Dr. Stephen D. Nightingale led the clinical development of Mycobutin®, the sixth drug to be approved by FDA for treatment of patients living with HIV infection, and the Phase I/II trials of the intraocular slow-release drug delivery system now known as the Vitrasert®. He then served as a Medical Officer in the Center for Devices and Radiologic Health at FDA before becoming Senior Medical Advisor for Blood Safety to the Assistant Secretary for Health/Surgeon General. Dr. Nightingale left government in 2002 to form Burntside Partners with Mr. Tangen.
Dr. Nightingale graduated from Harvard College in 1967 and the University of Pennsylvania School of Medicine in 1971. He trained in Internal Medicine and Nephrology at Johns Hopkins, and is Board Certified in both disciplines. He subsequently taught at Case Western Reserve, Hopkins, The University of Chicago, and the Centre Universitaire des Sciences de la Sante in Yaounde, Cameroon, before becoming Chairman of General Medicine at Cook County Hospital in 1982 and the Medical Director of the AIDS Clinic at Parkland Hospital in 1988. He joined the FDA in 1996.
Having been a successful applicant, regulator, and policy official, Dr. Nightingale's fundamental approach as a regulatory consultant is to promote each party's understanding of the others' position ("secondary agreement" in negotiation parlance) and thereby accelerate the process and reduce the costs of bringing a product through regulation to market.
Dr. Nightingale has particular experience, and interest, in products subject to multiple regulations, e.g. environmental as well as therapeutic.
