Special Session at the 11th Nikkei-FT Conference on Infectious Diseases Establishment of an Infectious Drug Discovery Ecosystem: Toward the Implementation Phase
January 09, 2025
On October 23, 2024, a special session of the Pharmaceutical Cooperative Association was held at the 11th Nikkei-FT Conference on Infectious Diseases. The theme of this session was "Establishment of an Infectious Disease Drug Discovery Ecosystem: Toward the Implementation Phase," and discussions were held from the perspectives of industry, academia, and government on issues and strategies necessary to establish a drug discovery ecosystem in the infectious disease field. The following is a transcript of the seminar.
Lecture 1
Overview of White Paper on Promoting and Supporting Healthcare Startups
Manabu Sumi, Director, Infectious Disease Control Division, Health and Welfare Bureau, Ministry of Health, Labour and Welfare
Revise the Action Plan
Promote DX and strengthen R&D
In July 2024, the government action plan, which lays out what should be done to prepare for infectious disease crises in normal times, was fundamentally revised. The plan aims to expand the number of countermeasure items from 6 to 13, and to strengthen vaccines, therapeutic drugs, and diagnostic reagents as independent items, but this will require the involvement of companies, and the introduction of incentives to increase market predictability will be a challenge. Push-type incentives such as financial support for facility construction and research and development (R&D), and pull-type incentives such as guaranteed buy-backs, including stockpiling, will be necessary. Fostering and supporting healthcare startups will also be strengthened.
The horizontal axis of the action plan also emphasizes strengthening R&D through the promotion of digital transformation (DX). We must hurry to create a system to quickly share information from electronic medical records and apply it to clinical trials and other activities. On the same horizontal axis, we will also focus on building domestic and international networks and promoting human resource development, in which we expect the National Institute for Health Risk Management (JIHS), which will be established in April 2013, to play a major role.
Infectious disease countermeasures must cover a wide range of infectious diseases, not just new coronas and new strains of influenza, and we plan to review the list of priority infectious diseases as well as the action plan every six years and follow up annually to ensure its effectiveness.
Lecture 2
Toward the Development of a Healthcare Venture Ecosystem in Japan
Shinichiro Kamoto, Partner, Eight Roses Ventures Japan
Toward a Virtuous Circle of Ventures
Funding in the U.S.
The MEDINET Group was founded as a VC firm in Boston, U.S.A., and has invested in healthcare startups in the U.S., China, India, Europe, and Japan. The Group has also established a science advisory board in the U.S., which provides support in various specialized areas that cannot be covered by capitalists alone.
Ideally, the venture ecosystem should be a virtuous cycle: startup → fundraising from VC firms → product development → acquisition of large sums of capital through initial public offerings (IPOs), etc. → further development of knowledge and human resource development → startup of new ventures. One reason is the scale of funding. Although the number of biotech ventures established in Japan is not small, the amount of investment per company in Japan is only 160 million yen compared to 2.5 billion yen in the U.S., and it is difficult to imagine that sufficient funds can be secured to turn the ecosystem around.
It is difficult for a Japanese bio-venture to compete globally even if it conducts clinical trials only in Japan and obtains approval only in Japan. We have also supported cases where Japanese ventures have changed their nationality, established a parent company in the U.S., and raised funds from U.S. VC firms to advance their business. We would like to introduce this as a means for Japanese ventures to spread their wings to the world.
Lecture 3
The Role of Academia in Establishing an Ecosystem for Drug Discovery in Infectious Diseases
Tetsuya Matsumoto, Professor, Department of Infectious Diseases, International University of Health and Welfare, School of Medicine
Encouraging free exchange of ideas
Narrowing the gap between companies and academia
In the drug discovery ecosystem, what is most expected of academia is undoubtedly the creation of seeds. To this end, basic research, which is the mother of innovation, must be strengthened, but currently there are a mountain of problems. According to the Science and Technology Indicators 2024, Japan ranks fifth in terms of the number of academic papers by country, but it ranks 13th in terms of the number of high-profile papers, indicating that the current situation is focused on earning the number of papers rather than on high quality papers.
In the background, there is an unstable employment environment for researchers in academia, evaluation standards that emphasize thesis writing, busyness caused by balancing research and teaching duties, and a lack of research funds, etc. The number of Ph.
The most serious problem, however, is the distance between pharmaceutical companies and academia. Pharmaceutical companies do not have sufficient visibility into what academia is doing, and academia is not able to pass on the seeds to companies. Therefore, we believe that it is important to have a system in which academia, pharmaceutical companies, and related ministries and agencies can develop new drugs with mutual commitment, and we have proposed the establishment of a consortium that allows free exchange of ideas. The consortium has already held meetings to exchange opinions between basic researchers and the Japan Pharmaceutical Manufacturers Association (JPMA), as well as meetings with the International Partnership for Combating Drug Resistance against Bacteria (CARB-X) to deepen collaboration.
Lecture 4
Making the Infectious Drug Discovery Ecosystem Really Work
Hiroaki Ueno, Chairman, Japan Pharmaceutical Manufacturers Association, Inc.
Preparing for the next crisis
Sharing concrete images
Looking at the past year, I feel that preparations for peacetime have advanced considerably. As we have been calling on the government to strengthen the command post function for drug discovery, I am hopeful that the JIHS, which will be established next April, will serve as a hub for building domestic and international networks and fostering biopharmaceutical human resources, and will be able to promote this. We also feel that a common understanding has emerged regarding the importance of push and pull incentives, and we will continue to call on the government to define clinical evaluation indicators in advance and design a practical emergency approval system.
On the other hand, the pharmaceutical industry would like to strengthen investment in academia and venture companies, as well as promote drug discovery human resource development, education, and public awareness. In the field of infectious diseases, we will also promote R&D and investment in collaboration with domestic and foreign organizations, including contributing to the establishment of an action fund for drug-resistant bacteria (AMR), which aims to launch two to four new antibacterial drugs by 2030.
Five years have already passed since the outbreak of the new corona, and if a pandemic occurs once every 10 years, half of the peacetime period has passed. If Japan is to be the first to introduce vaccines to its own country and neighboring countries in the next contingency, an actual production system for several hundred million people, including budget, and a stable production system for sufficient quantities of therapeutic drugs are necessary.
Panel Discussion
Moderator: Izuru Makihara, Professor, Research Center for Advanced Science and Technology, The University of Tokyo
Boosting Instantaneous Power in the Initial Phase
Makihara: In the infectious disease drug discovery ecosystem, what are the challenges in the preparation and initial response phases to a crisis?
Matsumoto: Projects such as the 100-day mission (an international goal to commercialize vaccines and treatments within 100 days of a crisis) are underway, led by the Strategic Center for Advanced Research and Development (SCARDA), but not all academia in Japan is involved and only a few are involved. However, academia throughout Japan is not involved, but only some of them. Players need to be expanded to deal with various infectious diseases.
Ueno: In order to increase the power of the project, it is necessary to draw up a blueprint of how much budget will be required and who will be involved in the initial phase. It was also pointed out that academia, ventures, and companies do not have a clear view of what each has in common. I believe that one of the major roles of the JIHS, which will be established this time, is to centralize and consolidate the information and to match seeds with technologies in the preparatory phase.
JIHS as a hub of collaboration
Makihara As academia and companies share information to create a process to confront the crisis, it is the government's role to push the operating button.
Sumi: In the case of the Corona disaster, there were various frameworks such as special exceptions and emergency approvals in the field of pharmaceutical regulations, and some parts of these frameworks could be used appropriately, while others could not be used sufficiently. In the field of R&D in the field of infectious diseases, where the market does not work well, we need to seriously consider how the JIHS can act as a hub to move collaboration among academia and companies, especially during the difficult initial phase.
Ueno: I believe that the pharmaceutical industry can make a human contribution to the JIHS. The JIHS can also share practical information for collaboration, such as ideas on how to put seeds to practical use and the costs and time required to implement production systems.
KAMOTO: The government's response to this initiative to strengthen the drug discovery venture ecosystem has been swift and world-class, and together with Japan's advanced science and technology, we can be confident that we are on the right track. We would like to create a database of seeds in Japan and market them to overseas investors.
Makihara I believe that the analysis and response by each player based on the reflections of the coronary disaster has provided us with a step-by-step outlook for the next pandemic to come.
(Reprinted from an article in the Nikkei Electronic Edition)