Caitilin Hamill

Biography

Dr. Hamill has over 15 years of experience in biotech R&D, clinical development of new therapeutic products and FDA regulation. Prior to joining Alira, Dr. Hamill spent seven years as a reviewer and review management officer at the US Food and Drug Administration (FDA). She acted as a Chemistry, Manufacturing & Controls (CMC) reviewer in the Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH) where she contributed to decisions regarding the clearance or approval of medical device and biological product submissions.

Research Interest

She reviewed combination products and participated in the Request for Designation (RFD) and Tissue Reference Group processes for determining medical product jurisdiction. As a Senior Review Management Officer within CBER’s Office of the Director, Dr. Hamill held responsibilities for center-level management of CBER’s review program. She has contributed to the development of more than 20 guidance documents and regulations and represented CBER and FDA on agency-level and international committees. She received a BS in Biochemistry from the University of Illinois at Chicago in 2000, a PhD in Neuroscience from Northwestern University in 2007 and a Master of Business Administration with a major in Finance from the Wharton School of the University of Pennsylvania in 2017.