Dr. Haffner is founder of Haffner Associates http://www.mhaffner.com, a firm dedicated to the field of rare and orphan diseases. She is the former Director of the Office of Orphan Products Development at the Food and Drug Administration (FDA) and since 2009 has been the CEO of her own firm. A graduate of the George Washington University School of Medicine, she trained in Internal Medicine, Dermatology and Hematology. Dr. Haffner is the recipient of numerous professional governmental awards and honors as well as academic awards and received the Outstanding Government Service Award from the John Hopkins University Bloomberg School of Public Health. A career Public Health Service Officer, Dr. Haffner rose to the rank of Rear Admiral in the US Public Health Service (USPHS). For 20 years, Dr. Haffner directed the Office of Orphan Products Development at the FDA, becoming one of the world’s experts on the research, development, and approval of designated orphan drugs and products for people suffering from rare diseases. On retiring from the USPHS in 2007, Dr. Haffner served as the executive director, global regulatory affairs and policy for Amgen, Inc, following which she founded her own firm. Having worked as a physician for both the FDA, and for a pharmaceutical company, she has a uniquely broad perspective on the subject of developing therapies for rare disorders. Currently, as a consultant, Dr. Haffner works with organizations for rare diseases to help them form constructive partnerships with researchers and pharmaceuticals to create and approve drugs for their condition. She is an adjunct Professor in the departments of Medicine and the Department of Preventive Medicine and Biometrics at the F. Edward Hébert School of Medicine, Uniformed Services University of Health Sciences (USUHS). She is a sought after speaker throughout the world and has given almost 300 presentations during her distinguished career.
Marlene Haffner, M.D., M.P.H.