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


Jacintha 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

Toxicological Evaluation of the Peripheral Nervous System to Support a First-in-human Study for a New Molecular Entity 



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

Preclinical Safety for a Small Molecule Sting Agonist Immunotherapy



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



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


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




Nathan Meorke, PhD

Scientist Contract Assay Services, STEMCELL Technologies

Utility of Human Pluripotent Stem-Cell Derived Cardiomyocytes in Cardiotoxicity Assays Using the MaestroTM MEA System and STEMdiffTM Cardiomyocyte Media



Christopher Strock, PhD

Director of Scientific Operations, Cyprotex US

Transforming DILI Prediction using Transcriptomics and AI



Sushma Jadalannagari, PhD

Principal Scientist, Emulate

The Human Duodenum Intestine-Chip for Applications in Safety, Absorption, Transport, and Metabolism


Juliette Hordeaux, DVM, PhD, DECVP

Senior Director, Translational Research, UPenn

MicroRNA-mediated Inhibition of Transgene Expression Reduces Dorsal Root Ganglion Toxicity by AAV Vectors in Primates



Sessions for the 2021 Discovery Toxicology Workshop

Session I:  IO in Discovery Toxicology Space

Session II:  Microphysiological Systems (MPS)

Session III:  Novel Approaches to Identify Off-target Drivers of Toxicity

Session IV:  Case Studies in Investigative Toxicology



Sessions for the 2021 Development Toxicology Workshop

Session I:  Vaccine Development and mAb; Regulatory Perspective

Session II:  Developing Products for Rare Diseases and Conditions

Session III:  Gene Therapy

Session IV:  Peripheral Neuropathy






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May 10-11, 2021 Discovery Toxicology

May 18-19, 2021 Development Toxicology

Virtual Event


The Boston Society

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