Deputy Director
US Food & Drug Administration
Dr. Lei Zhang serves as the Deputy Director of Office of Research and Standards within Office of Generic Drugs at the Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Dr. Zhang oversees the implementation of the Generic Drug User Fee Amendments (GDUFA) science and research program to ensure the therapeutic equivalence of generic drug products. Dr. Zhang was previously Senior Advisor for Regulatory Programs and Policy in the Office of Clinical Pharmacology at CDER, FDA. Dr. Zhang is an accomplished professional with more than 25 years of combined experiences in the areas of drug research, development and regulatory review and approval. She has contributed to numerous guidance development and research projects focused on science-based regulatory decision making. Before joining FDA in 2002, she worked at Bristol Meyers Squibb as a Research Investigator and Preclinical Candidate Optimization Team Leader. Dr. Zhang is an Adjunct Professor in the Department of Bioengineering and Therapeutic Sciences, University of California at San Francisco (UCSF), Schools of Pharmacy and Medicine. Dr. Zhang received her Ph.D. in Biopharmaceutical Sciences from UCSF. She is currently the Rapporteur for the ICH M13 Expert Working Group that is developing harmonized guidelines on bioequivalence (BE) for immediate-release oral dosage form drugs. She was a member of the ICH Generic Drug Discussion Group (GDG), serving as the U.S. FDA Topic Lead. Dr. Zhang is a member of ASCPT, ACCP, AAPS and ISSX. She serves/served on numerous committees of these societies. Dr. Zhang was named American Association of Pharmaceutical Scientists (AAPS) Fellow in 2013. She has published more than 130 peer-reviewed papers and book chapters.
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Monday, September 9, 2024
1:30 PM – 3:00 PM ET
Monday, September 9, 2024
1:30 PM – 3:00 PM ET