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Wenlei Jiang, PhD

Senior Advisor for Innovation & Strategic Outreach
US Food & Drug Administration

Dr. Wenlei Jiang is a Senior Biomedical Research and Biomedical Product Assessment Service (SBRBPAS) Expert and currently serves as Senior Advisor for Innovation and Strategic Outreach in the Office of Research and Standards/Office of Generic Drugs. She is leading complex product classification and research, promoting global harmonization of bioequivalence criteria, and developing opportunities for scientific outreach. She is current US Co-Chair for Global Bioequivalence Harmonization Initiative (GBHI) to facilitate science-driven regulations in the field of bioequivalence assessment. She also chairs International Pharmaceutical Regulator Programme (IPRP) Nanomedicine Working Group, and supports ICH M13, generic drug cluster, and other global regulatory affairs activities. She serves at National Cancer Institute (NCI) Nanotechnology Characterization Laboratory (NCL) Scientific Oversight Committee and was the immediate past Chair for Product Quality Research Institute (PQRI) Steering 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.

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