Ellis Unger, M.D.

Dr. Unger advises biotech and pharmaceutical companies on drug development and strategic direction—from phase 1 matters to complex phase 3 study design issues. A cardiologist, he served in leadership positions in FDA’s Center for Drug Evaluation and Research (CDER) for two decades. From 2012 until his FDA retirement in 2021, Dr. Unger was the Director of the former Office of Drug Evaluation I (ODE-I; 2012 – 2020) and subsequently the Office of Cardiology, Hematology, Endocrinology, and Nephrology (OCHEN; 2020 – 2021). These Offices had oversight for the regulation of drugs in the following therapeutic areas: cardiovascular disease, nephrology, neurology, psychiatry, non-malignant hematology, and endocrinology. During his tenure as an FDA Office Director, Dr. Unger was directly involved in the regulation and approval of scores of new drugs and therapeutic biologics. Key to his success is his ability to anticipate, understand, and address FDA concerns throughout drug development.

Throughout his FDA career, Dr. Unger was well known for his expertise and insights in the analysis, interpretation, and display of various forms of data. He supervised preparation for numerous advisory committee meetings and served as the FDA lead. He is a recognized leader in the safety assessment of drugs, as well as the consideration of complex benefit-risk scenarios. Dr. Unger was the FDA lead on the International Council for Harmonisation (ICH) Expert Working Groups for the key pre- and post-marketing safety reports: the Development Safety Update Report (DSUR; ICH E2F) and the Periodic Benefit-risk Evaluation Report (PBRER; ICH E2C(R2)), respectively. He was also an FDA lead on the benefits and risks section of ICH M4E(R2), the Common Technical Document for the Registration of Pharmaceuticals for Human Use (CTD). He was heavily involved in the development of FDA’s Benefit-risk Framework, which is incorporated into key FDA review documents, as well as FDA’s medical queries (FMQs).

Dr. Unger received his medical degree in 1980 from the University of Cincinnati College of Medicine. He completed a residency in Internal Medicine at the Medical College of Virginia, and received fellowship training in cardiovascular disease at the Johns Hopkins Hospital and the National Heart, Lung, and Blood Institute, National Institutes of Health. Dr. Unger joined the FDA in 1997, initially as a medical officer, team leader, and subsequently branch chief in FDA’s Center for Biologics Evaluation and Research (CBER). When regulatory authority for therapeutic biologics was transferred from CBER to CDER in 2003, Dr. Unger joined CDER as the Deputy Director of the former Division of Cardiovascular and Renal Products. In 2009, Dr. Unger was promoted to Deputy Director of the former ODE-I under then director Robert Temple. Dr. Unger became Director of that Office in 2012 and Director of OCHEN with the 2020 reorganization of the Office of New Drugs.