 8-9 from 1:00-4:00 p.m. each day. Information and a link to register are available here.

Registration is now open for upcoming webinars featuring winners of 2023 awards from the American Society for Cellular and Computational Toxicology (ASCCT) and the European Society for Toxicology In Vitro (ESTIV). Links to information about all events are available on the at the ASCCT calendar page.

The first webinar will be presented April 3 at 10:00 a.m. EDT. Presentations will include:

• Alexandre (Alex) Borrel, Inotiv (contractor supporting NICEATM), describing “Deep learning profile QSAR modeling to impute in vitro assay results and predict chemical carcinogenesis mechanisms.” Borrel won the Edward Carney Predictive Toxicology Award at the ASCCT 2023 annual meeting.
• Agnes Karmaus, Syngenta, discussing “Incorporating new approach methodologies into a tiered assessment framework for agrochemical metabolite human safety assessment.” Karmaus won a poster award at the ASCCT 2023 annual meeting.

The second webinar will be presented April 11 at 10:00 a.m. EDT. Presentations will include:

• Damaris Cristine Marios Ferreira Pinto, Grupo Boticário (Brazil), discussing “Assessing sunscreen product toxicity on coral fragments: a new approach methodology for enhancing reliability and addressing environmental concerns.” Ferreira Pinto won the International Travel Award at the ASCCT 2023 annual meeting.
• Jerry Achar, University of British Columbia, presenting on “Facilitating analysis of implicit uncertainties in QSAR prediction of chemical toxicity: a case study of neurotoxicity.” Achar won the Suzanne Fitzpatrick Student Travel Award at the ASCCT 2023 annual meeting.
• Kirsten Veltman, Dutch National Institute for Public Health and the Environment, describing “Application of weighted gene co-expression network analysis as mode of action screening method for suspected non-genotoxic carcinogens inducing oxidative stress.” Veltman won the ESTIV Best Poster Presentation at the EUROTOX2023 Congress.

A workshop on “AI in Drug Discovery” will be held as part of the 33rd International Conference on Artificial Neural Networks in Lugano, Switzerland on September 17-20. Workshop organizers are seeking cutting-edge contributions in the rapidly evolving field of artificial intelligence (AI)-driven drug discovery. Submissions can address various facets of the use of machine learning in chemistry such as generative models, uncertainty quantification, methodologies for mining very large compound data sets, analysis of HTS data, and identification of frequent hitters. Abstracts are due by March 15 if submitted through the conference submission system but will be accepted through April 15 via email. 

NICEATM has released Version 4.0.2 of the Integrated Chemical Environment (ICE). ICE provides chemical safety data and property predictions as well as tools to help query, review, and contextualize these data. Key features implemented in ICE 4.0.2 are:

• New data visualizations for Search tool query summary results.
• Updated filter chain options in Search.
• New overlays for data comparisons in the In Vitro to In Vivo Extrapolation (IVIVE) tool.
• Curve Surfer tool optimization.
• Updated cHTS data from the Invitrodb v3.5 release.
• Improved support for chemical name searching in the ICE REST API.

Demonstrations of ICE and other NICEATM computational tools will be given Monday, March 11 through Wednesday, March 13 at the Society of Toxicology (SOT) 2024 annual meeting in Salt Lake City, UT.

HSUS is seeking a Science Adviser for its Animal Research Issues department. Applicants should have a Ph.D. in biological, toxicological or computational sciences or related field or equivalent work experience, and at least two years’ experience in the field of alternatives to animal use for testing, research, or laboratories. The position is based in the Washington, DC, area but is eligible to be remote; an ability to travel is required. 

EPA is hosting a free NAMs Tools Training Workshop on April 24-25 from 9:00 a.m.–5:30 p.m. (EDT) both days. The workshop will be presented in-person only at EPA’s Research Triangle Park campus in Durham, NC. Space is limited. Preference will be given to registrants who are able to attend both days of the workshop.

This workshop builds on EPA’s ongoing NAMs virtual trainings and will give participants the opportunity to advance their knowledge on EPA NAMs tools through overview sessions, in-depth learning, interactions with tool and data owners, and tool-specific case studies. EPA NAMs tools featured in the workshop include:

• Adverse Outcome Pathway (AOP) Wiki
• Chemical Exposure (ChemExpo) Knowledgebase
• Cheminformatics Modules
• CompTox Chemicals Dashboard
• Ecotoxicology (ECOTOX) Knowledgebase
• Generalized Read-Across (GenRA) tool
• High-Throughput Toxicokinetics (httk) R package
• Sequence Alignment to Predict Across-Species Susceptibility (SeqAPASS) tool
• Toxicity Estimation Software Tool (TEST)
• Toxicity Forecasting (ToxCast)

Attendees will have an opportunity to get a sneak peek at a new Non-Targeted Analysis (NTA) Web Application and RapidTox, a new suite of workflows to address targeted human health data needs in support of decision-making.

An online webinar, sponsored by the Animal-Free Safety Assessment Collaboration and Humane Society International, will be held March 27 from 7:30–10:45 a.m. (EDT). The webinar will focus on theoretical aspects of non-animal-based vaccine batch release testing methods that have been incorporated into regulations and guidelines, to provide key insights and references to regulators and assessors. Representative case studies of animal testing substitution will be presented, highlighting some of the available mechanisms of dialogue and collaboration between industry and regulatory agencies. 

NIEHS seeks candidates for the position of Senior Scientist and chief of the Mechanistic Toxicology Branch (MTB), in the Division of Translational Toxicology (DTT). The mission of the DTT is to evaluate environmental substances of public health concern by developing and applying tools of modern toxicology and molecular biology. The DTT provides critical data for regulatory and non-regulatory stakeholder decision making to protect human health using rodent studies, alternative in vivo model systems, in vitro high-throughput screens and/or computational approaches to gauge the potential of thousands of substances to perturb biological targets and pathways. The MTB chief leads and contributes to DTT multidisciplinary teams conceiving, developing, designing, interpreting, and reporting toxicology, carcinogenicity, and other applied and basic science research activities.

The ideal candidate will have a research-based professional degree in the life sciences, as well as experience in in vivo and in vitro toxicology studies and demonstrated experience directing laboratory research. In addition, the candidate will have demonstrated working knowledge of carcinogenesis, genomics, molecular biology, molecular genetics, cellular biology, systems biology, pathology, and statistics. The branch chief should reside within the local commuting area of Research Triangle Park, North Carolina, and this position is not eligible for remote work. Review of applications will begin March 25. 

An ICCVAM document, “Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies,” is now available. This document updates a model for validation and regulatory acceptance of new and alternative test methods originally described in the 1997 ICCVAM report, “Validation and Regulatory Acceptance of Toxicological Test Methods.” The updated document describes an approach to NAMs validation that reflects modern toxicity testing, placing less emphasis on replacement of in vivo tests with a single alternative method and more emphasis on integrating results from multiple in vitro and in chemico assays and in silico approaches. Guided by the principles articulated in the 2018 ICCVAM Strategic Roadmap, the new document presents a more flexible approach to how confidence is established, to help ensure the adoption of new methods by federal agencies and regulated industries once validated for a specific application or context of use.

The new document was prepared by the ICCVAM Validation Workgroup, which was established in 2021 to update the 1997 document. It reflects input from a number of federal research and regulatory agencies, as well as public comments received following the release of a draft version before the 2023 meeting of the Scientific Advisory Committee on Alternative Toxicological Methods. 

The Keystone Symposium Virtual Conference, “AI in Biomedicine” will be held May 1-3. The conference is sponsored by the Cystic Fibrosis Foundation, DCVC Bio, and Moderna. Organizers are Thomas Hartung, Johns Hopkins University Center for Alternatives to Animal Testing; Weida Tong, U.S. Food and Drug Administration; and Yvonne Will, Crinetics Pharmaceuticals. Deadline to submit an abstract is March 1. 

Artificial intelligence (AI) and machine learning are rapidly advancing biomedicine by enabling novel insights into disease mechanisms, earlier diagnosis, improved prognostics, and enhanced precision medicine. This meeting will showcase cutting-edge applications of AI across diverse areas of biomedicine including oncology, neurology, cardiology, immunology, and genetics.

Sessions highlight real-world examples of how AI can address long-standing challenges in biomedicine through automated analysis of complex biomedical data. Talks focus on the near-term translatability of AI technologies and practical hurdles that must still be overcome. Discussions also address responsible and ethical implementation of AI in biomedicine. Speakers represent leading researchers across academia, industry, clinical medicine, and government. Collectively, they provide a comprehensive overview of the current state and future directions of AI in transforming biomedicine to improve human health.

A new paper by NICEATM and EPA scientists and collaborators describes an automated workflow to standardize chemical structures using consistent rules. The workflow is useful to prepare chemical sets for use in quantitative structure–activity relationship models for predictive toxicology and other applications.

Mansouri et al. 2024. Free and open-source QSAR-ready workflow for automated standardization of chemical structures in support of QSAR modeling. J Cheminform 16:19. https://doi.org/10.1186/s13321-024-00814-3.

A recent publication describes use of the Toxicological Prioritization Index (ToxPi) framework to rank relative toxicity of a group of chemicals. It was honored as a Paper of the Month by the National Institute of Environmental Health Sciences (NIEHS) Environmental Factor newsletter. David Reif, ICCVAM representative from NIEHS, is a co-author of the paper.

Fleming et al. 2024. Guided optimization of ToxPi model weights using a semi-automated approach. Comput Toxicol 29:100294. https://doi.org/10.1016/j.comtox.2023.100294.

Applications are being accepted for the United Kingdom National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs) annual prize awarded for a paper that describes outstanding and original work that has or could have major impacts on the replacement, reduction, or refinement of the use of animals in research. This prestigious award consists of a £28k prize grant and a £2k personal award. GlaxoSmithKline has contributed £20k toward the prize grant. Apply by Wednesday, May 1.

The 13th annual meeting of the American Society for Cellular and Computational Toxicology (ASCCT) will be held October 28-30 in Research Triangle Park, NC.

ASCCT is accepting proposals for continuing education (CE) courses and, for the first time this year, session proposals. One or two CE courses will likely be offered Tuesday and Wednesday mornings before the main meeting program. Submit proposals by April 10. Proposals should follow these guidelines:

• Unlike regular oral sessions, CE sessions should address or provide guidance on relatively established science or practice and have specific takeaways or learning objectives.
• All proposals should fit within the mission of the ASCCT to further the use of in vitro or computational toxicology methodologies.
• Topics that will promote discussion of scientific and regulatory policy elements and cross-sector collaboration are welcomed.
• Sessions will be two hours long. We suggest two to four speakers plus time for Q&A.
• Computational hands-on learning, data evaluation exercises, and participatory elements are welcomed; there may be support from the conference organizers available for participatory elements.

ASCCT is also accepting abstracts for oral and poster presentations with the following deadlines:

• June 30: Regular abstracts for oral, flash poster, or poster presentations.
• September 1: Late-breaking abstracts (posters only); submission portal will open during the summer.

Abstracts addressing all areas of in vitro, in silico, and other non-animal investigational and applied toxicology, as well as policy and engagement activities, are welcome. The meeting will again aim to emphasize the challenging topics of regulatory use and application of new tools, gaining confidence in new approaches, and advancing next-generation frameworks for risk and safety assessment. Ecological assessment topics are also encouraged.

A webinar on February 23, 10:00–11:00 a.m. EST, will discuss “Carcinogenomics – Assessing the Tumorigenic Potential of Chemicals Through Genomic Biomarkers to Reduce the Reliance on the Rodent Cancer Bioassay.” The webinar is hosted by the Society of Toxicology Carcinogenesis Specialty Section.

The rodent assay has been the long-required study for regulatory assessment of carcinogenic hazard and risk. However, recognition of genomic biomarkers as reducing the need for these conventional methods is growing within the scientific community. The goal of this research is to construct and qualify liver transcriptomic biomarkers of key molecular initiating events in short-term rat studies that inform on liver tumorigenic risk in the rodent cancer bioassay. This webinar describes a collaborative approach to develop and qualify biomarker gene expression panels that measure widely accepted molecular pathways linked to tumorigenesis and their activation levels to predict doses of chemicals from short-term exposures. Successful efforts will facilitate transition from current heavy reliance on conventional rodent cancer bioassays to more rapid animal- and resource-sparing approaches.

Speakers:

• Keith Tanis, Merck
• Connie Mitchell, HESI
• Udayan Apte, University of Kansas Medical Center

A new paper describes how NICEATM scientists and collaborators in other offices within the National Institute of Environmental Health Sciences developed automated tools to support standardization of extracted toxicological endpoint information by applying preexisting controlled vocabularies. Augmenting manual efforts with automation tools increased the efficiency of producing a findable, accessible, interoperable, and reusable (FAIR) dataset of regulatory guideline studies. This open-source approach can be readily applied to other legacy developmental toxicology datasets, and the code design is customizable for other study types.

Foster et al. 2024. Standardizing extracted data using automated application of controlled vocabularies. Environ Health Perspect 132(2):027006. https://doi.org/10.1289/EHP13215.

An article on Charles River Laboratories’ Eureka blog, “Can Scientific Research Thrive Without Animals?” discusses the impact of the FDA Modernization Act 2.0 on advancing alternatives to animal use for safety testing. The article highlights the role of ICCVAM and NICEATM in demonstrating which non-animal methods are as good if not better than the conventional tests done in animals. NICEATM Director Nicole Kleinstreuer is extensively quoted in the article, which presents the NICEATM uterotrophic database as an example of data resources that are needed to evaluate in vitro test methods and to build predictive in silico models. 

A virtual workshop, held on May 16 at 10:00 a.m. EST, will explore animal methods bias in funding. The workshop is hosted by the Coalition to Illuminate and Address Animal Methods Bias (COLAAB), an international collaboration of researchers and advocates aiming to provide concrete evidence on the existence and consequences of this bias, and to develop and implement solutions for overcoming it.

“Animal methods bias” is defined as the preference for animal-based research methods, which affects the fair consideration of animal-free approaches and hampers their update and dissemination. Non-animal new approach methodologies (NAMs) have advanced rapidly over the last decade. But because animals are still considered by many to be the “gold standard” for biomedical research, studies that do not use animals can be assessed in a biased manner. Evidence of this bias has been established in the realm of publishing as a condition for publication. Anecdotal evidence suggests this problem may also affect the assessment of grant proposals, imposing a funding barrier for research using NAMs. Participants in this workshop will gather perspectives on this issue from a variety of stakeholders, characterize animal methods bias in funding, and identify potential solutions, both individual and structural.

A public workshop, “Future Implications of Open-Access & FAIR Data Practices on Chemistry and Chemical Engineering Publications” will be held February 21-22. The event is hosted by a planning committee of the National Academies of Sciences, Engineering, and Medicine, and will be held in Washington, DC, and virtually.

Workshop participants will discuss the various benefits and issues related to open access and FAIR (Findable, Accessible, Interoperative, Reusable) data practices for chemistry and chemical engineering research and publications. The workshop will provide a forum to explore social, financial, scientific, and research impacts of transitioning into open access and FAIR data practices.

A new publication by United Kingdom National Center for the 3Rs and the British Toxicology Society has identified actions to allow the United Kingdom to develop a world-leading regulatory framework that firmly embeds the 3Rs in chemical safety testing. The paper sets out the investment and commitment required to improve domestic chemical safety regulation and enable the use of the latest technological and scientific developments. Four key areas where progress is needed are identified as:

• A shared aspiration and desire to modernize the chemicals regulation framework to ensure the highest protection of human health, safeguard the environment, and stimulate the economy.
• A long-term financial commitment by government combined with clear and decisive leadership and ambition.
• A coordinated approach to deliver a new regulatory framework that facilitates cooperation between regulatory agencies and provides the necessary training and career structure that encourages the recruitment and retention of strong scientific talent.
• Harmonization of approaches worldwide to promote a more modern approach to chemicals regulation that fosters international cooperation and trade. 

Slides and video from the ICCVAM Communities of Practice webinar, “Emerging Approaches for Anchoring Biological Relevance of New Approach Methodologies” are now available. This webinar discussed approaches to evaluating NAMs that are based on evaluating the biological relevance of the NAM to the species of regulatory interest. Ongoing activities and key insights were described in three presentations by speakers from the academic and private sectors focusing on applications of small model organisms, organs-on-chips, and models of absorption, distribution, metabolism, and excretion.

Please mark your calendars for the ICCVAM Public Forum, to be held May 20-21 at the National Institutes of Health in Bethesda, MD. Information on the Public Forum will be linked to the NICEATM 3Rs Meetings, Workshops, and Webinars page when it is available .

The United Kingdom National Center for the 3Rs (NC3Rs) is establishing its NAMs Network, a community of researchers, developers, and industry and regulatory end-users working together to accelerate the use of new approach methodologies. Network members will be able to:

• Engage with a community of NAMs experts.
• Join multidisciplinary conversations about new approaches.
• Receive feedback about method development and support that will accelerate the use of NAMs.
• Attend events to learn about new developments in NAMs.
• Receive informal updates from our members via the NAMs 3Rs digest, curated by the NC3Rs.

A NAMs Network launch event will be held Tuesday, April 30 from 9:30 a.m. to 5:00 p.m. GMT in London. There is no virtual option for this event; those unable to attend in person may join the Network online. 

A team led by Professor Toni Cathomen at the University of Freiburg (Germany) has received £1M of CRACK IT funding to develop an approach to evaluate the tumorgenicity of human engineered T-cell therapies. Collaborating with five industry sponsors and supported by the Health and Environmental Sciences Institute, Cathomen’s team will develop a tool that uses machine learning to identify predictors of tumorigenicity in genetically modified in vitro cultured CAR-T cells. 

CRACK IT is a challenge-led competition that funds collaborations between industry, academics, and subject matter experts to solve challenges and deliver 3Rs benefits, either by improving business processes or developing a commercial product. This funding continues United Kingdom National Center for the 3Rs' commitment to the development of 3Rs approaches and technologies in the evolving field of cell and gene therapy, which has reached a total investment of £4.8M. Cell and gene therapies offer huge potential in the treatment of previously incurable conditions through using genetically engineered cells that can target diseased tissue. To learn more or apply for or sponsor a challenge, visit the CRACK IT homepage.

The European Partnership for Alternative Approaches to Animal Testing (EPAA) provides grants to help students and young scientists with outstanding work in the field of alternative approaches attend a high-profile scientific event. All grants cover the reimbursement of the event registration fees for the scientist, as well as travel and accommodation fees, on the basis of expense receipts.

This year, a full grant of €1000 and a half grant of €500 will support travel to each of the following meetings:

• 22nd International Congress of the European Society of Toxicology In Vitro (ESTIV; June 3-6, Prague, Czech Republic): apply by April 15.
• 58th Congress of the European Societies of Toxicology (EUROTOX; September 8-11, Copenhagen, Denmark): apply by June 17.
• European Congress on Alternatives to Animal Testing (EUSAAT; September 18-20, Linz, Austria): apply by June 17.

Registration is now open for a webinar on Tuesday, February 27 from 10:00 to 11:00 a.m. EST that will feature presentations by winners of 2023 awards from the American Society for Cellular and Computational Toxicology (ASCCT) and the European Society for Toxicology In Vitro (ESTIV).

Presenters:

• Victoria Hull, Inotiv (contractor supporting NICEATM), will discuss “Curating chemical use categories and exposure predictions to inform chemical assessment.” Hull was the Best Poster Award winner at the ASCCT 2023 annual meeting.
• Elena Kromidas, Eberhard Karls University, will describe “Modeling the stages of cervical cancer pathogenesis: establishment of a healthy cervix, a pre-cancerous CIN, and an immunocompetent carcinoma-on-chip.” Kromidas won the ESTIV Best Oral Presentation Award at the 12th World Congress on Alternatives and Animal Use in the Life Sciences.

These promising early career scientists will share brief discussions of their work followed by a Q&A.

A review article co-written by NICEATM Director Nicole Kleinstreuer considers current and potential applications of artificial intelligence (AI) in the field of toxicology. Used judiciously, AI has immense potential to advance toxicology into a more predictive, mechanism-based, and evidence-integrated scientific discipline to better safeguard human and environmental wellbeing across diverse populations.

Kleinstreuer N, Hartung T. 2024. Artificial intelligence (AI)—it’s the end of the tox as we know it (and I feel fine)*. Arch Toxicol. https://link.springer.com/article/10.1007/s00204-023-03666-2.

The European Chemicals Agency (ECHA) has published a report describing “Key Areas of Regulatory Challenge.” This document, initially published in June 2023 and updated in November, is envisioned as an “evolving research and development agenda” to support and inspire the Partnership for the Assessment of Risks from Chemicals research community. Specific topics addressed in the document include identifying chemical effects in the areas of neurotoxicity, immunotoxicity, and endocrine disruption; addressing chemical pollution in the environment; shifting away from animal testing; and improving availability of chemical data.

The next webinar in the EPIC series on the use of NAMs in risk assessment, co-organized by the U.S. Environmental Protection Agency (EPA), PETA Science Consortium International, Institute for In Vitro Sciences, and the California Department of Pesticide Regulation (CPDR), will cover “Establishing confidence in new approach methodologies.” The webinar will be held on Wednesday, February 21 from 11:00 a.m.–12:30 p.m. EST. ICCVAM member Elijah Petersen, National Institute of Standards and Technology, will discuss the forthcoming ICCVAM document, “Validation, Qualification, and Regulatory Acceptance of New Approach Methods.” Corrie Ellison, Procter & Gamble, will present a case study discussing the process of gaining confidence in alternative approaches for assessing the toxicity of branched carboxylic acids. 

The EPIC series covers timely topics on the use of NAMs for risk assessment within EPA and CDPR. The series began in August 2023 and will continue quarterly.

A webpage is now available summarizing activities of NICEATM and ICCVAM at the March 10-14 Society of Toxicology (SOT) annual meeting. Please refer it as you plan your SOT itinerary.

NICEATM and ICCVAM will have a strong presence at SOT. An exhibitor-hosted session sponsored by the National Institute of Environmental Health Sciences will focus on the forthcoming ICCVAM document, “Validation, Qualification, and Regulatory Acceptance of New Approach Methods.” NICEATM scientists are coauthors on 24 posters and three platform presentations; five NICEATM scientists are chairing or co-chairing platform sessions. ICCVAM members are coauthors on an additional 25 posters and six talks. NICEATM and ICCVAM scientists are also presenters or co-chairs of four continuing education courses to be held on Sunday, March 10. 

A February 1 statement from NIH Director Monica Bertagnolli announced NIH acceptance of a working group's recommendations of activities on NAMs. 

A working group of the Advisory Committee to the Director was charged with identifying areas in which the development and use of novel alternative methods provide maximal value to biomedical research. The working group’s activities culminated in a December 2023 report to the Advisory Committee with seven specific recommendations on how NIH should work with the community to support development and use of NAMs. In her statement,  Bertagnolli noted how the recommendation build on an existing foundation of NIH investment in NAMs projects as NIH continues to advance the validation and regulatory implementation of NAMs in partnership with other federal agencies via ICCVAM.

On January 25, the NIH Council of Councils approved the concept for the new NIH Common Fund's Complement Animal Research In Experimentation (Complement-ARIE) program. Complement-ARIE will speed the development, standardization, validation, and use of human-based NAMs, and significantly advance understanding of human health and disease by providing a range of ready and standardized biomedical research models. Developing these models will require expertise in disease research, personalized medicine, and in screening therapeutics for safety and effectiveness. Complement-ARIE will bring together experts in these areas via efforts such as technology development projects and centers, resource coordinating centers, validation networks, community engagement and training, and strategic key-partner engagement. 

The United Kingdom National Center for the 3Rs (NC3Rs) invites 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 Friday, February 16. 

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.

Registration is open for upcoming workshops on “Meeting the Requirements of the Animal Welfare Act” offered by the U.S. Department of Agriculture (USDA) Animal Welfare Information Center. Live virtual workshops will be offered on Wednesday and Thursday, March 6-7, from 1:00-4:00 p.m. EST each day, and on Wednesday and Thursday, May 8-9, from 1:00-4:00 p.m. EDT 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 an introductory video, is available on the Center’s website.

The Alternatives Research and Development Fund (ARDF) awards grants to support research projects that develop alternative methods to advance science and to replace or reduce animal use. ARDF is currently accepting applications for this year’s grants, with proposals due April 19. 

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 proposals that use in silico and in vitro methods with human cells or tissues.

The International Foundation for Ethical Research (IFER) is accepting applications for 2024-2025 graduate fellowships. Applications are due Tuesday, April 30. For more information, visit the IFER website or contact [email protected].

These one-year grants of up to $15,000 support projects by master’s and PhD students in the sciences. Eligible projects will address development, acceptance, and implementation of innovative scientific methodologies that advance science and 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. NICEATM scientist Helena Hogberg is on the scientific advisory board of IFER.

A new paper in Regulatory Toxicology and Pharmacology describes biomonitoring of volunteers in southern Brazil to assess exposure to triazole fungicides. Results indicate a health risk associated with environmental triazole exposure, highlighting the importance of biomonitoring. Luiz Paulo de Aguiar Marciano, the lead author of the study, is currently a visiting fellow with NICEATM.

Marciano et al. 2024. Biomonitoring and risk assessment of human exposure to triazole fungicides. Reg Toxicol Pharmacol. https://doi.org/10.1016/j.yrtph.2024.105565.

Videos are now available from the August 2023 3Rs Symposium co-hosted by the National Institutes of Health (NIH) Office of Laboratory Animal Welfare, the U.S. Department of Agriculture Animal Welfare Information Center, the Johns Hopkins University (JHU) Department of Molecular and Comparative Pathobiology, and the JHU Center for Alternatives to Animal Testing. In addition to presentations on improving animal welfare, topics discussed included replacement of non-human primates and performance assessment of microphysiological systems.

The National Center for Biotechnology Information (NCBI) is hosting a codeathon on “Building Transparent ML/AI Solutions to Advance Biological Research.” The event will address the growing need for collaboration, knowledge sharing, and exploration of the transparent deployment of machine learning (ML) and artificial intelligence (AI) in research. The codeathon will be held virtually from February 26 to March 1; those interested in participating should register by Monday, January 15.

This event will bring together developers, data scientists, and tech enthusiasts to build equitable and transparent ML/AI solutions that tackle various problems in healthcare, research, education, and more. During the week-long codeathon, teams of 5-10 people will collaborate virtually to design and build innovative solutions that promote fairness, transparency, and accountability in AI/ML algorithms and models. Teams that want to leverage NCBI databases or publicly available scientific data for deep learning are encouraged to apply. Priority will be given to projects that make use of NCBI data and tools. At the end of the event, teams will present their work to each other, representatives from the National Institutes of Health (NIH), and the public. Team products will be made publicly available, and participants will be encouraged to co-author a joint manuscript and share their work online and at conferences .

A January 29 webinar will focus on “Implementing Computational Approaches for Regulatory Safety Assessments” This webinar is the latest in the Communities of Practice series presented by NICEATM on behalf of ICCVAM.

Computational toxicology methods can be useful for generating bioactivity predictions for chemicals for which limited toxicity data are available. They can also help users understand and interpret large, diverse bioactivity data sets, or predict how a chemical might behave in the body. However, users with limited experience with such methods may find it difficult to use them or interpret their outputs, or even understand how the methods could be applied in a specific context.

This webinar will cover how to establish confidence in computational approaches for regulatory applications. Ongoing activities and key insights will be described in three presentations by speakers from the U.S. government and the private sector focusing on applications of tools such as structure-based models to predict chemical bioactivity and pharmacokinetic models to support understanding of chemical metabolism and disposition.

The abstract deadline for the 2024 MPS World Summit has been extended to January 20. Abstracts are invited on the topic of new developments in microphysiological systems (MPS) and applications of MPS. Abstracts will be evaluated for their alignment with the four meeting tracks:

• Track 1: MPS for (patho)physiology
• Track 2: Modeling, fabrication and manufacturing of MPS
• Track 3: Validation, qualification, meeting regulatory requirements
• Track 4: MPS in toxicology and drug development

Abstracts must be in English and no more than 350 words. Submitters should indicate their preferred track.

The 2024 MPS World Summit will be held June 10-14 in Seattle. Registration for the summit is open and discounted registration is available through March 15. 

A January 17 webinar on “Advancing Research: Reducing Animal Models in Experiments,” addresses the pressing need to reduce reliance on animal models in scientific research, particularly in light of the FDA Modernization Act 2.0. The event encompasses an overview of the current research environment, exploring innovative alternatives such as virtual control groups, organ-on-a-chip technology, and in vitro methods. The webinar is sponsored by the Pistoia Alliance.

The agenda includes:

• Overview of the Current Environment
• Virtual Control Groups
• Organ-on-a-Chip Technology
• In Vitro Method Alternatives
• The Validation of Alternative Approaches
• Poll and Q&A

In a Federal Register notice published January 9, the U.S. Environmental Protection Agency (EPA) announced a new framework for identifying eye irritation and corrosion hazards for new chemicals reviewed under the Toxic Substances Control Act (TSCA).

With this new framework, EPA will place increased weight on data from non-animal test methods that are more reproducible and provide results more relevant to humans. This will streamline the decision-making process and increase efficiency through a standard process for EPA to use each time it evaluates eye irritation or corrosion hazards test data. The new framework supports EPA’s mandate under TSCA to promote the development and implementation of alternative test methods and strategies that can provide information on chemical hazards without animal testing. This framework also supports EPA’s ongoing efforts to reduce the use of animal testing and make the Agency’s review of new chemicals more efficient, helping to bring new chemicals to market more quickly while protecting human health

Defined approaches for skin sensitization (DASS) identify potential chemical skin sensitizers by integrating data from multiple non-animal tests based on human cells, molecular targets, and computational model predictions using standardized data interpretation procedures. While several DASS are internationally accepted by regulatory agencies, the data interpretation procedures vary in logical complexity, and manual application can be time-consuming or prone to error. A new paper describes the DASS App, an open-source web application to facilitate user application of three regulatory testing strategies for skin sensitization assessment. 

To et al. 2024. Computational application of internationally harmonized defined approaches to skin sensitization: DASS App. BMC Bioinformatics. https://doi.org/10.1186/s12859-023-05617-1

The South Korea Ministry of Food and Drug Safety (MFDS) has issued “MFDS NAMs Report: Regulatory Acceptance and Research Outcomes,” which describes past activities and current status of promoting and implementing NAMs for safety assessment. South Korea participates with ICCVAM and other international partners in the International Cooperation on Alternative Test Methods (ICATM). The MFDS report is also posted on the NICEATM ICATM webpage.

The Government of Canada intends to develop a strategy to guide continued efforts to replace, reduce, or refine the use of vertebrate animals when addressing chemical assessment data needs under the Canadian Environmental Protection Act, 1999 (CEPA). While this strategy is initially being developed within the context of CEPA, it could be applicable, where relevant and possible, to other Government of Canada regulatory programs. Canada will work closely with national and international partners on the development, standardization, and implementation of fit-for-purpose new approach methodologies (NAMs).

People living in Canada, Indigenous partners, and scientific and international stakeholders are invited to submit feedback on this notice by January 29. Input is sought on the following key questions:

• What are your views on these proposed key elements?
  • Identification and prioritization of needs for NAMs for use in chemical regulatory programs under CEPA.
  • Advancement of NAMs research and data generation to support methods development, standardization, and translational research.
  • Promotion of harmonization, collaboration, communication, and engagement.
  • Implementation of NAMs to reduce reliance on vertebrate animal toxicity testing in chemical regulatory programs under CEPA.
• What other elements or considerations, if any, should be included in the strategy to replace, reduce or refine vertebrate animal testing?
• What else can we do to support the transition towards not relying on vertebrate animals in regulatory decision making?

The Government of Canada Safe Environments Directorate (SED), to support its mandated role to protect the health of Canadians from hazards posed by chemical substances, is compiling a list of qualified companies that have a broad range of expertise in the area of human health risk assessment. Qualified companies will provide scientific services which may include:

• Gathering scientific information for conducting a human health risk assessment.
• Development of methodologies and tools for human health risk assessment.
• Providing scientific expertise and training on human health risk assessments.
• Conducting human health risk assessments (may include exposure assessment or hazard characterization).
• Scientific peer review of assessment reports or scientific manuscripts.
• Consultations on scientific issues relating to the conduct of human health risk assessment of chemicals, air and water contaminants, novel substances and contaminated sites.

Responses are requested by January 22.

The Physicians Committee for Responsible Medicine (PCRM) is accepting applications for its Summer Immersion on Innovative Approaches in Science, to be held May 30-June 1 in Washington DC. This workshop is designed to educate the next generation of scientists committed to advancing science ethically using nonanimal methods for research and testing. The program provides an overview of in vitro, in silico, and in chemico approaches and their many applications in basic, translational, and regulatory science to replace animals. Attendees will participate in scientific talks, career development workshops, poster presentations, technology demonstrations, case studies, networking opportunities, and more. Steering committee members include ICCVAM members Warren Casey, National Institute of Environmental Health Sciences, and Suzanne Fitzpatrick, U.S. Food and Drug Administration.

The Summer Immersion welcomes undergraduate and graduate students, post-docs and early-career scientists interested or engaged in academic, industry, or government research in biomedical sciences. Apply by March 15.

Save the date for the next ICCVAM Communities of Practice webinar, to be presented January 29, 2024 on the topic of “Implementing Computational Approaches for Regulatory Safety Assessments.” An agenda and link to register for the webinar will be placed on the webinar information page when available.

Computational toxicology methods can be useful for generating bioactivity predictions for chemicals for which limited toxicity data are available. They can also help users understand and interpret large, diverse bioactivity data sets, or predict how a chemical might behave in the body. However, users with limited experience with such methods may find it difficult to use them or interpret their outputs, or even understand how the methods could be applied in a specific context.

This webinar will discuss how to establish confidence in computational approaches for regulatory applications. Ongoing activities and key insights will be described in three presentations by speakers from the U.S. government and the private sector focusing on applications of tools such as structure-based models to predict chemical bioactivity and pharmacokinetic models to support understanding of chemical metabolism and disposition.

The U.S. Environmental Protection Agency (EPA) has committed to developing and implementing a work plan to reduce the use of animals in chemical testing. EPA will prioritize ongoing efforts and direct existing resources toward activities that will demonstrate measurable impacts in the reduction of animal 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.

EPA is planning its 4th NAMs Conference for Fall 2024 and seeks ideas for topics. Attendees will hear from representatives from EPA and other federal agencies, industry, universities, and international organizations on the state of the science on the development and use of NAMs for chemical safety testing. The deadline to provide input is January 5, 2024.

The California EPA (CalEPA) Office of Environmental Health Hazard Assessment, in collaboration with the Texas A&M Superfund Research Center, is offering a workshop, “Toxicokinetic Tools for Decision Making Using New Approach Methodologies,” Thursday, January 11, 2024 from 12:00 p.m.-7:00 p.m. EST (9:00 a.m. – 4:00 p.m. U.S. Pacific Time). The workshop will be held in the CalEPA Headquarters Building in Sacramento CA, and will also be webcast.

Participants will explore the use of toxicokinetics in applying new approach methodologies (NAMs) to chemical assessments, with a focus on read-across methods and high-throughput tests for accelerating the evaluation of chemicals that lack traditional assessments. Register for the workshop and view a list of speakers/panelists and the agenda on the workshop information page.

A March 2023 workshop explored the feasibility of using historical control data rather than concurrent control groups in animal toxicity studies, which would enable reduction of animal use in these studies. Participants included stakeholders from the FDA, pharmaceutical and chemical industry, academia, contract research organizations, and non-governmental organizations. A report from the workshop summarizes the pros and cons of such a concept and what would have to be done to implement it without threatening the reliability of the study outcome or the resulting human risk assessment.

Golden et al. 2023. Toward implementing virtual control groups in nonclinical safety studies: workshop report and roadmap to implementation. ALTEX. https://doi.org/10.14573/altex.2310041.

The University of Buenos Aires, the Argentine agricultural products company Atanor, and collaborators presented a November 22 virtual workshop on “Alternative Methods for Evaluation of Phytosanitary Products.” NICEATM Director Nicole Kleinstreuer discussed “Progress in Implementing Alternatives for Acute Toxicity Testing.” She was joined by presenters from around the world describing use of new approach methodologies for safety evaluation of crop protection products. A recording of the workshop is now available; note that most presentations were given in Spanish.

AFSA Collaboration has developed a “Master Class in Animal-free Safety Assessment for Cosmetics.” The goal of this class is to build confidence and global capacity in the use of animal-free data in safety decision-making.

A new module on “Global Regulatory Landscape” was released in November. This module focuses on how regulatory requirements impact cosmetic risk assessment in key global markets, including current challenges in implementing animal-free safety assessment and approaches to address them.

The Master Class is designed for stakeholders engaged in cosmetic and chemical safety assessment and regulation, and will be especially useful for:

• Product and chemical safety assessors and regulators.
• Regulatory affairs and compliance specialists.
• Contract research organizations and other GLP laboratories.
• Small and medium enterprises.
• Graduate students.
• Non-governmental organizations.

Course content is based on the principles of next-generation risk assessment, an exposure-led, hypothesis-driven risk assessment approach integrating existing knowledge with in silico, in chemico, and in vitro approaches in a tiered framework identifying situations in which a product or ingredient may be used safely. Students can pick and choose modules based on their interests or view them all. More information is available on the AFSA website.

FDA has published guidance on “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions.” Computational modeling and simulation (CM&S) can be used in a variety of ways in medical device applications, including to perform “in silico” device testing or as part of software embedded in a device. This guidance provides a risk-informed framework for credibility assessment of CM&S used in medical device regulatory submissions. The guidance is intended to promote consistency and facilitate efficient review of medical device submissions, to increase confidence in the use of CM&S in regulatory submissions, and to facilitate improved interpretation of CM&S credibility evidence submitted in regulatory submissions. Publication of the guidance was announced in a November 17 Federal Register notice. 

Abstracts are being accepted for the 2024 MPS World Summit, to be held June 10-14, 2024, in Seattle. Abstracts are invited on the topic of new developments in MPS and applications of MPS. Abstracts will be evaluated for their alignment with the four meeting tracks:

• Track 1: MPS for (patho)physiology
• Track 2: Modeling, fabrication and manufacturing of MPS
• Track 3: Validation, qualification, meet regulatory requirements
• Track 4: MPS in toxicology and drug development

Submit abstracts by December 15. Abstracts must be in English and no more than 350 words. Submitters should indicate their preferred track.

The MPS World Summit is organized by the International MPS Society (IMPSS), which facilitates connection, exchange, and education within the community of MPS developers and users. The IMPSS Early Career Investigators Interest Group is presenting a webinar on “Startups Within the Microphysiological Systems Field: How Should I Start?” Thursday, December 14 at 10:00 a.m. EST. The webinar will feature perspectives from four speakers who have successfully navigated the startup landscape within the MPS field. 

Scientists with the U.S. Food and Drug Administration (FDA) have published an analysis of data from studies that used dogs to test food additives. While the study found that in nearly 40% of studies, the dog data were considered to be decisive to the safety decision, most studies did not rely upon dog studies to set an Acceptable Daily Intake. The study conclusion encourages future research to investigate the use and value of alternative animal models as replacements for the use of a second species in food and color additive safety assessments.

Flannery et al. 2023. Retrospective analysis of dog study data from food and color additive petitions. Reg Toxicol Pharmacol. https://doi.org/10.1016/j.yrtph.2023.105523.

A webinar presented by the U.S. Environmental Protection Agency (EPA) will consider combining use of new approach methodologies (NAMs) and adverse outcome pathways (AOPs) for ecological risk-based screening prioritization. Daniel Villeneuve, EPA Center for Computational Toxicology and Exposure, will present four case studies to illustrate the complementary use of NAMs and AOPs to help prioritize higher tiers of testing and support efficient ecological risk assessment. The webinar is Thursday, December 7 at 11:00 a.m. EST.

Small businesses can learn about applying for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grants at the SBIR/STTR Fall Innovation Conference November 28-29 just outside of Washington, DC. At this event applicants, awardees, and supporters can meet with and learn from SBIR/STTR agency representatives, as well as network with other innovators and supporters from across the country. Participating federal agencies include the Department of Defense, Health and Human Services, National Science Foundation, and the U.S. Environmental Protection Agency.

When registering, use code 23SBIRDSC for a 20% discount when you select the “SBIR/STTR Program Only” registration option. This includes the Keynote Session, SBIR/STTR panel sessions and access to the SBIR Pavilion in the Expo Hall. Registration fees are waived for active duty military personnel; contact [email protected] for more information.

The European Food Safety Agency (EFSA) is developing TKPlate, an online platform that offers a space and a suite of tools for scientists and regulators to model and predict toxicokinetic and toxicodynamic properties of chemicals found in food and feed. TKPlate will support modeling and predicting the toxicity of chemicals and what happens to them inside humans and animals, enabling reduction of animal use for this purpose. A detailed description of the platform is published in an article (Dorne et al.) in the EFSA Journal, available at https://doi.org/10.2903/j.efsa.2023.e211101.

Registration is now open for a webinar on “Accurate evaluation of hepatocyte metabolisms on a nobel oxygen-permeable material with low sorption characteristics,” on Monday, December 11 from 9:00 to 10:00 a.m. EST. This webinar is presented by the American Society for Cellular and Computational Toxicology (ASCCT), the European Society of Toxicology In Vitro, and the Japanese Society for Alternatives to Animal Experiments. To register for the webinar, visit the ASCCT event calendar page and click on the event title in the right sidebar.

Primary cultured hepatocytes are often used to assess hepatic metabolism and toxicity in vitro, but a drawback to this model is the functional deterioration upon isolation due to the lack of a physiological environment. Researchers have reported that culturing hepatocytes in microphysiological systems using polydimethylsiloxane (PDMS) improves the function of isolated hepatocytes by its high oxygen permeability. However, the high chemical sorption property of PDMS has impeded its practical use in drug development. In this webinar, Masaki Nishikawa, University of Tokyo, will describe his group’s evaluations of a new culture material, 4-polymethyl-1-pentene polymer (PMP), comparing it to PDMS and conventional tissue culture polystyrene. Using primary rat hepatocytes, they found that PMP represents a superior alternative to both PDMS and TCPS, making it a promising material for various drug testing systems. High levels of liver function were maintained at least for 1 week on PMP. They also demonstrated that low chemical sorption characteristics and high oxygen permeability of PMP were key factors in both exploiting the potential of primary cultured hepatocytes and performing an accurate evaluation of hepatic metabolism.

The Research Institute for Fragrance Materials (RIFM) will hold its second virtual Annual Science Symposium on November 29. During the four-hour, multi-track symposium, RIFM’s scientists will highlight recently published and ongoing research on fragrance safety. RIFM’s staff will provide details and answer audience questions about its safety assessment program. Topics to be discussed will include clustering of fragrance ingredients by safety profile, ensuring the safe use of natural complex substances, RIFM’s Environmental Framework 2.0, and application of NAMs. A preliminary program and link to register are available at https://events.hubilo.com/weve-got-it-covered/register.

The National Institutes of Health (NIH) Common Fund is accepting proposals for projects to catalyze the development, standardization, validation, and use of new approach methodologies (NAMs) that will more accurately model human outcomes. The Complement-Animal Research In Experimentation (Complement-ARIE) challenge is soliciting entries for new methods and approaches that will complement, make more efficient, or in some cases replace traditional animal models, transforming the way biomedical researchers conduct basic, translational, and clinical sciences.

The NIH Common Fund has committed $1,000,000 to this challenge, which will be divided among up to 20 winners. To be eligible to win prizes, participants must be led by a citizen or permanent resident of the United States or be an entity incorporated in and maintaining a primary place of business in the United States. Applicants should submit a 15-page white paper demonstrating how their project will:

• Innovate in vitro modeling.
• Power in silico models and simulations.
• Explore in chemico systems.
• Integrate NAMs.

Applications are due January 11, 2024.

The U.S. Environmental Protection Agency (EPA) has five openings for biologists/toxiologists in the Office of Pollution Prevention and Toxics. These are onsite positions at locations in Washington, DC, and Research Triangle Park, NC. Applicants must be U.S. citizens. Apply by Friday, November 17.

Registration is now open for a webinar on “ToxPi: visual analytics for communicating integrated models from environmental health and toxicology,” on Wednesday, January 10, 2024. This webinar is presented by the Applied Genetic Toxicology Special Interest Group of the Environmental Mutagenesis and Genomics Society.

The ToxPi (Toxicological Prioritization Index) framework provides tools for integrating, visualizing, and communicating complex data sets. ToxPi was originally developed for assessing the relative toxicity of multiple chemicals or stressors by synthesizing complex toxicological data to provide a single comprehensive view of the potential health effects. It continues to be used for profiling chemicals and has since been applied to other types of “sample” entities, including geographical data and other profiling applications. In this webinar, David Reif, National Institute of Environmental Health Sciences, will introduce the ToxPi methodology and survey recent applications in risk assessment and decision support. The presentation will describe new methodological extensions, including a bidirectional ToxPi and artificial intelligence/machine learning-guided weight optimization, and introduce integrated software applications beyond those available in previous releases.

Presentation slides and videos from the webcast of the September 21-22 meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) are now available. Meeting minutes are currently being reviewed by the committee and will be posted on this page when they are available. A summary of the meeting was published this month in the National Institute of Environmental Health Sciences (NIEHS) Environmental Factor newsletter.

Next year’s SACATM meeting will be held on September 17-18, 2024, at the National Institutes of Health in Bethesda, MD. Meeting information will be posted on the NTP "Upcoming SACATM Meetings" webpage as it becomes available. Information about other upcoming and recent NICEATM and ICCVAM events is posted on NICEATM's "3Rs Meetings, Workshops & Webinars" webpage.

Registration is now open for the 5th International Conference on Developmental Neurotoxicity Testing, to be held April 7-10, 2024, in Konstanz, Germany. The conference theme is “Developmental Neurotoxicity: A Call for Implementation of New Approach Methodologies for Regulatory Purposes”.

This conference will bring together diverse stakeholders from around the globe, including research scientists, regulators, industry representatives, academics, and pediatricians to discuss the actions to take for improving development of time-efficient and human-relevant predictive in vitro developmental neurotoxicity (DNT) methods and boosting their use for risk assessment and regulatory decision making.

A discount for early registration is available through January 7, 2024. Registrants may also submit abstracts for poster presentations; abstracts are due March 1, 2024. 

The U.S. Environmental Protection Agency (EPA) has committed to developing and implementing a work plan to reduce the use of animals in chemical testing. EPA will prioritize ongoing efforts and direct existing resources toward activities that will demonstrate measurable impacts in the reduction of animal 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. Planning for the next EPA New Approach Methodologies (NAMs) conference, to be held in the fall of 2024, is underway. This will be a hybrid meeting in Research Triangle Park, NC. Attendees will hear from representatives from EPA, other federal agencies, industry, universities, and international organizations on the state of the science on the development and use of NAMs for chemical safety testing.

EPA is soliciting ideas for topics to highlight during the 2024 EPA NAMs Conference. To provide input, please complete a survey by January 5, 2024.

The second webinar in the EPIC series on the use of NAMs in risk assessment, co-organized by the U.S. Environmental Protection Agency (EPA), PETA Science Consortium International, Institute for In Vitro Sciences, and the California Department of Pesticide Regulation (CPDR), will cover “Development and application of NAMs workflows and tools.” The webinar will be held on Wednesday, November 29 from 11:00 a.m.–12:30 p.m. EST. The speakers include Alistair Middleton, Unilever, on “Evaluating a systemic safety toolbox for use in NGRA,” and Tara Barton-Maclaren, Health Canada, on “In vitro bioactivity workflows for enhanced prioritization and rapid screening of existing chemicals in Canada: a journey of insights and learnings.”

The EPIC series covers timely topics on the use of NAMs for risk assessment within EPA and CDPR. The series began in August 2023 and will continue quarterly. 

NICEATM and U.S. Environmental Protection Agency (EPA) scientists and collaborators have published results from testing 29 agrochemical formulations in defined approaches (DAs) for eye irritation. Hazard classification concordance was assessed using orthogonal validation rather than direct concordance analysis with the historical in vivo rabbit eye data, the standard used for agrochemical formulations in some countries. The in vitro and ex vivo methods used in the DAs were demonstrated to be as or more fit for purpose and reliable and relevant than the in vivo rabbit test, thereby increasing scientific confidence in the use of these DAs for assessing eye corrosion/irritation potential of agrochemical formulations.

van der Zalm et al. 2023. Defined approaches to classify agrochemical formulations into EPA hazard categories using EpiOcularTM reconstructed human corneal epithelium and bovine corneal opacity and permeability assays. Cut Ocular Toxicol. https://doi.org/10.1080/15569527.2023.2275029

Registration is now open for a webinar on “Application of cell painting for chemical hazard evaluation in support of screening-level assessments,” on Monday, November 27 from 10:00 to 11:00 a.m. EST. This webinar is presented by the American Society for Cellular and Computational Toxicology (ASCCT) and the European Society of Toxicology In Vitro. To register for the webinar, visit the ASCCT event calendar page and click on the event title in the right sidebar.

Presenter’s abstract: Jo Nyffeler, Helmholtz Centre for Environmental Research – UFZ. “Cell painting” is an imaging-based, high-throughput method to obtain phenotypic information of individual cells. Initially used mainly in pharma industry for hit discovery, cell painting can be applied to other research questions, such as safety assessment. This presentation will describe the applicability of cell painting and how it can be used to obtain in vitro potency estimates for chemicals that can be compared to exposure information, and can be used to group chemicals with similar mode-of-actions. Cell painting highlights critical differences that would not have been apparent when only looking at structural information. This webinar will give an overview of possible application of cell painting in the context of safety assessment.

Registration is now open for a webinar on “The role of mixtures for effect-based trigger values in water quality assessment,” on Tuesday, November 14 from 10:00 to 11:00 a.m. EST. This webinar is presented by the American Society for Cellular and Computational Toxicology (ASCCT) and the European Society of Toxicology In Vitro. To register for the webinar, visit the ASCCT event calendar page and click on the event title in the right sidebar.

Presenter’s abstract: Beate Escher, Department of Cell Toxicology, Helmholtz Centre for Environmental Research – UFZ, Leipzig, Germany. Bioanalytical tools have been applied for monitoring of water quality worldwide for several decades. Most research has focused on surface waters and domestic and industrial wastewaters. Cell-based bioassays have been used for benchmarking drinking and surface water quality as well as assessing treatment efficacy of wastewater and advanced water treatment. A lack of trigger values and interpretation guidelines has hampered greater adoption of bioanalytical tools for (regulatory) monitoring applications. This presentation will give an overview on the derivation of effect-based trigger (EBT) values for human health (drinking water) and the environment (surface water). These EBT are designed to be protective for mixture effects stemming from chemical cocktails in water.

The Lush Prize is the largest prize fund in the non-animal testing sector, with a prize fund of £250,000 to support initiatives to end or replace animal testing. The Lush Prize Conference provides an opportunity for scientists, campaigners and other experts from around the world to exchange ideas and information about the movement to end animal testing.

The 2024 Lush Prize Conference will be held on Tuesday, November 14 as an online event focusing on the theme of “How can roadmaps help bring forward an end to all animal use in chemical safety testing?” The Conference is free and open to the public. NICEATM Director Nicole Kleinstreuer will present in a session on “Learning from experience of roadmaps around the world.” 

The Physicians Committee for Responsible Medicine (PCRM) is seeking a Nonanimal Research Advocacy Intern for the spring 2024 semester. Applicants should currently be enrolled in undergraduate or graduate studies in the life sciences, public health, or toxicology and interested in advancing nonanimal methods of research and testing. The internship is a volunteer, part-time, and remote opportunity.

The intern will assist the Research and Regulatory Affairs team with developing resources to advance the field of nonanimal methods of research and testing. Learning opportunities may include:

• Supporting the growth and development of early-career researchers advancing 21st-century science programs.
• Developing a database of academic laboratories in North America using nonanimal, new approach methodologies (NAMs).
• • Assisting with planning for the Summer Immersion on Innovative Approaches in Science, including program development and promotion. If interested, the intern will be provided with travel funds for attending the program in summer 2024.
• Establishing a catalog of student groups and graduation organizations to invite to apply to the Summer Immersion program.

Applications are being accepted on a rolling basis for the 2024 spring semester.

The following job opportunities are now available at the U.S. Environmental Protection Agency (EPA). Applicants must be U.S. citizens.

• Biologist/toxicologist, New Chemicals Division, Office of Pollution Prevention and Toxics. Position is onsite in the Washington, DC, area. Apply by October 16.
• Computational toxicologist, Center for Computational Toxicology and Exposure. Position is onsite in the Research Triangle Park, NC, area. Apply by November 10.

Abstracts are being accepted for the 2024 MPS World Summit, to be held June 10-14, 2024, in Seattle. Abstracts are invited on the topic of new developments in microphysiological systems (MPS) and applications of microphysiological systems. Abstracts will be evaluated for their alignment with the four meeting tracks:

• Track 1: MPS for (patho)physiology
• Track 2: Modeling, fabrication and manufacturing of MPS
• Track 3: Validation, qualification, meet regulatory requirements
• Track 4: MPS in toxicology and drug development

Submit abstracts by December 15. Abstracts must be in English and no more than 350 words. Submitters should indicate their preferred track.

A preliminary program for the Summit is available, as are sponsorship opportunities. Click on the “Subscribe to Our Newsletter" button on the meeting website to have meeting updates emailed to you.

Registration is open for the upcoming webinar, “The New OECD (Q)SAR Assessment Framework: Details and Examples,” on Monday, October 30 from 9:00-11:00 a.m. EDT. This webinar is presented by the American Society for Cellular and Computational Toxicology (ASCCT) and the European Society of Toxicology In Vitro. To register for the webinar, visit the ASCCT event calendar page and click on the event title in the right sidebar.

This webinar will provide an overview of the Organisation for Economic Co-operation and Development (OECD) (Quantitative) Structure-Activity Relationship ((Q)SAR) Assessment Framework (QAF), systematic and harmonized framework for the regulatory assessment of (Q)SAR models, predictions, and results based on multiple predictions. The primary audience of this document is regulatory authorities and their stakeholders, but all (Q)SAR users are encouraged to refer to the QAF.

The webinar will start with an overview of the project. Then, two talks will cover the main aspects of the framework, the assessment of models and of results based on individual or multiple predictions. The presentations will include examples of assessments using the checklists in the OECD document for using (Q)SARs for regulatory purposes. 

In an October 2 Federal Register notice, the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs announced a public meeting of the Pesticide Program Dialogue Committee (PPDC) on November 15 and 16. The meeting will be held in person and limited opportunities for virtual participation will be offered. The PPDC provides a public forum to discuss a wide variety of pesticide regulatory developments and reform initiatives, evolving public policy and program implementation issues associated with evaluating and risks from the use of pesticides. 

An October 27 webinar will discuss “AI Use for Regulatory Application: Using Machine Learning to Reduce Animal Use in Toxicology.” The webinar will be presented at 10:00 a.m. EDT.

Webinar presenters will describe how they use machine learning to reveal molecular mechanisms, simulate testing, estimate toxicity values, and harness available information. Presenters include ICCVAM member David Reif, National Institute of Environmental Health Sciences, and NICEATM collaborator Weida Tong, U.S. Food and Drug Administration National Center for Toxicological Research.

The webinar is hosted by the Physicians Committee for Responsible Medicine as part of its NAMs Use for Regulatory Application continuing education program to promote the use of new approach methodologies (NAMs) within regulatory frameworks. 

The National Institutes of Health (NIH) Common Fund is planning a program to catalyze the development, standardization, validation, and use of new approach methodologies (NAMs) that will more accurately model human outcomes. As part of the Complement-Animal Research In Experimentation (Complement-ARIE) strategic planning process, the Office of Strategic Coordination intends to publish a prize competition announcement to solicit entries for new methods and approaches that would complement, make more efficient, or in some cases replace traditional animal models, transforming the way biomedical researchers conduct basic, translational, and clinical sciences.

A September 21 notice provides potential solvers with available details about the Complement-ARIE Challenge. Publication of the Challenge announcement and launch of the submission portal are planned for November 7. Potential applicants are encouraged to sign up for the Complement-ARIE listserv to receive updates about the Challenge. The estimated submission deadline for submissions is January 11, 2024.

The NIH Common Fund intends to award up to $1,000,000 to up to 20 winners (up to $50,000 each). To be eligible to win prizes, participants must be led by a citizen or permanent resident of the United States or be an entity incorporated in and maintaining a primary place of business in the United States.

The AFSA (Animal-free Safety Assessment) Collaboration has developed a “Master Class in Animal-free Safety Assessment for Cosmetics.” The goal of this class is to build confidence and global capacity in the use of animal-free data in safety decision-making. The Master Class is designed for stakeholders engaged in cosmetic and chemical safety assessment and regulation, and will be especially useful for:

• Product and chemical safety assessors and regulators.
• Regulatory affairs and compliance specialists.
• Contract research organizations and other GLP laboratories.
• Small and medium enterprises.
• Graduate students.
• Non-governmental organizations.

Course content is based on the principles of next-generation risk assessment, an exposure-led, hypothesis-driven risk assessment approach integrating existing knowledge with in silico, in chemico, and in vitro approaches in a tiered framework identifying situations in which a product or ingredient may be used safely. Students can pick and choose modules based on their interests or view them all. Sign up and preview webinars on the class portal website.

The U.S. Environmental Protection Agency (EPA) will offer training on use of its high-throughput toxicokinetics (httk) package in two 2-hour virtual sessions on Wednesday, November 8, and Thursday, November 9, from 10:00 a.m.-12 noon EST both days.

Toxicokinetics (TK) provides a bridge between toxicity and exposure assessment by predicting tissue concentrations due to exposure. Traditional TK methods can be resource-intensive and require chemical-specific data. EPA’s freely available httk R package uses data from in vitro high-throughput screening datasets, which can be used to fill data gaps in traditional TK methods. This training will familiarize those engaged in chemical exposure assessment, including researchers, regulators, and health and environmental safety professionals, with EPA’s generic and open-source models and data for TK, including reverse dosimetry and physiologically based pharmacokinetic modeling for internal dose calculation. The training will include an application-oriented presentation and demonstration (Day 1), as well as opportunities for participatory learning and engagement (Day 2).

To get notified of future training opportunities and other activities, sign up for EPA email updates, or contact [email protected].

The Institute for In Vitro Sciences (IIVS) and PETA Science Consortium International will present a two-part webinar series on in vitro phototoxicity testing. Part 1 includes a methodological overview on phototoxicity assays. Part 2 covers case studies from industry applying the methods.

• Webinar 1 - In Vitro Phototoxicity Testing Part 1: Methodological Overview, Wednesday, October 4, 9-10:00 a.m. EDT. Presenters: Allison Hilberer, IIVS, and Satomi Onoue, University of Shizuoka.
• Webinar 2 - In Vitro Phototoxicity Testing Part 2: Application Case Studies, Wednesday, October 11, 10-11:00 a.m. EDT. Presenters: Gretchen Ritacco, Research Institute for Fragrance Materials, and Edward Chikwana, Corteva. 

The Johns Hopkins Center for Alternatives to Animal Testing (CAAT) is accepting proposals for the 2023 Reduction and Humane Education Grants.

• The Reduction Grant focuses on research projects that help reduce animal use by identifying areas of research and testing where animal models lack reproducibility and translational value. This grant is intended for researchers who conduct systematic reviews, meta-analyses, or citation analyses of animal studies or similar work with the goal to reduce animal use in science.
• The Humane Education Grant is given for the development of animal-free training resources for veterinary, medical or laboratory courses. The grant is intended for educators and training material developers with the goal to foster respect and compassion for animals.

Each grant includes prize money of $6,000 U.S. Preference will be given to studies that have broad applicability and a potentially large impact. The proposal should include a detailed description of the planned study and its anticipated outcomes. It should provide sufficient detail so reviewers can understand what is being proposed and how the data will be evaluated and used. Review criteria include innovation, likelihood of obtaining publishable data, and quality of study design. Apply by November 15.

The National Institutes of Health (NIH) is gathering input to inform a potential Common Fund research program called “Complement Animal Research in Experimentation (Complement-ARIE)” aimed at development, standardization, validation, and use of new approach methodologies (NAMs). These NAMs are intended to more accurately model human biology and will complement or in some cases replace traditional animal models, transforming the way NIH does basic, translational, and clinical science.

NIH is hosting three listening sessions to gather input on the Complement-ARIE concept and potential opportunities for partnership, collaboration, and coordination among multiple sectors of government, industry, academia, and nongovernmental organizations. Three sessions are planned, with each one targeted for a specific interest group:

• Monday, October 2, 12 noon-2:00 p.m. EDT: industry and academic partners.
• Monday, October 16, 12 noon-2:00 p.m. EDT: nongovernmental organization representatives.
• Monday, October 30, 12 noon-2:00 p.m. EDT: U.S. government and international partners.

For more information and to register for a listening session, visit the project page on the National Institute of Environmental Health Sciences website.

A June 2022 workshop organized by the National Center for Advancing Translational Sciences (NCATS) and collaborators considered applications of 3D tissue models for the study of viruses with pandemic potential. The report of the workshop provides an overview of the use of existing 3D tissue models for antiviral drug development, practical advice, best practices, and case studies about the application of available 3D tissue models to infectious disease modeling. NICEATM Director Nicole Kleinstreuer participated in the workshop and is a coauthor of the report.

Jordan et al. 2023. Report of the Assay Guidance Workshop on 3-Dimensional Tissue Models for Antiviral Drug Development. J Infectious Diseases. https://doi.org/10.1093/infdis/jiad334. 

A new publication by NICEATM scientists and German government collaborators announces the availability of a large high-quality set of human skin sensitization data. This data set, which has already supported international acceptance of a non-animal strategy for identifying skin sensitizers, is now available to any researcher for developing evaluating additional test methods.

Computational and cell-based methods show promise for replacing animals for chemical safety testing. However, high-quality data, preferably from humans, are needed to demonstrate that new methods can reliably identify whether a chemical could be toxic to humans. The data set described in this paper is the largest set of human data ever assembled for the purpose of evaluating non-animal approaches for chemical safety testing.

Strickland et al. 2023. A database of human predictive patch test data for skin sensitization. Arch Toxicol. https://doi.org/10.1007/s00204-023-03530-3. 

A new publication by NICEATM scientists and international collaborators provides a comprehensive review of acute systemic toxicity testing requirements for international jurisdictions including Brazil, Canada, China, the European Union, Japan, South Korea, Taiwan, and the United States. Chemical sectors included in the review were cosmetics, consumer products, industrial chemicals, pharmaceuticals, medical devices, and pesticides. The understanding of international regulatory requirements for acute systemic toxicity testing provided by this review will inform strategies for the development, acceptance, and implementation of non-animal alternatives.

Strickland et al. 2023. International regulatory uses of acute systemic toxicity data and integration of new approach methodologies. Crit Rev Toxicol. https://doi.org/10.1080/10408444.2023.2240852. 

NICEATM will present two webinars next week on non-animal models for gastrointestinal absorption and toxicity. Those registering to view any webinar will be registered to view all subsequent webinars. All webinars will be presented from 9:00-10:00 a.m. EDT.

Webinar 1 on Monday, September 18, will focus on de-risking systemic toxicity and models for absorption and pharmacokinetics. Speakers and topics for this webinar will be:

• Maureen Gwinn, U.S. Environmental Protection Agency, “Development of New Approach Methodologies (NAMs) for Decision-Making.”
• Steven Musser, U.S. Food and Drug Administration, “The Importance of Identifying Regulatory Gaps Prior to Tool Development.”

Webinar 2 on Wednesday, September 20, will focus on gastrointestinal models for toxicity. Speakers and topics for this webinar will be:

• George Kass, European Food Safety Authority, “The Gut as a Target Organ and Barrier: Challenges and Opportunities for NAMs in Chemical Risk Assessment.”
• José Vicente Tarazona, Spanish National Environmental Health Centre, Instituto de Salud Carlos III, “NAMs as Tools for Mechanistic Understanding of Gastrointestinal Tract Toxicity.”

A third webinar on October 6 will focus on models to evaluate potential allergenicity. These webinars provide background information for an October 11-12 workshop on the state of the science of new approach methodologies to predict gastrointestinal tract absorption and toxicity. 

A preliminary agenda is available for the meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) on Thursday, September 21 and Friday, September 22. The meeting will be at the Research Triangle Park, NC, campus of the National Institute of Environmental Health Sciences (NIEHS) and will also be webcast. The registration deadline to attend in person and to present oral statements is Thursday, September 14, 5:00 p.m. EDT. Registration is not required to view the webcast. 

Those planning to attend in person should be aware that the NIEHS cafeteria will be closed. Food and beverage options at NIEHS will be limited to vending machines. Attendees should be prepared to use cash or credit card for purchases and to be escorted to vending machines during meeting breaks. Lunch options outside NIEHS are available, and the lunch break will allow those who choose to leave campus for lunch to do so.

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) progress toward implementing the recommendations of the ICCVAM Strategic Roadmap in the areas of replacing acute toxicity tests and advancing validation approaches; (2) the role of new approach methodologies (NAMs) in improving environmental health protection; and (3) update on NICEATM computational resources.

Registration is open for the upcoming webinar, “Application of Cell Painting for Chemical Hazard Evaluation in Support of Screening-Level Assessments,” on Thursday, September 28 from 10:00-11:00 a.m. EDT. This webinar is presented by the American Society for Cellular and Computational Toxicology (ASCCT) and the European Society of Toxicology In Vitro. To register for the webinar, visit the ASCCT event calendar page and click on the event title in the right sidebar.

Jo Nyffeler, Helmholtz Centre for Environmental Research, will outline the applicability of cell painting using multiple examples. Cell painting is an imaging-based, high-throughput method to obtain phenotypic information of individual cells. Initially used mainly in pharma industry for hit discovery, cell painting can be applied to other research questions such as safety assessment. The Center for Computational Toxicology and Exposure at the U.S. Environmental Protection Agency has applied cell painting to environmental chemicals and explored its use for screening-level chemical hazard evaluation of environmental chemicals.

The U.S. Environmental Protection Agency (EPA) will offer training on use of its high-throughput toxicokinetics (httk) package in two two-hour virtual sessions on Wednesday, November 8, and Thursday, November 9, from 10:00 a.m.-12 noon EST both days. To get updates on the training, sign up for EPA email updates or contact [email protected].

Toxicokinetics (TK) provides a bridge between toxicity and exposure assessment by predicting tissue concentrations due to exposure. Traditional TK methods can be resource-intensive and require chemical-specific data. EPA’s freely available httk R package uses data from in vitro high-throughput screening datasets, which can be used to fill data gaps in traditional TK methods. This training will familiarize those engaged in chemical exposure assessment, including researchers, regulators, and health and environmental safety professionals, with EPA’s generic and open-source models and data for TK, including reverse dosimetry and physiologically based pharmacokinetic modeling for internal dose calculation. The training will include an application-oriented presentation and demonstration (Day 1), as well as opportunities for participatory learning and engagement (Day 2) .

Nominations are being accepted through December 1 for the 2024 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.

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

The European Partnership for Alternatives to Animal Testing (EPAA) invites the submission of solutions based on NAMs to inform the development of a future classification system for systemic toxicity of human health based on the activity and potential systemic availability of chemicals.

• The NAM-based classifications should reflect levels of concern related to, but not synonymous with, the current classification system addressing systemic toxicity.
• The NAMs do not need to literally predict the outcomes of animal studies, nor are they expected to reproduce existing classifications.

Resources on the project webpage include a recording of a July 13 webinar describing the project.

EPAA will provide a reference list of approximately 150 chemicals, along with identifiers reflecting three levels of concern. The number of chemicals in each class (High, Medium, and Low) will also be provided, but participants will not be told which chemical belongs to which class. Submitters will be expected to propose prototype NAM-based solutions that categorize some or all of the chemicals on the reference list. In this initial prototype phase, specific data generation is not necessarily required, but rather ideas for a NAM-based classification scheme can be explored using existing information. EPAA will provide a reporting template, including guidance. Interested persons can email [email protected] to request updates on the designathon.

NICEATM and collaborators are organizing an October 11-12 workshop “Trust Your Gut: Establishing Confidence in Gastrointestinal Models, an Overview of the State of the Science and Contexts of Use.” The workshop will be at the Porter Neuroscience Research Center at the National Institutes of Health in Bethesda, MD, and will also be webcast. A series of three webinars presented from September 18-October 6 will introduce the three principal topics of the workshop: (1) de-risking systemic toxicity and understanding absorption/pharmacokinetics; (2) gastrointestinal toxicity; and (3) evaluating potential allergenicity. Registration for both the webinars and the workshop is now open.

The gastrointestinal tract (GIT) is one of the most common chemical exposure routes. Orally administered substances are first metabolized by the GIT, and both parent substance and metabolites can be absorbed through and potentially damage the GIT. Since toxicity in the GIT can result in systemic toxicity, screening of potential toxicants using GIT models could provide an efficient way to identify potential systemic toxicants. Even in the absence of toxicity, understanding GIT absorption can inform the potential for toxicity in other target organs. While in vivo rodent studies have historically been used for understanding GIT absorption and toxicity, animal models have well-documented differences from humans. Mammalian cell culture methods of varying complexity can be used in a variety of applications including rapid response, metabolism/metabolite secretion, and microbiome studies, and generating data for pharmacokinetic modeling. This workshop will examine the state of the science for using new approach methodologies (NAMs) to predict GIT absorption and toxicity.

The third Pan-American Conference for Alternative Methods, organized by the Johns Hopkins University Center for Alternatives to Animal Testing (CAAT), will be held Sunday, August 27 from 12:30 to 3:00 p.m. EDT. This is a satellite meeting of the 12th World Congress on Alternatives and Animal Use in the Life Sciences and will be held in Room 211 of the Niagara Convention & Civic Centre in Niagara Falls, Ontario, Canada.

This conference brings scientists from South, Central, and North America together to further alternatives to animal testing and build collaboration for the exchange of scientific ideas. This year, the conference will focus on allowing attendees to reconnect post-pandemic and share new developments in the governmental commitment for the alternatives.

Speakers for the event:

• Welcome Remarks: Charu Chandrasekera, Canadian Centre for Alternatives to Animal Methods – 12:30 p.m.
• Pan American: History and Updates, Thomas Hartung (CAAT) and Kristie Sullivan (Institute for In Vitro Sciences) – 12:35 p.m.
• Updates on Regulations: Nicole Kleinstreuer (NICEATM) and Jose Mauro Granjeiro (Brazilian National Institute of Metrology, Standardization, and Industrial Quality [INMETRO]) – 1:15 p.m.
• Governmental Structure and Dissemination: Luciene Balottin (INMETRO) and Maria Laura Gutierrez (Argentina National Scientific and Technical Research Council) – 2:00 p.m.
• Open Discussion and Closing Remarks – 2:45 p.m.

On August 18, NICEATM released version 4.0.1 of the Integrated Chemical Environment (ICE). ICE provides data and tools to help query, review, and interpret toxicological data, predictions, and tools.

Key features implemented in ICE 4.0.1 are:

• Availability of population-level exposure predictions across multiple pathways through the ICE Search tool in addition to the ICE REST API and the ICE In Vitro to In Vivo Extrapolation tool.
• Functional use categories added to the ICE Chemical Characterization tool.
• A new "Curated Product Use Explorer" in the ICE Chemical Characterization tool that expands and improves upon the former "Consumer Use Explorer."
• Improved support for chemical name searching in all ICE tools.
• Harmonization of structure and data fields in the dermal irritation/corrosion data set to make data computationally accessible and facilitate interoperability on the ICE user interface.
• New Chemical Quick Lists:
  • Mixtures and Formulations in ICE.
  • ToxCast Phase I, Phase II, and e1k.
• Further development of data visualizations and query summaries for ICE Search tool results (beta version).

Presentations describing features available in ICE 4.0.1 and planned for future releases will be given next week at the 12th World Congress on Alternatives and Animal Use in the Life Sciences. 

The Physicians Committee for Responsible Medicine and InSphero are pleased to announce the deadline has been extended to Tuesday, September 5 to apply for the Human Advanced In Vitro Model Initiative (HUMAIN) Award. This award will provide materials, funds, and support for up to five laboratories to expand access to and accelerate the uptake of human-specific nonanimal approaches. Awards may cover disease modeling, predictive safety and efficacy screening, or mechanistic and investigative safety testing.

Each award includes InSphero technology or services, training and customized support from InSphero experts, and funding for scientific promotion of results. Five awardees will receive:

• $20,000 U.S. toward InSphero technology or services.
• Access to an inaugural one-day training course in the U.S. or Switzerland, with a $1000 U.S. travel grant per award.
• Two hours of monthly consulting with InSphero experts.
• Up to $2000 U.S. in travel grants to present findings at scientific conferences.
• $2500 U.S. toward open access publication fees.

The Coalition to Illuminate and Address Animal Methods Bias (COLAAB) presents “The Author Guide for Addressing Animal Methods Bias in Publishing” in an interactive virtual event on Wednesday, November 8 from 9:00-10:30 a.m. ET. COLAAB is an international collaboration of researchers and advocates gathering information evidence of animal methods bias and mitigating its detrimental effects on biomedical research.

There is growing recognition that animal methods bias, the preference for animal-based methods where they are not necessary or where nonanimal methods are suitable, can impact the likelihood or timeliness of manuscript acceptance for publication. The guide was developed to aid researchers in responding to animal methods bias from manuscript reviewers. 

A comprehensive review paper on in vitro to in vivo extrapolation (IVIVE) with authors from eight ICCVAM member agencies and the European Union has been named by the journal Toxics as one of its “Hot Review Papers” for 2021-2022. 

The IVIVE review 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. Xiaoqing Chang (Inotiv, contractor supporting NICEATM) was first author on the paper.

Chang et al. 2022. IVIVE: facilitating the use of in vitro toxicity data in risk assessment and decision making. Toxics 10(5):232. https://doi.org/10.3390/toxics10050232.

A draft program is available for the annual meeting of the American Society for Cellular and Computational Toxicology on October 23-25, and registration for the meeting is open. Discounted registration is available through Friday, September 15. ASCCT is still accepting abstracts for poster presentations. Abstracts may discuss any aspect of advancement of in vitro or computational toxicology methodologies. Submit abstracts by Friday, September 1.

NICEATM and ICCVAM scientists will be giving the following platform presentations at ASCCT:

• ICCVAM co-chair John Gordon (U.S. Consumer Product Safety Commission): “Implementing the ICCVAM Roadmap: Establishing Confidence”
• Aswani Unnikrishnan (Inotiv, contractor supporting NICEATM): “Expanding PBPK Modeling to Predict Chemical Distribution in Brain and Adipose Tissues”
• Alexandre Borrel (Inotiv, contractor supporting NICEATM): “ChemMaps.com v2.0: Exploring the Environmental Chemical Universe”

NICEATM and ICCVAM scientists are coauthors on nine other abstracts that have been accepted for oral or poster presentations. NICEATM scientists will also present at two continuing education courses:

• Open-access Data and Computational Tools to Investigate Chemical Bioactivity
• Putting Theory into Practice: Using In Vitro and Computational New Approach Methodologies in Human-relevant Risk Assessment

A full list of NICEATM and ICCVAM activities will be available on the NTP website next month.

Michigan State University’s Center for Research on Ingredient Safety Science Day 2023 will be held on September 12 from 1:00-5:00 p.m. This year’s theme is “New Approach Methodologies in Support of Weight of Evidence Assessments for Regulatory Decisions.” This is a hybrid meeting and registration is free.

This event features experts from academia, industry, governmental, and non-governmental organizations. Presenters will cover modern testing and evaluation methods, generative artificial intelligence (AI) applications, and innovative risk assessment frameworks. A panel discussion on new approach methodologies in immunotoxicology for weight-of-evidence assessments will follow presentations. Register by August 25.

During the 12th World Congress, conference sponsor Unilever will host the World Café on the evening of Tuesday, August 29. The World Café will feature a Science Slam at which scientists will give five-minute presentations on their work to a non-expert audience. Presenters are invited to be creative and incorporate props, music, and other performance elements into their talks. Apply to present in the Science Slam by August 17.

A webpage is available listing activities of NICEATM and ICCVAM agencies at the 12th World Congress on Alternatives and Animal Use in the Life Sciences, to be held August 27-31 in Niagara Falls, Ontario, Canada. The page includes downloadable files of selected abstracts.

• NICEATM Director Nicole Kleinstreuer and ICCVAM member Suzanne Fitzpatrick (principal agency representative, U.S. Food and Drug Administration) will co-chair a platform session “Chems-on-Chips: MPS for Organ Tox & Chemical Risk Assessment.”
• ICCVAM member David Reif (NIEHS) will co-chair a platform session “On the Runway: Interactive Predictive Tox Models.”
• Kleinstreuer will co-chair platform sessions “Artificial Intelligence (AI): Current Advancements and Applications in Advancing the 3Rs” and “Meeting at the Falls: ICATM Partner Updates.”
• Fitzpatrick will co-chair a platform session “What’s in the Mix? New Approach Methods for Chemical Mixtures Risk Assessment.”
• Ruchir Shah, Sciome (contractor supporting NICEATM), and Aswani Unnikrishnan, Inotiv (contractor supporting NICEATM) will co-chair a platform session “Predictive Toxicology: Data, Development, Delivery, and Application.”
• NICEATM and ICCVAM will present nearly two dozen oral presentations at 17 platform sessions, and over a dozen posters at sessions throughout the meeting. 

The NIEHS Small Business Program is accepting applications for its Applicant Assistance Program (AAP). This free, 10-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 January 5, 2024, 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 August 4. Submit applications by September 12, 5:00 pm ET.

A preliminary agenda is available for the meeting of SACATM to be held on Thursday, September 21 and Friday, September 22. Registration deadline for the onsite meeting and to present oral statements is September 14, 5:00 p.m. ET. Registration is not required to view the webcast. 

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) progress toward implementing the recommendations of the ICCVAM Strategic Roadmap in the areas of replacing acute toxicity tests and advancing validation approaches; (2) the role of new approach methodologies in improving environmental health protection; and (3) update on NICEATM computational resources.

A draft document, “Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies,” is now available for public comment. Public comments on the document are being accepted through September 5. Please send comments to Amber Daniel at [email protected].

This document updates a model for validation and regulatory acceptance of new and alternative test methods originally described in the 1997 ICCVAM report, “Validation and Regulatory Acceptance of Toxicological Test Methods.” The ICCVAM Validation Workgroup was established in 2021 to update the 1997 document and align it with the principles articulated in the 2018 ICCVAM publication, “A Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States.”

ICCVAM invites public comments from all stakeholders on the draft document. Commenters should include their name, mailing address, telephone number, email address, and affiliation and/or sponsoring organization if applicable. Please refer to guidelines for public comments submitted to NTP. All comments received will be posted on the NTP website and identified by the individual’s name and affiliation and/or sponsoring organization

NIH will hold a virtual workshop on approaches, challenges, and opportunities relating to the development of Novel Alternative Methods (NAMs). The workshop will feature discussion on identifying incentives and barriers to successful implementation of NAM technologies. Speakers will include NICEATM Director Nicole Kleinstreuer and ICCVAM members Elijah Petersen (National Institute of Standards and Technology), Donna Mendrick (U.S. Food and Drug Administration), and Jessie Carder (U.S. Department of Agriculture). The workshop will be Monday, August 21 from 9:00 a.m. to 5:00 p.m. EDT. Viewers are asked to preregister to view the workshop.

In a related Request for Information published June 12, NIH requested public input on challenges and opportunities for the further development and use of NAMs in biomedical research. Building on recommendations of the Advisory Committee to the Director on high priority areas for NAMs development, NIH requested input on the following areas:

• Use of NAMs to study human biology, circuits, systems, and disease states.
• Approaches for catalyzing the development and validation of NAM technologies.
• Strategies for maximizing the research value of NAM technologies.

NIH will accept responses through August 16. 

On July 4, OECD published two new test guidelines and 19 updated or corrected test guidelines.

One new Test Guideline, Test No. 444A, describes the IL-2 assay, an in vitro assay intended to be used as a part of a battery to determine immunotoxic potential of chemicals. The other new test guideline, Test No. 126, describes a method to measure hydrophobicity of nanomaterials. Among the updated and corrected test guidelines are tests describing non-animal approaches for assessing skin sensitization, eye irritation, endocrine activity, and phototoxicity.

In addition to the test guidelines, OECD also added two documents to its Series on Testing and Assessment: “Initial Recommendations on Evaluation of Data from the Developmental Neurotoxicity (DNT) In Vitro Testing Battery” and a “Workshop Report on How to Prepare the Test Guidelines for Emerging Technologies.” NICEATM scientist Helena Hogberg is a member of the OECD Expert Group on the DNT in vitro battery that contributed to the document, which describes application of data from 17 different in vitro assays to inform an assessment of the DNT potential of a chemical.

The Physicians Committee for Responsible Medicine and InSphero are pleased to offer the Human Advanced In Vitro Model Initiative (HUMAIN) Award to five laboratories to expand access to and accelerate the uptake of human-specific nonanimal approaches. Awards may cover disease modeling, predictive safety and efficacy screening, or mechanistic and investigative safety testing.

Each award includes InSphero technology or services, training and customized support from InSphero experts, and funding for scientific promotion of results. Five awardees will receive:

• $20,000 U.S. toward InSphero technology or services.
• Access to an inaugural one-day training course in the U.S. or Switzerland, with a $1000 U.S. travel grant per award.
• Two hours of monthly consulting with InSphero experts.
• Up to $2000 U.S. in travel grants to present findings at scientific conferences.
• $2500 U.S. toward open access publication fees.

The deadline to apply is Wednesday, August 23. 

A new webinar series on the use of new approach methodologies (NAMs) in risk assessment is being co-organized by the U.S. Environmental Protection Agency (EPA), PETA Science Consortium International, Institute for In Vitro Sciences, and the California Department of Pesticide Regulation (CDPR). The “EPIC” series will cover timely topics on the use of NAMs for risk assessment within EPA and CDPR. The series will begin in August and will continue quarterly.

The first webinar will be Wednesday, August 23 from 11:00 a.m.–12:30 p.m. ET. Charles Kovatch and Tim Shafer, both from EPA, will discuss recent updates from the Organisation for Economic Co-operation and Development, including information about an in vitro test battery for developmental neurotoxicity. 

The Department of Health and Human Services has released the 2023-24 SBIR and 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:

• Informatics tools and platforms to organize, store, retrieve, extract, and integrate information on exposures and health effects data.
• Application of machine learning methods and natural language processing for extracting and integrating diverse data types and for generating causal networks from experimental data and public knowledgebases.
• Adapting or developing new methods and tools for automating environmental health-related literature and systematic reviews, including article selection and prioritization, data extraction, study quality evaluation, and summarization of for environmental health impacts.
• Mid- to high-throughput and high-content assays using in vitro or tissue chip technologies to screen and rank toxicity of emerging engineered nanomaterials for cytotoxicity, genotoxicity, and metabolic toxicity.
• Human and rodent organotypic culture models and microphysiological systems.
• Approaches to characterize and integrate key molecular and cellular changes related to effects of toxicant exposures in carcinogenicity, developmental neurotoxicity, or cardiotoxicity.
• Screening systems that incorporate genetic diversity into toxicology testing.
• Short-term tests, assays, or systems designed specifically to reduce or replace existing regulatory animal studies for acute toxicity (oral or inhalation), reproductive or developmental toxicity, carcinogenicity, or ocular toxicity.

The first deadline for applications under this announcement is September 5. Complete information about eligibility, applying, and deadlines is available at:

• PA-23-230, SBIR opportunities: https://grants.nih.gov/grants/guide/pa-files/PA-23-230.html
• PA-23-232, STTR opportunities: https://grants.nih.gov/grants/guide/pa-files/PA-23-232.html 

The United Kingdom National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs) will honor this year’s winner of their International 3Rs Prize at an online event on Thursday, July 20, at 11:00 a.m. EDT. Lisa Wagar, University of California – Irvine, was awarded the prize for her animal-free tonsil organoid model of respiratory infection and immunity. Wagar used this model to investigate how immunity develops after vaccinations. The event will also recognize Alex Frangi and Ali Sarrami-Foroushani, University of Leeds, for their “highly commended paper” describing the first in silico clinical trial for a medical device.

The International 3Rs Prize is sponsored by GlaxoSmithKline. NC3Rs collaborates with NICEATM on projects including leadership of the Microphysiological Systems for COVID Research working group.

A new article summarizes an October 2021 symposium on “Challenges in Public Health Protection in the 21st Century: New Methods, Omics and Novel Concepts in Toxicology.” The paper also describes outcomes of a subsequent workshop at which experts analyzed the technological readiness and conceptual and regulatory hurdles facing increased application of NAMs for chemical safety assessment. NICEATM director Nicole Kleinstreuer is a coauthor of the paper.

Schmeisser et al. 2023. New approach methodologies in human regulatory toxicology – Not if, but how and when! Environment International. https://doi.org/10.1016/j.envint.2023.108082.

The Organisation for Economic Co-operation and Development (OECD) is exploring how to adapt its Test Guidelines Programme to encompass emerging technologies. A December 2022 workshop on this topic identified incentivizing participation in validation studies as a key issue. To address this issue, OECD needs information from stakeholders on operational and financial aspects of validation.

OECD invites stakeholders to provide information on this topic via a survey. Results from the survey will be used to develop materials for a stakeholders’ workshop in December 2023. The survey will be available through September 15.

The U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs invites nominations to be considered for its Pesticide Program Dialogue Committee (PPDC). The PPDC provides EPA with advice on a range of pesticide regulatory developments and reform initiatives, evolving public policy, and program implementation issues associated with evaluating and reducing risks from pesticide use. Nominees will be considered from a range of stakeholder groups representing industry, academia, government, and nongovernmental organizations. The PPDC usually meets twice a year, and members may be asked to serve on work groups to develop recommendations to address specific policy issues. Nominations must be received by August 10.

The journal Human Genomics is calling for submissions to a planned collection of articles on "New Approach Methodologies to Address Population Variability and Susceptibility in Human Risk Assessment." This collection will focus on the development and use of new approach methodologies (NAMs), such as in vitro, in silico, and small organism models, that address variability or factors associated with susceptibility to adverse effects of chemical exposure. Population-level variability and susceptibility can arise from numerous factors such as genetics, life stage, concurrent stressors, and co-morbidities. Papers are encouraged to deal with human health risk assessment and feature research developing, refining, or implementing NAMs with consideration of population variability or susceptibility.

NICEATM scientists Helena Hogberg-Durdock (National Institute of Environmental Health Sciences) and Kim To (Inotiv, contractor supporting NICEATM) are guest editors for the collection. Submit articles by December 31.

NICEATM director Nicole Kleinstreuer will speak at a webinar “(R)Evolution in Validation: Establishing Scientific Confidence in NAMs” on July 18 at 11:00 a.m. Eastern Time. The webinar is being presented by ScitoVation. 

Kleinstreuer will discuss a framework comprising essential elements to establish scientific confidence in NAMs for regulatory use. Key concepts include:

• Understanding the needs of regulatory decision makers will facilitate development of relevant NAMs.
• Flexible, fit-for-purpose approaches to establishing confidence in NAMs are necessary to ensure regulatory consideration and implementation.
• Examples will be presented that embody the key concepts involved in applying such a scientific confidence framework.

Kleinstreuer’s work is centered on domestic and international efforts to develop novel testing, modeling, and analysis strategies that provide more rapid, mechanistic, and human-relevant predictions of potential environmental chemical hazards. 

The University of Birmingham seeks candidates for faculty positions in its newly established Centre for Environmental Research and Justice:

• Assistant Professor of Environmental Health Data: job reference 101769
• Assistant Professor of New Approach Methodologies: job reference 101745
• Assistant Professor of Biomedical Semantics: job reference 101744
• Assistant Professor of Environmental Impact on Health: job reference 101749
• Assistant Professors of Environmental Law and Environmental Advocacy (two positions): job reference 10147

To apply, visit the University of Birmingham jobs website and search on the job reference number. Apply by July 17.

Presentation slides and video are available from the May 18-19 ICCVAM Public Forum. At this meeting, representatives from 12 federal agencies discussed activities directed toward reducing and replacing animal use for chemical safety testing. Representatives from six non-governmental stakeholder groups also presented oral statements at the meeting. Statements welcomed agencies’ recognition that they need to clearly communicate which non-animal tests would be accepted. They encouraged engagement with communities concerned about chemical exposures, and asked ICCVAM to consider how new approach methodologies, or NAMs, might be used to better protect populations at particular risk for harmful effects of chemicals. Commenters also welcomed ICCVAM’s development of an updated validation guidance document on criteria to establish confidence in new methods for regulatory application. 

Video is also available from a May 31-June 1 virtual workshop, “From Research to Readiness: Advancing Research and Regulatory Acceptance of MPS for Infectious Disease Applications,” co-hosted by NICEATM and the United Kingdom National Centre for the Replacement Refinement & Reduction of Animals in Research. Workshop participants explored the use of human-based organ models known as microphysiological systems (MPS) or “tissue chips” for understanding and developing treatments for emerging infectious diseases. Speakers representing international organizations, government agencies, and private laboratories described MPS models and their applications to disease research. 

• Meeting of the Scientific Advisory Committee on Alternative Toxicological Methods, September 21-22, National Institute of Environmental Health Sciences, Research Triangle Park, NC. Information and a link to register will be available soon on the meeting webpage.
• Workshop to examine the state of the science for NAMs models of the gastrointestinal tract and the context of use of such models for regulatory consideration, to be held at the Porter Neuroscience Center at the National Institutes of Health in Bethesda, MD, on October 11-12. A link to information about the workshop and planned preceding webinar series will be placed when available on the NICEATM 3Rs Meetings, Workshops, and Webinars webpage.

Registration is now open for the 12th Annual Meeting of the American Society for Cellular and Computational Toxicology (ASCCT) on October 23-25 in Silver Spring, MD. The meeting will feature presentations, panel discussions, and activities designed to support and engage members, students, and scientists in the practice and advancement of in vitro and computational toxicology. The third day of the meeting will be devoted to continuing education courses. Information about the meeting, including a general schedule, registration costs, and links to register and submit abstracts, is available on the meeting webpage. Discounted early registration is available through September 15.

Abstracts are still being accepted for oral and poster presentations. Submission of proposals addressing scientific advancement, regulatory policy elements, cross-sector collaboration, optimization and validation, application, weight-of-evidence, and other relevant topics is encouraged. General information about abstract submission is available on the meeting information page; submit abstracts by Friday, July 14.

The U.S. Consumer Product Safety Commission (CPSC) seeks a recognized expert in computational toxicology or chemistry to fill a temporary 2-4 year position. The Chief Toxicologist (Computational) will serve as the Commission's recognized expert and consultant to plan, develop, and implement projects and activities for the CPSC Hazard Identification and Analysis and Hazard Assessment and Reduction Programs. Candidates should be familiar with how to apply combinations of experimental data and mechanistic computational chemistry models and chemical grouping approaches and assessment methods to evaluate the effects of environmental chemicals on human health. The position is located in Bethesda, MD, with occasional travel required, and applicants must be U.S. citizens. Apply by July 12.

An agenda is available for the ASPIS Open Symposium, to be held in person in Ljubljana, Slovenia, on September 14-15 in conjunction with the 57th Congress of the European Societies of Toxicology. The Animal-free Safety Assessment of Chemicals: Project Cluster for Implementation of Novel Strategies, or ASPIS, is an umbrella project to coordinate efforts among European Union Horizon 2020 projects to advance sustainable, animal-free, and reliable chemical risk assessment. Speakers from academia, industry, and government agencies will describe activities to advance application of NAMs in a variety of sectors. Attendance is free for ASPIS cluster members and €60 for non-members. Register by August 31.

The European Partnership for Alternatives to Animal Testing (EPAA) invites the submission of solutions based on new approach methodologies (NAMs) to inform the development of a future classification system for systemic toxicity of human health based on the activity and potential systemic availability of chemicals.

• The NAM-based classifications should reflect levels of concern related to, but not synonymous with, the current classification system addressing systemic toxicity.
• The NAMs do not need to literally predict the outcomes of animal studies, nor are they expected to reproduce existing classifications.

EPAA will provide a reference list of approximately 150 chemicals, along with identifiers reflecting three levels of concern. The number of chemicals in each class (High, Medium, and Low) will also be provided, but participants will not be told which chemical belongs to which class. Submitters will be expected to propose prototype NAM-based solutions that categorize some or all of the chemicals on the reference list. In this initial prototype phase, specific data generation is not necessarily required, but rather ideas for a NAM-based classification scheme can be explored using existing information. EPAA will provide a reporting template, including guidance. Interested persons can email [email protected] to request updates on the designathon.

A virtual workshop on June 29-30 will assess the current state of the science of using signatures from “omic” data types to link environmental exposures to cancer. Participants will explore potential uses of such signatures of carcinogenic exposure to aid cancer prevention. Computational biologists, epidemiologists, exposure scientists, and cancer researchers will identify key questions, knowledge gaps, and opportunities for the field. While the meeting will focus on linking exposure signatures to cancer, a range of technologies, models, and exposures will be considered. The workshop is organized by the National Institute of Environmental Health Sciences (NIEHS) and National Cancer Institute (NCI). 

The Department of Defense (DoD) report, “Future Directions Workshop: Advancing the Next Scientific Revolution in Toxicology,” is now available on the Office of the Under Secretary of Defense for Research and Engineering (OUSD R&E) website. Click the icon to download the report.

The Future Directions Workshop series, sponsored by the Basic Research Office of the OUSD R&E, examines emerging research and engineering areas that are most likely to transform future technology capabilities. These workshops are designed primarily around small-group breakout sessions and large-group discussions for scientists and engineers from academia, national laboratories, and industry. An intent is to encourage participants to express their perspectives and outlooks over areas of rapid progress in fundamental research and shed insight on three overarching questions:

• How might the research impact science and technology capabilities of the future?
• What is the possible trajectory of scientific achievement over the next 10-15 years?
• What are the most fundamental challenges to progress?

Interested persons can submit ideas for future workshop topics on the OUSD R&E website.

Join the International MPS Society and be part of a growing community of MPS developers and users. The society’s first annual business meeting, which will be held at the June 26-30 MPS World Summit in Berlin, will install the board and establish bylaws. Membership fees will be waived for 2023.

Benefits to society members include:

• Staying informed about recent developments in the field through the annual MPS World summit, virtual webinars, and conferences.
• Receiving newsletters with summaries of events and news on publications and general updates about the field.
• Access to an education program for hands-on training and workshops.
• Opportunity to participate in three regional chapters and interest groups.

Registration is open for the upcoming webinar, “PARC Consortium and Human Biomonitoring,” on Friday, June 23 from 10:00-11:30 a.m. EDT. This webinar is presented by the American Society for Cellular and Computational Toxicology (ASCCT) and the European Society of Toxicology In Vitro. To register for the webinar, visit the ASCCT event calendar page and click on the event title in the right sidebar.

Greta Schoeters, University of Antwerp, and Mirjam Luitjen, Netherlands National Institute for Public Health and the Environment, will discuss “Human biomonitoring to support risk assessment and chemical policies in Europe: results from HBM4EU.” Human biomonitoring (HBM) measures chemicals or their metabolites directly in human tissues or fluids and hence aggregates chemical exposure from different sources and intake routes. HBM provides a picture of real-life exposure to chemicals, which is essential information for hazard characterization and chemical risk assessment. This presentation will discuss a coherent HBM framework to track progress towards reducing pollution levels to no longer be harmful to health by 2050. HBM4EU has set up a laboratory network to produce comparable high quality analytical data, provide wide access to data, and facilitate interpretation of results by developing indicators and human biomonitoring guidance values. The HGM4EU project demonstrated not only regulations but clear strategies are needed to prevent further pollution on the human body.

Recordings and other materials from this webinar will be posted on the ASCCT webinar archive shortly after the webinar’s close.

NIH seeks public input on challenges and opportunities for the further development and use of NAMs in biomedical research. Building on recommendations of the Advisory Committee to the Director on high priority areas for NAMs development, NIH requests input on the following areas:

• Use of NAMs to study human biology, circuits, systems, and disease states.
• Approaches for catalyzing the development and validation of NAM technologies.
• Strategies for maximizing the research value of NAM technologies.

Responses must be received by August 16.

FDA has finalized the guidance document, “Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals.” The purpose of this guidance is to assist sponsors in the nonclinical evaluation of the immunotoxic potential of drug products and biopharmaceuticals.

The guidance addresses evaluation of topical pharmaceuticals for skin sensitization potential. Specifically, the guidance states that, for individual chemicals, “FDA will consider a battery of studies (e.g., in silico, in chemico, in vitro) that have been shown to adequately predict human skin sensitization with an accuracy similar to existing in vivo methods.”

In a May 30 press release, the European Chemicals Agency (ECHA) announced that it has published its fifth report on the use of alternatives to testing on animals for the Regulation for Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). The report finds that progress is being made in the increased use of alternatives to gather data on the properties of substances, in place of animal testing. The most common applications include testing waivers and data-based approaches to predicting chemical properties, such as read-across, modeling, or weight-of evidence analyses. However, there has been a notable increase in the use of in vitro test methods, which involve studies with cells, tissues, or organs. These are used specially to obtain data for skin corrosion/irritation, serious eye damage/eye irritation and skin sensitization. 

The U.S. Consumer Product Safety Commission (CPSC) has updated its Animal Testing web page. It has been re-designed to be more user friendly and have direct access to necessary information and documents. 

The U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration (PHMSA) and the Occupational Safety and Health Administration (OSHA) will hold a hybrid public meeting on Wednesday, June 21. The purpose of the June 21 meeting is to consider public comments and gather information in advance of:

• The 62nd session of the United Nations Sub-Committee of Experts on the Transport of Dangerous Goods on July 3-7.
• The 44th session of the United Nations Sub-Committee of Experts on the Globally Harmonized System of Classification and Labelling of Chemicals on July 10-12.

Specific information about the OSHA meeting will be posted when available on the OSHA website. Specific information on the PHSMA meeting and links to access the conference call will be posted when available on their International Program Overview page under Upcoming Events. General information about both meetings, including specific information about all attendance options, is available in a May 24 Federal Register notice.

Interested parties may submit written comments by July 2. Details on submitting written comments are available in the Federal Register notice.

If you are going to attend in person you must register with PHMSA. 

The Environmental Health Language Collaborative (EHLC) will present its next webinar, “Methods2AOP: An International and Interdisciplinary Effort to Strengthen the Role of Test Methods in the Adverse Outcome Pathway (AOP) Framework.” on Thursday, June 1, from noon-1:00 p.m. ET. Clemens Wittwehr, group leader in the Systems Toxicology Unit of the European Commission’s Joint Research Centre, will present collaborative work on the Methods2AOP project. Anna Maria Masci, National Institute of Environmental Health Sciences (NIEHS) will describe how ontologies and controlled vocabularies are being applied in the project. No registration is required.

EHLC is a NIEHS-supported community-driven initiative to advance integrative environmental health research by developing and promoting adoption of a harmonized language. More information about EHLC and links to join its email list and view past webinars and workshops are available on its home page.

The Methods2AOP project is an international effort to annotate assay data according to internationally accepted guidance to better relate these assays to key events in AOPs. The goal is to facilitate the incorporation of assays into AOP-based defined approaches for chemical safety testing, which will in turn support increased regulatory uptake of these approaches. NICEATM supports the Methods2AOP project along with the U.S. Environmental Protection Agency and other partners. 

The Physicians Committee for Responsible Medicine (PCRM) will present a webinar on “Using NAMs to Solve Regulatory Challenges: Quantitative Investigations of PFAS Chemicals” on Friday, May 26 from 10:00-11:30 a.m. EDT. This is Session 2 of the Using New Approach Methodologies (NAMs) to Solve Regulatory Challenges (NURA) series, “DyNAMic Discussions: The Future is Already Here.” Agenda and materials from past webinars are available on the DyNAMic Discussions learning portal page.

The May 26 webinar will feature the following speakers and presentations:

• A Human Health Based Guidance Value for Perfluorooctanoic acid – A NAM Based Approach: George Loizou, HSE Science and Research Centre, and Arthur de Carvalho e Silva, University of Birmingham. Loizou is a computational toxicologist with over 37 years’ experience in quantitative, mechanistic, chemical toxicology. Silva is Computational Toxicology Fellow at the University of Birmingham and a member of Prof. Mark Viant and Prof. John Colbourne research groups.
• Quantitative In Vitro To In Vivo Extrapolation for the PFAS Family: A Comparison With Dietary Exposure: Stella Fragki, esqLABS GmbH: Fragki is a human toxicologist who is passionate about promoting the use of alternatives to animal testing in chemical safety.

Registration is now open for a webinar, “The Latest in Liver Toxicity Assessment In Vitro,” on Wednesday, May 24 from 10:30-noon EDT. The webinar is hosted by the American Society for Cellular and Computational Toxicology (ASCCT) and the European Society for Toxicology In Vitro. To register, visit the ASCCT events calendar page and click on the webinar title under the “Upcoming Events” heading in the right sidebar.

Presenters’ abstracts:

• Liver Spheroids as an In Vivo Like Human In Vitro System for Prediction of Nonalcoholic Steatohepatitis (NASH), Drug Metabolism, and Drug-Induced Hepatotoxicity: Magnus Ingelman-Sundberg, Karolinska Institutet. Liver toxicity is a significant contributor to safety failures in drug development. This lecture will explore recent applications of liver spheroids for analyzing drug-induced liver toxicity, evaluating the disposition and metabolism of low clearance drugs, and developing treatments for metabolic and infectious liver diseases.
• In Vitro Prediction of Liver Toxicity Using Adverse Outcome Pathways: Mathieu Vinken, Vrije Universiteit Brussel. Many adverse outcome pathways (AOPs) and AOP networks related to liver toxicity have been introduced over the past decade. This webinar will focus on the development and practical validation of an AOP network mechanistically describing the accumulation of noxious bile acids in the liver induced by chemical compounds, including pharmaceutical drugs, food additives, and cosmetic ingredients. It will be demonstrated how this AOP network can serve as the conceptual basis for reliable in vitro detection and prediction of chemical-induced cholestatic liver injury.

NICEATM and collaborators are planning a workshop to examine the state of the science for new approach methodologies (NAMs) models of the gastrointestinal tract (GIT) and the context of use of such models for regulatory consideration. The workshop will be held in person at the Porter Neuroscience Center at the National Institutes of Health in Bethesda, MD, on October 11-12. A webinar series to provide background information for the in-person workshop is planned for September.

The GIT is one of the most common chemical exposure routes, and toxicity to the GIT typically results in systemic toxicity. Even in the absence of GIT toxicity, understanding gut absorption provides insight into systemic exposure levels that inform upon the potential for toxicity in other target organs. In vivo rodent studies have historically been used for understanding both GIT absorption and toxicity, but they have well documented anatomical, physiological, and biochemical differences from humans. The goal of this workshop is to consider the state of the science of mammalian cell culture models and other NAMs in the context of regulatory needs for assessing GIT exposure and toxicity.

NICEATM requests nominations of topics and speakers for the workshop and preceding webinars. Topics could include, but are not limited to:

• NAMs to evaluate GIT toxicity.
• NAMs to evaluate GIT absorption and metabolism.
• How GIT toxicity models might integrate the microbiome.
• Current use of GIT NAM models, including context of use.
• Integrating human genetic diversity into GIT NAM models.

To nominate a topic and/or speaker, please contact Amber Daniel at [email protected] by Friday, June 30.

NICEATM and collaborators will present a May 31-June 1 virtual workshop focused on advancing microphysiological systems (MPS) for understanding and treating infectious diseases. “From Research to Readiness: Advancing Research and Regulatory Acceptance of Microphysiological Systems for Infectious Disease Applications” will facilitate discussion and collaboration about current regulatory approaches and to raise awareness of opportunities for accelerating the integration of MPS models in the regulatory framework.

The workshop will feature presentations on MPS models for infectious disease research and where they are in terms of readiness as well as presentations from international regulators. There will be opportunities for registered participants to ask clarifying questions about the presentations during the event, as well as opportunities for group discussion.

The workshop is being organized by the Microphysiological Systems for COVID Research (MPSCoRe) working group, which was organized to coordinate the use of MPS to reduce animal use in studies of COVID-19 and other infectious diseases. 

An upcoming webinar, “Time for a Change: Evidence-Based Approaches for the Biological Safety Assessment of Medical Devices," examines the problems with current medical device biological safety assessment approaches and suggests that evidence-based strategies could be the solution. The webinar will be hosted live and available on-demand Thursday, May 25 at 2:30 p.m. ET. The webinar is presented by The Scientist magazine and sponsored by Sartorius.

In the webinar, Ron Brown, Director, Risk Science Consortium, discusses:

• The problems associated with current approaches used to assess the biological safety of medical devices.
• The development of an evidenced-based toxicology (EBT) approach for assessing the validity of new and existing testing strategies.
• How to incorporate data-driven methods into a streamlined workflow for medical device safety assessment.
• The implications of this proposed approach for patients, test method developers, medical device manufacturers, and regulatory agencies.

Brown is a board-certified toxicologist with 35 years of experience in regulatory toxicology and risk assessment, including over 20 years spent at FDA.

The Advanced Research Projects Agency for Health (ARPA-H) is seeking unique and creative ideas on how to best collaborate with FDA to encourage and incentivize public-private partnerships in the health ecosystem, with the goal of accelerating better health outcomes for everyone. Review the full Request for Information: Accelerating Innovation through ARPA-H and FDA Collaboration and instructions on the ARPA-H website.

Topics of interest include:

• New and innovative models to accelerate pre-competitive development of platform technologies to support downstream development of products resulting from those platform approaches in a disease agnostic manner.
• Strategies to accelerate alternatives to traditional human or animal research for medical product development.
• Case studies on the development of innovative technologies that highlight best practices for using existing FDA regulatory pathways.

Interested persons and organizations are invited to submit comments on or before May 30 by 5 p.m. ET. Early submissions are encouraged as materials will be reviewed on a rolling basis. Submit comments electronically to [email protected] and include “RFI Response: Accelerating Innovation through ARPA-H and FDA Collaboration” in the subject line of the email.

A webinar on non-animal alternatives for endotoxin-focused pyrogen testing will be presented on Thursday, May 4 from 9:30 – 11:30 a.m. EDT. Speakers:

• Bernhard Illes, Microcoat Biotechnologie: “Experiences of a Contract Laboratory - Comparison of the Implementation of LAL and rFC Based Methods for Release Testing.”

• Carmen Marin, Roche: “Method Validation Strategy for Recombinant Factor C in Adherence to 3R Principle for Animal Welfare.”

• Marine Marius, Sanofi: “Recombinant Factor C: from Evaluation to Implementation.”

This webinar concludes the Physicians Committee for Responsible Medicine’s New Approach Methodologies (NAMs) Use for Regulatory Applications (NURA) virtual training series, “Advancing Non-Animal Pyrogens and Endotoxins Testing.” A printable agenda is available through the learning portal; recordings and slides from both webinars in the series will be posted on the learning portal as well.

FDA will hold its virtual 2023 Science Forum Tuesday, June 13 from 9:00 a.m. – 3:30 p.m. EDT and Wednesday, June 14 from 9:00 a.m. – 2:00 p.m. EDT. This event is presented to inform the public about the breadth of research underway at the Agency, and to show how cutting-edge science informs FDA’s regulatory decision-making to protect and promote public health. More information and a link to register are available on the FDA website.

The theme for the 2023 FDA Science Forum, ‘‘Advancing Regulatory Science Through Innovation,’’ will highlight areas of FDA research, including advancing products based on novel technologies, food and cosmetic safety, and tools to effectively use big data.

ICCVAM will hold a public forum Thursday, May 18 from 9:00 a.m. until about 3:30 p.m. EDT and Friday, May 19 from 9:00 a.m. until about 12:30 p.m. An agenda and links to register to attend and to present oral public statements are available on the meeting webpage.

This year’s public forum will be held in person at the Natcher Conference Center, National Institutes of Health, Bethesda, MD, with an option to view remotely. Registration to attend in person is encouraged and will be open through Wednesday, May 17. Registration to view the webcast is required and will be open through the end of the meeting on May 19.

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 Tuesday, May 9.

The public forum 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.

The Johns Hopkins University Center for Alternatives to Animal Testing (CAAT) sponsors the Next Generation Humane Science Award to acknowledge and encourage early-career researchers who focus on replacing animal experiments. The 2023 award will provide a prize of up to $5,000 to recognize the outstanding work of one young scientist. Depending on the number and quality of the applications, a second award of $4,000 may be presented. 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 2013. Applications are due May 31.

A draft program is now available for the ASCCT annual meeting to be held October 23-25 in Silver Spring, MD. The theme of the meeting is “Spotlight on NAMs: Elevating New Approaches in Risk Assessment.” Complete information about the meeting is available on the ASCCT website; registration will open in mid-June.

ASCCT is accepting proposals for continuing education (CE) courses, which will be presented the morning of Wednesday, October 25. Submit proposals by June 2. Proposals should follow these guidelines: 

• Unlike regular oral sessions, CE sessions should address or provide guidance on relatively established science or practice and have specific takeaways or learning objectives. 
• All proposals should fit within the mission of the ASCCT to further the use of in vitro or computational toxicology methodologies.
• Topics that will promote discussion of scientific and regulatory policy elements and cross-sector collaboration are welcomed. 
• Sessions will be two hours long. We suggest 3-4 speakers plus time for Q&A. 
• Participatory elements are welcomed; there may be support from the conference organizers available for participatory elements. 

ASCCT is also accepting abstracts for the annual meeting. Submissions will be evaluated for three types of presentations: oral, poster, and flash poster. Abstracts should relate to the advancement of in vitro or computational toxicology methodologies. While submissions on all relevant topics are welcome, some session topics for this meeting may include:

• Filling knowledge gaps in regulatory submissions 
• Integrating NAMs into decision-making 
• Endocrine system
• Liver 
• Mixtures
• Medical devices 
• NAMs as problem solvers 
• Ecotoxicity/ONE health 

Submit abstracts by July 14.

NIEHS is offering funding to develop resources, new methods, and approaches that can be applied in testing strategies to better understand the role of environmental chemicals in the etiology of neurodevelopmental disorders. Specifically, this funding opportunity will support the development and application of novel and innovative approaches, including NAMs, that expand the framework to evaluate environmental chemicals with neurodevelopmental toxicity potential. Specific objectives to be addressed by the funding include:

• Approaches using human cells or alternative model systems modeling neurodevelopment.
• Focus on one or more developmental neurotoxicity-relevant endpoints to gain reliable knowledge.

Only U.S. small business concerns are eligible for this funding. Letters of intent are due June 7, with funding applications due July 7 by 5:00 p.m. local time of applicant organization. 

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 September 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 April 25; a course outline, eligibility requirements, and key dates are now available. Submit applications by May 22, 5:00 pm EDT.

The National Nanotechnology Coordination Office (NNCO) seeks public input in updating the National Nanotechnology Initiative (NNI) Environmental, Health, and Safety (EHS) Research Strategy. The NNI’s currently strategy was prepared in 2011 with substantial public engagement. Federal agencies participating in the NNI have begun to review the 2011 NNI EHS Research strategy and request input to help inform a revised and updated EHS strategy. 

To that end, NNCO invites interested persons and organizations to submit input  on or before June 2, by 5 p.m. EDT. Input is focused around six specific questions around the NNI’s accomplishments, remaining research gaps, and suggestions for themes and scope of the updated EHS strategy. Participants are encouraged to respond to as many questions as they are able, submit comments only once, and include the Docket ID at the top.

Judy Strickland, Principal Predictive Toxicologist at Inotiv, Inc. (contractor supporting NICEATM), will receive a Rosalind Franklin Society Award in Science for the article “Application of Defined Approaches to Assess Skin Sensitization Potency of Isothiazolinone Compounds” published in 2022 in Applied In Vitro Toxicology. This award is given to the best paper of the year by a woman or underrepresented minority in each of the Mary Ann Liebert Inc. journals in health, medicine, and biotechnology. Winners will be formally announced in July. The paper is available at https://doi.org/10.1089/aivt.2022.0014.

Strickland has 22 years’ experience in evaluating test methods that reduce, refine, or replace animals for regulatory chemical safety testing. She has both coordinated and evaluated national and international validation studies to assess the performance of non-animal methods for assessing chemical toxicity. Her evaluations of non-animal methods for the assessment of chemical skin sensitizers contributed to the first internationally harmonized guideline for non-animal approaches that can replace animal tests to identify skin sensitizers and classify their potency. Strickland serves on the OECD Expert Groups on Skin Sensitization and Defined Approaches for Skin Sensitization. She received her Ph.D. in pharmacology from East Carolina University and is a Diplomate of the American Board of Toxicology.

ICCVAM will hold a public forum Thursday, May 18, and Friday, May 19, from 9:00 a.m. until about 3:00 p.m. EDT both days. This year’s public forum will be held in person at the Natcher Conference Center, National Institutes of Health, Bethesda, MD, with an option to view remotely. Registration to attend in person is encouraged and will be open through Wednesday, May 17. Registration to view the webcast is required and will be open through the end of the meeting on May 19.

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 Tuesday, May 9

The public forum 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.

A webinar on the monocyte activation test and other non-animal alternatives for pyrogen testing will be presented on Friday, April 21 from 9:00 – 11:30 a.m. EDT.

Speakers:

• Thomas Hartung, Johns Hopkins University Center for Alternatives to Animal Testing: “Introduction to Monocyte Activation Test.”

• Ruth Daniels, Janssen: “Analytical Performance Validation of an In-House GMP MAT Method.”

• Ingo Spreitzer, Paul-Ehrlich-Institut: “The New Strategy of the European Pharmacopeia on Pyrogenicity.”

• Molly Ghosh, U.S. Food and Drug Administration Center for Devices and Radiological Health: “Considerations for Qualification of MAT Methods to Support Regulatory Medical Device Submissions.”

The webinar is the first of the Physicians Committee for Responsible Medicine’s New Approach Methodologies (NAMs) Use for Regulatory Applications (NURA) virtual training series, “Advancing Non-Animal Pyrogens and Endotoxins Testing.” A printable agenda is available through the NURA learning portal; the recording and slides from the webinar will be posted on the learning portal as well.

Registration is now open for the 12^th World Congress on Alternatives and Animal Use in the Life Sciences (WC12) on August 27-31 in Niagara Falls, Canada. The meeting will feature over 400 platform and 400 poster presentations organized into about 60 sessions focused on six themes. In addition to all platform and poster sessions, registration covers refreshments and three catered lunches, a gala dinner at a local winery, and other special events. Discounted early registration is available through June 30. General information about registration is available on the WC12 website.

Students and early-career researchers will be eligible for travel awards enabling them to receive refunds for registration, airfare, and accommodations to attend the conference. To be eligible, applicants must have submitted an abstract to WC12. Apply by May 15.

The number of travel awards will depend on availability of sponsorship funds. Sponsorship opportunities are still available; to find out more about how your organization can support student and early-career attendees and other features of the meeting, visit the WC12 website.

EPA's Generalized Read-Across (GenRA) tool is a publicly available, automated approach to make reproducible read-across predictions of toxicity. Read-across is a commonly used data gap-filling technique whereby endpoint information for one substance is used to predict the same endpoint for another substance, supported by structural or other feature similarities. While read-across is sometimes reliant on subjective or expert judgement, the GenRA tool can provide more objective and reproducible read-across predictions.

A free virtual training session on GenRA will be presented on Tuesday, May 23, from 11:00 a.m.-1:30 p.m. EDT. Specifically targeted for decision-makers, this training will provide:

• An overview of GenRA's purpose and scope.
• Demonstration of GenRA's interface and navigation.
• Opportunities for participatory learning and engagement.

This training will feature Grace Patlewicz of the EPA Center for Computational Toxicology and Exposure (CCTE). It will include a plenary presentation, small group discussions, and a chance to try out your skills with GenRA. The training is divided into two parts to accommodate a variety of interests and schedules. Registration for one or both sessions is required.

Session 1 (Presentation and Q&A) 11:00 a.m. - 12:30 p.m. EDT

This session will provide an overview of GenRA content and function with opportunities for participation and Q&A.

Session 2 (Breakout Sessions) 12:30 - 1:30 p.m. EDT

This session will break participants into breakout rooms to work on exercises in small groups, aided by facilitators. 

The EPA Center for Computational Toxicology and Exposure seeks candidates for Director of its Scientific Computing and Data Curation Division in Research Triangle Park, NC. The Director oversees development of information architecture necessary for integrating, transforming, and managing large-scale data streams related to assessing the risk of chemicals and ecological integrity. They work closely with the EPA Office of Science and Information Management on the implementation and deployment of software applications and tools for internal and external stakeholder utilization.

Applicants must be U.S. citizens. They must have doctoral degrees in data science, computational toxicology, biology, physical sciences, chemistry, or related fields as well as substantive relevant work experience. Ideal candidates will be recognized internationally as outstanding scientists or engineers and highly sought after as advisors and consultants. Apply by May 1.

An upcoming webinar will discuss the creation and use of the Source-to-Outcome framework. Doug Wolf, Syngenta, will describe how the framework facilitated application of a new approach methodology (NAM) to estimate the human equivalent concentration for inhalation risk assessment of the broad-spectrum fungicide chlorothalonil. The risk assessment was based upon the relevant aerosol characterization, respiratory dosimetry modeling, and endpoints derived from an in vitro assay using human respiratory epithelial tissue. The webinar will be on Tuesday, April 4 at 11:00 a.m. EDT and is presented by ScitoVation. 

The Physicians Committee for Responsible Medicine (PCRM) will present a webinar Friday, April 14 from 10:00-11:30 a.m. EDT on “New Strategies for Safety Assessments of EDCs.” This is the latest webinar in the NAMs Use for Regulatory Applications (NURA) series, "DyNAMic Discussions: The Future is Already Here." Materials from the previous webinars in the series, including presenter’s slides, session recordings, and supplementary publications, are available on the PCRM website. April 14 presentations:

• Richard Judson, U.S. Environmental Protection Agency Office of Research and Development, "Availability of New Approach Methodologies (NAMs) in the Endocrine Disruptor Screening Program (EDSP)."
• Tara Barton-Maclaren, Health Canada, “Exploring the use of New Approach Methods for screening and assessment of endocrine disrupting chemicals under Canada’s Chemicals Management Plan.”

A webinar on Friday, April 28 from 10:00-11:00 a.m. EDT will discuss “Modeling of Adverse Outcomes - Insights from the ONTOX Project.” ONTOX is a European Union initiative to advance human risk assessment of chemicals without the use of animals in line with the principles of 21st century toxicity testing and next-generation risk assessment. The webinar is hosted by ASCCT and ESTIV. 

Devon Barnes, Utrecht Institute for Pharmaceutical Sciences, will describe “Development of an Adverse Outcome Pathway for Kidney Tubular Necrosis.” An ontological knowledge framework was developed to support predicting systemic repeated-dose toxicity effects of nephrotoxic chemicals associated with kidney tubular necrosis. Data extracted will assess confidence levels in previously described key events (KEs) and key event relationships and identify potential new KEs. The resulting adverse outcome pathway network will form the conceptual basis for establishing a test battery of in vitro assays to characterize nephrotoxic chemicals.

Job Berkhout, RIVM, will discuss “Computational Modelling of Neural Tube Closure Defects.” The study aim was development of an in silico model of human neural tube closure. A physiological map of human neural tube closure was used to build a multicellular agent-based model of the all-trans-retinoic acid related molecular pathways that leads to closure of the neural tube. The morphogenetic events driven by gene expression changes are visualized by the computational model. The computational model will be applied to predict chemical-induced changes in gene expression and cell characteristics. The predictions of the model will be validated using a set of dedicated in vitro assays in conjunction with existing knowledge on in vivo developmental neurotoxicity. Such computational models may ultimately provide an alternative in silico approach for chemical safety assessment without the use of animals.

EURL ECVAM has issued its 2022 Status Report, “Non-animal Methods in Science and Regulation.” The report describes research, dissemination and promotion activities undertaken by EURL ECVAM to further the uptake and use of non-animal methods and approaches in science and regulation. 

Specific activities described in the report include:

• Providing guidance and training on the validation of in vitro methods, application of Good In Vitro Methods Practices, and introduction of test readiness criteria.
• Evaluation of methods to measure cytotoxicity, skin sensitization, and genotoxicity.
• Validation of in vitro methods measuring different modes of action relevant to the thyroid endocrine system.

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. NICEATM and ICCVAM collaborate with EURL ECVAM via the International Cooperation on Alternative Test Methods (ICATM).

The National Cancer Institute (NCI) is interested in understanding the processes for storage, preservation, and sharing of scientific data generated by cancer research funded by the National Institutes of Health at academic, research, and medical institutions in order to develop guidance on scientific data management. NCI is also interested in learning the types of services, technologies, and processes relevant to these topics provided by scientific core facilities within an institution.

To that end, NCI invites stakeholders and staff across the cancer research enterprise to complete the “Request for Information on Existing Data Sharing Processes for NIH-Funded Research” by April 3. All participants are encouraged to respond to as many questions as they are able, no matter their role in the research enterprise.

NIEHS is offering funding to support resource projects to enable environmental health sciences (EHS) communities to openly develop, extend, adapt, or refine data and metadata standards as well as associated tools to implement standards. This program is intended to provide catalytic support for a diverse array of EHS-focused standards development activities that address unmet needs within the NIEHS strategic mission. Specific areas of focus to be addressed by the funding include:

• Collaborator, contributor, and user-community engagement.
• Open standards for data and metadata.
• Tools for standards implementation.

Institutions eligible for this funding include U.S. nonprofit and for-profit organizations and government institutions. Letters of intent are due April 10, with funding applications being due May 10. 

The National Institute of Allergy and Infectious Diseases (NIAID) will provide up to $9 million in FY 2024 to establish Bioinformatics Resource Centers for Infectious Diseases. Components of the envisioned centers will include:

• Interactive knowledgebase(s) for relevant omics-based data and analysis.
• Research and development of innovative bioinformatics tools, software, and algorithms.
• Access to leading-edge expertise in bioinformatics services for the infectious diseases community for complex or unique situations.
• Cutting-edge informatics support during a public health emergency, outbreak, or pandemic.

NIAID anticipates making one or two awards, with awardees being funded for up to five years. For-profit and nonprofit organizations and government entities both within and outside the U.S. are anticipated to be eligible for this funding. Availability of this funding is being announced in advance to allow potential applicants time to develop meaningful collaborations, interdisciplinary teams, and responsive applications. More information about the funding opportunity, including anticipated opening and due dates, is available on the NIH Grants website. 

On March 20, NICEATM released version 4.0 of the Integrated Chemical Environment (ICE). ICE provides data and tools to help query, review, and interpret toxicological data, predictions, and tools. Key features implemented in ICE 4.0 are:

• Updated Search results page with improved data navigation and query summary visualizations.
• A new Exposure Predictions data set. This can be downloaded from the Data Sets page or via the ICE REST API. Exposure predictions can also be visualized as an overlay option in the ICE IVIVE (In Vitro to In Vivo Extrapolation) tool results.
• Updates to the ICE PBPK (Physiologically Based Pharmacokinetic) and IVIVE tools:
  • The version of httk R package has been updated to the newest version, v2.2.2.
  • A human gestational model from httk v2.2.2 has been added to both tools.
  • Predicted half-life and area under curve values are available in PBPK model output.
  • A new chemical concentration unit, parts per million per unit volume (ppmv), is available when modeling chemical exposure as gas.
• Acceptance of chemical names and synonyms as input.

NICEATM has also released the DASS App, a web app for predicting skin sensitization hazard and potency. The DASS App takes a user-provided data set and applies defined approaches on skin sensitization (DASS) that are described in OECD Guideline No. 497 and by the U.S. Environmental Protection Agency. The defined approaches predict skin sensitization hazard (either a sensitizer or non-sensitizer) and potency by integrating data from in vitro assays and in silico hazard predictions. 

ASCCT and ESTIV will present a webinar on “New approach methodologies for evaluating cardio- and developmental toxicity” on Friday, March 24 from 10-11 a.m. EDT. Registration is required to attend. 

Presenters’ abstracts:

• A multiorgan on-chip platform for the in vitro investigation of off-target cardiotoxicity of liver-metabolized anticancer drugs – Erika Ferrari (BiomimX Srl). Off-target cardiotoxicity is one of the main causes of drug withdrawal from the market. Multiorgan-on-chip (MOoC) platforms represent a disruptive solution to predict liver metabolism on off-target organs to ultimately improve drug safety testing during drug development. This project integrates liver and cardiac models in a compartmentalized valve-based MOoC and shows its application in studying the effects of liver-metabolized terfenadine on cardiac microtissues.
• Predicting developmental toxicity of pyrethroid insecticides in vitro using human-induced pluripotent stem cells - Yanying Ma (National Food Institute, Technical University of Denmark). Metabolites of pyrethroid insecticides are detected in most urine samples from the general population. Pyrethroids are suspected to be cardiotoxic and to interfere with thyroid hormones that are essential for fetal brain development. Thus, exposure to pyrethroids during vulnerable windows in pregnancy may adversely affect child neurodevelopment and cardiovascular health. The project findings highlight the risks posed by insecticides on human fetal development, supporting the need to restrict their use in order to reduce human exposure.

ASCCT is offering a student travel award to attend the QSAR 2023 Workshop in Copenhagen. One awardee will be provided with an up to $2000 travel expense reimbursement to attend the meeting plus free registration.  

Awardees must meet the following requirements:

• Awardee must be an ASCCT member. Join or renew your membership.  
• Awardee must be presenting at the meeting.
• Awardee must meet the conference requirements for registration as a student.

If you have questions or to apply, email ASCCT Secretary Kristie Sullivan at  [email protected]. Application materials include an accepted presentation abstract and letter from advisor attesting to student status. The deadline for applications is March 31.

Submission is now open for abstracts and continuing education (CE) course proposals for the 12th ASCCT Annual Meeting, which will be held October 23-25 in the Washington DC area.

This year for the first time,  ASCCT will present CE courses at the annual meeting. Up to four CE proposals will be chosen to be presented the morning of Wednesday, October 25. CE proposal guidelines: 

• Unlike regular oral sessions, CE sessions feature presentations addressing or providing guidance on relatively established science or practice, and are planned with specific takeaways or learning objectives in mind. 
• All proposals should fit within the mission of the ASCCT to further the use of in vitro or computational toxicology methodologies, alone or in concert.
• Topics that will promote discussion of scientific and regulatory policy elements and cross-sector collaboration are welcomed. 
• Sessions will be two hours long. We suggest 3-4 speakers plus time for Q&A. 
• Participatory elements are welcomed; there may be support from the conference organizers available for participatory elements. 

The submission deadline is June 2. ASCCT will endeavor to notify CE submitters of acceptance by June 15. 

ASCCT is also accepting abstracts for the annual meeting. Submissions will be evaluated for three types of presentations: oral, poster, and flash poster. Abstracts should relate to the advancement of in vitro or computational toxicology methodologies, alone or in concert. Submission of proposals addressing scientific advancement, regulatory policy elements, cross-sector collaboration, optimization and validation, application, weight-of-evidence, and other relevant topics is encouraged. Some session topics for this meeting may include:  

• Filling knowledge gaps in regulatory submissions 
• Integrating NAMs into decision-making 
• Endocrine system
• Liver 
• Mixtures
• Medical devices 
• NAMs as problem solvers 
• Ecotoxicity/ONE health 

However, submissions on all topics are welcome. The submission deadline is July 14. 

A three-hour virtual symposium on March 9 will provide an overview of recent achievements using MPS in cell and gene therapy, immunology, and cancer. The symposium, “Global MPS Day”, is being presented by Emulate, Inc. It is free and open to the public but registration is required.

An agenda for the symposium is available on the EmulateBio website. NICEATM Director Nicole Kleinstreuer will participate in a panel discussion exploring the implications of the FDA Modernization Act on applications of MPS and other NAMs to drug development. Breakout sessions will focus on topics such as managing MPS data and getting funding for MPS development.

Nominations are being accepting for the 2023 Russell and Burch Award, which recognizes those who have played an important role in limiting the use and suffering of animals in laboratories. The award is named in honor of William Russell and Rex Burch, the scientists who formulated the 3Rs approach of replacement, reduction, and refinement. The Award is now being cosponsored by The Humane Society of the United States and the Humane Society International, and the prize money has been increased to $10,000. Nominations are due by May 2. The award will be presented at the 12^th World Congress on Alternatives and Animal Use in the Life Sciences in August. 

Sponsors welcome nominations of scientists who have made outstanding contributions to the advancement of alternative methods in the areas of research, testing, or higher education. Any nominations from last year will not need to be resubmitted. 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 [email protected].

The Health and Environmental Sciences Institute (HESI) and the United Kingdom National Centre for the Replacement Refinement & Reduction of Animals in Research (NC3Rs) are jointly presenting the HESI Annual Meeting on June 7-8 in London. “Not Just Another NAMs Meeting: NAMs for Safety Assessment, from Aspiration to Implementation” will focus on the “why” of NAMs implementation, considering drivers of different stakeholder groups, as well as the “how” of a defined implementation strategy. A draft agenda for the meeting is available on the HESI website; registration will be available soon on this page.

A paper by NICEATM and EPA collaborators describes a retrospective analysis of data for 181 pesticides to explore using fewer fish species to support conventional pesticide risk assessments. The results support potentially using fewer than three fish species to conduct ecological risk assessments for the registration of conventional pesticides.

NICEATM scientist Xiaoqing Chang (Inotiv, contractor supporting NICEATM) is first author on two 2022 publications describing applications of in vitro to in vivo extrapolation (IVIVE) that were honored by the publishing journals.

• “IVIVE: facilitating the use of in vitro toxicity data in risk assessment and decision making” was included by the journal Toxics on its list of “Annual Recommended Reviews in 2022.” 
• “Quantitative in vitro to in vivo extrapolation for developmental toxicity potency of valproic acid analogues” received the 2023 James G. Wilson Publication Award from the Society of Birth Defects Research and Prevention. The award recognizes the best paper accepted or published in the journal Birth Defects Research during the prior year. Chang will receive her award at the Society’s 63rd Annual Meeting in Charleston, South Carolina this summer. 

Registration is now open for the next joint ASCCT-ESTIV award winners’ webinar: “New approach methodologies for evaluating cardio- and developmental toxicity,” on Friday, March 24 from 10:00 to 11:00 a.m. EST. 

Presenters’ abstracts:

• A multiorgan-on-chip platform for the in vitro investigation of off-target cardiotoxicity of liver-metabolized anticancer drugs: Erika Ferrari, BiomimX Srl. Off-target cardiotoxicity is one of the main causes of drug withdrawal from the market. Multiorgan-on-chip (MOoC) platforms represent a disruptive solution to predict liver metabolism on off-target organs to ultimately improve drug safety testing during drug development. This presentation will describe how liver and cardiac models can be integrated in a compartmentalized value-based MOoC, and demonstrate application of the MOoC in studying the effects of liver-metabolized terfenadine on cardiac microtissues.
• Predicting developmental toxicity of pyrethroid insecticides in vitro using human-induced pluripotent stem cells: Yanying Ma, National Food Institute, Technical University of Denmark. Metabolites of pyrethroid insecticides are detected in most urine samples from the general population. Pyrethroids act primarily by interfering with voltage-gated sodium channels, which are essential for nerve cell function and cardiac muscle contraction. Therefore, pyrethroids are suspected to be cardiotoxic. Furthermore, pyrethroids are suggested to interfere with thyroid hormones that are essential for fetal brain development. This presentation will describe the risks posed by insecticides on human fetal development, supporting the need to restrict their use in order to reduce human exposure.

The National Cancer Institute (NCI) is hosting a virtual workshop, “Cancer AI Research: Computational Approaches Addressing Imperfect Data”, April 3-4 from 11:00 a.m. to 5:00 p.m. EST. This workshop will highlight the importance of leveraging advances across fields to accelerate cancer research and discovery through artificial intelligence (AI), enable early detection, and improve diagnosis. An agenda is available on the NCI website. 

The goals of this workshop are to:

• Examine the state of the science for AI methods designed to operate on noisy, complex, or low-dimensional data.
• Explore how these methods may be applied to key areas of cancer research.
• Discuss processes for identifying the biological questions that will motivate further advances in machine learning.

The workshop will be chaired by Caroline Uhler (Massachusetts Institute of Technology and Broad Institute), and Olivier Gevaert (Stanford University). The event is open and free to attend, but registration is required. 

A webpage is available listing activities of NICEATM and ICCVAM at the upcoming SOT Annual Meeting  on March 19-23. The page includes downloadable files of selected abstracts.

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.”
• A March 21 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.
• ICCVAM committee members are presenting at a March 23 satellite meeting on 21^st Century Toxicology: Sneak Preview of Ongoing Relevant Activities. This event is organized by the Johns Hopkins University Center for Alternatives to Animal Testing and Humane Society International/Animal-free Safety Assessment Collaboration. It is free and open to both SOT attendees and remote viewers.

An article on the website of the European Union’s Joint Research Center presents an overview of the COVID-19 Through Adverse Outcome Pathways (CIAO) project, which has applied the concept of adverse outcome pathways to better understanding the effects of COVID-19. This international project has increased understanding of how COVID-19 affects a number of organ systems. NICEATM scientist Helena Hogberg was lead author on a CIAO project publication focused on nervous system effects.

Hogberg et al. 2022. The adverse outcome pathway framework applied to neurological symptoms of COVID-19. Cells 11(21):3411. https://doi.org/10.3390/cells11213411.

The Humane Society International is accepting applications for the position of Director, Chemicals. This scientist will spearhead multinational efforts to shift the safety assessment and regulatory paradigm for chemicals and related products toward animal-free approaches with an aim to phase out testing on animals in key global regions within the foreseeable future. Applicants must have a master’s or higher degree in toxicology or a related field and at least five years’ work experience in risk assessment or regulatory affairs. Supervisory experience and fluency in at least one non-English language are both desirable. More information is available by contacting Catherine Willett at [email protected]. Apply by March 9.

The American Cleaning Institute (ACI) is hosting a workshop, “New Approach Methods (NAMs) for the In Vitro Assessment of Cleaning Products for Respiratory Irritation,” on March 2 in Arlington, VA. The workshop will review in vitro cellular and tissue-based testing methods for assessing the potential hazard of respiratory irritation throughout the life cycle of cleaning products. The content of the workshop will be used to generate a published Workshop Proceedings Report to assist the cleaning products industry in best practices and principles when selecting testing methods for their products.

This workshop is an in-person event. Registration is $450, and you must have or create a free ACI account to register. A program agenda is available on the registration page, as well as lodging information. Speaker biographies are available on the Meet the Speakers page.

NIH and FDA are offering Small Business Innovation Research and Small Business Technology Transfer grants to support development of neuromuscular junction tissue chips to replace the mouse lethality assay for testing potency of botulinum toxin. The goal is to position the “Botulinum Toxin Potency Assay using Tissue Chips” as an alternative test method that can be used to replace the mouse assay.

Applications are due August 21. Only U.S. small businesses are eligible for this funding. Applicants are encouraged to contact FDA and the NIH National Center for Advancing Translational Sciences (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. 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.

Abstract deadlines have been extended for two upcoming meetings:

• Abstracts for the 12^th World Congress on Alternatives and Animal Use in the Life Sciences are now due Friday, February 24. Information about abstract submission is available on the meeting website. Submit abstracts at https://insight.klinkhamergroup.com/wc12/login. The meeting will be held on August 27-31 in Niagara Falls, Canada.
• Abstracts for the 20th International Workshop on (Q)SAR in Environmental and Health Sciences are now due Wednesday, March 1. A tentative list of topics is available; instructions and a link to submit abstracts are available at https://dtu.events/qsar2023abstracts. The meeting will be held June 5-9 in Copenhagen, Denmark.

Slides and video are now available for the January 30 ICCVAM Communities of Practice webinar on “Emerging Approaches for Anchoring Biological Relevance of New Approach Methodologies.” This webinar considered 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 were 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.

Save the date for the ICCVAM Public Forum, to be held in person May 18-19 at the NIH Natcher Conference Center in Bethesda, MD. Links to register to attend or present public statements and other information about the meeting will be placed on the meeting webpage when available.

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has established the (Re)Building a Kidney (RBK) Consortium to apply new technologies to understand and treat kidney diseases. Strategies of interest include development of in vitro cultures and organoids.

The Consortium is offering grants of up to $100,000 that may be applied to direct and indirect costs of relevant activities. Researchers affiliated with U.S. and foreign non-profit and for-profit organizations are encouraged to apply. Applications are due Monday, April 3.

Abstracts are due Monday, February 20, for the 20th International Workshop on (Q)SAR in Environmental and Health Sciences. A tentative list of topics is available and includes development, validation, and application of (Q)SARs; big data and bioinformatics; and toxicokinetic modeling.

The 20^th International Workshop on (Q)SAR in Environmental and Health Sciences will be held June 5-9 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.

An upcoming webinar will consider “Evaluation of Chemical-induced Cardiotoxicity: Challenges and Progress.” The webinar will be held Thursday, February 23, from 6:00-7:30 a.m. EST (noon-1:30 p.m. CET). It is presented by the ALTERNATIVE project, a multidisciplinary consortium that is developing innovative platforms to detect and assess cardiotoxicity of chemicals and their biotransformation products. Webinar presentations will focus on epidemiological evidence for chemical-induced cardiotoxicity, the ALTERNATIVE project, and computational tools to assess cardiotoxicity; the webinar will close with a discussion session focusing on next steps.

The Physicians Committee for Responsible Medicine (PCRM) will present a three-part webinar training series on “Tomorrow’s Data, Today: Sunsetting the 2-year Carcinogenicity Assay.” The series will begin Thursday, February 23, with subsequent webinars to be presented March 2 and March 9. All webinars are from 10:00 a.m. to 12 noon EST. You only need to register once to attend the entire series.

There is a growing consensus among experts that the current carcinogenicity assessment paradigm needs to shift from the traditional 2-year rodent “bioassay” to a more predictive, human-relevant carcinogenicity assessment. This series features international experts from regulatory, industry, and academic backgrounds working to achieve this goal.

The North American 3Rs Collaborative and the New Jersey Association for Biomedical Research announce the return of their 3Rs Sharing Conference April 26 from 7:30 a.m. to 4:00 p.m., in Somerset, New Jersey. The theme of this year’s conference is “The 3Rs Across the Research Pipeline,” with content focused on improving rigor and translatability in biomedical research through the robust incorporation of the 3Rs. The potential for integrating translational digital biomarkers, machine learning, and non-animal technologies will be explored. Presentations will address the use of current and emerging technologies to guide future drug development, study design, animal methodology, and best practices to promote laboratory animal welfare.

The Reagan-Udall Foundation and FDA have launched the Regulatory Science Accelerator. This initiative will convene a series of conversations to engage the scientific community to identify the most pressing scientific gaps, emerging sciences and technologies, goals/objectives, and implementation strategy for regulatory science. The first series of meetings will focus on in silico alternative methods. In silico alternative methods are mathematical and/or computational methods and approaches that may help bring FDA-regulated products to market faster, with improved efficacy, or prevent products with increased toxicological risk from reaching the market. Additionally, these methods may harness the potential to replace, reduce, and/or refine animal testing. Those interested in participating in these conversations should fill out a questionnaire to communicate their interest and to share relevant information about in silico alternative methods. The deadline for the questionnaire is March 1. Contact [email protected] with any questions.

PCRM is seeking a Regulatory Science Policy Specialist who will set strategy and oversee policy, scientific, and outreach activities related to the reduction and replacement of animal tests required or conducted by regulatory agencies and companies. This is a full-time position that may be performed remotely from any location in the United States. Candidates should have master’s or PhD degrees in toxicology, pharmacology, cell biology, or a related field and at least 10 years’ work experience, five of which should have been spent in a position related to regulatory testing or compliance.

The National Institute of Environmental Health Sciences (NIEHS) is seeking candidates for the position of Scientific Director of the Division of Translational Toxicology (DTT), formerly the Division of the National Toxicology Program, to provide creative scientific vision and innovative leadership. The qualified applicant must have a doctoral degree in biomedical sciences and an exceptional record of research accomplishments in toxicology or a related field. Review of applications will begin March 27 and the search will be closed once the position is filled.

DTT conducts innovative toxicology research that aligns with real-world public health needs to translate scientific evidence into knowledge that can inform individual and public decision making. It has four strategic programmatic areas of focus: Exposure-based Research, Health Effects Innovation, Responsive Research, and Strengthening Capabilities. Scientists within DTT use a variety of traditional and cutting-edge approaches to better understand how factors in our environment impact our health.

Abstract submission for the 2023 MPS World Summit has been extended to February 14. Abstracts are invited on the topic of new developments in microphysiological systems (MPS) and applications of MPS, and should be relevant to one of these three tracks:

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

MPS covers cell culture systems replicating (patho-) physiology through engineered organ architecture and functionality. This includes especially 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.

Top-scored abstracts will be selected for an oral presentation at one of 24 scientific sessions.

The deadline has been extended to submit abstracts to the 12th World Congress on Alternatives and Animal Use in the Life Sciences. Abstracts are due Monday, February 20. Information about preparing abstracts is available on the 12th World Congress website.

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.

The 12^th 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 [email protected].

The Humane Society of the United States (HSUS) is accepting nominations for the 2023 Russell and Burch Award. The award is named in honor of William Russell and Rex Burch, the scientists who formulated the 3Rs 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. Nominations are due by May 2. The award will be presented at the 12^th World Congress on Alternatives and Animal Use in the Life Sciences in August. The awardee will receive a $5000 award and a plaque.

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. Any nominations from last year will not need to be resubmitted. 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 [email protected].

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.

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.

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.

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 [email protected] with questions about the application process.

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

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.

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.

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. 

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.

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.

Register now for the 2^nd 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.

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.

• Information and application link for federal employees.
• Information and application link for general public (applicants must be U.S. citizens).

Applications must be received by February 10.

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.

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.

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 [email protected] by Tuesday, January 17. 

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.

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.

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.

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 12^th 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 [email protected].

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.

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.

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.

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. 

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/.

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.

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.

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.

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.

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.

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.

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.

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.

The 20^th 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.

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 [email protected]. 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 [email protected]. Application deadline is Sunday, January 31, 2023.

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.

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.

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.

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.

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.

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

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

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.”

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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. 

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.  

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.

The 2022 Lush Prize conference will be held online over two half days on Wednesday, November 9^th and Thursday, November 10^th. 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. 

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.

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.

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.

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.

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.

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.

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.

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.

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

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.>

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.

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.

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.”

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

The 11^th 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

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”

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.

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.

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 [email protected].

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
• 21^st 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.

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.

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.

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.

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 60^th session of the United Nations Sub-Committee of Experts on the Transport of Dangerous Goods on June 27-July 6.
• The 42^nd 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.

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.

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.

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 [email protected].

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.

The 12^th 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
• 21^st 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.

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.

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.

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.

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.”

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

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.

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.

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.

The 12^th 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
• 21^st 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.

The 11^th 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.

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.

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.

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.

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.

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.

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.

• 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

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.

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.

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.

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

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.

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.

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.

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.

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.

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.”

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.

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.

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.

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.

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:

• Pregnancy models allowing simulations for both mother and fetus (based on Kapraun et al. 2019, https://doi.org/10.1371/journal.pone.0215906).
• Structure-based quantitative structure–activity relationship models for repeat dose toxicity (Pradeep et al. 2020, https://doi.org/10.1016/j.comtox.2020.100139) and pharmacokinetic parameter prediction (Dawson et al. 2021, https://doi.org/10.1021/acs.est.0c06117).

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

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

• 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.

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.

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.

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.

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.

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.

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.

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 [email protected].

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 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. 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.

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).”

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.

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.

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.

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.

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.

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.

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.

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.

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 21^st International Congress of the European Society for Toxicology In Vitro (ESTIV 2022) in Barcelona, Spain.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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”).

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.

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.

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 [email protected].

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.

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.

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:

• Lowe et al. 2021. Incorporating human exposure information in a weight of evidence approach to inform design of repeated dose animal studies. https://doi.org/10.1016/j.yrtph.2021.105073.
• Tan et al. 2021. Opportunities and challenges related to saturation of toxicokinetic processes: Implications for risk assessment. https://doi.org/10.1016/j.yrtph.2021.105070.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.