Duke University cardiologist Robert Califf is joining the FDA, an appointment that brings to the agency a doctor with deep experience in the development and testing of new drugs.
The FDA on Monday named Califf deputy commissioner for Medical Products and Tobacco, a position that reports to FDA Commissioner Margaret Hamburg. The appointment comes nearly six years after Califf was a candidate for the top post at the FDA, a job that went to Hamburg.
Califf was the founding director of the Duke Clinical Research Institute, a contract research organization within Duke that conducts clinical trials. He has also worked with companies developing new drugs. Califf served on the medical advisory board for Basking Ridge, NJ-based Regado Biosciences, a company whose research originated in Duke labs (Regado has since merged with San Francisco’s Tobira Therapeutics). He was also a member of the board of directors for Portola Pharmaceuticals (NASDAQ: PTLA). The South San Francisco, CA, company announced Monday that Califf is retiring from the board to take the FDA post.
Califf is currently vice chancellor of clinical translational research at Duke. He is also director of the Duke Translational Medicine Institute as well as a professor of medicine at the university’s medical school. Califf was also lead investigator for longitudinal study at the North Carolina Research Campus in Kannapolis, NC, tracking heart disease, high blood pressure, cancer, and other diseases in residents of Kannapolis and surrounding Cabarrus County.
In his new role at the FDA, Califf will lead the agency’s Center for Drug Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Tobacco Products. He will also oversee the Office of Special Medical Programs in the Office of the Commissioner.
Califf received his undergraduate and medical degrees from Duke. He did his internship and residency at the University of California, San Francisco, and then returned to Duke for a fellowship in cardiology. The FDA says Califf will join the agency in late February.