New regulatory ‘playbook’ from FDA-supported Bespoke Gene Therapy Consortium aims to accelerate development

BY RACHEL COE, MSC

Yesterday, the Bespoke Gene Therapy Consortium, a public-private partnership focused on creating resources to streamline the process for moving AAV-based gene therapies from the lab to the clinic, published a comprehensive summary of the lessons the group has learned so far. The regulatory playbook acts as a comprehensive resource – especially for those not well-versed in how the FDA’s regulatory processes function.

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