Robert Califf, MD FDA
Robert M. Califf, MD, MACC, is Deputy Commissioner for Medical Products and Tobacco for the U.S. Food and Drug Administration. Appointed in February 2015, Dr. Califf provides executive leadership to the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health and the Center for Tobacco Products. He also oversees the Office of Special Medical Programs and provides direction for cross-cutting clinical, scientific and regulatory initiatives, including personalized medicine, orphan drugs, pediatric science, and the advisory committee system.
He attended Duke both as an undergraduate and for medical school, completing his residency at UCSF before returning to Duke for a cardiology fellowship. Dr. Califf served as the Donald F. Fortin, MD, Professor of Cardiology at Duke and most recently, Vice Chancellor for Clinical and Translational Research. An international leader in cardiovascular medicine, health outcomes, healthcare quality, and medical economics, he is recognized by the Institute for Scientific Information as one of the top 10 most cited medical authors, with more than 1,200 peer-reviewed publications.
Dr. Califf co-chaired the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by Duke and the FDA to identify and promote practices that will increase the quality and efficiency of clinical trials. He also served as co-principal investigator of Duke’s Clinical and Translational Science Award, funded by the NCATS; principal investigator for the coordinating center of the NIH Health Care Systems Research Collaboratory, a Common Fund program that develops, tests, and disseminates innovative methodologies for pragmatic clinical research; and co-principal investigator for the Baseline Study, a collaboration among Duke, Stanford, and Google that seeks new understandings of states of health and disease in humans.
He attended Duke both as an undergraduate and for medical school, completing his residency at UCSF before returning to Duke for a cardiology fellowship. Dr. Califf served as the Donald F. Fortin, MD, Professor of Cardiology at Duke and most recently, Vice Chancellor for Clinical and Translational Research. An international leader in cardiovascular medicine, health outcomes, healthcare quality, and medical economics, he is recognized by the Institute for Scientific Information as one of the top 10 most cited medical authors, with more than 1,200 peer-reviewed publications.
Dr. Califf co-chaired the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by Duke and the FDA to identify and promote practices that will increase the quality and efficiency of clinical trials. He also served as co-principal investigator of Duke’s Clinical and Translational Science Award, funded by the NCATS; principal investigator for the coordinating center of the NIH Health Care Systems Research Collaboratory, a Common Fund program that develops, tests, and disseminates innovative methodologies for pragmatic clinical research; and co-principal investigator for the Baseline Study, a collaboration among Duke, Stanford, and Google that seeks new understandings of states of health and disease in humans.