Host: The Japanese Society of Toxicology
Name : The 47th Annual Meeting of the Japanese Society of Toxicology
Date : 2020 -
Gene-edited cellular therapy products (ex vivo gene-edited products) are categorized as cellular and tissue-based products in Japan. However, PMDA requests their safety assessment according to the guidelines for not only cellular and tissue-based products, but also gene therapy products.
In this presentation, I will outline the basic concepts related to the preclinical safety assessment of the cellular and tissue-based products and the gene therapy products, and then introduce the general principles for nonclinical safety evaluation of ex vivo gene-edited products, focusing on safety concerns specific to this technology.
