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Robert M. Califf, MD, MACC, Professor of Medicine, Duke University, founding Director of the Duke Clinical Research Institute and former Food and Drug Administration Commissioner presented "An Approach to Medical Evidence Generation"
Dr. Califf served as the Deputy Commissioner for Medical Products and Tobacco at the FDA from February 2015 until his appointment as Commissioner in February 2016. In that capacity, he provided 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 oversaw the Office of Special Medical Programs and provided direction for cross-cutting clinical, scientific, and regulatory initiatives, including precision medicine, combination products, orphan drugs, pediatric therapeutics, and the advisory committee system.
Prior to joining the FDA, Dr. Califf was a Professor of Medicine and Vice Chancellor for Clinical and Translational Research at Duke University. He also served as director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute; he has recently returned to Duke as a Professor of Medicine. He is a nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, healthcare quality, and clinical research, and has published more than 1,200 peer reviewed articles.
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