Scientific Advisory Committee on Alternative Toxicological Methods Meeting Final Documents
September 11 - 12 , 2025
Federal Register Notices September 11 - 12 , 2025
Scientific Advisory Committee on Alternative Toxicological Methods Meeting Meeting Materials
September 11 - 12 , 2025
Presentation Abstracts and Background Materials
- Session 1: Organization, Roadmaps, and Collaboration
- Session 2: Data Standards, Validation, and Qualification
- Session 3: Computational Resources
- Session 4: ICCVAM Public Outreach and Education
Public Comments
| Agenda Topic | Name, Affiliation, Sponsorship | Technical and Scientific Public Comments |
|---|---|---|
| All sessions | Vicki Katrinak: Humane World for Animals and Naomi Maxwell: Humane World Action Fund | Public comment received September 3, 2025 |
| (none specified) | John K. Colbourne, PhD, FRSB, Jonathan Freedman, PhD, Joseph R. Shaw, PhD and Jason Tennessen, PhD: PrecisionTox Consortium | Public comment received September 3, 2025 |
| (none specified) | Janine McCarthy, MPH and Shagun Krishna, PhD: Physicians Committee for Responsible Medicine (PCRM) | Public comment received September 3, 2025 |
| (none specified) | Private Citizen | Public comment received September 3, 2025 |
| (none specified) | Private Citizen | Public comment received September 3, 2025 |
| (none specified) | Private Citizen | Public comment received September 3, 2025 |
| (none specified) | Private Citizen | Public comment received September 3, 2025 |
| (none specified) | Private Citizen | Public comment received September 3, 2025 |
| (none specified) | Private Citizen | Public comment received September 3, 2025 |
| (none specified) | Private Citizen | Public comment received September 3, 2025 |
| (none specified) | Private Citizen | Public comment received September 3, 2025 |
| (none specified) | Private Citizen | Public comment received September 3, 2025 |
| (none specified) | Private Citizen | Public comment received September 3, 2025 |
| (none specified) | Private Citizen | Public comment received September 3, 2025 |
| (none specified) | Private Citizen | Public comment received September 3, 2025 |
| (none specified) | The 3Rs Collaborative (3RsC) Presentation accompanying oral comment |
Public comment received September 3, 2025 |
| All sessions | Shaun D. McCullough, PhD: RTI International | Public comment received September 2, 2025 |
| (none specified) | Americans for Medical Progress (AMP) Presentation accompanying oral comment |
Public comment received September 2, 2025 |
| (none specified) | Private Citizen | Public comment received September 1, 2025 |
| (none specified) | Private Citizen | Public comment received September 1, 2025 |
| (none specified) | Private Citizen | Public comment received September 1, 2025 |
| (none specified) | Private Citizen | Public comment received September 1, 2025 |
| (none specified) | Private Citizen | Public comment received August 29, 2025 |
| (none specified) | Private Citizen | Public comment received August 29, 2025 |
| (none specified) | Private Citizen | Public comment received August 29, 2025 |
| (none specified) | Private Citizen | Public comment received August 29, 2025 |
| (none specified) | Private Citizen | Public comment received August 29, 2025 |
| (none specified) | Private Citizen | Public comment received August 28, 2025 |
| All sessions | Amy J. Clippinger, PhD and Katherine Groff, MS: People for the Ethical Treatment of Animals | Public comment received August 27, 2025 |
| (none specified) | Private Citizen | Public comment received August 27, 2025 |
| (none specified) | Private Citizen | Public comment received August 27, 2025 |
| (none specified) | Private Citizen | Public comment received August 27, 2025 |
| (none specified) | Private Citizen | Public comment received August 26, 2025 |
| (none specified) | Private Citizen | Public comment received August 26, 2025 |
| (none specified) | Private Citizen | Public comment received July 19, 2025 |
Scientific Advisory Committee on Alternative Toxicological Methods Meeting Presentations
September 11 - 12 , 2025
September 11, 2025
Updates, Roadmaps, and Collaboration
- NIH Prioritization of Human-based Research Technologies
Warren Casey, PhD, National Institute of Environmental Health Sciences (NIEHS) - FDA Roadmap Implementation to Reducing Animal Testing in Preclinical Safety Studies
Tracy Beth Hoeg, MD, PhD, U.S. Food and Drug Administration (FDA) Office of the Commissioner and Center for Biologics Evaluation and Research - FDA’s Innovative Science and Technology Approaches for New Drugs (ISTAND) Program
Vanitha Sekar, PhD, FDA Center for Drug Evaluation and Research - Engaging NAMs for Toxicant Regulation and Effects (ENTRÉE): A Draft Pilot Program for US FDA Human Foods Program (HFP) – How to Qualify a New Approach Method (NAM) for Food Safety Use
Steven Hermansky, PhD, FDA Human Foods Program - ICCVAM Roadmap and Increased Opportunities
Helena Hogberg, PhD, NIEHS/National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM)
Data Standards, Validation, and Qualification
- Validation and Qualification Network (VQN) Public–Private Partnerships for Adoption and Implementation of New Approach Methodologies (NAMs)
Margaret Ochocinska, PhD, National Institutes of Health - International Harmonization of Test Methods Validation – The Role of Readiness Criteria to Amplify Success
Alison Harrill, PhD, U.S. Environmental Protection Agency (EPA) - ICCVAM Common Data Elements (CDE) Workgroup
Geetha Senthil, PhD, National Center for Advancing Translational Sciences
September 12, 2025
Computational Resources
- Collection of Alternative Methods for Regulatory Application (CAMERA)
Katie Needham, PhD, Axle (contractor supporting NIEHS Division of Translational Toxicology) - Updates to the Integrated Chemical Environment (ICE)
Kamel Mansouri, PhD, NIEHS/NICEATM - New Apps for Skin Sensitization
Emily Reinke, PhD, Inotiv (contractor supporting NICEATM)
ICCVAM Public Outreach and Education
- ICCVAM Public Forums
Anna Lowit, PhD, EPA - ICCVAM Communities of Practice Webinars
Natalia Vinas, PhD, EPA - Engaging the Public: Trainings, Workshops, and Demonstrations of NICEATM Tools
Victoria Hull, MS, Inotiv (contractor supporting NICEATM)