Nina S. Cauchon, PhD, leads external engagement activities within RA-CMC. She was a lead for early phase & commercial programs, including both small molecules & biologics. She is chair of the AAPS CMC Community, and is active on the ISPE Expedited Regulatory Pathways workstream. Her areas of interest are regulatory challenges for innovative modalities & emerging technologies, CMC aspects of expedited review pathways, regulatory harmonization, and science & risk-based approaches to regulations.