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Name, Title at FAST: Jennifer Panagoulias, Head of Regulatory and Policy, Co-Director of ABOM
A message from Jennifer: I have worked in drug development for many years as the company liaison to the FDA. This experience has taught me so much about the life-cycle of drug development, having weighed in on development plans at the earliest stages of animal research all the way through a drug’s approval and reimbursement process with insurance companies. I have worked to help patients and families with serious diseases using my knowledge of the regulatory process to help identify ways to get meaningful treatments to patients as soon as possible, but making sure we don’t sacrifice quality to do so. It was early in my career when my sister learned her daughter, Samantha, had Angelman syndrome. At that time, there were no companies we knew of developing treatments for Angelman syndrome. I hoped there would be a day I could lend my efforts to help bring therapies to patients. The landscape for AS is now so rich and I’m so excited for the future. I am humbled by the opportunity to work with FAST to further our mission and to use my learnings as part of a team focused on accelerating the development of potential therapies for the community.
How will you support FAST’s mission to a cure: As a volunteer, I will pitch in wherever I am needed and keep an eye on changes in the regulatory landscape so that we are poised to leverage new policies/programs to accelerate research and development in AS. I understand the process can be lengthy so it demands commitment and perseverance to see it through so when dealing with regulators, it is important to keep my focus on the long-term goal when challenges present.
What did you do before FAST? I have worked in drug development for over 20 years, primarily focused on advancing global development programs for the treatment of rare neurological diseases. I spent 16 years in Regulatory Affairs at Genzyme where I held various roles including Global Therapeutic Head, Regulatory Affairs Neurology. At Genzyme, I supported global registration efforts for Myozyme® (alglucosidase alfa), an enzyme replacement therapy for children and adults with Pompe disease; a rare, genetic, neuromuscular disorder. I have experience in working with global regulatory agencies including the US FDA, the European Medicines Agency, and the Pharmaceutical and Medical Device Agency in Japan to support diverse drug and biological therapy development programs in both the development and post-marketing stages. Most recently, I have worked on the development of oligonucleotide drugs as Senior Vice President of Regulatory, Compliance, and Policy at Wave Life Sciences.
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