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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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Haffner Associates, LLC

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Welcome to the website of Haffner Associates, LLC. We are delighted you found your way here and hope that we have the expertise for which you are looking.

Haffner Associates was founded in 2009 by Marlene Haffner, MD, MPH, former Director of the Office of Orphan Products Development at the Food and Drug Administration (FDA). As a company, Haffner Associates is dedicated to facilitating the development of therapies for the diagnosis, treatment and prevention of rare and devastating diseases – orphan diseases. Products for rare diseases are not easy to develop. Assisting pharmaceutical and biotechnology companies, working with regulatory agencies around the globe, finding patients, working with consumer support groups, and understanding “FDA think” are all part of a day’s work at Haffner Associates.

As a company Haffner Associates specializes in working with -

Biotechnology and pharmaceutical companies of all sizes and stages to:

  • create individualized orphan product strategies that include guidance on regulatory strategy and feasibility of drug development, scientific review of proposed drug repurposing plans, evaluation of clinical study design, and trouble-shooting regulatory and development issues
  • author and review applications for orphan drug designations, pediatric rare disease designation vouchers, breakthrough therapy designations, and other expedited review applications
  • develop materials for meetings with the FDA and EMA and assist with meeting preparations
  • facilitate connections with patient advocacy groups and key opinion leaders
  • interpret policies and communications from regulatory agencies around the world

Patients and patient advocacy groups to:

  • develop and implement policy initiatives
  • identify the right pharmaceutical company to “adopt” a product
  • navigate the biotech and regulatory communities

If you have a problem or question concerning rare diseases and/or developing a drug to treat a rare disease, Haffner Associates is the place for you to come to have your questions answered or your issues addressed.