AVP
Merck, United States
Weining Hu has more than 20 years of regulatory CMC experiences ranging from vaccines, monoclonal antibodies/peptides/ADC, and cell and gene therapy products. She holds a BSc in Chemistry from the Sichuan University (China), MSc in Biochemistry from University of Wisconsin Milwaukee, and MSc in QA/RA from Temple University.
Weining is an Associate Vice President at Merck and is leading Global Regulatory Affairs CMC for ADC and Cell and Gene Therapy. Prior to joining Merck, Weining worked at Gan & Lee Pharmaceuticals in Bridgewater, NJ as the VP of Global Regulatory Affairs, where she built the regulatory team to support the development and registration of biosimilar products and NCE for oncology. Weining was also a Director in Global Biologics CMC at Merck previously and had led/contributed the filing of BLA/MAA for multiple biological products, including initial Keytruda BLA filing and subsequent worldwide marketing authorization applications.
While working at GSK Vaccine, she was the CMC lead for Cervarix US BLA submission as well as the development of multiple immunotherapeutic vaccines (Gene Therapy Products). In this role, she had worked with FDA, Office of Tissues and Advanced Therapies (OTAT), previously Office of Cellular/Tissue/Gene Therapy (OCTGT).
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Monday, April 24, 2023
3:00 PM – 3:30 PM ET