Government panel releases interim report with recommendations on medical care DX

A government panel that aims to achieve rapid delivery of the latest pharmaceuticals to the public through strengthening drug discovery capabilities (chaired by Hideki Murai, Deputy Chief Cabinet Secretary) has released an interim report that includes the establishment of a new public−private council to attract foreign pharmaceutical companies and VC funds to Japan. Sanae Takaichi, Minister of State for Healthcare Policy, said, "The report includes recommendations for enhancing research and development support for academia and startups, establishing intellectual property business strategies, promoting basic research to maintain and improve sustainable drug discovery capabilities, and integrating fields such as artificial intelligence (AI) and robotics with drug discovery, and medical care DX. We would like to reflect these recommendations in the next health care strategy currently under consideration and in AMED's next medium- to long-term plan."

The interim report sets forth three strategic goals: "to promptly deliver the latest pharmaceuticals to meet the expectations of all patients seeking treatments, including those to shed light on rare diseases and other areas where the patient population is small and no treatments are available," "to make Japan a world-class center for drug discovery," and "to create a social system where investment and innovation continue to develop in a spiral manner so that the stimulation of research and development produces results, which then attract investment for the next generation."

To strengthen drug discovery capabilities, a prerequisite for realizing these goals, an environment that allows for demonstrating comprehensive capabilities, including social systems and regulations as well as a wide range of research and development capabilities from basic to practical applications, will be created. In addition to actively attracting and utilizing human resources with practical application know-how and funds from overseas, a public-private council, including foreign companies and VCs, will be established to align the policy with their needs to attract overseas investment (people, goods, funds, and know-how). Matching events between academia/startups and pharmaceutical companies/VCs of Japan and other countries will be organized to link ideas from Japanese academia to drug discovery. Moreover, Japan's efforts to establish a world-class clinical trial implementation system will include the development of a First-in-Human (FIH) trial implementation system, promotion of the contribution of clinical research core hospitals to drug discovery and international clinical trials/studies, support of developing human resources and career tracks to engage in clinical trial operations and overseas companies in conducting clinical trials in Japan, implementation of a single institutional review board (IRB) system as a rule, and promotion of DCT, information disclosure, and public understanding.

A domestic manufacturing system for new modality drugs will be established by strengthening support for CDMOs, fostering bio-manufacturing human resources and attracting them from overseas, promoting the integration of international-level CDMOs and FIH trial sites, and collaborating with overseas sites and other efforts. Furthermore, the government will: enhance research and development support for academia and start-ups; establish intellectual property and business strategies; promote basic research to maintain and improve sustainable drug discovery capabilities; integrate the fields of AI/robotics and drug discovery, regenerative/cell medicine and gene therapy; promote regenerative/cell medicine, and gene therapy, and medical care DX; and create the environment to improve research and development capabilities of university hospitals and other facilities. In particular, the report has pointed out the critical situation of university hospitals.

Masahito Moriyama, Minister of Education, Culture, Sports, Science, and Technology, said, "We would like to make every possible effort to improve the research environment in the field of medical care by establishing university hospital reform guidelines that university hospitals can use as a reference to prepare their reform plans according to their actual conditions, and by creating an environment to improve research and development capabilities of university hospitals through projects to support initiatives using research supporters and other means."