Developmental and reproductive toxicology at ACT 2026

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

21 organizations at ACT 2026 present work in developmental and reproductive toxicology: 13 service, testing and tools companies, 7 drug developers and 1 university, agency or non-profit. Between them they bring 71 presentations to the program. Most represented: Labcorp (12 on the program), Johnson & Johnson (8 on the program), Novartis (6 on the program). As of Oct 8, 2026.

All 231 organizations at ACT 2026 →

Showing 1–5 of 21 organizations

Organization	ACT 2026 Attendance
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
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
Lilly Indianapolis, IN	◆Diamond Supporter
lilly.com Pharmaceutical companiesDiamond Supporter Global pharmaceutical company with medicines in diabetes, obesity, oncology, immunology and neuroscience.	Talk Sun Nov 15 10:00am–10:35am Part of The ABCs of EFDs: A Modern Guide to Embryofetal Development Testing (CE3) Interpreting EFD Study Data (CE3-5) DART Talk Sun Nov 15 10:00am–10:30am Part of Working with Global Regulators for Streamlined Nonclinical Development (CE4) Sponsor Strategies for Successful Regulatory Agency Interactions (CE4-5) Regulatory Talk Tue Nov 17 9:50am–10:15am Part of Overcoming the Blood-Brain Barrier and Translational Challenges in the Nonclinical Development of CNS Drugs (S08) Nonclinical Developmental Considerations for Neuronal Delivery of Oligonucleotides (S08-4) Biologics and new modalities · Neurotoxicology Session Tue Nov 17 2:00pm–5:00pm From Policy to Practice: Progress on the FDA’s 2025 Roadmap to Reduce Animal Use in Antibody Platform Development (S12) New approach methods · Regulatory · with Neurocrine Biosciences 2:00pmWelcome and Overview (S12-1)Neurocrine Biosciences 2:05pmA Brief History of Regulatory Efforts to Reduce Animal Use in Drug Development (S12-2)Lilly 2:20pmThe FDA Roadmap and Adoption of NAMs for Regulatory Decision Making (S12-3)U.S. Food and Drug Administration 2:50pmIndustry Experience: DruSafe/BioSafe Survey (S12-4)Agios Pharmaceuticals 3:45pmNAM Qualification Pathway for an ISTAND Drug Development Tool (S12-5)Integral Molecular Talk Tue Nov 17 2:05pm–2:20pm Part of From Policy to Practice: Progress on the FDA’s 2025 Roadmap to Reduce Animal Use in Antibody Platform Development (S12) A Brief History of Regulatory Efforts to Reduce Animal Use in Drug Development (S12-2) Regulatory · New approach methods Talk Wed Nov 18 9:00am–9:10am Part of Modernizing Drug Development: Advanced Translational Methodologies for CNS and PNS Risk Assessment (S13) Introduction on CNS Risk Assessment (S13-1) Neurotoxicology Session Wed Nov 18 9:00am–12:00pm Modernizing Drug Development: Advanced Translational Methodologies for CNS and PNS Risk Assessment (S13) Neurotoxicology · with Charles River 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
SAFE Pharmaceutical Services Great Falls, VA
safecro.com Contract research organizations (CROs) Contract research organization with GLP, AAALAC-accredited toxicology facilities across China and its own primate breeding colony, plus a US advisory team.	Booth Exhibiting at Booth 717 Mon, Nov 169:30am–6:30pmTue, Nov 178:00am–4:30pm Poster Mon Nov 16 5:00pm–6:30pm Comparative Toxicity and Pharmacokinetic Profile of Oligonucleotide Therapeutics in Cynomolgus Monkeys (P408) Nelson Exhibit Ballroom · Poster P408 Biologics and new modalities · Bioanalysis and biomarkers Poster Mon Nov 16 5:00pm–6:30pm Experimental Design and Outcome Analysis for Preclinical Dependence Assessment of α₂δ Subunit Ligands of Voltage-Gated Calcium Channels (P416) Nelson Exhibit Ballroom · Poster P416 Safety pharmacology Poster Mon Nov 16 5:00pm–6:30pm ICH S11-Compliant Juvenile NHP Studies: A Retrospective Analysis of 12 Toxicology Studies Supporting Pediatric Drug Development (P422) Nelson Exhibit Ballroom · Poster P422 DART · Animal models Poster Mon Nov 16 5:00pm–6:30pm Repeated Dose Toxicity and Toxicokinetic Study of Inhaled Powder X-101 in Mice (P448) Nelson Exhibit Ballroom · Poster P448 Inhalation toxicology

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