Yang (Frank) Gao

Shanghai Bioraylab Medicine Co., LTD.

Dr. Yang (Frank) Gao currently serves as the chief strategic officer of Shanghai BRL Medicine Co., Ltd.; board member of ISPE Shanghai and chairman of its Gene & Cell Therapy Committee; core member of ISPE Asia-Pacific Regulatory Taskforce; core member of GCT Committee of China Regulatory Science Association In BRL Medicine, Dr. Gao is responsible for the drug development, regulatory affairs, portfolio & project management for company's gene and cell therapy products, and assists the CEO in the company operation. Dr. Gao had nearly 20 years of management and development experience in the pharmaceutical industry. He played critical roles in a range of pharmaceutical areas including regulatory agency, multinational pharmaceutical enterprise, biotechnology company and global leading CRO which enabled him an in-depth understanding on how innovative drugs are developed from A to Z, especially in drug development strategy, regulatory strategy, quality strategy and commercialization strategy. He used to be a senior reviewer and team leader in Center for Drug Evaluation (CDE) of China FDA, focus on CMC and bioequivalence cross different therapeutic areas. In Eli Lilly, he served as the head of regulatory CMC and medical devices, led CMC strategy, technology transfer strategy and medical device registration strategy. Meanwhile, he served as the rotating chairman of CMC Committee of RDPAC, led seven working groups. He served as regulatory affairs director in AscentagePharm to lead China and US R&D and registration strategies in both China and USA. Dr. Gao served as principal R&D and regulatory consultant in Parexel and helped about 30 domestic and foreign biopharmaceutical companies on 50 projects’ R&D and regulatory strategies to successfully get regulatory approval in China and USA. Dr. Gao has a doctorate in pharmacokinetics and a master degree in pharmacy from China Pharmaceutical University, and a bachelor degree in pharmacy from Shandong University. He is reading EMBA at CEIBS.


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