About me
Sarah Pope Miksinski has been with Gilead since July 2023 and is currently an Executive Director in CMC Regulatory Affairs. She represents Gilead in various external capacities – including serving on PhRMA’s Global Quality and Manufacturing Committee, serving as chair of ISPE’s Regulatory Steering Council (2020-2025), and supporting multiple other advocacy efforts (review/inspection standards, nitrosamines, PDUFA, and KASA). In 2021, she was appointed as the PhRMA Topic Lead for ICH M4Q(R2) and served on the ISPE Board of Directors from 2022-2025. Previously, Sarah served at AstraZeneca for over 5 years. Prior to that, she held a lengthy tenure at FDA, lasting from 2002-2018.
