Chemical and environmental risk assessment at ACT 2026

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

38 organizations at ACT 2026 present work in chemical and environmental risk assessment: 17 service, testing and tools companies, 15 universities, agencies and non-profits and 6 drug developers. Between them they bring 91 presentations to the program. Most represented: U.S. Food and Drug Administration, Johnson & Johnson and Novartis. As of Oct 8, 2026.

All 231 organizations at ACT 2026 →

Showing 1–5 of 38 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
Johnson & Johnson New Brunswick, NJ
jnj.com Pharmaceutical companies Healthcare company whose Innovative Medicine arm, formerly Janssen, discovers, develops and markets prescription medicines.	Talk Sun Nov 15 8:00am–8:05am Part of Working with Global Regulators for Streamlined Nonclinical Development (CE4) Introduction (CE4-1) Regulatory Session Sun Nov 15 8:00am–11:30am Working with Global Regulators for Streamlined Nonclinical Development (CE4) Regulatory · with MEC Regulatory & Toxicology Consulting 8:00amIntroduction (CE4-1)Johnson & Johnson 8:05amTop Tips for Successful Nonclinical Regulatory Interaction (CE4-2)Charles River 8:30amIdeal Interaction During Drug Development: FDA Regulator's Perspective (CE4-3)U.S. Food and Drug Administration 9:00amIdeal Interaction During Drug Development: European Regulator's Perspective (CE4-4)Medicines Evaluation Board 10:00amSponsor Strategies for Successful Regulatory Agency Interactions (CE4-5)Lilly 10:30amInteractive Workshop: Practical Case Studies to Model Successful Regulatory Agency Interactions (CE4-6)MEC Regulatory & Toxicology Consulting Talk Sun Nov 15 9:00am–9:30am Part of The ABCs of EFDs: A Modern Guide to Embryofetal Development Testing (CE3) Conducting an EFD Study: The Essentials of Getting it Right (CE3-4) DART Talk Sun Nov 15 3:00pm–3:20pm Part of Immunotherapies and Collaborative Approaches to Immunosafety Assessment (CE6) Effectively Evaluating, Understanding, and Communicating the Risky Behavior of Immunotherapies: The Complex and Diverse Role of a Project (Program) Toxicologist (CE6-5) Immunotoxicology Talk Mon Nov 16 2:00pm–2:05pm Part of Navigating Safety Signals and Clinical Holds: Lessons Learned from Nonclinical and Clinical Development (S06) Introduction (S06-1) Translational safety Session Mon Nov 16 2:00pm–5:00pm Navigating Safety Signals and Clinical Holds: Lessons Learned from Nonclinical and Clinical Development (S06) Translational safety 2:00pmIntroduction (S06-1)Johnson & Johnson 2:05pmDe-risking of Nonclinical Renal Safety Signals through Investigative Studies and Robust Clinical Monitoring (S06-2)Bristol Myers Squibb 2:40pmDILI Whodunnit: Responding to Drug Induced Liver Injury during TAK-994 Clinical Trials (S06-3)Takeda 3:45pmClinical Holds in the Development of Novel Genetic Medicines (S06-4)Bioepisteme 4:20pmProspective and Retrospective Risk Assessments of Safety Signals for a Rare Disease Biotherapeutic (S06-5)Amgen Poster Mon Nov 16 5:00pm–6:30pm Validation of Organ-Specific Risk Estimates Derived from a Gene-Based Machine Learning Algorithm (P447) Nelson Exhibit Ballroom · Poster P447 In silico and AI Talk Tue Nov 17 3:45pm–4:15pm Part of The Evolving Landscape of Secondary Pharmacology and Off-Target Assessments in Pharmaceutical Development (S10) Evolving Selectivity Assessment of Biologic Products with Cell-Based Protein Arrays and Derisking Strategies (S10-4) Biologics and new modalities · Safety pharmacology Talk Wed Nov 18 2:25pm–2:45pm Part of Invisible Ingredients, Critical Functions: The Risk Narrative around Excipients and PFAS (S17) Risk Communication and Perception of Forever Chemicals and the Consequences for Pharma (S17-2) Chemical risk assessment
Novartis Basel, Switzerland
novartis.com Pharmaceutical companies Swiss pharmaceutical company; its preclinical safety teams present on first-in-human dosing, oligonucleotides, minipig lactation studies and excipient safety.	Session Sun Nov 15 8:00am–11:30am First-in-Human Dose Selection: Translational Strategies and Special Considerations across Modalities and Organ Systems (CE1) Translational safety · with Boehringer Ingelheim 8:00amFoundational Approaches to FIH Dose Selection (CE1-1)White Oak Regulatory Tox 8:20amModel-Informed Approaches to FIH Dose Prediction (CE1-2)Bedard ADME-Tox Solutions, Tango Therapeutics 8:45amCNS-Delivered Therapeutics: Anatomic, Physiologic, and Modality-Specific Considerations (CE1-3)Akkeri 9:10amInter-Species Dose Extrapolation for Ocular Therapeutics: Translational Frameworks for Eye-Delivered Products (CE1-4)Novartis 10:00amCrossing the Species Divide in Inhaled Dosing (CE1-5)Novartis 10:25amInteractive Session: Hypothetical Challenge Scenarios in FIH Setting (CE1-6)Boehringer Ingelheim Talk Sun Nov 15 9:10am–9:30am Part of First-in-Human Dose Selection: Translational Strategies and Special Considerations across Modalities and Organ Systems (CE1) Inter-Species Dose Extrapolation for Ocular Therapeutics: Translational Frameworks for Eye-Delivered Products (CE1-4) Translational safety Talk Sun Nov 15 10:00am–10:25am Part of First-in-Human Dose Selection: Translational Strategies and Special Considerations across Modalities and Organ Systems (CE1) Crossing the Species Divide in Inhaled Dosing (CE1-5) Inhalation toxicology · Translational safety Poster Mon Nov 16 5:00pm–6:30pm Coadministration of Two GalNAc-Conjugated siRNAs in Rats Produces Nonadverse Effects Similar to the Findings of the Individual siRNAs in General Toxicology Studies (P405) Nelson Exhibit Ballroom · Poster P405 Biologics and new modalities Poster Mon Nov 16 5:00pm–6:30pm Comparison between the Intravenous (IV) and Subcutaneous (SC) Routes of Administration of Inclisiran on Pharmacodynamics (PD), Toxicokinetics (TK) and Safety in the Nonhuman Primate (P409) Nelson Exhibit Ballroom · Poster P409 Biologics and new modalities · Bioanalysis and biomarkers Poster Mon Nov 16 5:00pm–6:30pm Neonatal Excipient Safety: Risk Assessment Considerations for Ethyl Benzoate in a Vulnerable Patient Population (P427) Nelson Exhibit Ballroom · Poster P427 Chemical risk assessment Poster Mon Nov 16 5:00pm–6:30pm The Göttingen Minipig as a Preclinical Model of Drug Transfer during Lactation (P440) Nelson Exhibit Ballroom · Poster P440 DART · Animal models Talk Wed Nov 18 2:05pm–2:30pm Part of Hot Topics (S18) Cross-Industry Survey of Nonclinical Development Strategies for Oligonucleotide Therapeutics: Species Selection, Dose Setting, and Translational Approaches (S18-2) Biologics and new modalities · Animal models
Bristol Myers Squibb
bms.com Pharmaceutical companies Global pharmaceutical company with marketed medicines in oncology, immunology, cardiovascular disease and neuroscience.	Talk Mon Nov 16 2:05pm–2:40pm Part of Navigating Safety Signals and Clinical Holds: Lessons Learned from Nonclinical and Clinical Development (S06) De-risking of Nonclinical Renal Safety Signals through Investigative Studies and Robust Clinical Monitoring (S06-2) Translational safety Poster Mon Nov 16 5:00pm–6:30pm Terminology Translation of SEND and MedDRA for Enabling Translational Safety: Challenges, Use Cases, and Collaborative Opportunities (P528) Nelson Exhibit Ballroom · Poster P528 Study data · Translational safety Poster Mon Nov 16 5:00pm–6:30pm Unlocking the Value of Shared Toxicology Data: How BioCelerate Members Use Historical Data to Support Preclinical Research (P445) Nelson Exhibit Ballroom · Poster P445 Study data Talk Tue Nov 17 2:05pm–2:40pm Part of Safety Assessment of Extractables and Leachables under the New ICH Q3E Guideline (S11) Introduction to the ICH Q3E Draft Guideline: Extractables & Leachables - A Pharmaceutical Industry Perspective (S11-2) Chemical risk assessment · Regulatory Session Wed Nov 18 2:00pm–3:15pm The Versatile Toxicologist: How to Leverage Expertise into Opportunity (S16) Careers · with BioMarin 2:00pmConventional and Unconventional Trajectories to a Toxicologist Career in the Pharmaceutical Sector (S16-1)Boehringer Ingelheim 2:20pmTransitioning from Government Regulator to the Private Sector (S16-2)BlueRock Therapeutics 2:40pmSo You Want to Be a Consultant? (S16-3)Biologics Consulting
HESI Washington, DC	◇Silver Supporter
hesiglobal.org Societies and non-profitsSilver Supporter Non-profit running collaborative scientific programs among industry, government and academic scientists on human health and environmental safety questions.	Poster Mon Nov 16 5:00pm–6:30pm Expectations and Opinions on an ICH S7A Revision: Stakeholder Survey Results (P207) Nelson Exhibit Ballroom · Poster P207 Safety pharmacology · Regulatory Talk Wed Nov 18 9:00am–9:15am Part of The Future of Nonclinical Carcinogenicity Testing: NAMs in a Weight-of-Evidence Paradigm Shift (S15) From Rodent Bioassays to Mechanistic Evidence: The Future of Carcinogenicity Assessment (S15-1) Genetic toxicology Session Wed Nov 18 9:00am–12:00pm The Future of Nonclinical Carcinogenicity Testing: NAMs in a Weight-of-Evidence Paradigm Shift (S15) Genetic toxicology · New approach methods · with White Oak Regulatory Tox 9:00amFrom Rodent Bioassays to Mechanistic Evidence: The Future of Carcinogenicity Assessment (S15-1)HESI 9:15amCarcinogenicity Assessments Based on a Weight of Evidence Approach and the Role of NAMs in Supporting This Approach (S15-2)White Oak Regulatory Tox 9:45amIntegrating Error-Corrected Sequencing into OECD Test Guidelines: Advancing Precision Mutagenesis in Regulatory Toxicology (S15-3)Health Canada 10:45amAssessing Clonal Expansion of Cancer Driver Mutants as an Early Cancer Biomarker (S15-4)U.S. Food and Drug Administration 11:15amIndustry Perspectives on Advanced Methods for Carcinogenicity Risk Assessment (S15-5)GSK Talk Wed Nov 18 2:30pm–2:55pm Part of Hot Topics (S18) Benchmark Dose Modeling: Advancing Transparency and Next-Generation Applications in Risk Assessment (S18-3) In silico and AI · Chemical risk assessment Talk Wed Nov 18 2:55pm–3:15pm Part of Hot Topics (S18) Emerging Insights on QTc Risks in Targeted Protein Degraders (S18-4) Safety pharmacology

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