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Dedicated to facilitating the development of therapies for the diagnosis,
treatment and prevention of rare and devastating diseases.

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About Our Team

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Haffner Associates LLC Orphan Drug Development

Marlene Haffner, MD, MPH,
(retired Rear Admiral in the USPHS)

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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Haffner Associates LLC Orphan Drug Development

Sandra Heibel, PhD

Dr. Sandra Heibel joined Haffner Associates in 2015 as a regulatory consultant. Sandra brings with her extensive knowledge of drug development research for rare diseases as well as experience in regulatory strategy, scientific writing, regulatory submissions, and project management. In addition to her work with Haffner Associates, Sandra concurrently serves as a Project Manager for Scientific Operations for BioPontis Alliance for Rare Diseases, a non-profit corporation dedicated to the development of new therapeutic agents to treat rare diseases.

Prior to joining Haffner Associates, Sandra worked as Project Manager for Regulatory Science at Coté Orphan, a firm specializing in regulatory submissions for orphan drugs, and spent 13 years doing preclinical research. Sandra completed her PhD at the University of Maryland where she studied the molecular biology of rare heritable diseases of metabolism in the laboratory of Mendel Tuchman, MD at the Children’s National Medical Center in Washington, DC. Through her doctoral experience and as part of a scientist-clinician team, she identified and characterized disease-causing mutations in patients with ultra-rare diseases, assisted with clinical studies, and learned about the need for, and value of developing drugs for rare diseases. These studies and experiences have become the driving force of her career.

Sandi is an active member of Women In Bio, a non-profit that supports the careers of women in the biosciences across all stages. She is a passionate supporter of STEM education for women and developed mentoring programs to assist women in career development from graduate school through the C-suite. She received her Master’s degree in Animal Science from the University of Maryland and her Bachelor’s degree in Animal Bioscience from Penn State University. For 10 years she and her husband have lived in the Washington, DC area, and when not working in the rare disease field, she enjoys traveling, SCUBA diving, tasting international cuisine, and spending time with her friends and family.