Nina S. Cauchon, PhD, has worked at Amgen Inc. in Thousand Oaks, CA, since 1998 and leads Regulatory Affairs – CMC Advocacy and External Engagement. She has been a Global Regulatory CMC Lead for early phase to commercial programs, including both small molecules and biologics, and prior to that she was a director leading Analytical Development within Pharmaceutics/Process Development. She holds a PhD in Medicinal Chemistry from the School of Pharmacy at Purdue University, and a RAC certification from RAPS.
She is the current chair of the AAPS CMC Community, and has been a member of its steering committee (which organizes the annual CMC Regulatory Exchange Forum) for the past 7 years. She is active on the ISPE Expedited Regulatory Pathways workstream, and is also active in other external organizations and organizing committees including CASSS, PQRI, BIO, and PhRMA, and is the PhRMA Deputy Topic Lead on the ICH Expert Working Group for ICH Q14/ICH Q2(R2) – Analytical Procedure Development/Validation.
Her areas of interest are: regulatory CMC challenges for innovative modalities and emerging technologies, CMC aspects of expedited review pathways, regulatory harmonization, and science and risk-based approaches to regulations. In addition to numerous technical publications, her regulatory publications include a comprehensive review article in JPharmSci on regulating innovation in CMC ( July 2019), co-authorship on an article in Pharm Eng on CMC Challenges for Expedited Products (July-August 2019), and cover articles for the AAPS Newsmagazine on the past, present, and future of pharmaceutical regulations and on combination products.