marlene e. haffner, MD, MPH,
Marlene e. Haffner, MD, MPH is the CEO of Haffner Associates, LLC a firm dedicated to the strategy, development and policy of drug development with a special emphasis on rare diseases and the products that treatment them. For 20 years, Dr. Haffner served as Director of the Office of Orphan Products Development (OOPD) of the Food and Drug Administration (FDA). As OOPD Director she was responsible for the leadership and management of the FDA orphan products development program, the first Orphan Products program in the world. In addition to her FDA responsibilities, Dr. Haffner assisted in the development of Orphan Drug programs in the EU, Japan, Australia and beyond. She is well known as an expert in orphan drug development and is a sought after speaker and consultant in that area of regulatory science. In addition to her consulting activities Marlene is Adjunct Professor, Department of Preventive Medicine and Biometrics, and Clinical Professor, Department of Medicine, at the F. Edward Hébert School of Medicine, Uniformed Services University of the Health Sciences (USUHS) in Bethesda, Maryland. A sought after speaker and consultant, Dr. Haffner has received many awards for her work in drug development including The Outstanding Contributions to Pharmaceutical Medicine Award from the American Academy of Pharmaceutical Physicians, and the Woodrow Wilson Award for Outstanding Government Service from the Johns Hopkins University. She is the author of multiple articles in peer reviewed literature concerning issues of orphan product development.