Workshop on integration site analysis during long term follow-up for gene therapies with integrating viral vectors (from Catapult’s regulatory round-up for November 2024)
The FDA’s CBER Office of Therapeutic Products (OTP) hosted a virtual scientific public workshop on 14th November 2024 to discuss the clinical use of integration site analysis (ISA) during long term follow-up following administration of gene therapies with integrating viral vectors. In this workshop, FDA convened a panel of external experts to discuss the risk of insertional mutagenesis and best practices for ISA method design, data analysis, and clinical interpretation. The video recording of this workshop is available here.
Published on the 3rd of december 2024. Read the entire Regulatory Round-up – November 2024 here.
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adelage (12 février 2025). Workshop on integration site analysis during long term follow-up for gene therapies with integrating viral vectors (from Catapult’s regulatory round-up for November 2024). ELSIBI. Consulté le 18 mars 2025 à l’adresse https://doi.org/10.58079/13axq