Nina Cauchon

Nina Sipahimalani Cauchon, PhD, is Director Regulatory Affairs-CMC at Amgen Inc where she leads advocacy and external engagement activities. She has experience leading both early phase and commercial programs, including small molecules and biologics. Her areas of interest are regulatory harmonization, science and risk-based approaches to regulations, regulatory challenges for innovative modalities and emerging technologies, and CMC aspects of expedited review pathways. 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 former member of the ISPE International Board of Directors and the ICH Q2(R2)/Q14 Expert Working Group, and a member of the CASSS Board of Directors, the PhRMA Global Quality and Manufacturing (GQM) group, and the BIO MQD group. She holds a PhD in Medicinal Chemistry from Purdue University.