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Deyi Zhang, Ph.D.
Senior Chemist, Office of Research and Standards, Office of Generic Drugs, CDER at US FDA

Profile

Deyi Zhang is a senior chemist in the Office of Research and Standards, Office of Generic Drugs (OGD) at FDA specializing in complex drug substances, including peptides and oligonucleotides. In his work, he provides scientific input for regulatory policy and product-specific guidance development on such products and manages related research activities. He has over 20 years of experience from academia, industry and regulatory agency. Prior to joining FDA in 2015, he was an Executive Director in Crown Bioscience, a biotech company focusing on oncology drug discovery and translational medicine. Before joining Crown, he had worked at Eli Lilly and Company for 10 years. He received his Ph.D. in Organic Chemistry from the University of Notre Dame and finished his NIH Postdoc Fellowship training at the University of Pennsylvania. He has over 10 US patents and 40 publications and presentations.

Agenda Sessions

  • Considerations for Abbreviated New Drug Application of Generic Peptide Drug Products

    On Demand
  • Panel Discussion Moderator and Panelists

    11:15am