Immunotoxicology at ACT 2026

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

21 organizations at ACT 2026 present work in immunotoxicology: 14 service, testing and tools companies, 4 drug developers and 3 universities, agencies and non-profits. Between them they bring 69 presentations to the program. Most represented: U.S. Food and Drug Administration (14 on the program), Johnson & Johnson (8 on the program), Charles River (5 on the program). As of Oct 8, 2026.

All 231 organizations at ACT 2026 →

Showing 1–5 of 21 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
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
Boehringer Ingelheim Ingelheim, Germany
boehringer-ingelheim.com Pharmaceutical companies Family-owned German pharmaceutical company developing human medicines and animal health products.	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 Novartis 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 Session Sun Nov 15 8:00am–11:30am From Predictive Models to Collaborative Intelligence: The Role of Agentic AI in the Future of Toxicology (CE2) In silico and AI · with Human Chemical 8:00amWelcome and Course Overview (CE2-1)Human Chemical 8:05amAgentic AI 101: A Primer for Drug Discovery and Development Toxicologists (CE2-2)Taiho Oncology 8:30amAgentic AI Frameworks for Predictive Toxicology-Based Literature Searches (CE2-3)Coincidence Labs 9:00amSynthesizing Experimental Results and In-Silico Predictions for Autonomous Hypothesis Generation (CE2-4)Human Chemical 10:00amLeveraging Agentic AI to Reassess and Optimize Previously Failed Compounds (CE2-5)Ignota Labs 10:30amChemistry Foundation Models for Optimal Drug Design (CE2-6)deepmirror Talk Sun Nov 15 10:25am–11:30am Part of First-in-Human Dose Selection: Translational Strategies and Special Considerations across Modalities and Organ Systems (CE1) Interactive Session: Hypothetical Challenge Scenarios in FIH Setting (CE1-6) Translational safety Poster Mon Nov 16 5:00pm–6:30pm IL-10–Associated Thrombocytopenia Is Not Mediated by Direct Platelet Effects (P129) Nelson Exhibit Ballroom · Poster P129 Immunotoxicology · Pathology Poster Mon Nov 16 5:00pm–6:30pm Strengthening Regulatory Confidence in Liver MPS: Insights from The 3Rs Collaborative’s & FDA CDER’s Cross Platform DILI Project (P213) Nelson Exhibit Ballroom · Poster P213 New approach methods · Regulatory Session Tue Nov 17 9:00am–12:00pm Next-Generation Liver Toxicity Assessment: Integrating Human-Relevant NAMs, AI, and Exposure Modeling (S07) New approach methods · In silico and AI · with Physicians Committee for Responsible Medicine 9:00amIntroduction (S07-1)Physicians Committee for Responsible Medicine 9:05amAn Integrated NAM Platform Combining Bioactivity Prediction with PBPK and Literature Intelligence for Chemical Liver Toxicity Assessment (S07-2)Human Chemical 9:30amMulticellular Hepatic In Vitro Models Using NANOSTACKS™: Flow-Driven Differential Toxicity and Human-Relevant Drug Response Prediction (S07-3)Revivocell 9:55amAI-Enabled, Exposure-Anchored DILI Prediction Using Human 3D Liver Microtissues (S07-4)InSphero 10:45amFrom Exposure Dynamics to Uncertainty: A Hybrid Framework for Drug-Induced Liver Injury Prediction (S07-5)ESQlabs 11:25amNovel Optical Techniques to Study Hepatic Microplastic Pollution: Optical Imaging as a Powerful New Approach Methodology (S07-6)University of New Mexico Talk Wed Nov 18 2:00pm–2:20pm Part of The Versatile Toxicologist: How to Leverage Expertise into Opportunity (S16) Conventional and Unconventional Trajectories to a Toxicologist Career in the Pharmaceutical Sector (S16-1) Careers
TriApex Nanjing, China	◆Platinum Supporter
tri-apex.com Contract research organizations (CROs)Platinum Supporter Chinese nonclinical and clinical CRO with NMPA GLP certification, presenting work on ADCs, oligonucleotides, siRNA and gene therapy.	Talk Mon Nov 16 7:00am–7:55am Context-Driven Tiered and Integrated Nonclinical Evaluation: From Framework to ADC Nonclinical Implementation Grand Oaks Ballroom O Biologics and new modalities · Regulatory Poster Mon Nov 16 5:00pm–6:30pm A Tiered Strategy for Evaluating In Vivo Complement Activation Risk of Chemically-Modified ASOs in Nonclinical Studies (P505) Nelson Exhibit Ballroom · Poster P505 Immunotoxicology · Biologics and new modalities Poster Mon Nov 16 5:00pm–6:30pm Biodistribution and Neurotoxicity Assessment of rAAV1 Gene Therapy after Round Window Membrane Injection (P120) Nelson Exhibit Ballroom · Poster P120 Biologics and new modalities · Neurotoxicology Poster Mon Nov 16 5:00pm–6:30pm Toxicokinetic Characteristics and Toxicity Findings of Lipid-Delivered Small Interfering RNA Drugs in Cynomolgus Studies (P139) Nelson Exhibit Ballroom · Poster P139 Biologics and new modalities · Bioanalysis and biomarkers

Instantly find 20 buyers in immunotoxicology

Get a list of who you should contact, their contact info, and what to say.

Totally free and instant, no sign up necessary!

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

Instantly find 20 buyers in immunotoxicology

Browse ACT 2026 by