Nina Cauchon

Nina S. Cauchon, PhD, works at Amgen Inc. in Thousand Oaks, CA, and is currently leading external engagement activities within Regulatory Affairs - CMC. She has been a Global Regulatory CMC Lead for many 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 has been a member of AAPS for over 20 years. 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 6 years. She is active on the ISPE Expedited Regulatory Pathways workstream, including an upcoming white paper. She is also active in other external organizations and organizing committees including CASSS, PQRI, and PhRMA, and was recently nominated as the PhRMA Deputy Topic Lead on the ICH Expert Working Group for ICH Q14/ICH Q2(R1).

Her areas of interest are: regulatory 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 two cover articles for the AAPS Newsmagazine, one on the past, present, and future of pharmaceutical regulations, and one on regulatory requirements for combination products.