Marlene Haffner, M.D.
Dr. Haffner is an internist and hematologist who graduated from the George Washington University School of Medicine and did further training at the Columbia University School of Medicine and the Albert Einstein College of Medicine, in New York City. Marlene received her Masters of Public Health from the Johns Hopkins Bloomberg School of Public Health in Baltimore.
For more than twenty years, Dr. Haffner was the Director of the Office of Orphan Products Development at the FDA. During her tenure in that program, it became one of the leading orphan products programs in the world. In addition to assisting in the development of more than 300 products in the United States, she is credited with assisting in the development of programs in Japan, the European Union, Australia, and beyond. Her extensive speaking and writing brought the term “orphan products” to the mind of many in the pharmaceutical world. In addition to her work at FDA, Dr. Haffner was also employed for two years by Amgen, the largest biotech company in the world. Her responsibilities there were as Executive Director, Global Regulatory Intelligence and Policy.
During her tenure at the FDA, and as stated above, more than 300 products were brought to market. Those 300 products have the ability to treat more than 15 million individuals in the United States and far more beyond those borders.