After I became the chairperson in June 2023, we have recognized that the term “regenerative medicine” has been clearly included in the Japanese government’s Basic Policy on Economic and Fiscal Management and Reform (also known as HONEBUTO) and that various discussions have been held among politicians, the government, industries, and the academia to enhance the dissemination and industrialization of regenerative medicine. Furthermore, clinical development related to iPS cells has been activated, based on the trend of 20 products of regenerative medicine being approved as of June 2024. In other words, Japan is currently at an exciting stage in the field of regenerative medicine. Seizing this opportunity, FIRM has been working diligently over the past one year on “delivering proposals that create change,” “continuously creating innovation,” and “providing reliable information,” as stated in FIRM VISION 2025. I express my deepest gratitude to all those involved in these activities.
Regarding “delivering proposals that create change,” we have led discussions with stakeholders involved in regenerative medicine and contributed to the formulation of many recommendations (e.g., by the Council of Diet Members Promoting Regenerative Medicine; the Japan Business Federation, also known as KEIDANREN; and the “Envisioning Japan’s Future through Regenerative Medicine” Research Conference organized by the Graduate School of Project Design). In these recommendations, we have consistently advocated for 1) developing an environment, including legal regulations, that suits the diversity of regenerative medicine products; 2) evaluating innovation and establishing a medical insurance system to make regenerative medicine more accessible; and 3) strengthening the ecosystem to support start-ups and bio-manufacturing organizations. Especially in terms of regulations, we have submitted requests to the Minister of Health, Labour and Welfare for the exceptional provision of non-standard autologous cell products as a first step toward concrete change. If the existing regulations do not cover the scope of the diverse products of regenerative medicine, we believe it is important to make timely and appropriate changes in them. The changes brought about by our recommendations will help in creating an attractive R&D environment and Japanese market, and help resolve issues such as drug lag/loss.
In terms of “continuously creating innovation,” the iPS cell field has shown tremendous progress, becoming Japan’s strength and source of innovation; for example, the initial public offering and/or overseas business expansion of iPS cell-related start-ups has been observed. Our efforts are directed to not only making proposals to the government about support measures for start-ups, but also continuing FIRM’s own activities to enhance the ecosystem. FIRM’s Entrepreneurship Academy, which supports academic researchers to start their own businesses, marked its sixth anniversary in 2023. In biomanufacturing, we are collaborating with ARM, a US industry association related to regenerative medicine, to understand the needs and challenges of global pharmaceutical companies and start-ups when they establish manufacturing sites in Japan. Additionally, we have implemented the FIRM Mark Certification System for the supporting industries to ensure that their products and services comply with the global standards. We believe that this system will contribute to creating innovation by enhancing awareness about quality control among both the suppliers and users of the target products.
In terms of “providing reliable information,” a series of easy-to-understand videos about regenerative medicine have been created and released to improve the general public’s literacy in regenerative medicine. The FIRM-sponsored digital media program featuring the leading expert in regenerative medicine has been viewed more than 100,000 times. We will continue to provide reliable information to enhance the general public’s knowledge and awareness about regenerative medicine.
Regenerative medicine is a “game changer” that overturns the existing concept of medical treatments and drugs. We believe that this “game change” can help provide innovative treatments to patients as well as contribute greatly to economic growth, including that of the supporting industries. As a top-tier professional organization of regenerative medicine experts, let us move forward together to achieve our VISION.
Yoshitsugu Shitaka, Chairperson of the Forum for Innovative Regenerative Medicine