Min Gui

  PhotoDr. Min Gui is the CMC Regional Expert – Asia Pacific of the Global Regulatory and Safety Science – CMC at Bristol-Myers Squibb (BMS). She worked on an expatriate assignment for 3.5+ years as the Director of CMC Asia Pacific, China CMC and Regulatory Strategy Management and Operation before returning to the US in July 2013. She is the co-founder and 2012 Chair of RDPAC CMC Focus Group leading an industry group of 44 members from 26 companies, and serves as one of the RDPAC representatives in the China ICH Study Group-Quality Working Group. She also served on the Program Committees of DIA China 2011 and 2013, and ISPE China 2011 to 2013. She has been very actively participating, advising and leading RDPAC initiatives in CMC policy related areas influencing regulators. Dr. Gui has successfully led/co-led RDPAC CMC Focus Group forum organization committees for 8 technical forum between regulators in China and industry experts promoting ICH and driving for alignment of China CMC related policies with international practices. Dr. Gui has significant working experience in Analytical Development supporting new drug product development and filing, technology transfers supporting filing and launching of new products worldwide, and providing central technical support to worldwide regulatory inquiries and API and drug product QO and stability sites during her tenure with PR&D of AstraZeneca at Wilmington, DE, US, and Merck & Co, Inc. at West Point, PA, USA. She received her BS in Physics and MS in Atomic, Molecular, and Laser Physics from Tsinghua University, Beijing China and her PhD in Analytical Chemistry/Biopharmaceutical Analysis from Virginia Commonwealth University in the USA.