Government agencies and regulators at ACT 2026

Nov 15–18, 2026 San Antonio, TX ~1.4k attendees Website

6 government agencies and regulators are at ACT 2026 — 30 presentations on the program and 1 with a booth in the exhibit hall. Most represented: U.S. Food and Drug Administration (14 on the program), National Institutes of Health (3 on the program), Health Canada (1 on the program). 3 of them have their own page in this guide. As of Oct 8, 2026.

All 231 organizations at ACT 2026 →

Showing 1–6 of 6 organizations

Organization	ACT 2026 Attendance
U.S. Food and Drug Administration Silver Spring, MD
fda.gov Government agencies and regulators US agency regulating drugs and biologics; its reviewers and researchers present on NAMs, immunosafety, genetic toxicology and carcinogenicity.	Talk Sun Nov 15 8:30am–9:00am Part of Working with Global Regulators for Streamlined Nonclinical Development (CE4) Ideal Interaction During Drug Development: FDA Regulator's Perspective (CE4-3) Regulatory Session Sun Nov 15 1:00pm–4:30pm Beyond Animal Models: Navigating New Approach Methodologies in Modern Drug Development with Case Study Examples (CE5) New approach methods · with Labcorp 1:00pmIntroduction (CE5-1)U.S. Food and Drug Administration 1:05pmFDA's 2025 Roadmap to Reduce Animal Testing: Leveraging NAMs to Address Preclinical Safety (CE5-2)U.S. Food and Drug Administration 1:30pmNew Approach Methodologies (NAMs): Role of Nonclinical Scientists (CE5-3)Gilead Sciences 2:00pmComplex Human-Derived Models as New Approach Methodologies (NAMs) for Drug Discovery and Development (CE5-4)Sanofi 3:00pmNew Approach Methodologies in Practice: Creating Virtual Control Groups for Nonclinical Studies (CE5-5)Labcorp 3:30pmNAMs Adoption in a Global Drug Development Laboratory (CE5-6)Labcorp Session Sun Nov 15 1:00pm–4:30pm Immunotherapies and Collaborative Approaches to Immunosafety Assessment (CE6) Immunotoxicology · with Papenfuss Consulting 1:00pmThe Immunology Behind Developing and Evaluating New Immunotherapies (CE6-1)Papenfuss Consulting 1:30pmEvaluation of NAMs for Immunosafety and How to Incorporate Them into the Development of Immunotherapies (CE6-2)GSK 1:50pmHistopathologic Evaluation of Immune Changes for Immunotherapies: Why Is It So Challenging? (CE6-3)D Weinstock Consulting 2:10pmRegulatory Considerations for Risk Assessment of Immunotherapies (CE6-4)U.S. Food and Drug Administration 3:00pmEffectively Evaluating, Understanding, and Communicating the Risky Behavior of Immunotherapies: The Complex and Diverse Role of a Project (Program) Toxicologist (CE6-5)Johnson & Johnson 3:20pmRound Table Discussion: Scientific Perspectives and Key Communication Considerations by Scientific Experts for an Immunosafety (Case Study) Scenario (CE6-Panel)Papenfuss Consulting Talk Sun Nov 15 1:00pm–1:05pm Part of Beyond Animal Models: Navigating New Approach Methodologies in Modern Drug Development with Case Study Examples (CE5) Introduction (CE5-1) New approach methods Talk Sun Nov 15 1:05pm–1:30pm Part of Beyond Animal Models: Navigating New Approach Methodologies in Modern Drug Development with Case Study Examples (CE5) FDA's 2025 Roadmap to Reduce Animal Testing: Leveraging NAMs to Address Preclinical Safety (CE5-2) New approach methods · Regulatory Talk Sun Nov 15 2:10pm–2:30pm Part of Immunotherapies and Collaborative Approaches to Immunosafety Assessment (CE6) Regulatory Considerations for Risk Assessment of Immunotherapies (CE6-4) Immunotoxicology · Regulatory Talk Sun Nov 15 3:30pm–4:00pm Part of Navigating Genetic Toxicology through Drug Development: Interface of Practice, Strategy, and Regulatory Principles (CE7) Making Decisions on Positive Genotoxicity Results: FDA Guidance on Follow-Up Testing Strategies for Ames-Positive Findings in Drug Development (CE7-5) Genetic toxicology · Regulatory Talk Mon Nov 16 2:55pm–3:15pm Part of Safety and Regulatory Roadmap for Immune Engagers: Strategies to Translate Novel Modalities (S05) Safety Assessment of Immune Engagers for Autoimmune Disease: An FDA Perspective (S05-4) Biologics and new modalities · Regulatory Talk Tue Nov 17 11:15am–11:45am Part of What Did You Forget on Your Way to Your NDA/MAA? Strategic Considerations for Late-Stage Nonclinical Safety Studies (S09) Strategic Approaches for a Successful Regulatory submission (S09-6) Regulatory Session Tue Nov 17 2:00pm–5:00pm Safety Assessment of Extractables and Leachables under the New ICH Q3E Guideline (S11) Chemical risk assessment · Regulatory · with Gilead Sciences 2:00pmWelcome (S11-1)Gilead Sciences 2:05pmIntroduction to the ICH Q3E Draft Guideline: Extractables & Leachables - A Pharmaceutical Industry Perspective (S11-2)Bristol Myers Squibb 2:40pmAssessing the Data Landscape of Extractables and Leachables and Implications for Read Across Strategies (S11-3)Instem 3:45pmSafety Assessment Principles for Extractable/Leachables from an FDA Perspective (S11-4)U.S. Food and Drug Administration 4:15pmApplication of Read-Across Methodology for Extractables and Leachables to Derive a Class-based Acceptable Exposure Level for Cyclic Siloxanes (S11-5)Gilead Sciences Talk Tue Nov 17 2:00pm–2:15pm Part of The Evolving Landscape of Secondary Pharmacology and Off-Target Assessments in Pharmaceutical Development (S10) Targeted Secondary Pharmacology Panels: Advantages and Applications (S10-1) Safety pharmacology Session Tue Nov 17 2:00pm–5:00pm The Evolving Landscape of Secondary Pharmacology and Off-Target Assessments in Pharmaceutical Development (S10) Safety pharmacology · with Genentech 2:00pmTargeted Secondary Pharmacology Panels: Advantages and Applications (S10-1)U.S. Food and Drug Administration 2:15pmDeveloping And Validating Off-Target Screening Methods for New and Established Modalities (S10-2)Genentech 2:45pmAdvancing Secondary Pharmacology: Cross-Industry Insights and a Path Toward Global Harmonization (S10-3)UCB 3:45pmEvolving Selectivity Assessment of Biologic Products with Cell-Based Protein Arrays and Derisking Strategies (S10-4)Johnson & Johnson 4:15pmA Regulatory Perspective on Secondary Pharmacology and Off-Target Assessments for Pharmaceutical Products (S10-5)U.S. Food and Drug Administration Talk Tue Nov 17 2:20pm–2:50pm Part of From Policy to Practice: Progress on the FDA’s 2025 Roadmap to Reduce Animal Use in Antibody Platform Development (S12) The FDA Roadmap and Adoption of NAMs for Regulatory Decision Making (S12-3) New approach methods · Regulatory Talk Tue Nov 17 3:45pm–4:15pm Part of Safety Assessment of Extractables and Leachables under the New ICH Q3E Guideline (S11) Safety Assessment Principles for Extractable/Leachables from an FDA Perspective (S11-4) Chemical risk assessment · Regulatory Talk Tue Nov 17 4:15pm–4:45pm Part of The Evolving Landscape of Secondary Pharmacology and Off-Target Assessments in Pharmaceutical Development (S10) A Regulatory Perspective on Secondary Pharmacology and Off-Target Assessments for Pharmaceutical Products (S10-5) Safety pharmacology · Regulatory Talk Wed Nov 18 10:45am–11:15am Part of The Future of Nonclinical Carcinogenicity Testing: NAMs in a Weight-of-Evidence Paradigm Shift (S15) Assessing Clonal Expansion of Cancer Driver Mutants as an Early Cancer Biomarker (S15-4) Genetic toxicology Talk Wed Nov 18 11:25am–11:45am Part of Do You Hear What I Hear? Evaluating Otic and Vestibular Toxicity in Clinical Development (S14) Regulatory Perspective: Guidance, Expectations, and Safety Pharmacology Assessment (S14-6) Neurotoxicology · Regulatory Session Wed Nov 18 2:00pm–5:00pm Hot Topics (S18) with AbbVie 2:00pmIntroduction (S18-1)U.S. Food and Drug Administration, AbbVie 2:05pmCross-Industry Survey of Nonclinical Development Strategies for Oligonucleotide Therapeutics: Species Selection, Dose Setting, and Translational Approaches (S18-2)Novartis 2:30pmBenchmark Dose Modeling: Advancing Transparency and Next-Generation Applications in Risk Assessment (S18-3)HESI 2:55pmEmerging Insights on QTc Risks in Targeted Protein Degraders (S18-4)HESI 3:45pmWinning the Rat Race: Repurposing GLP-1 Receptor Agonists for Addiction (S18-5)National Institutes of Health 4:15pmFDA Forensic Investigations of Product Adulteration (S18-6)U.S. Food and Drug Administration Talk Wed Nov 18 2:00pm–2:05pm Part of Hot Topics (S18) Introduction (S18-1) with AbbVie Talk Wed Nov 18 4:15pm–4:45pm Part of Hot Topics (S18) FDA Forensic Investigations of Product Adulteration (S18-6) Chemical risk assessment
National Institutes of Health Bethesda, MD
nih.gov Government agencies and regulators US federal medical research agency that funds and conducts biomedical research across 27 institutes and centers.	Session Sun Nov 15 1:00pm–4:30pm Quantitative Structure–Activity Relationship Demystified: Foundations, Best Practices, Regulatory Use, and Practical Applications (CE8) In silico and AI · with JRF Global 1:00pmIntroduction (CE8-1)JRF Global 1:05pmFoundations of QSAR: Principles, Model Types, and the Science Behind Structure–Activity Relationships (CE8-2)JRF Global 1:30pmBuilding Reliable QSAR Models: Standardized Workflows, Data Quality, and Practical Modeling Considerations (CE8-3)National Institutes of Health 2:00pmIntegrating QSAR Modeling and Weight-of-Evidence into Read-Across Frameworks (CE8-4)Sciome 3:00pmOECD QSAR Toolbox in Practice: Chemical Profiling, Category Formation, Read-Across, Data Gap Filling, and Interpretation (CE8-5)Physicians Committee for Responsible Medicine Talk Sun Nov 15 1:30pm–2:00pm Part of Quantitative Structure–Activity Relationship Demystified: Foundations, Best Practices, Regulatory Use, and Practical Applications (CE8) Building Reliable QSAR Models: Standardized Workflows, Data Quality, and Practical Modeling Considerations (CE8-3) In silico and AI Talk Mon Nov 16 9:00am–9:05am Part of The Role of Professional Judgment in Toxicology amidst the Rise of Artificial Intelligence and Computational Tools (S02) Introduction (S02-1) In silico and AI Session Mon Nov 16 9:00am–12:00pm The Role of Professional Judgment in Toxicology amidst the Rise of Artificial Intelligence and Computational Tools (S02) In silico and AI · with Certara 9:00amIntroduction (S02-1)National Institutes of Health 9:05amEnhancing Toxicological Literature Review through AI and Expert Insight (S02-2)ToxStrategies 9:25amNo Spreadsheet Left Unharmonized: A Human-in-the-Loop Framework for AI-Assisted Toxicology Data Extraction and Standardization (S02-3)Certara 9:50amWhen AI Gets It Wrong: Interpreting Predictive Models from Omics and High-Content Data (S02-4)Human Chemical 10:45amChemical Similarity in Practice: Navigating Endpoint-Agnostic and Endpoint-Specific Approaches (S02-5)National Institutes of Health 11:15amIntegrating Artificial Intelligence and Professional Expertise in Structure-Activity Assessments (S02-6)Inductive Bio Talk Mon Nov 16 10:45am–11:15am Part of The Role of Professional Judgment in Toxicology amidst the Rise of Artificial Intelligence and Computational Tools (S02) Chemical Similarity in Practice: Navigating Endpoint-Agnostic and Endpoint-Specific Approaches (S02-5) In silico and AI Talk Wed Nov 18 3:45pm–4:15pm Part of Hot Topics (S18) Winning the Rat Race: Repurposing GLP-1 Receptor Agonists for Addiction (S18-5) Neurotoxicology
Health Canada Ottawa, ON, Canada
canada.ca Government agencies and regulators Canadian federal health department that regulates drugs, medical devices and consumer chemicals and conducts regulatory toxicology research.	Talk Wed Nov 18 9:45am–10:15am Part of The Future of Nonclinical Carcinogenicity Testing: NAMs in a Weight-of-Evidence Paradigm Shift (S15) Integrating Error-Corrected Sequencing into OECD Test Guidelines: Advancing Precision Mutagenesis in Regulatory Toxicology (S15-3) Genetic toxicology
LB Leidos Biomedical Research Frederick, MD
Government agencies and regulators Leidos subsidiary that operates the Frederick National Laboratory for Cancer Research for the US National Cancer Institute.	Poster Mon Nov 16 5:00pm–6:30pm New Approach Methodologies for Cardiac Safety Assessments Using 2D and 3D Models (P522) Nelson Exhibit Ballroom · Poster P522 Safety pharmacology · New approach methods
Medicines Evaluation Board Utrecht, Netherlands
cbg-meb.nl Government agencies and regulators Dutch medicines regulator that assesses and authorizes human and veterinary medicines and contributes to European Medicines Agency reviews.	Talk Sun Nov 15 9:00am–9:30am Part of Working with Global Regulators for Streamlined Nonclinical Development (CE4) Ideal Interaction During Drug Development: European Regulator's Perspective (CE4-4) Regulatory
NC3Rs London, UK
nc3rs.org.uk Government agencies and regulators UK national centre, largely government funded, that promotes replacing, reducing and refining animal use in research and testing.	Booth Exhibiting at Booth 106 Mon, Nov 169:30am–6:30pmTue, Nov 178:00am–4:30pm Talk Tue Nov 17 8:00am–8:55am Rethinking the ICH M3 Two-Species Requirement: Evidence for Data-Driven Single-Species Approaches Grand Oaks Ballroom O Regulatory · Animal models

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Not affiliated with or endorsed by the American College of Toxicology (ACT). Organization details are derived from ACT’s published program, exhibitor floor plan and supporter list, and each organization’s own website. Submit a correction

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