The Bespoke Gene Therapy Consortium has published a regulatory playbook designed to serve as a “Guiding framework for the development and regulatory submission of adeno-associated virus gene therapies for rare diseases.” The playbook is free to access and draws upon publicly available resources, including FDA guidances and other official publications.
To find out more about the inspiration for the playbook, we spoke with Courtney Silverthorn, Vice President, Strategic Alliances and Innovation of the Foundation for the National Institutes of Health’s Accelerating Medicines Partnership Program. She discusses the hurdles to accelerating the development of gene therapy, exciting advances in the field, and how she hopes the playbook will help drug developers. Watch the interview in the video below.
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