Amy Hummel joined the Yale Center for Clinical Investigation in 2018 as the Associate Director of IND and IDE Management. Under her leadership the team provides both strategic guidance and operational assistance to Yale investigators whose research requires that they hold an IND (drugs and biologics) or IDE (devices) with the FDA.

Amy holds an undergraduate degree in Biological Sciences from Carnegie Mellon University and a Masters degree in Quality Assurance and Regulatory Affairs from Temple University.  Prior to joining Yale, she worked in the Regulatory Affairs departments of a variety of biopharmaceutical companies, managing assets in such therapeutic areas as women’s health, infectious disease, hematology, autoimmune disease, and inborn errors of metabolism. She has experience guiding programs through all stages of the product lifecycle from preclinical/discovery, through Phase 1-3 clinical trials and marketing application development, to postmarketing activities including labeling extensions and advertising and promotional material support.