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. 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. Nina is active in several external organizations which provide a strong network and knowledge base, including being a speaker/committee member for ISPE, CASSS, PQRI, AAPS, IQ, and DIA. She is a member of the ISPE International Board of Directors, the PhRMA Global Quality and Manufacturing group, and the ICH Q2(R2)/Q14 Expert Working Group.