New approach methods at ACT 2026

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

54 organizations at ACT 2026 present work in new approach methods: 35 service, testing and tools companies, 10 universities, agencies and non-profits and 9 drug developers. Between them they bring 145 presentations to the program. Most represented: U.S. Food and Drug Administration (14 on the program), Labcorp (12 on the program), Charles River (5 on the program). As of Oct 8, 2026.

All 231 organizations at ACT 2026 →

Showing 1–3 of 54 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
Labcorp Burlington, NC
labcorp.com Contract research organizations (CROs) Laboratory services company whose drug development arm runs nonclinical toxicology, pathology and safety studies for drug and chemical developers.	Booth Exhibiting at Booth 310 Mon, Nov 169:30am–6:30pmTue, Nov 178:00am–4:30pm 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 U.S. Food and Drug Administration 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 Talk Sun Nov 15 3:00pm–3:30pm Part of Beyond Animal Models: Navigating New Approach Methodologies in Modern Drug Development with Case Study Examples (CE5) New Approach Methodologies in Practice: Creating Virtual Control Groups for Nonclinical Studies (CE5-5) Study data · New approach methods Talk Sun Nov 15 3:30pm–4:00pm Part of Beyond Animal Models: Navigating New Approach Methodologies in Modern Drug Development with Case Study Examples (CE5) NAMs Adoption in a Global Drug Development Laboratory (CE5-6) New approach methods Session Mon Nov 16 9:00am–12:00pm Beyond the Vessel Wall: Translational Insights into Vascular Inflammation (S03) Pathology · Translational safety · with Korsana Biosciences 9:00amIntroduction to Vascular Inflammation (S03-1)Korsana Biosciences 9:15amDrug Induced Vascular Injury (DIVI) Related to Biologic Therapies: Mechanisms and Sensitivity (S03-2)International Academy of Toxicologic Pathology 9:45amA Regulatory Perspective (S03-3)ToxStrategies 10:45amBiomarkers of Vascular Injury (S03-4)Merck 11:15amInnovative Tools and Future Directions (S03-5)Kymera Therapeutics Poster Mon Nov 16 5:00pm–6:30pm Applying a Virtual Control Group Retrospectively to a 26-Week Subcutaneous Repeat Dose Toxicity Study in the Cynomolgus Monkey (P508) Nelson Exhibit Ballroom · Poster P508 Study data Poster Mon Nov 16 5:00pm–6:30pm Assessment of a Functional Observational Battery in Minipigs across Multiple Research Sites (P117) Nelson Exhibit Ballroom · Poster P117 Safety pharmacology · Animal models Poster Mon Nov 16 5:00pm–6:30pm Development of an Integration Site Analysis Assay in AAV2 and AAV9 Administered Murine Models (P301) Nelson Exhibit Ballroom · Poster P301 Biologics and new modalities · Genetic toxicology Poster Mon Nov 16 5:00pm–6:30pm Enabling Flexible yet Comparable Cell Counting Strategies in Cell and Gene Product Development: A Comparative Evaluation of Automated Platforms (P206) Nelson Exhibit Ballroom · Poster P206 Biologics and new modalities · Bioanalysis and biomarkers Poster Mon Nov 16 5:00pm–6:30pm Evaluation of Wild Type and Humanized IgG1/4 Göttingen Minipigs for Subchronic Toxicology Assessment of Biotherapeutics (P127) Nelson Exhibit Ballroom · Poster P127 Animal models · Biologics and new modalities Poster Mon Nov 16 5:00pm–6:30pm Feasibility of a Paddling Pool Test (PPT) as an Alternative Assessment to the Morris Water Maze (MWM) in Mice (P517) Nelson Exhibit Ballroom · Poster P517 Neurotoxicology Poster Mon Nov 16 5:00pm–6:30pm MRI-Guided Targeted Delivery of AAV9 to the Putamen of Nonhuman Primates and Göttingen Minipigs: A Translational Framework for CNS Gene and Cell Therapies (P302) Nelson Exhibit Ballroom · Poster P302 Biologics and new modalities · Neurotoxicology Poster Mon Nov 16 5:00pm–6:30pm Nonhuman Primate Species Considerations for Preclinical Gene Therapy Studies (P132) Nelson Exhibit Ballroom · Poster P132 Animal models · Biologics and new modalities Poster Mon Nov 16 5:00pm–6:30pm Pulmonary Embolism of Marrow Tissue Secondary to Bone Marrow Aspiration for Immunophenotyping in Cynomolgus Monkeys (P136) Nelson Exhibit Ballroom · Poster P136 Pathology · Animal models Poster Mon Nov 16 5:00pm–6:30pm Validation of the Cincinnati Water Maze for Egocentric Learning and Memory in Developmental Neurotoxicity Studies (P530) Nelson Exhibit Ballroom · Poster P530 Neurotoxicology · DART Talk Tue Nov 17 8:00am–8:55am Beyond the Roadmaps: Applying Human-Relevant NAMs to Weight-of-Evidence Assessments Grand Oaks Ballroom Q New approach methods · Regulatory
Charles River Wilmington, MA	◆Diamond Supporter
criver.com Contract research organizations (CROs)Diamond Supporter Contract research organization running discovery and GLP safety studies worldwide, including general, genetic, reproductive and neurotoxicology, with study-data and virtual control tools.	Booth Exhibiting at Booth 303 Mon, Nov 169:30am–6:30pmTue, Nov 178:00am–4:30pm Talk Sun Nov 15 8:05am–8:30am Part of Working with Global Regulators for Streamlined Nonclinical Development (CE4) Top Tips for Successful Nonclinical Regulatory Interaction (CE4-2) Regulatory Poster Mon Nov 16 5:00pm–6:30pm Can Jacketed Telemetry Provide QTc Data Which Is Sensetive and Reproducible to Meet ICH E14/S7B Requirements (P510) Nelson Exhibit Ballroom · Poster P510 Safety pharmacology Poster Mon Nov 16 5:00pm–6:30pm Data Driven Strategy Supporting Adequate Virtual Control Groups in Nonclinical Studies (P123) Nelson Exhibit Ballroom · Poster P123 Study data Poster Mon Nov 16 5:00pm–6:30pm Refining General Toxicology with Longitudinal MRI Assessments and AI-Enabled Analytics as a Platform for Cardioxicity and Neurotoxicity Monitoring in Cynomolgus Monkeys and Beagle Dogs (P436) Nelson Exhibit Ballroom · Poster P436 Animal models · Safety pharmacology Talk Tue Nov 17 8:00am–8:55am Virtual Control Groups and Digital Pathology: Shaping the Next Generation of Toxicologic Assessment Grand Oaks Ballroom P Study data · Pathology Talk Tue Nov 17 9:05am–9:30am Part of What Did You Forget on Your Way to Your NDA/MAA? Strategic Considerations for Late-Stage Nonclinical Safety Studies (S09) Immunotoxicity Studies: Integrating Immunotoxicity Assessment into Nonclinical Safety Programs (S09-2) Immunotoxicology Talk Tue Nov 17 12:00pm–12:55pm New Frontiers in NAMs Applications: Cutting-Edge Solutions for Immunogenicity, Developmental and Reproductive Toxicology, and Cardiac Safety Screening Grand Oaks Ballroom R New approach methods Session Wed Nov 18 9:00am–12:00pm Modernizing Drug Development: Advanced Translational Methodologies for CNS and PNS Risk Assessment (S13) Neurotoxicology · with Lilly 9:00amIntroduction on CNS Risk Assessment (S13-1)Lilly 9:10amNeurotoxicology in General Toxicology Studies: Interactive Case Studies to Explore Common Challenges, Regulatory Strategies, and Innovative Approaches (S13-2)Charles River 9:40amMechanistic Insights into Species-Specific Seizure Susceptibility (S13-3)ApconiX 10:45amThe Complexity of Drug Development Illustrated with Nav1.7-Associated Dysautonomia (S13-4)Genentech 11:10amCNS NAMs for modeling of neural plasticity and learning in neural organoids (S13-5)Johns Hopkins University Talk Wed Nov 18 9:10am–9:40am Part of Modernizing Drug Development: Advanced Translational Methodologies for CNS and PNS Risk Assessment (S13) Neurotoxicology in General Toxicology Studies: Interactive Case Studies to Explore Common Challenges, Regulatory Strategies, and Innovative Approaches (S13-2) Neurotoxicology

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