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Session 7: Driving Understanding of Human Risk Through Nonclinical Studies in Early Clinical Trials
Session Chair(s)
Barbara Hendrickson, DrMed, MD
Clinical Associate, Pediatric Infectious Diseases
University of Chicago, United States
Ranjeeta Sinvhal, MD
Executive Medical Director, Medical Safety
AbbVie, United States
The session starts with an overview of standard preclinical assessments. This overview will include species selection, general GLP toxicology, safety pharmacology, dose determination for oncology and non-oncology drugs, as well as specialized studies like immunotoxicity and phototoxicity. The evolving FDA perspective on New Approach Methodologies (NAMs) and reducing animal testing in preclinical safety studies also will be discussed. Interactive case studies with audience engagement and interdisciplinary panel discussion are planned. The panel discussion will address differences in approaches for biologics versus non-biologics, limitations of transgenic animal models, the translatability of animal findings to humans and the potential impact to early human studies with a move away from animal studies to NAMs.
Learning Objective : At the conclusion of this session, participants should be able to:- Explain the current approach to assembling a nonclinical safety package to support early human clinical studies
- Describe FDA’s recently posted Roadmap to reducing animal testing and types of new approach methodologies
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Appraise how nonclinical data impacts the safety planning of early human clinical trials
Speaker(s)
Overview of Current Approach to the Preclinical Safety Package
Sherry Ralston, PhD
AbbVie, United States
Executive Director, Development Biological Sciences
FDA Roadmap to Reducing Animal Testing and New Approach Methodologies
Representative Invited
FDA, United States
Case Studies Examining the Role of Nonclinical Data in Human Safety Risk Assessment
William E. Achanzar, PhD
Bristol Myers Squibb, United States
Scientific Executive Director, Nonclinical Safety
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