NDA Partners LLC: A Development Partner to Biopharmaceutical Investors and Companies

Marlene Haffner, MD, MPH

Practice Area Focus

  • Development Strategy
  • Regulatory Strategy
  • Rare Diseases
  • Orphan Products
  • Internal Medicine
  • Dermatology
  • Hematology


Marlene Haffner, MD, MPH, is former Director of the Office of Orphan Products Development (OOPD) of the US 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. After leaving the FDA, she served as Executive Director, Global Regulatory Policy and Intelligence at Amgen, Inc.

In addition to her consulting activities, Dr Haffner 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. For 36 years she served in the United States Public Health Service beginning her career with the Indian Health Service in Gallup, New Mexico. She received her MD from the George Washington University School of Medicine where she then interned in Internal Medicine. She received further training in internal medicine, dermatology and hematology at the Presbyterian Hospital, New York and at the Albert Einstein College of Medicine, New York. She received an MPH from the Johns Hopkins University Bloomberg School of Public Health. During her Public Health career, she rose to the rank of Rear Admiral in the USPHS.