Senior Science Advisor
US Food and Drug Administration
Silver Spring, Maryland
Biography: Dr. Wenlei Jiang is an expert pharmacologist and currently serves as a Senior Science Advisor in the Office of Research and Standards (ORS)/Office of Generic Drugs (OGD)/Center for Drug Evaluation and Research (CDER)/U.S. FDA. She is leading complex drug product classification and research, promoting global harmonization of bioequivalence criteria, developing opportunities for scientific outreach, and coordinating post-market generic drug safety investigation. Previously she served as the Acting Deputy Director of ORS, where she provided oversight on Generic Drug User Fee Act (GDUFA) regulatory science research programs. Her research interests center around bioequivalence standard development for generic complex drug products, solid oral modified release drug products, narrow therapeutic index drugs, and post-market surveillance of generic drugs. She is current Chair at Product Quality Research Institute (PQRI) Biopharmaceutical Technical Committee and serves at National Cancer Institute (NCI) Nanotechnology Characterization Laboratory (NCL) Scientific Oversight Committee. Prior to joining FDA, she was at Novartis Pharmaceutical Corporation where her responsibilities included formulation development of conventional liquid and solid dosage forms, as well as advanced parenteral drug delivery systems. She received her PhD in Pharmaceutics and Pharmaceutical Chemistry from The Ohio State University.