U.S. Food and Drug Administration at ACT 2026

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

U.S. Food and Drug Administration takes part in 20 sessions at ACT 2026 in San Antonio. Its program centres on regulatory expectations and new approach methods, including the agency's roadmap to reduce animal testing. It also covers the safety of immune engagers and immunotherapies, follow-up testing after a positive Ames mutagenicity result, and extractables and leachables under the new ICH Q3E guideline.

OrganizationACT 2026 Attendance
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. 1:00pmIntroduction (CE5-1)U.S. Food and Drug Administration
  2. 1:05pmFDA's 2025 Roadmap to Reduce Animal Testing: Leveraging NAMs to Address Preclinical Safety (CE5-2)U.S. Food and Drug Administration
  3. 1:30pmNew Approach Methodologies (NAMs): Role of Nonclinical Scientists (CE5-3)Gilead Sciences
  4. 2:00pmComplex Human-Derived Models as New Approach Methodologies (NAMs) for Drug Discovery and Development (CE5-4)Sanofi
  5. 3:00pmNew Approach Methodologies in Practice: Creating Virtual Control Groups for Nonclinical Studies (CE5-5)Labcorp
  6. 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. 1:00pmThe Immunology Behind Developing and Evaluating New Immunotherapies (CE6-1)Papenfuss Consulting
  2. 1:30pmEvaluation of NAMs for Immunosafety and How to Incorporate Them into the Development of Immunotherapies (CE6-2)GSK
  3. 1:50pmHistopathologic Evaluation of Immune Changes for Immunotherapies: Why Is It So Challenging? (CE6-3)D Weinstock Consulting
  4. 2:10pmRegulatory Considerations for Risk Assessment of Immunotherapies (CE6-4)U.S. Food and Drug Administration
  5. 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
  6. 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
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
  1. 2:00pmTargeted Secondary Pharmacology Panels: Advantages and Applications (S10-1)U.S. Food and Drug Administration
  2. 2:15pmDeveloping And Validating Off-Target Screening Methods for New and Established Modalities (S10-2)Genentech
  3. 2:45pmAdvancing Secondary Pharmacology: Cross-Industry Insights and a Path Toward Global Harmonization (S10-3)UCB
  4. 3:45pmEvolving Selectivity Assessment of Biologic Products with Cell-Based Protein Arrays and Derisking Strategies (S10-4)Johnson & Johnson
  5. 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
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

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