APPLIED PHARMACEUTICAL TOXICOLOGY 2021 - Virtual Event

Save the Date for 2021!

May 10 - 11, 2021 Discovery Toxicology Workshop

May 18-19, 2021 Development Toxicology Workshop

Plenary Speakers for 2021

Laura Dill Morton, DVM, PhD

Director of Toxicology at Aclairo Pharmaceutical Development Group, Inc.

Engaging CBER on Preclinical Gene Therapy Projects - a Consultant's Perspective

Daniel Nomura, PhD

Professor of Chemical Biology, University of California at Berkeley

Reimagining Druggability using Chemoproteomic Platforms

Lisa Plitnick, PhD

Distinguished Scientist, Merck

Discovery and Development of Vaccines and Worldwide Regulatory Experience

Jacinta Shenton, PhD

Senior Scientific Director, Nonclinical Safety Therapeutic Area Lead Immuno-Oncology, Janssen

Navigating Through Uncharted Territory at the Frontlines of Immuno-Oncology Innovation as a Nonclinical Safety Scientist

Speakers Confirmed for 2021

		Ahmet Hoke, MD, PhD Professor of Neurology and Neuroscience, Director of Neuromuscular Division, Johns Hopkins School of Medicine Toxic Peripheral Neuropathies: Clinical Perspective		Christopher Aluise, PhD Senior Research Scientist, Toxicology, Eli Lilly and Company Title TBA

		Lauren E. Black, PhD Distinguished Scientist, Scientific Advisory Services, Charles River Laboratories Adapting Traditional Tox Strategy to Patients with High Risk, Genetic Disorders: Do Regulations Speak to the Heart of the Issue?		Christopher Brynczka, PhD, DABT Senior Principal Scientist, Merck STINg in IO Space Immunomodulators

		Juliane Gust, MD, PhD Center for Integrative Brain Research, Seattle Children's Hospital CAR T Neurotoxicity: Translational Insights		Tomomi Kiyota, PhD Senior Scientist, Investigative Toxicology, Genentech 3D Renal Proximal Tubule-on-a-Chip for Assessing Drug-Induced Nephrotoxicity

		Kavita Raman, PhD Senior Scientist, Amgen Experience with Nonhuman Primate Models in CAR-T Therapy Nonclinical Safety Assessment		Kerry Jo Lee, MD Acting Associate Director for Rare Diseases, OND/CDER/FDA Regulatory Challenges and Considerations in Rare Disease Drug Development

		Changhua Ji, MD, PhD Associate Research Fellow, Pfizer Nonclinical Evaluation of CD3 Bispecific Antibodies		Matt Liu, PhD, DABT Fellow, Toxicology, Regeneron Pharmaceuticals, Inc. Rapid Development of REGN-COV2, an Anti-Spike Antibody Cocktail for Treatment and Prevention of COVID-19

		Lisa Mangus, DVM, PhD, DACVP Assistant Professor, Dept. of Molecular & Comparative Pathobiology, Johns Hopkins School of Medicine Intra-Epidermal Nerve Fiber Analysis: a Sensitive, Clinically-Relevant Tool for Assessing Sensory Nerve Damage in Animal Models		Kim Maratea, DVM, PhD, DACVP Associate Director Pathology, Oncology Safety, AstraZeneca Early Assessment of Bone Marrow Toxicity in Immunodeficient Mice

		John McNulty, PhD Senior Director/Drug Safety Therapeutic Lead - Rare Disease, Takeda Safety Considerations in the Development of Pharmacologically Active Proteins for Rare Diseases		Scott Mittelstadt, PhD Director of Investigative Toxicology and Safety Pharmacology, AbbVie CiPA: Practical Applications in Discovery

		Suman Mukherjee, PhD Director, In Vivo PK and TK Group, Safety Assessment, Merck The Impact of Toxicokinetics on the Design and Interpretation of Toxicology Studies		Lutz Mueller, PhD Distinguished Scientist - Project Leader, F. Hoffmann- La Roche Ltd. Risdiplam - Fast Development to Turn the First Small Molecule mRNA Splice Modifier Into an Approved Medicine

		Michael Polydefkis, MD MHS Professor, Neurology, Johns Hopkins University School of Medicine TBA		Chandra Saravanan, PhD Senior Veterinary Pathologist, Novartis Institutes for BioMedical Research Spectral Imaging/Multispectral Imaging Approaches to Understand Mechanism of Toxicity

		Nicola Stagg, PhD, DABT Senior Scientist/Toxicologist, Genentech Improving Preclinical to Clinical Translation of Drug-induced Peripheral Neuropathy: A Case Example with MMAE Containing Antibody Drug Conjugates		Jonathan Stauber, PhD Director, ImaBiotech Role of Drug Exposure Quantification for Safety and Efficacy Evaluation in Non Clinical and Clinical Trials

		Richard Stebbings, PhD Director Oncology ICA Safety Sciences & Discovery, AstraZeneca COVID19 Vaccine AstraZeneca: Mission Impossible EUA		Jessica Sutherland, PhD, DABT Senior Director, Toxicology, Alnylam Pharmaceuticals The Nonclinical Safety Profile of ONPATTRO® (patisiran), a First-in Class RNAi Therapeutic for the Treatment of Polyneuropathy of Hereditary Transthyretin-mediated Amyloidosis (hATTR amyloidosis)

		John Vahle, DVM, PhD, DACVP Senior Research Fellow, Eli Lilly Nonclinical Safety Assessment Strategies for COVID19 Mabs: Expediting Clinical Trials and Emergency Use Authorizations		Andy Vo, PhD Senior Scientist - Computational Toxicology, AbbVie Integrating a Big Toxicity Data Framework to Better Evaluate Drug Safety

		Matt Wagoner, PhD Director of Investigative Toxicology, Takeda Pharmaceuticals Surviving the Technology Hype Cycle/Where MPS are Having an Impact Today, and Where They're Needed Next		Larry Whiteley, DVM, PhD, DACVP Senior Director, Pfizer Things to Consider When Translating Gene Therapy Nonclinical Data to Support Clinical Trials

		Javier Waksman, MD, DABT, FAACT Vice President, Head of Drug Safety, Sangamo Therapeutics, Inc. Hepatotoxicity Associated with AAV-based Gene Therapy: Evaluation, Mechanism, and Treatment		Nathan Meorke, PhD Scientist Contract Assay Services, STEMCELL Technologies Utility of Human Pluripotent Stem-Cell Derived Cardiomyocytes in Cardiotoxicity Assays Using the Maestro^TM MEA System and STEMdiff^TM Cardiomyocyte Media

		Christopher Strock, PhD Director of Scientific Operations, Cyprotex US Transforming DILI Prediction using Transcriptomics and AI