Workshop on integration site analysis during long term follow-up for gene therapies with integrating viral vectors (Catapult’s regulatory round-up – September 2024)

On 14th November 2024, the FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting a virtual scientific public workshop on 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 a panel of external experts will discuss the risk of insertional mutagenesis and best practices for ISA method design, data analysis, and clinical inter...

Publication Details

Journal
Industrias Culturais (Universidade de Coimbra)
Published
2024-11-19
DOI
https://doi.org/10.58079/12prz
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 (Catapult’s regulatory round-up – September 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 (Catapult’s regulatory round-up – September 2024)

article en

Abstract

On 14th November 2024, the FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting a virtual scientific public workshop on 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 a panel of external experts will discuss the risk of insertional mutagenesis and best practices for ISA method design, data analysis, and clinical inter...

Industrias Culturais (Universidade de Coimbra)
Openalex Percentile: Top 67%
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 (Catapult’s regulatory round-up – September 2024) · Industrias Culturais (Universidade de Coimbra) (2024) | TGRS Research Map | TGRS