桂敏,百时美施贵宝,全球注册科学部亚太区CMC

Dr. Min Gui joined the Global Regulatory Science - CMC, Bristol-Myers Squibb (BMS) as an Associate Director in October 2009. She is mainly responsible for providing CMC support to product registration, monitoring the changing CMC regulatory landscape and influencing regulators on CMC related topics in Asia Pacific. She has been actively contributing to RDPAC CMC related initiatives, and is now co-leading RDPAC QbD Taskforce. Prior to joining BMS, Dr. Gui worked as a Scientific Fellow managing a group of scientists in Regulatory and Analytical Science-Analytical of MERCK & Co., INC. in the US for ~6 years, where she co-led global cross function teams supporting technology transfers, and served as functional representative on global teams supporting filing and launching of new products worldwide. She also supervised central analytical support to worldwide regulatory inquiries, and API and drug product QO and stability sites worldwide for the Anti-Infective, Anti-Viral and Pulmonary therapeutic areas of 10+ marketed products. Prior to that, she worked in the Analytical Development of PR&D for AstraZeneca, US, for ~5 years, where her major responsibility was to provide analytical support to new product development and registration. She graduated from Virginia Commonwealth University in Richmond, VA, USA with a PhD in Analytical Chemistry/Biopharmaceutical Analysis. She received her M.S. degree in Atomic, Molecular and Laser Physics/Optics and her bachelor degree in Laser Physics/Optics from Tsinghua University, in Beijing, China.