Sarah C. Pope Miksinski, PhD

Gilead Sciences, Inc.
Executive Director, CMC Regulatory Affairs
Sarah Pope Miksinski has been with AstraZeneca since February 2018 and is currently an Executive Director in CMC Regulatory Affairs, AstraZeneca. Her duties include leadership of a global team covering CMC regulatory strategy for development and commercial health authority submissions, as well as serving as a key contributor to several ongoing initiatives including benefit/risk, continuous manufacturing and Q12 implementation. She represents AstraZeneca in various external capacities – including serving on PhRMA’s Global Quality and Manufacturing Committee, serving as both chair of ISPE’s Regulatory Steering Council and as a member of the ISPE Board of Directors, and supporting multiple other advocacy efforts (review/inspection standards, nitrosamines, and KASA/M4Q). In 2021, she was appointed as the PhRMA Topic Lead for ICH M4Q, and she is the Rapporteur of the ICH Informal Quality Discussion Group.
At the time of her departure from FDA, she was the head of two offices in FDA’s Office of Pharmaceutical Quality – serving permanently as the director of the Office of New Drug Products (2014-2018) and simultaneously serving as the interim director of the Office of Surveillance (2016-2017).
Sarah began her FDA career in 2002 and served as a primary, secondary, and tertiary reviewer. Prior to joining FDA, she completed a postdoctoral fellowship at the National Institute of Health. She is trained as an organic chemist and possesses a PhD in organic chemistry (Oklahoma State University, 1999). She also has a B.A. in chemistry (Earlham College, 1994).

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Update from the ISPE Regulatory Steering Council

Virtually every ISPE member has at least one story to tell about how health authority inspections or the review and approval of regulatory applications have affected their efforts to supply critically needed medications to patients globally. Although these stories may emphasize the considerable challenges that ISPE members face, they also frequently identify great opportunities for innovation...