Deputy Director - Office of Research and Standards
US Food & Drug Administration
Dr. Lei Zhang, PhD, is Deputy Director of the Office of Research and Standards (ORS), Office of Generic Drugs (OGD), at the Center for Drug Evaluation and Research (CDER), the U.S. Food & Drug Administration (FDA). She was Senior Advisor for Regulatory Programs and Policy in the Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), CDER, FDA. She is an accomplished professional with 20 years of combined experiences in the areas of drug research, development and regulatory review and approval. She received her PhD in Biopharmaceutical Sciences from the Univ of California, San Francisco (UCSF). She worked at Bristol-Meyers Squibb Company as a Research Investigator and Preclinical Candidate Optimization Team Leader before she joined the FDA in 2002. Dr. Zhang has contributed to the development of numerous regulatory guidances including guidances on drug interaction and regulatory research focuses on the science-based regulatory decision-making. Dr. Zhang is a member of the International Transporter Consortium (ITC). Dr. Zhang is a member of ASCPT, ACCP, AAPS and ISSX. She serves/served on numerous committees of these societies. She is currently an ASCPT Board member and serves on the Clinical Pharmacology and Therapeutics Editorial Board. She is also a member of the ISSX Council and the Committee of Regulatory Affairs. Dr. Zhang was named AAPS Fellow in 2013. She is an Adjunct Professor in the Dept of Bioengineering and Therapeutic Sciences, UCSF Schools of Pharmacy and Medicine. Dr. Zhang has authored and co-authored numerous papers, book chapters, abstracts, and delivered numerous invited presentations.