Yang (Frank) Gao, M.S.

Yang (Frank) Gao, M.S.

Yang (Frank) Gao, M.S.

Principal Consultant

Frank has recognized China Drug Administration drug review experience with a particular focus on CMC/Bioequivalence and regulatory strategy across therapeutic areas. Frank provides strategic guidance to clients on drug development, regulatory submissions, communications with regulators, commercialization, and lifecycle management independently or by coordinating and leveraging Parexel’s multidisciplinary expertise.

Work Experience

Prior to joining Parexel, Frank was a Regulatory Affairs Director in a top start-up company in China focusing on first-in-class oncology products. He successfully empowered the regulatory team and brought several IND approvals in both the US and China. He was a China Regulatory CMC and Device at Eli Lilly, responsible for developing CMC strategy, gap analysis, communicating with CFDA for Lilly Global and alliances in China, covering INDs, NDAs and Post-approval CMC changes for small molecular, large molecular and medical device. As a chairman in RDPAC CMC working group, Frank built up the trust between multinational companies and CFDA, drafted the positioning paper and successfully lobbied the Regulators. Before joining the industry, Frank was a senior CMC reviewer at the Center of Drug Evaluation of China Food and Drug Administration. He is proficient in drug regulatory aspects, possesses technical acumen, and drug review evaluations of INDs, NDAs, ANDAs and supplementary applications.

Education

Frank is currently studying his Ph.D. in pharmacokinetics and pharmacodynamics at China Pharmaceutical University. He received his master in pharmaceutical science at China Pharmaceutical University and Bachelors in pharmacy at Shandong Medical University. In addition, Frank received professional training on soft skills including leadership, communication, problem solving, project management etc. at Eli Lilly. Frank is fluent in English and Chinese.

We are always available for a conversation.

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