Module 4: Early In Vivo Exploratory and Derisking Studies

Recorded On: 05/07/2026

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Following extensive in silico, in vitro, and ex vivo characterization of a drug candidate, the next step is often to further understand potential on-target and off-target safety risk in vivo. This presentation will review different types of exploratory studies that could be considered prior to the FIH-enabling nonclinical toxicology studies. Topics may include early targeted studies evaluating toxicities that often impact drug development, such as cardiovascular safety and hepatotoxicity, the use of exploratory studies to understand a novel mechanism of action, consideration of customized endpoints (biomarkers) in vivo based on the target.

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Module 4 Early In Vivo Exploratory and Derisking Studies
Module 4: Early In Vivo Exploratory and Derisking Studies, J. Eric McDuffie, PhD
Recorded 05/07/2026  |  90 minutes
Recorded 05/07/2026  |  90 minutes Following extensive in silico, in vitro, and ex vivo characterization of a drug candidate, the next step is often to further understand potential on-target and off-target safety risk in vivo. This presentation will review different types of exploratory studies that could be considered prior to the FIH-enabling nonclinical toxicology studies. Topics may include early targeted studies evaluating toxicities that often impact drug development, such as cardiovascular safety and hepatotoxicity, the use of exploratory studies to understand a novel mechanism of action, consideration of customized endpoints (biomarkers) in vivo based on the targe
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J. Eric McDuffie, PhD

J. Eric McDuffie, PhD

Neurocrine Biosciences, Inc.

Dr. J. Eric McDuffie currently serves as Senior Scientific Director of Investigative Toxicology at Neurocrine Biosciences, Inc. in San Diego, California. Dr. McDuffie has over 25 years of experience in the application of mechanism-based in vitro and in vivo models and related assays as well as expertise in regulatory toxicology to enable early- and late-stage drug candidate development.

He joined Neurocrine in 2021, after a 14-year tenure at Janssen Research & Development, LLC. At Janssen, Dr. McDuffie served as Director of Mechanistic & Investigative Toxicology. Previously (2000 – 2007), he served as Senior Scientist/Manager of the Laboratory Core Group and later the Investigative Pathology and Immunotoxicology groups at Pfizer’s Ann Arbor and Plymouth, Michigan sites, respectively.

Dr. McDuffie earned a PhD degree in Pharmacology from Meharry Medical College and completed a postdoctoral research fellowship at the University of Michigan Medical School in the Pathology Department. He has given numerous platform presentations, co-authored several peer reviewed manuscripts/posters/book chapters, and edited multiple books.