Dr. Meng brings extensive experience in drug research and development, including over 15 years in global regulatory affairs. She has spearheaded regulatory strategies and implementations for over two dozen programs spanning all stages of development (from pre-clinical to registration and post-marketing) and in diverse therapeutic areas, particularly Oncology, Hematology and rare diseases. Dr. Meng has successfully led and guided multiple submissions and approvals for New Molecular Entities and new indications in the US and globally.
Prior to joining OBI, Dr. Meng served as Executive Director, Global Regulatory Portfolio Lead at Bristol Myers Squibb, overseeing strategic and operational aspects of oncology programs such as OPDIVO/YERVOY GI, Antibody Drug Conjugates (ADC), and early immune-oncology assets. Her previous roles include Global Regulatory Lead at Amgen, responsible for several hematology assets including Bi-specific T-cell engagers, and positions at Bayer Healthcare as Global Regulatory Strategist, where she led oncology and rare diseases programs, and began her regulatory career in Global Regulatory CMC Biologics.
Dr. Meng holds PhD in Biochemistry from New York Medical College and BS in Pharmacy from Peking University. She has maintained Regulatory Affairs Certification from Regulatory Affairs Professionals Society since 2011.