Weining Hu

Merck & Co., Inc.

Weining Hu has nearly 20 years of regulatory CMC experiences ranging from vaccines, monoclonal antibodies/peptides, and cell and gene therapy products (immunotherapeutic vaccines). 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 a Distinguished Scientist/Executive Director at Merck and is leading Global Regulatory Affairs CMC for new 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. 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 multiple therapeutic vaccines (from Phase 1 through Phase 3). In this role, she had worked with FDA, Office of Tissues and Advanced Therapies (OTAT), previously Office of Cellular/Tissue/Gene Therapy (OCTGT). She was responsible for CMC regulatory strategies and had led CMC meetings with OCTGT in support the development of novel immunotherapeutic vaccines.