May 16-18, 2023 @ Genentech, South San Francisco, CA





 Speakers Confirmed for 2022

Plenary Lecture

Claudia Lindemann, PhD

Associate Director, Non-clinical Safety, BioNTech

Entering a New Era of Pharmaceuticals – Opportunities for mRNA Beyond COVID Vaccines


Sandhya Sanduja, PhD

Team Lead, Cell and Gene Therapies Regulation, CBER, FDA

Developing Gene Therapy Products Incorporating Human Genome Editing: Considerations for Preclinical Studies


Ronald Wange, PhD

Associate Director for Pharmacology and Toxicology, OND, CDER, FDA

Alternatives to the NHP: FDA Guidance and Past Practice



Susan Laffan, PhD

Senior Director, Global Head Investigative Safety, GSK

ICH S5 and S11 – From Principles to a Project Plan (Pharma)

Eric Jacquinet, DVM, PhD, DABT

Senior Director, Pathology, Moderna

Safety of mRNA Lipid Nano Particle-Based Vaccines


Richard Peterson, DVM, PhD

Research Fellow, AbbVie

Species Selection and Preclinical Development of Immune Cell Engagers and Cell-Based Therapies

Binu Philip, PhD, DABT

Director, Toxicology, Moderna

Species Selection and Preclinical Development of mRNA Based Therapeutics - tentative 


Jessica Grieves, PhD, DVM

Director of Pathology, Ionis

Nonclinical Safety of GalNAc-conjugated ASOs

Will Proctor, PhD, DABT

Senior Director, Non-Clinical Safety, Kymera

Non-Clinical Safety Challenges When Developing Targeted Protein Degraders


Nathan Moerke, PhD

Scientist/Drug Discovery Assay Development, STEMCELL Technologies 

Human Hepatic Organoids for Predictive Toxicology


Danuta Herzyk, PhD

Distinguished Scientist, Merck Research Laboratories

'A New Age’ for Reduction of NHP Use in Drug Development


Matt Wagoner, PhD

Global Head of Investigative Toxicology, Takeda Pharmaceuticals

Leveraging Competitor Safety Information to Investigate Clinical Toxicities of New Modalities


Lisa Marroquin, PhD

Scientist @ Pfizer, CT 

Title TBA


Prathap Kumar Mahalingaiah, DVM, PhD, DABT

Principal Scientist @ AbbVie

Application of Human Lung Alveolus MPS Model in Investigating Mechanism of ADC-induced Lung Toxicity

Dale Cooper, DVM

Senior Director and Attending Veterinarian @ Charles River Laboratories 

Significance of Country of Origin in Cynomolgus Macaques


Mark Jimenez-Canet, PhD

Senior Scientist, Toxicology @ Denali Therapeutics

Toxicology Screening Strategy for CNS-Penetrant Therapeutics: Key "Watch Outs" in Discovery Stage


Kary Thompson, PhD

Scientific Director, Global Head Study Toxicology @ The Janssen Pharmaceutical Companies of Johnson & Johnson 

Science-based Approach to Harmonize Contraception Recommendations in Clinical Trials & Pharmaceutical Labels


Christopher Regan, PhD

Senior Director, Safety & Exploratory Pharmacology @ Merck

E141/S7B Q&A – Overview & Implementation from a “User Perspective” 


Pragati Coder, PhD, DABT

Senior Director, Developmental and Reproductive Toxicology (DART) and Juvenile Toxicology @ Charles River Laboratories 

ICH S5 and S11 – From Principles to Practice (CRO)


Jeff Moffit, PhD, DABT

Vice President, Head of Nonclinical Development @ Biotech in Stealth Mode

Nonclinical Safety Considerations for Gene Therapy Products


Elizabeth Mutter-Rottmayer, PhD

Scientist/Toxicology@ Genentech 

Early Investigative Safety Assessment for TCR T Cell Therapy Products


Kathleen Meyer, PhD

Vice President, Nonclinical Development @ Sangamo Therapeutics

Strategies for Nonclinical Development of Genome Editing Products


Alain Stricker-Krongard, PhD

CEO, Envol Biomedical

The Future of Non-Human Primates Preclinical Research in the U.S


Sessions for the 2022 Discovery Toxicology Workshop

Session I: Nontraditional Therapeutic Modalities

Session II: Species Selection Paradigms for Large Molecules & New Modalities 

Session III: General Case Studies in Investigative and Discovery Toxicology


Sessions for the 2022 Development Toxicology Workshop

Session I: Nonhuman Primates (NHP) Shortage

Session II: Capsids, and Transgenes, and Double-Strand Breaks, “Oh My!”: Development of Gene Therapy/Editing Products

Session III: Updated ICH Guidance



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May 10-11, 2022 Discovery Toxicology

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