AI Article Synopsis
- Regulators and industry experts are looking for better ways to assess the cancer-causing potential of gene therapies, as current methods may not be sufficient.
- A meeting in London in March 2023 brought together specialists to reach a consensus on key themes such as vector genotoxicity, uncertainty sources, and appropriate toxicological endpoints for gene therapy evaluation.
- The recommendations from this meeting aim to guide the creation of new regulatory guidelines for the nonclinical toxicological assessment of gene therapy products.
Article Abstract
Regulators and industry are actively seeking improvements and alternatives to current models and approaches to evaluate potential carcinogenicity of gene therapies (GTs). A meeting of invited experts was organized by NC3Rs/UKEMS (London, March 2023) to discuss this topic. This article describes the consensus reached among delegates on the definition of vector genotoxicity, sources of uncertainty, suitable toxicological endpoints for genotoxic assessment of GTs, and future research needs. The collected recommendations should inform the further development of regulatory guidelines for the nonclinical toxicological assessment of GT products.
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| http://dx.doi.org/10.1089/hum.2024.033 | DOI Listing |
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