Yang Gao, PhD

Shanghai Bioraylab Medicine
Chief Strategy Officer
Yang Gao, PhD, is Chief Strategy Officer at Shanghai Bioraylab Medicine, fully responsible for the drug development, regulatory affairs, and portfolio and project management for company’s Cell and Gene Thereapies products. Frank has nearly 20 years of management and development experience in the pharmaceutical indus-try, and a comprehensive and profound understanding in regulatory science and regulatory and technical guidelines from the CDE, FDA, EMA, and ICH. He played critical roles in a range of pharmaceutical areas, including a regulatory agency, multinational pharmaceutical enterprise, biotechnology company, and leading global contract research organization. He has been Chair of CMC committee of RDPAC, a Senior Reviewer in the NMPA CDE and the Regula-tory CMC, and Medical Device Head in Eli Lilly China. He’s also been the Regulatory Affairs Director in AscentagePharm for China and US research and development and registration strategies, and a Principal Research and Development and Regulatory Consultant at Parexel. He is a member of ISPE and is currently the chair of the Cell and Gene Thereapies subcommittee in ISPE China.

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With the Chinese government initiating drug regulatory reform in 2015 and China joining the International Council for Harmonisation (ICH) in 2017, a significant number of measures have been implemented by the government. The aim is to make fundamental changes to China’s drug regulatory administration system so it can facilitate pharmaceutical development and better meet patient needs in the...