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Session 3 Tracks 1 and 2: Regulatory Considerations of Novel Conjugates: Translational and Clinical Pharmacology Perspectives
Session Chair(s)
Louis St. L. O'Dea, DrMed, MD, FRCPC
Strategic Advisor, P235936NW, United States
Patrik Andersson, PhD
Senior Director, AstraZeneca R&D, Sweden
Session 3 Tracks 1 and 2: Regulatory Considerations of Novel Conjugates: Translational and Clinical Pharmacology Perspectives
Learning Objective : - Apply principles and considerations to novel oligonucleotide-based conjugate therapeutics in regulatory review
- Identify approaches taken in evaluation of compound molecules that contain several active or novel elements that may warrant individual regulatory consideration
- Apply advice received, or likely to be received based on regulatory principles, for the preclinical and clinical safety evaluation of such molecules
Speaker(s)
Sydney Stern, PhD, MS
, Independent Consultant, United States
Regulatory Considerations/Principles
Kelle Franklin
Director, Eli Lilly and Company, United States
Pharmacologic, Non-Clinical Consideration
Debra B Feldman
Chief Regulatory Affairs Officer, Dyne Therapeutics, United States
Early Human/Translational Considerations[
Representative Invited
Professor of Cardiology, Director of Clinical Trial Center, Peking University Third Hospital, China
Speaker