FDA Pushes for Faster CGT Development with Prior Knowledge Initiative
The FDA's Office of Therapeutic Products (OTP) recently hosted a public listening session on September 18, 2025. The event focused on leveraging prior knowledge to enhance cell and gene therapy (CGT) product development and review. Following presentations, a live Q&A session allowed attendees to gain insights into valuable data types to share, navigate data leveraging across partnerships, and integrate knowledge across disciplines to bolster development and risk assessment.
Paris Margaritis, PhD, Chief Scientific Officer of GeneVentiv Therapeutics, and Jacob Smith, Head of Technical Development & CMC Strategy at Viralgen, will delve into these topics in an upcoming GEN webinar. They will explore the role of prior knowledge across CMC, nonclinical, clinical, and manufacturing contexts in fostering efficiency, safety, and innovation.
The FDA's initiative and the upcoming webinar underscore the importance of leveraging prior knowledge in CGT development and review. By integrating data across various contexts, the industry can improve efficiency, ensure safety, and drive innovation.
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