Director
Amgen
THOUSAND OAKS, California
Nina S. Cauchon, PhD, works at Amgen Inc. in Thousand Oaks, CA, and leads advocacy and external engagement activities for Regulatory Affairs - CMC. She has led strategy development for early phase to commercial programs, including both small molecules and biologics, and prior to that she managed a group doing Analytical Development within Pharmaceutics/Process Development. She holds a PhD in Medicinal Chemistry from the School of Pharmacy at Purdue University. She sits on the ICH Q2(R2)/Q14 Expert Working Group for Analytical Procedure Development and Validation, is the past chair of the AAPS CMC Community, and is also active in ISPE (International Board of Directors, Regulatory Steering Council), CASSS (Associate Director), IQ, DIA, and PQRI. She is a member of the PhRMA GQM. 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 review articles in the Journal of Pharmaceutical Sciences on regulatory challenges for new technologies and structured content management in regulatory submissions, and two cover articles for the AAPS Newsmagazine.
Disclosure information not submitted.
Wednesday, October 19, 2022
9:00 AM – 9:30 AM ET