Deputy Director
US Food and Drug Administration
Dr. Lei Zhang is currently Deputy Director in the Office of Research and Standards (ORS), OGD, CDER, U.S. FDA. ORS implements the Generic Drug User Fee Amendments (GDUFA) science and research commitments to ensure the therapeutic equivalence of generic drug products. Dr. Zhang received her Ph.D. in Biopharmaceutical Sciences from UCSF. She is an accomplished professional with more than 23 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 the science-based regulatory decision-making. Prior to 2002, she worked at Bristol-Meyers Squibb Company as a Research Investigator and Preclinical Candidate Optimization Team Leader. Dr. Zhang has been a member of ASCPT since 2007 and has served on the scientific program committee, scientific award task force and DRO Network leadership. She was a Board member of ASCPT (2019-2021) and serves on the Clinical Pharmacology and Therapeutics Editorial Board. Dr. Zhang is the Rapporteur for ICH M13 Expert Working Group that is developing M13 guideline to harmonize bioequivalence (BE) study design for immediate-release oral dosage form drugs. Dr. Zhang was named American Association of Pharmaceutical Scientists (AAPS) Fellow in 2013. Dr. Zhang is a member of the International Transporter Consortium (ITC) that published a transporter whitepaper in 2010 and several whitepapers/position papers in 2013 and 2018. She is an Adjunct Professor in the Department of Bioengineering and Therapeutic Sciences, UCSF Schools of Pharmacy and Medicine. Dr. Zhang has authored and co-authored more than 120 papers.
Disclosure information not submitted.
Tuesday, January 11, 2022
1:15 PM – 2:15 PM ET
Friday, March 18, 2022
1:15 PM – 2:15 PM ET
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