About me
Nina S. Cauchon, PhD, leads external engagement and advocacy for RA-CMC at Amgen Inc. She has experience leading both early phase & commercial programs, including small molecules and biologics. Her areas of interest are regulatory harmonization including collaboration, regulatory challenges for innovative modalities and emerging technologies, and science and risk-based approaches to regulations. Nina is active in several external organizations which provide a strong network and knowledge base, including being a speaker/committee member for ISPE (PQLI co-lead), CASSS Board of Directors, PhRMA GQM, AAPS, IQ, and DIA. She is a former member of the ICH Q2(R2)/Q14 EWG and the ISPE International Board of Directors.
