Host: The Japanese Society of Toxicology
Name : The 50th Annual Meeting of the Japanese Society of Toxicology
Date : June 19, 2023 - June 21, 2023
Toxicity study with two animal species is mandatory in drug development, with one selected from rodents and the other from non-rodents. Dog, NHPs, pig or rabbit are generally selected as non-rodent. NHPs are selected for about half of the new active ingredient drugs. In particular, the use of NHPs in biopharmaceuticals has reached about 90%, making their use essential as various modalities have been developed. However, since NHP exports from China were cut off in 2020, the global supply of NHP has been in short supply and prices have been soaring, which is starting to hinder the development of pharmaceuticals, especially biopharmaceuticals. In this changing environment, FDA has issued guidelines on the minimize the use of NHPs, and HESI is studying the evaluation of reproductive and developmental toxicity using the WoE approach with the aim of reducing number of NHPs in these toxicity studies. In addition, countries such as the United States and Korea are making national efforts to establish their own monkey colonies to improve their import-dependent monkey supply. In Japan, since 2022, a research team has been set up to strengthen research on alternative methods and promote replacement of NHP with other nonrodent species. We are also considering the need for a research group to investigate the number of NHP needed for overall biomedical research in Japan and the need for domestic breeding colonies for monkeys (as of March 2023). JPMA conducts a questionnaire at the R&D Committee to understand the status of large animal studies, and the Non-clinical Evaluation Expert Committee cooperates with JALAS and other organizations in conducting these group studies. In this session, the current situation is introduced and the survey results to date are introduced as a preliminary report, and the necessity of nonrodent studies and species selection are discussed.
