Staff Biographies

Glen D. Jones, Ph.D. is the Associate Director for Regulatory Affairs in FDA/CDER’s Office of Oncology Drug Products. He earned his B.S. from Lynchburg College and Ph.D. in biochemistry from the University of Virginia (UVA). His research at UVA and subsequently at the American Red Cross focused on mechanisms of blood platelet activation and intracellular signaling.

Dr. Jones joined CDER in 2003 when FDA responsibility for regulation of therapeutic biological products was transferred to CDER. In addition to providing leadership of the regulatory programs to facilitate review and availability of oncology drug and biological products, Dr. Jones is involved in many other CDER initiatives, including those to improve the drug review process.

Before coming to CDER, Dr. Jones managed and participated in the review of biological products for twelve years in FDA’s Center for Biologics Evaluation and Research (CBER). He joined CBER as a researcher/reviewer in 1991, and in 1993 moved to the CBER Office of Therapeutics Research and Review (OTRR). He participated in the review of many biological product submissions as reviewer, regulatory coordinator, and inspector. From 1998 to 2003, Dr. Jones served as OTRR’s Associate Director for Review, as well as Director of the Division of Application Review and Policy. Dr. Jones’ responsibilities included developing and implementing regulatory priorities, policies, and procedures as well as directing, coordinating, and evaluating the review of IND, BLA, PMA, 510K, and NDA submissions for therapeutic biological products to ensure quality and consistency of regulatory and scientific decisions. He was a member of CBER’s Review Management and Information Management Coordinating Committees, as well as intercenter PDUFA3 implementation groups.

Robert Justice, M.D. is the Director of the Division of Drug Oncology Products in the Office of Oncology Drug Products at the Food and Drug Administration. Dr. Justice earned his B.S. degree in Life Sciences from Massachusetts Institute of Technology, his M.D. degree from University of California, Davis, and his M.S. degree in Biotechnology from Johns Hopkins University. He completed his internal medicine residency training at the University of Hawaii and his Medical Oncology Fellowship at the Cancer Center of Hawaii. Before coming to FDA, Dr. Justice was an Assistant Professor of Medicine at Texas Tech University. At FDA he has been a Medical Officer, Medical Team Leader, Deputy Director, and Acting Director in the Division of Oncology Drug Products; Director of the Division of Gastrointestinal and Coagulation Drug Products; and Deputy Director of the Division of Biologic Oncology Products. In addition, Dr. Justice spent two years at Genentech, Inc. as a Senior Clinical Scientist.

Patricia Keegan, M.D. received her medical degree and internal medicine residency training at Loyola University School of Medicine and her medical oncology fellowship training at Roswell Park Memorial Institute. She served as a faculty member at the University of North Carolina at Chapel Hill before coming to FDA in 1990. She has served as Chief of the Oncology Branch in FDA’s Center for Biologic Evaluation and Research, and since 2003 as the Director of the Division of Biologic Oncology Products in FDA’s Center for Drug Evaluation and Research. She is board-certified in both internal medicine and medical oncology and is the author of several articles and book chapters in the field of medical oncology.

Richard Pazdur, M.D. has a distinguished career in clinical and academic oncology in addition to his experience as a regulatory expert at FDA. A native of Indiana, he obtained his M.D. from Loyola Stritch School of Medicine, where he also trained in internal medicine. He was a fellow in oncology at Rush Presbyterian-St. Luke's Medical Center at the University of Chicago. Dr. Pazdur has served as a practicing oncologist, researcher, and teacher at Wayne State University, where he was director of the medical oncology fellowship program, and for many years at the M.D. Anderson Cancer Center at the University of Texas, where he was a tenured Professor of Medicine and Assistant Vice President for Academic Affairs. He joined FDA in 1999 as the Director of the Division of Oncology Drug Products and was named Director of the Office of Oncology Drug Products in April 2005. He has authored over 160 peer-reviewed papers in the field of oncology, has written chapters for over 30 oncology textbooks, and is the editor of two standard reference oncology texts.

Dr. Pazdur is well known in the oncology community as a strong scientific leader who is committed to the care and treatment of patients with cancer. He is a member of many oncology professional societies and has served on numerous local, state, national, and international committees focused on cancer treatment, drug development, patient education, and chemoprevention. Since coming to FDA, Dr. Pazdur has collaborated extensively with the leaders at the National Cancer Institute on many aspects of facilitating sound and rapid product development for cancer treatment and prevention.

Karen Weiss, M.D. is the deputy director of the Office of Oncology Drug Products in CDER/FDA. Dr. Weiss received her medical degree at Ohio State University, completed her pediatric residency in Grand Rapids, Michigan, and her pediatric hematology-oncology training at St Jude Children's Research Hospital. She was an assistant professor in the department of pediatrics at Georgetown University before joining FDA in 1989 as a medical reviewer in the Center for Biologics Evaluation and Research (CBER). She went on to hold several supervisory positions in CBER. Dr. Weiss moved to CDER with the reassignment of authority of therapeutic biologics from CBER to CDER, and directed the office in CDER responsible for regulation of therapeutic biologics. She has been the Deputy Director in the Office of Oncology Drug Products since the office was created in 2005. Dr. Weiss holds board certification in both general pediatrics and pediatric oncology. Her areas of expertise include drug development of biological protein products and issues related to pediatric drug development. She has published multiple articles in the fields of oncology and clinical trials.