SPARK 28 - Regulatory Strategy for Orphan Indications

| 05:00 PM - 07:00 PM
Room Number : V20-1000 Seminar Room
Pharmacy and Pharmaceutical Sciences Building
12850 East Montview Boulevard
Aurora, CO
Email :
Phone :
(303) 724 - 3720

Presented by : Marlene Haffner, MD, MPH

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Dr. Marlene Haffner was the Director of the Office of Orphan Products Development at the Food and Drug Administration (FDA) for 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, 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.

Marlene is a problem solver and creative thinker. She founded Haffner Associates in 2009 in order to continue to apply her extensive experience in development of orphan products by working with small to large biotech/pharmaceutical companies, patient advocacy groups, and government agencies. In addition to her work at Haffner Associates, Marlene serves as an expert advisor and board member to companies throughout the world. 

Trained as an internist and hematologist, Marlene 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 Masters of Public Health from the Johns Hopkins Bloomberg School of Public Health in Baltimore. Following her tenure at FDA and prior to forming Haffner Associates, Marlene served as Executive Director, Global Regulatory Intelligence and Policy for two years at Amgen, the largest biotech company in the world.

Marlene has worked in the Washington, DC metropolitan area for more than 30 years. She has seen many changes in the regulatory scene during that period of time and is both sensitive and knowledgeable about politics and the political landscape. She knows “FDA think” and maintains close ties with her friends and colleagues in the agency.
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