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 o...

Publication Details

Journal
Industrias Culturais (Universidade de Coimbra)
Published
2025-02-12
DOI
https://doi.org/10.58079/13axq
Primary Topic
Virus-based gene therapy research
Type
article
Field-Weighted Citation Impact
0.00
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article

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)

Industrias Culturais (Universidade de Coimbra)
Virus-based gene therapy research
article

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)

article en

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...

Industrias Culturais (Universidade de Coimbra)
Openalex Percentile: Top 55%
Virus-based gene therapy research
DOIOpen Access PDFOpenAlex
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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) · Industrias Culturais (Universidade de Coimbra) (2025) | TGRS Research Map | TGRS