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View summaries
The annual ASGCT–FDA Liaison Meeting is an opportunity for our subject matter expert members to engage directly with FDA staff. Each year Society presenters share information about the key challenges and new opportunities facing the field. In return, FDA provides a presentation relevant to ASGCT members’ interests.
See past presentations
View presentations and read a recap of the sixth annual FDA liaison meeting last month with CBER's Office of Therapeutic Products.
ASGCT reviewed FDA’s adoption of prior Society recommendations & opportunities for use of novel engineered AAV capsids in GT development. FDA provided an update on RMAT and OTAT operations.
ASGCT discussed AAV-based GTs, including integration/insertion considerations & PNS ganglia toxicities, and CMC expectations for CGT products. FDA discussed the CBER/OTAT Growth Program.
ASGCT made recommendations on immunogenicity testing, risk assessment for animal models and nonclinical data, & innovative clinical study design. FDA discussed a range of GT development challenges.
ASGCT shared recommendations on surrogate endpoints & discussed comparability for pre- and post-marketing manufacturing changes. FDA discussed common GT IND deficiencies.
May 13-17, 2025 | New Orleans
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