FDA's Prior Knowledge Session: CGT Experts Share Insights in Upcoming GEN Webinar
Join us for an upcoming GEN webinar featuring Paris Margaritis, PhD, Chief Scientific Officer at GeneVentiv Therapeutics, and Jacob Smith, Head of Technical Development & CMC Strategy at Viralgen. They will discuss the implications of the FDA's recent listening session on leveraging prior knowledge for cell and gene therapy (CGT) product development and review.
The FDA's Office of Therapeutic Products (OTP) held a public listening session on September 18, 2025, to explore ways to accelerate development and streamline review of CGT products. The session focused on how to use prior knowledge across various contexts, including CMC, nonclinical, clinical, and manufacturing, to enhance efficiency, safety, and innovation.
The webinar will delve into the types of valuable data to share, navigating data leveraging across partnerships, and integrating knowledge across disciplines to bolster development and risk assessment. Attendees can look forward to insights from industry experts and a live Q&A session to ask questions and engage with the panelists.
Mark your calendars for this informative webinar, where Paris Margaritis and Jacob Smith will share their expertise on leveraging prior knowledge to advance CGT product development and review. Don't miss this opportunity to learn and engage with industry leaders in the field.
