In a written interview, Professor Yamanaka Shinya (山中伸弥) said that companies are expected to take center stage in the next 20 years of iPS cell development, with a focus on promoting domestic development and supplying products at fair prices. He also emphasized the development of social infrastructure to improve safety and the use of domestic stockpiles.
Yamanaka Shinya (山中伸弥), a professor at Kyoto University, said that companies will take center stage in the next 20 years of iPS cell development, adding that competition is being driven by increasingly active research and development in the US and China. He indicated that he places importance on working with companies in order to deliver therapeutic products to patients in Japan as quickly as possible.
As part of efforts to ensure safety, he said that verification work has continued for many years, including testing the numerous cancer-related genes in manufactured cells, and that the necessary foundation for approval as therapeutic products has been established.
As a strategy prioritizing domestic development, the initiative has continued to stockpile medical-use iPS cells in advance and provide them free of charge to research institutions and at low cost to companies. The interview described efforts to deter overseas players from securing a monopoly through stockpiling since 2015 and a patent strategy, citing the conditional approvals of the iPS-derived products Amchepri and Reheart as results of these efforts.
Japan lags behind the US and China in the number of clinical development plans, making the coming period a critical juncture for advancing research and development under an all-Japan framework that combines corporate funding with government support. The interview stated that the public and private sectors must discuss and resolve the challenge of ensuring fair prices while maintaining corporate profitability in order to expand the use of cell therapies, which tend to be expensive.