Genotoxicity evaluation of gene therapies: A report from the International Workshop on Genotoxicity Testing (IWGT) 2022.

IF 2.3 4区 医学 Q3 ENVIRONMENTAL SCIENCES Environmental and Molecular Mutagenesis Pub Date : 2024-09-20 DOI:10.1002/em.22633
S Libertini, J K Jadlowsky, T A Lanz, L M Mihalcik, D M Pizzurro
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Abstract

At the 8th International Workshop on Genotoxicity Testing meeting in Ottawa, in August 2022, a plenary session was dedicated to the genotoxicity risk evaluation of gene therapies, including insertional oncogenesis and off-target genome editing. This brief communication summarizes the topics of discussion and the main insights from the speakers. Common themes included recommendations to conduct tailored risk assessments based on a weight-of-evidence approach, to promote data sharing, transparency, and cooperation between stakeholders, and to develop state-of-the-art validated tests relevant to clinical scenarios.

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基因疗法的遗传毒性评估:2022 年遗传毒性测试国际研讨会(IWGT)报告。
2022 年 8 月,在渥太华举行的第八届国际遗传毒性测试研讨会上,有一场全体会议专门讨论了基因疗法的遗传毒性风险评估,包括插入性致癌和脱靶基因组编辑。本简讯概述了讨论主题和发言人的主要观点。共同的主题包括建议根据证据权重法进行有针对性的风险评估,促进利益相关者之间的数据共享、透明度和合作,以及开发与临床情况相关的最新验证测试。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
5.40
自引率
10.70%
发文量
52
审稿时长
12-24 weeks
期刊介绍: Environmental and Molecular Mutagenesis publishes original research manuscripts, reviews and commentaries on topics related to six general areas, with an emphasis on subject matter most suited for the readership of EMM as outlined below. The journal is intended for investigators in fields such as molecular biology, biochemistry, microbiology, genetics and epigenetics, genomics and epigenomics, cancer research, neurobiology, heritable mutation, radiation biology, toxicology, and molecular & environmental epidemiology.
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