Dr. Robert Temple serves as CDER’s Deputy Center Director for Clinical Science and Senior Advisor in the Immediate Office of the Office of New Drugs (OND). As the senior advisor, Bob is a consultant to the OND director and other FDA officials on matters related to clinical program objectives.
Dr. Temple received his medical degree from the New York University School of Medicine in 1967. In 1972, he joined CDER as a Medical Officer in the Division of Metabolic and Endocrine Drug Products. He later moved into the position of Director of the Division of Cardio-Renal Drug Products.
Before becoming Senior Advisor in OND, Dr. Temple was the Acting Deputy Director of OND’s Office of Drug Evaluation-I (ODE-I) which is responsible for the regulation of cardiovascular and renal, neurology, and psychiatry drug products. He served in this capacity for more than 23 years—since the office’s establishment in 1995.
Dr. Temple has a long-standing interest in the design and conduct of clinical trials. He has written extensively on this subject, especially on choice of control group in clinical trials, evaluation and active control trials, trials to evaluate dose-response, and trials using “enrichment” designs. He has been involved in the development of many International Conference on Harmonization (ICH) guidelines and numerous FDA guidances, including ones on study enrichment and on issues related to the design and interpretation of non-inferiority studies.