September 19–20, 2019 Scientific Advisory Committee on Alternative Toxicological Methods Meeting
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September 19–20, 2019
Federal Register Notices September 19–20, 2019
Scientific Advisory Committee on Alternative Toxicological Methods Meeting Meeting Materials
September 19–20, 2019
US Strategic Roadmap: New Approaches to Validation
Presentation Abstracts: Introduction and EPA Activities
Presentation Abstracts: International Activities
Background Materials
- EPA Issue Paper - Evaluation of a Proposed Approach to Refine Inhalation Risk Assessment for Point of Contact Toxicity: A Case Study Using a New Approach Methodology (NAM)
- OECD Guidance Document on the Reporting of Defined Approaches to be Used Within Integrated Approaches to Testing and Assessment
- US Strategic Roadmap Website
New Approach Methodologies: Computational Tools
Background Materials
- Integrated Chemical Environment
- Casey et al. 2018. Evaluation and optimization of pharmacokinetic models for in vitro to in vivo extrapolation of estrogenic activity for environmental chemicals. Environ Health Perspect https://ehp.niehs.nih.gov/doi/10.1289/ehp1655
- Alberga et al. 2019. Prediction of acute oral systemic toxicity using a multifingerprint similarity approach. Toxicol Sci 167(2):484-495.
- Kleinstreuer et al. 2018. Predictive models for acute oral systemic toxicity: A workshop to bridge the gap from research to regulation. Comput Toxicol 8:21-24.
- Ring et al. 2019. Consensus modeling of median chemical intake for the U.S. population based on predictions of exposure pathways. Environ Sci Toxicol 53(2):719-732.
- Dionisio et al. 2018. The Chemical and Products Database, a resource for exposure-relevant data on chemicals in consumer products. Sci Data 5:180125.
- Phillips et al. 2017. High-throughput screening of chemicals as functional substitutes using structure-based classification models. Green Chem 19(4):1063-1074.
- Sobus et al. 2017. Integrating tools for non-targeted analysis research and chemical safety evaluations at the US EPA. J Expo Sci Environ Epidem 28:411-426.
- EPA Fact Sheet: Rapid Chemical and Dose Research
New Approach Methodologies: Translational Impact and Human Relevance of Microphysiological Systems
Background Materials
- Ewart et al. 2017. Navigating tissue chips from development to dissemination: A pharmaceutical industry perspective. Exp Biol Med 242(16):1579-1585.
- Low and Tagle. 2017. Tissue chips - innovative tools for drug development and disease modeling. Lab Chip 17(18):3026-3036.
- Science vol. 364, issue 6444: Special issue on "Organoids"
- Purnell and Lavine. 2019. Approximating organs. Science 364(6444):946-947.
- Shahbazi et al. 2019. Self-organization of stem cells into embryos: A window on early mammalian development. Science 364(6444):948-951.
- Tuveson and Clevers. 2019. Cancer modeling meets human organoid technology. Science 364(6444):952-955.
- Takebe and Wells. 2019. Organoids by design. Science 364(6444):956-959.
- Park et al. 2019. Organoids-on-a-chip. Science 364(6444):960-965.
- NCATS webpage: About Tissue Chip
- NCATS webpage: Tissue Chip Initiatives & Projects
- McAleer et al. 2019. On the potential of in vitro organ-chip models to define temporal pharmacokinetic-pharmacodynamic relationships. Sci Rep 9(1):9619.
- Sakolish et al. 2018. Technology transfer of the microphysiological systems: A case study of the human proximal tubule chip. Sci Rep 8(1):14882.
- Mina et al. 2019. Assessment of drug-induced toxicity biomarkers in the brain microphysiological system (MPS) using targeted and untargeted molecular profiling. Front Big Data https://doi.org/10.3389/fdata.2019.00023
- McAleer et al. 2019. Multi-organ system for the evaluation of efficacy and off-target toxicity of anticancer therapeutics. Sci Transl Med 11(497)pii: eaav1386.
Public Comments
| Agenda Topic | Name, Affiliation, Sponsorship | Technical and Scientific Public Comments |
|---|---|---|
| US Strategic Roadmap: New Approaches to Validation |
Jessica Ryman-Rasmussen, PhD, DABT, American Petroleum Institute |
Public comment received Sept. 11, 2019 |
| US Strategic Roadmap: New Approaches to Validation New Approach Methodologies: Computational Tools New Approach Methodologies: Translational Impact and Human Relevance of Microphysiological Systems |
Vicki Katrinak, Humane Society of the United States and Gillian Lyons, Humane Society Legislative Fund |
Public comment received Sept. 12, 2019 |
| New Approach Methodologies: Translational Impact and Human Relevance of Microphysiological Systems |
Elizabeth Baker, Physicians Committee for Responsible Medicine |
Public comment received Sept. 12, 2019 |
Scientific Advisory Committee on Alternative Toxicological Methods Meeting Presentations
September 19–20, 2019
September 19, 2019
US Strategic Roadmap: New Approaches to Validation
- Evaluation of a Proposed Approach to Refine the Inhalation Risk Assessment for Point of Contact Toxicity: A Case Study Using a New Approach Methodology
Monique Perron, PhD, U.S. Environmental Protection Agency - OECD Activities to Increase the Utility and Uptake of AOPs in Regulatory Contexts Across Countries
Bob Diderich, Organisation for Economic Co-operation and Development - Antibodies and Non-antibody Affinity Reagents Generated Using Animal-free Technologies, for Use in Research and Diagnostics
João Barroso, European Union Reference Laboratory for Alternatives to Animal Testing
New Approach Methodologies: Computational Tools
- Balancing Machine Learning and Mechanistic Modeling
Nicole Kleinstreuer, PhD, NIEHS/NTP - Collaborative Acute Toxicity Modeling Suite
Kamel Mansouri, PhD, ILS - New Approach Methodologies for Exposure from EPA's ExpoCast Project
Kristin Isaacs, PhD, U.S. Environmental Protection Agency
September 20, 2019
New Approach Methodologies: Translational Impact and Human Relevance of Microphysiological Systems
- Introduction
Brian Berridge, PhD, NIEHS/NTP - The NIH Microphysiological Systems Program: Tissue Chips for Drug Safety and Efficacy Studies
Danilo Tagle, PhD, and Lucie Low, PhD, National Center for Advancing Translational Sciences - Advancing Regulatory Science by Innovation: In Vitro Microphysiological Systems
Suzanne Fitzpatrick, PhD, U.S. Food and Drug Administration - Beyond 3-D Models: Building Confidence in Microphysiological Models
Szczepan Baran, PhD, Novartis