Patricia Keegan, MD, is the Director of the Division of Oncology Products 2 (DOP2) in the Office of Hematology and Oncology Drug Products, in the Center for Drugs Evaluation and Review (CDER) at FDA. Dr. Keegan joined the FDA in 1990 in the Center for Biologics Evaluation and Review (CBER) and served as Branch Chief for the Oncology Branch within Division of Clinical Trials Design and Analysis (DCTDA) in the Office of Therapeutics Research and Review from 1993-1998 and as Deputy Division Director, DCTDA from 1998-2003. From 2003 to 2011, she served as the Director of the Division of Therapeutic Biologic Oncology Products in CDER with regulatory oversight of pre- and post-market clinical development of well-characterized biologic products for cancer and from 2011 to the present as the Director, DOP2. Dr. Keegan’s long-standing interest in the field of immunologic product development includes participation in NCI Cooperative Group and pharmaceutical trials as a clinical investigator and within FDA, providing oversight of drug development programs and of initial and supplemental approvals for numerous monoclonal antibodies (e.g., rituximab, ipilimumab, pembrolizumab, nivolumab) and therapeutic proteins (aldesleukin, interferon alfa, pegylated interferon alfa).
Prior to joining FDA, Dr. Keegan was on the staff of the Division of Medical Oncology at the University of North Carolina at Chapel Hill (UNC-CH) and Roswell Park Cancer Center. In addition, to serving on the medical school faculty at the UNC-CH, Dr. Keegan was an active investigator in CALGB and industry-sponsored clinical trials; she also served as a member of the Institutional Review Board at RPCC. Dr. Keegan obtained her MD from Loyola University, Stritch School of Medicine, in Maywood IL. Her post-graduate training included an internal medicine residency at Loyola University Medical Center, Maywood IL and an oncology fellowship at Roswell Park Memorial Institute, Buffalo, NY.