Sarah Barkow, PhD

Sarah Barkow, PhD is the Lead for GxP External Engagement with Bristol-Myers Squibb Company, where she plays a key role in supporting and contributing to the execution of the GxP regulatory surveillance process. This includes working closely with PhRMA, BIO, IFPMA and other trade organizations and tracking regulatory and policy developments across the GxP realm. Sarah is a former Senior Advisor and Acting Director, Manufacturing Quality Guidance and Policy Staff in FDA CDER’s Office of Compliance. She also served as a Special Assistant to Donald Ashley in CDER Compliance. At FDA, Sarah was instrumental in drafting multiple guidance and policy documents and developing internal processes.

Prior to joining FDA, Sarah served as a Project Lead in Immunoassay Development working on thyroid assays at Beckman Coulter. She has her PhD in Physical Chemistry from MIT.