FDA's Upcoming CGT Webinar: Leveraging Prior Knowledge for Faster Reviews
Following a public listening session held by the FDA's Office of Therapeutic Products (OTP) on September 18, 2025, a live Q&A session will take place, offering attendees the chance to engage with expert panelists. The session aims to gather insights from the cell and gene therapy (CGT) community to accelerate development and streamline reviews by leveraging prior knowledge.
The upcoming webinar, scheduled for a later date, will delve into key themes from the FDA's listening session. Experts will explore the implications of these themes for future product development and regulatory strategies. Attendees can expect to learn about valuable data types to share, navigating data leveraging across partnerships, and integrating knowledge across various disciplines to bolster development and risk assessment.
The webinar will cover the role of prior knowledge in different contexts, including chemistry, manufacturing, and controls (CMC), nonclinical, clinical, and manufacturing. It will also discuss how this knowledge can inform efficiency, safety, and innovation. Paris Margaritis, PhD, Chief Scientific Officer at GeneVentiv Therapeutics, was among the panelists at the GEN webinar on the same day, discussing these very themes and their implications for the CGT sector.
The live Q&A session and the subsequent webinar present valuable opportunities for the CGT community to engage with experts and gain insights into leveraging prior knowledge to enhance product development and regulatory strategies. By attending, participants can stay informed about the latest trends and best practices in the field.
