Bazarragchaa Damdinsuren, MD, PhD is a product quality team leader at Office of Biotechnology Products (OBP), Office of Pharmaceutical Quality at CDER, FDA. Dr. Damdinsuren received his MD from National Medical University in Mongolia and his PhD from Osaka University in Japan, and completed postdoc in immunology and cell biology at the National Institutes of Health (NIH). He joined the OBP/FDA as a Commissioner’s Fellow in 2010.
In the current position, Dr. Damdinsuren supervises product quality/CMC reviews of INDs and BLAs, and conducts manufacturing facility inspections for originator and biosimilar protein therapeutics, including monoclonal antibodies, antibody derivatives (Fc fusion proteins, Fab, etc.), antibody drug conjugates, and recombinant proteins.