Lei Zhang PhD

Dr. Lei Zhang is Deputy Director of the Office of Research and Standards (ORS), Office of Generic Drugs at the Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (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 was previously Senior Advisor for Regulatory Programs and Policy in the Office of Clinical Pharmacology at CDER, FDA. She is an accomplished professional with more than 22 years of combined experience in the areas of drug research, development, and regulatory review and approval. Before joining FDA in 2002, she worked at Bristol-Meyers Squibb Company as a Research Investigator and Preclinical Candidate Optimization Team Leader.

Dr. Zhang is an Adjunct Professor in the Department of Bioengineering and Therapeutic Sciences, the University of California at San Francisco, Schools of Pharmacy and Medicine. She has authored and co-authored numerous papers, book chapters, abstracts, and invited presentations in the area of clinical pharmacology and regulatory science. Dr. Zhang received her Ph.D. in Biopharmaceutical Sciences from UCSF. She is a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Generic Drug Discussion Group (GDG), serving as the U.S. FDA Topic Leader. Additionally, she is the Rapporteur for ICH M13 Expert Working Group that is developing M13 guideline on “Bioequivalence (BE) for Immediate-Release Solid Oral Dosage Forms”. Dr. Zhang was named American Association of Pharmaceutical Scientists (AAPS) Fellow in 2013.