Marlene Haffner, MD, MPH

Senior Orphan Drug Regulatory Advisor

Novateur Advisor Since

2016

Field

Regulatory Global

Specialties

Orphan Drugs, Regulatory, Therapeutics

Dr. Marlene Haffner was the Director of the Office of Orphan Products Development at the FDA for more than 20 years. During her tenure in that program, it became THE orphan products program in the world. In addition to assisting in the development of more than 300 products in the US, Dr. Haffner 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. Following her tenure at FDA, and prior to forming Haffner Associates, Dr. Haffner served as Executive Director, Global Regulatory Intelligence and Policy for two years at Amgen, the largest biotech company in the world.

 

Dr. Haffner 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. She received her Master’s of Public Health from the Johns Hopkins Bloomberg School of Public Health in Baltimore.

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