The US Food and Drug Administration’s Office of Therapeutic Products (OTP) convened a public listening session on September 18, 2025, asking the cell and gene therapy (CGT) community how prior knowledge can be leveraged to accelerate the development and streamline the review of cell and gene therapy (CGT) products. But what does that mean for developers, regulators, and external partners who are tasked with developing effective, safe therapies?
In this GEN webinar, an outstanding panel of CGT experts will unpack some of the key themes raised during the recent FDA Listening Session and examine their implications for the future of product development and regulatory strategy. They will discuss the role of prior knowledge across chemistry, manufacturing, and controls (CMC), nonclinical, clinical, and manufacturing contexts and its potential to inform efficiency, safety, and innovation. Webinar attendees will learn:
- What types of data are most valuable to share and where the boundaries should be.
- How sponsors and CDMOs can navigate data leveraging across partnerships and the product lifecycle.
- Strategies for integrating knowledge across disciplines to strengthen development and risk assessment.
A live Q&A session will follow the presentations, offering you a chance to pose questions to our expert panelists.
Produced with support from:
