The new threat posed by COVID-19 calls for major changes in society. In addition, it is changing the daily routines that we had during times of stability due to the labile international situation. We are now in an era when it is necessary to think more deeply about how to face these risks, while we continue to strive toward the development of a sustainable society.
In Japan, five regenerative medicine products were approved in 2021. In 2022, two products were approved as of the end of May. I would like to express my heartfelt gratitude to everyone who has been committed to the cause, as the time required for approval has been shortened. Sixteen cell and gene therapy products have been approved in our country. The preparation for regenerative medicine and other products to form a wide variety of market has been progressing smoothly. With the aim of widespread use of regenerative medicine, we have proposed three steps: (1) developing regenerative medicine products, (2) creating a regenerative medicine industry, and (3) creating a culture of regenerative medicine. We aim to reach (2) by FY2025. In light of this, I would like to evaluate that five products have been launched in the past year, as our first step of “developing regenerative medicine products” has steadily progressed. Although we do not have many products yet, we will continue to work this year so that we can rapidly move to the second step of “creating a regenerative medicine industry.”
Regenerative medicine that aimed to enable “tissue regeneration using cells” was mainly developed in our country. However, gene therapy-related products have attracted significant attention in recent years. In addition to CAR-T cell therapies, which can be considered a typical example of ex vivo gene therapy, attention is focused on in vivo gene therapies that directly use genes for the treatment of various diseases as well. In our country, all of these are considered “regenerative medicine products” and are placed in a third product category that differs from “pharmaceuticals” and “medical devices.” From the living cells themselves to the genes that offer advanced therapeutic mechanisms, we are dealing with a group of products with the ultimate diversity. Until now, the Forum for Innovative Regenerative Medicine (FIRM) has considered new modalities in the form of cells, such as production systems, quality-control systems, concepts that form the foundation of efficacy and safety, and the establishment of business models that contribute to industrialization. With a more flexible way of thinking, we bring together diverse experiences from member companies and conduct an active exchange of opinions. New modalities will be created henceforth as well. We hope that FIRM will continue to serve as a treasure trove for these new health care ideas, as well as a place where companions congregate and think together.
With the approval of FIRM’s Board of Directors in March 2022, the Specific Processed Cells Committee was officially established. In addition to the two core committees of FIRM, the Cell and Gene Therapy Products (CGTP’s) Committee and the Supporting Industries Committee, we have organized a group of companies aiming to provide regenerative medicine based on the Act on the Safety of Regenerative Medicine (Safety Act). Nowadays, there are various ways to deliver regenerative medicine to patients. In addition to obtaining marketing approval and providing this product as a regenerative medicine product, the appropriate use of the Safety Act is crucial. Moreover, the realization of rational production methods specifically for regenerative medicine and the cell processing facilities that provide them should also be addressed. In the future, we would like to contribute to increasing the value of new regenerative medicine through the activities of the Specific Processed Cells Committee.
We began to see opportunities to regain the communication opportunities as we used to have, but it is premised on COVID-19-related support.
We would like to respond more flexibly to regenerative medicine, which has various aspects, and to exchange opinions with more people to create a bold regenerative medicine culture.
Ken-ichiro Hata, Chairperson of the Forum for Innovative Regenerative Medicine