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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)

Year: 2025

Type: other

Abstract: 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 o...

Source: Industrias Culturais (Universidade de Coimbra)

DOI: 10.58079/13axq

Author: Adelage

Language: English

Topic: Virus-based gene therapy research

Subfield: Genetics

Field: Biochemistry, Genetics and Molecular Biology

Domain: Life Sciences

SDG: Good health and well-being

Open Access status: green

OpenAlex ID: W6899013380

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