N. Calvin Han, MD

FDA

College Park, MD

Dr. Han received his M.D. from the University of Southern California School of Medicine and completed his residency at the Los Angeles County–USC Medical Center. This was followed by a fellowship at Massachusetts General Hospital and the Harvard Cyclotron Laboratory.

He served as a commissioned officer in the U.S. Army, attaining the rank of Major, and held the position of Deputy Director of the Radiation Oncology Service at Madigan Army Medical Center. Dr. Han was also a National Cancer Institute (NCI) Scholar at the Laboratory of Medicinal Chemistry at the National Institutes of Health (NIH). In addition, he worked as Medical Director of Radiation Oncology Departments at several major corporate hospitals.

Most recently, Dr. Han served as a Medical Officer in the Office of New Drugs within the Division of Imaging and Radiation Medicine (DIRM) at the U.S. Food and Drug Administration (FDA), where he worked for five years until his departure in September. In this capacity, he was responsible for clinical review and regulatory evaluation of submissions involving radiopharmaceuticals, theranostics, optical imaging agents, and medical countermeasures (chemical, biological, radiological, and nuclear). His regulatory oversight spanned all stages of development, including proof-of-concept studies, first-in-human trials, pre-IND, IND, NDA, post-marketing, and Emergency Use Authorizations (EUAs).

Dr. Han has been an invited speaker at the Society of Nuclear Medicine and Molecular Imaging (SNMMI), the American Society for Radiation Oncology (ASTRO), and the National Cancer Institute (NCI).

Disclosures: