SAVE THE DATE !
APPLIED PHARMACEUTICAL TOXICOLOGY (APT) 2022
APT will be an in-person meeting. However, remote attendance will be an option in case you are still not able to travel.
May 10-12, 2022 @ Vertex Pharmaceuticals, Boston, MA
DOWNLOAD APT 2022 PROGRAM GUIDE
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Speakers Confirmed for 2022
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Plenary Lecture Claudia Lindemann, PhD Associate Director, Non-clinical Safety, BioNTech Entering a New Era of Pharmaceuticals – Opportunities for mRNA Beyond COVID Vaccines |
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Sandhya Sanduja, PhD Team Lead, Cell and Gene Therapies Regulation, CBER, FDA Developing Gene Therapy Products Incorporating Human Genome Editing: Considerations for Preclinical Studies |
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Ronald Wange, PhD Associate Director for Pharmacology and Toxicology, OND, CDER, FDA Alternatives to the NHP: FDA Guidance and Past Practice
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Susan Laffan, PhD Senior Director, Global Head Investigative Safety, GSK ICH S5 and S11 – From Principles to a Project Plan (Pharma) |
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Eric Jacquinet, DVM, PhD, DABT Senior Director, Pathology, Moderna Safety of mRNA Lipid Nano Particle-Based Vaccines |
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Richard Peterson, DVM, PhD Research Fellow, AbbVie Species Selection and Preclinical Development of Immune Cell Engagers and Cell-Based Therapies |
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Binu Philip, PhD, DABT Director, Toxicology, Moderna Species Selection and Preclinical Development of mRNA Based Therapeutics - tentative |
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Jessica Grieves, PhD, DVM Director of Pathology, Ionis Nonclinical Safety of GalNAc-conjugated ASOs |
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Will Proctor, PhD, DABT Senior Director, Non-Clinical Safety, Kymera Non-Clinical Safety Challenges When Developing Targeted Protein Degraders |
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Nathan Moerke, PhDScientist/Drug Discovery Assay Development, STEMCELL Technologies Human Hepatic Organoids for Predictive Toxicology
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Danuta Herzyk, PhD Distinguished Scientist, Merck Research Laboratories 'A New Age’ for Reduction of NHP Use in Drug Development |
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Matt Wagoner, PhD Global Head of Investigative Toxicology, Takeda Pharmaceuticals Leveraging Competitor Safety Information to Investigate Clinical Toxicities of New Modalities |
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Lisa Marroquin, PhD Scientist @ Pfizer, CT Title TBA |
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Prathap Kumar Mahalingaiah, DVM, PhD, DABT Principal Scientist @ AbbVie Application of Human Lung Alveolus MPS Model in Investigating Mechanism of ADC-induced Lung Toxicity |
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Dale Cooper, DVM Senior Director and Attending Veterinarian @ Charles River Laboratories Significance of Country of Origin in Cynomolgus Macaques |
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Mark Jimenez-Canet, PhD Senior Scientist, Toxicology @ Denali Therapeutics Toxicology Screening Strategy for CNS-Penetrant Therapeutics: Key "Watch Outs" in Discovery Stage |
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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 |
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Christopher Regan, PhD Senior Director, Safety & Exploratory Pharmacology @ Merck E141/S7B Q&A – Overview & Implementation from a “User Perspective” |
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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) |
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Jeff Moffit, PhD, DABT Vice President, Head of Nonclinical Development @ Biotech in Stealth Mode Nonclinical Safety Considerations for Gene Therapy Products |
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Elizabeth Mutter-Rottmayer, PhD Scientist/Toxicology@ Genentech Early Investigative Safety Assessment for TCR T Cell Therapy Products |
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Kathleen Meyer, PhD Vice President, Nonclinical Development @ Sangamo Therapeutics Strategies for Nonclinical Development of Genome Editing Products |
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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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