Full Name
Qun Wang
Job Title
Primary Reviewer
Company
FDA
Speaker Bio
Dr. Qun Wang obtained her Ph.D. in the Division of Medicinal and Natural Product Chemistry at the University of Iowa, followed by a postdoctoral fellowship in Dr. Dennis Kasper’s lab in the Department of Microbiology and Immunology at the Harvard Medical School. She worked in pharmaceutical industries for more than 10 years, where she was a senior scientist at Medimmune/AstraZeneca and led a research group to develop monoclonal antibodies and novel vaccine platforms for the treatment of infectious diseases, inflammation, and cancer. She was also heavily involved in the microbiome research and novel target discoveries. Her research experience includes assay development, antibody and vaccine discovery platforms, in vivo models, and early clinical research. Dr. Wang has published 30 peer-reviewed publications and held three patents. She served as a reviewer for NIAID R01 grant applications and multiple journal articles. Currently, Dr. Wang is a Primary Reviewer and Regulatory Project Manager at the Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, U. S. Food and Drug Administration. She reviews regulatory submissions pertaining to preventive vaccines, allergenics, microbiota for transplantation and live biotherapeutic products under Investigational New Drug Application (IND) and the Biologics License Application (BLA). In addition, she leads the discussion during regulatory meetings and manages related communications between sponsors/applicants and the Agency.
Qun Wang