Takeaways from a scientific exchange between the FDA and developers
The following brief reflects the facilitated discussion in the all-day scientific exchange on November 1, 2023, co-sponsored by the Alliance for Regenerative Medicine (ARM) and The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). The meeting included cell and gene therapy (CGT) developers, FDA staff, and other key stakeholders. The session identified building blocks and/or platform technologies that could be leveraged to improve the time and resource efficiency of CGT development and regulatory review. A full white paper summary of the exchange will be published in early 2024.
