Special Session at the "12th Nikkei-FT Conference on Infectious Diseases ~The 11th Nikkei-FT Conference on Infectious Diseases held
On October 7, 2025, a special session of the Pharmaceutical Manufacturers Association of Japan (PMAJ) was held at the "12th Nikkei-FT Conference on Infectious Diseases". The theme of this session was "Toward Securing Crisis-Response Medicines and Other Products for Infectious Diseases (MCM*)," and discussions were held from the viewpoints of industry, academia, and government on the importance of strengthening the research infrastructure in the field of infectious diseases, especially human resource development and improving business predictability, which are essential for continuing MCM research and development.
-
The discussion was focused on the importance of strengthening the research infrastructure in the field of infectious diseases, particularly human resource development and improving the predictability of projects.Medical Countermeasures
Special Sessions
Lecture 1: Efforts to Improve Drug Discovery Capability and Vaccine Strategy and its Review
Mr. Naoya Horiuchi, Counselor, Secretariat for Health and Medical Strategy, Cabinet Office, Government of Japan
The turning point brought by the pandemic
The pandemic of the new coronavirus infection brought about a major turning point in Japan's infectious disease countermeasures. The country experienced a situation in which it had to compete with other countries to secure vaccines produced overseas, and it became strongly recognized that vaccines are important not only for maintaining the health of the Japanese people, but also from the perspective of diplomacy and national security. In response to these challenges, the Vaccine Strategy was formulated as a national strategy that should be addressed on a long-term and continuous basis, and is currently being revised into the MCM Strategy.
Challenges in Countermeasures against Infectious Diseases
Various issues have been highlighted in the fight against infectious diseases, including the lack of research resources and allocation of research funds, the lack of experience in clinical trials required for the development of new infectious disease vaccines, as well as difficulties in investment in terms of manufacturing, the fragility of the domestic vaccine industry, and the unpredictability of the return on investment. These issues are not limited to vaccines, but are common to all therapeutic and diagnostic agents for infectious diseases.
Promotion of Policies to Solve Issues
To resolve these issues, a multifaceted policy is being promoted, including the formation of R&D centers in academia, strengthening of funding functions, improvement and expansion of the clinical trial environment, speeding up the pharmaceutical affairs process, development of manufacturing bases, fostering venture companies, promotion of the vaccine industry, and strengthening of international cooperation and monitoring. Strategic initiatives include the establishment of a system for large-scale clinical trials, the development of an urgent approval system, and the strengthening of manufacturing bases, and the system must continue to be enhanced.
Importance of Vaccines, Therapeutics, and Diagnostics
Even if a vaccine is developed, infectious disease outbreaks themselves do not disappear, and when they do occur, therapeutic drugs are needed, and rapid diagnosis is also important for this purpose. Some therapeutic agents, such as influenza drugs, have been approved for prophylactic administration, and in recent years, antibody drugs and small molecule drugs have also been developed for long-term prophylactic efficacy. The fact that the boundary between vaccines and prophylactic drugs is disappearing is also an important issue for MCM strategies. Currently, a review of the vaccine strategy and expansion of support for therapeutic and diagnostic agents are underway. At the Infectious Disease Council, the Ministry of Health, Labor and Welfare and the Ministry of Education, Culture, Sports, Science and Technology have reported on the status of their discussions, and discussions are underway for the revision of the MCM strategy by the end of the fiscal year.
Future Prospects
Infectious disease countermeasures cannot be solved by a single ministry alone. It is important for ministries, academia, and industry to collaborate and share issues in peacetime and in contingencies, and through the revision of the strategy, appropriately secure MCM from Japan in preparation for the next infectious disease contingency. We will continue to contribute to securing national and international health and hygiene.
Lecture 2: Toward Securing Critical Care Medicines for Infectious Diseases (MCMs)
Center for Advanced Research and Development Strategies (SCARDA), Japan Agency for Medical Research and Development (AMED)
Provost Masayuki Yuda
SCARDA is promoting two projects that are particularly important among the nine pillars of the strategy to strengthen the vaccine development and production system: the formation of world-class R&D centers and the enhancement of strategic research funding functions.
Project to Form a World-Class Research and Development Center
Centered on the flagship center, the University of Tokyo, together with synergy centers (Hokkaido University, Osaka University, Chiba University, and Nagasaki University) and support institutions for research support, we are strengthening our research infrastructure by promoting innovative research and development, practical application through industry-government-academia collaboration in vaccine research and the field, and also by focusing on human resource development. Each center handles a diverse range of viruses, and cutting-edge virus research is underway. Among these, eight projects have been selected for public solicitation for new modalities and are moving toward practical application. Notable achievements include the recognition of a virus isolated by Hokkaido University as one of the World Health Organization's candidate strains for vaccines.
Research and development of new vaccine modalities
In preparation for future pandemics, we are supporting research and development incorporating new modalities from ordinary times and promoting three open call frameworks with the aim of delivering vaccines that are safe and effective against infectious disease contingencies and that can contribute internationally, both domestically and internationally.
-
Support for vaccine development up to Phase 2 for eight priority infectious diseases decided by the government: 10 issues
-
Support for new modalities that can be applied to priority infectious diseases up to Phase 1: 12 projects
-
New modalities to obtain Proof of Concept (POC) in animal studies: 21 projects
Within these frameworks, we also provide support for non-clinical trials and carrier technologies to encourage participation from researchers outside the vaccine field.
Research and Medical Strategy for the Third Phase
In addition to vaccines, we intend to expand the areas of therapeutic drugs and diagnostics. While the R&D environment for practical application of therapeutic drugs in Japan remains challenging, we recognize the need to revitalize the industry as a whole, develop human resources, and strengthen the procurement system in Japan. In addition, we experienced delays in R&D during the development of the coronavirus vaccine due to difficulties in obtaining reagents and materials made overseas, and we believe it is important to establish a system that enables procurement in Japan as much as possible in the future.
Finally, we have identified the following expectations and challenges for MCM R&D.
- As for the promotion of early participation by companies and the need for support for such participation, while there are only a limited number of companies in Japan that are conducting research and development of drugs for infectious diseases, many drugs for infectious diseases, like vaccines, are in low demand in normal times, so there are barriers to participation by companies, and pull-type incentives should be offered from the development stage, for example. Therefore, it is necessary to strengthen the industrial infrastructure in addition to creating an environment that facilitates corporate participation in development, such as by offering pull-type incentives from the development stage.
- In order to ensure the sustainability of R&D, it is important to strengthen the strength of domestic industry, which is responsible for R&D and production of infectious disease drugs, as well as vaccines, and to develop human resources. In addition, since it is difficult to recover R&D investment in infectious disease drugs, it is essential to have R&D incentives and a mechanism to ensure profitability. All Japan should provide support from basic research to ensuring profitability after commercialization, with an eye on exit strategies.
Lecture 3: Toward securing crisis medicine (MCM) for infectious diseases
Asuka Miyahashira, Chairman, Japan Pharmaceutical Manufacturers Association, Inc.
Appreciation for those involved in public health in Japan and the role of the pharmaceutical industry
Public health in Japan is supported by the efforts of many predecessors and the field. The efforts of our predecessors and the dedication of all participants in the Nikkei-FT Infectious Disease Conference who are currently working to protect public health are the foundation of public health in Japan. The concept of "fūyō fūdō" is one of respecting traditions and values while incorporating new ones in response to changing times and circumstances. In this spirit, we are expected to contribute to public health in Japan and around the world through the creation of innovative new drugs on the foundation of public health built by our predecessors.
Past Contributions and Challenges of the Pharmaceutical Industry
The pharmaceutical industry not only extends the healthy life expectancy of the public through a stable supply of medicines, but also contributes to society through economic development, job creation, and tax payment. In addition, companies have saved many lives through the creation of innovative drugs such as vaccines and antibacterial agents. On the other hand, Japan's drug discovery capability is on the decline, and the number of drugs developed in the field of infectious diseases is considered low compared to the rest of the world. Factors contributing to this trend include low market predictability, the impact of policy changes, and economic security risks due to changes in international conditions, all of which make it difficult for companies to make investment decisions. Infectious diseases are an area of high volatility, as it is difficult to predict the timing of outbreaks, types of viruses, and the scale of epidemics.
Importance of Co-creation (Co-creation)
These issues cannot be solved by the pharmaceutical industry alone. It is essential to make progress toward solving common issues through dialogue with a wide range of stakeholders, including the public, patients, government, and researchers. It is important to deepen mutual understanding and engage in value co-creation, and I believe that co-creation through concerted efforts is crucial in the area of infectious diseases.
Improvement of Business Potential of Therapeutic Products for Infectious Diseases and Activation of Human Resource Development
In the area of infectious diseases, national strategies also have a significant impact. Demand for infectious disease drugs is low during normal times, making it difficult for companies to secure business feasibility, and companies also bear the risk of storing and disposing of excess inventory. Furthermore, in the event of a contingency, a sharp increase in global demand will cause a struggle for resources, threatening a stable supply. This is why it is essential to develop a domestic supply system and guarantee business predictability through pull-type incentives. This will make it easier for companies to make investment decisions in R&D and production. In addition, the declining attractiveness of the market is causing uncertainty in the career development of researchers, creating a vicious cycle of declining numbers of antimicrobial researchers. The Pharmaceutical Manufacturers Association of Japan (PMAJ) is working to improve the attractiveness of R&D in the field of infectious diseases by strengthening cooperation with academia and experts and contributing to the development of research personnel.
Future Prospects
Through preparedness from normal times, ensuring business predictability, and attracting and fostering human resources, we will promote value co-creation through industry-academia-government collaboration to protect public health in Japan and society from the threat of infectious diseases, and the Pharmaceutical Manufacturers Association of Japan is committed to contributing to this effort.
Panel Discussion
Moderator: Dr. Yui Kono, Manager, Health Policy Institute of Japan (HGPI)
Panelists Mr. Naoya Horiuchi, Mr. Masayuki Yuda, Ms. Asuka Miyahashira, Chairman
Mr. Kono
I would like to know two points as follows.
-
What is the importance of co-creation in terms of countermeasures against infectious diseases and securing therapeutic drugs?
-
As an example of a new initiative, you mentioned pathogen transport simulation. What specific actions are being taken to promote such new challenges in the future, difficulties in implementing them, and cooperation with local governments?
Mr. Horiuchi
-
Importance of Co-creation
Drug development requires diverse technologies and human resources, and it is important to have a system that does not rely solely on inventors. Involvement of diverse players from the early stage will increase the efficiency of practical application.
In the field of infectious diseases, business predictability and profitability are low, and value creation through international expansion as well as government support is required. In the field of vaccines, in particular, the delay in international expansion to deliver products to where there is demand is a challenge. -
(Pathogen transport) simulation efforts
There are diverse stages, processes, and parties involved in research and development. Based on this, we intend to conduct necessary simulations appropriately in the future.
Mr. Yabuta
-
Challenges in human resource development
The number of researchers in the field of infectious diseases continues to decline worldwide, and it is essential to revitalize industry and academia in order to continue. Under such circumstances, the number of researchers funded by SCARDA in the field of vaccines has been increasing, albeit gradually, and progress is being made in the move toward practical application. We would like to expand these developments to therapeutics and diagnostics.
-
Promotion of public understanding in implementing new initiatives
It is important for the public to understand the importance of infectious diseases.
We would like to deepen understanding of the importance of infectious diseases and vaccines through science-based (science-based) dialogue.
Chairman, Miyahashira
-
Co-creation and expectations from an industrial perspective
Government measures are essential, and we expect strategic expansion into therapeutic and diagnostic drugs.
Project predictability, pull-type incentives, and human resource development are particularly important, and industry, academia, and government must work together. -
National Strategy and Co-creation Philosophy
National strategies are key in the area of infectious diseases.
We hope to achieve better medical care and public health through collaboration between industry, academia, and government, and through drug discovery with the participation of patients and citizens.
Mr. Kono
(Question to Chairperson Miyabashira) Compared to oncology and neurology, how should we promote co-creation in the area of drug resistance and other infectious diseases, where it is difficult to create patient/stakeholder groups?
Chairman, Miyahashira
Expectations for Co-creation by Industry-Academia-Government + Citizens
We would appreciate it if industry, academia, and government could engage in dialogue for co-creation.
In the future, I hope that MCM will be added to the Co-creation process, and that it will be expanded to include not only vaccines but also therapeutic drugs.
We would like to promote sustainable contributions through dialogue, and work together as an All-Japan team to address the issues of pull-type incentives and human resource development.
Oncology business is relatively easy to predict, but the infectious disease field is difficult.
As someone involved in the oncology and neurology fields, I know that in the infectious disease field, national strategies for public health and infectious disease control are important, but since companies cannot participate on their own, each stakeholder must be involved in the overall strategy and co-creation is always necessary.
Co-creation with the participation of patients and citizens is also necessary, and we would like to build a better environment for medical care and public health that should exist.
Mr. Kono
The day after tomorrow, October 9, 2025, the Infectious Disease Council will also meet. We would like to contribute to better countermeasures against infectious diseases by having industry, academia, government, and the private sector play their respective roles and co-create.
(International Committee/Industrial Policy Committee Nikkei-FT Infectious Disease Council Task Force)
