FDA Explores Leveraging Prior Knowledge to Accelerate Cell & Gene Therapy Development
The FDA's Office of Therapeutic Products (OTP) recently held a public listening session to discuss leveraging prior knowledge to accelerate cell and gene therapy (CGT) product development and reviews. The session, held on September 18, 2025, aimed to explore implications for developers, regulators, and external partners. An upcoming GEN webinar, supported by unspecified partners, will delve into key themes from the session and their impact on future product development and regulatory strategies.
The listening session brought together a diverse range of external partners, including academic institutions like University Medicine Leipzig and Fraunhofer Institute for Cell Therapy and Immunology (IZI), small and medium-sized enterprises (SMEs), and major pharmaceutical industry partners such as Novartis and Bristol-Myers Squibb (BMS). These partners collaborate within the CREATION center, integrating research, clinical application, and industrial translation across locations in Hannover, Göttingen, and Leipzig. This structure facilitates data sharing, enabling seamless interaction between research, GMP production, and clinical development to support regulatory and clinical trial processes.
The webinar, featuring CGT experts, will explore the role of prior knowledge across various contexts, including CMC, nonclinical, clinical, and manufacturing. Attendees will learn about valuable data types to share, navigating data leveraging across partnerships, and integrating knowledge across disciplines to strengthen development and risk assessment. A live Q&A session will follow the presentations, allowing attendees to engage with the expert panelists.
The upcoming GEN webinar, produced with support from unspecified partners, promises to provide valuable insights into leveraging prior knowledge to accelerate CGT product development and streamline reviews. By exploring key themes from the FDA's listening session, the webinar aims to inform future product development and regulatory strategies, fostering collaboration and innovation within the CGT community.
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