avatar for Nina Cauchon

Nina Cauchon

Amgen Inc.
Director Regulatory Affairs CMC
Nina S. Cauchon, PhD, leads external engagement activities within RA-CMC. She has experience leading both early phase & commercial programs, including small molecules and biologics. She is chair of the AAPS CMC Community, and in addition to AAPS is also active on the ISPE Expedited Regulatory Pathways workstream, CASSS/WCBP, and PQRI. 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.