Special Session Held at the “11th Nikkei-FT Infectious Diseases Conference” Establishing an Infectious Disease Drug Discovery Ecosystem: Moving Toward the Implementation Phase

January 9, 2025

On October 23, 2024, the JPMA held a special session at the “11th Nikkei-FT Infectious Diseases Conference.”The theme of this session was “Establishing an Infectious Disease Drug Discovery Ecosystem: Moving Toward the Implementation Phase,” and participants exchanged views from industry, academia, and government perspectives on the challenges and strategies necessary to establish such an ecosystem. Below is a transcript of the seminar.

Presentation 1

We also place great importance on strengthening R&D through the promotion of digital transformation (DX) as a key component of our action plan.We want to expedite the creation of systems to rapidly share information—such as electronic medical records—and utilize it in clinical trials and other contexts. Similarly, as another key pillar, we are focusing on building domestic and international networks and promoting human resource development; we expect the National Institute for Health Crisis Management (JIHS), to be established in April 2025, to play a major role in this effort.

Measures to combat infectious diseases must be designed to address a wide range of diseases, not just COVID-19 and novel influenza. Along with a review of the list of priority infectious diseases, we plan to review the action plan every six years and conduct annual follow-ups to ensure its effectiveness.

Presentation 2

In a venture ecosystem, the ideal scenario is a virtuous cycle: founding a company → raising funds from venture capital (VC) → developing a product → securing substantial capital through an initial public offering (IPO) → further developing expertise and nurturing talent → founding new ventures. However, such a virtuous cycle is difficult to achieve in Japan. One reason is the scale of funding.While the number of biotech ventures established in Japan is by no means small, the amount invested per company stands at only 160 million yen in Japan, compared to 2.5 billion yen in the United States; it is unlikely that sufficient funds can be secured to sustain the ecosystem.

Furthermore, it is difficult for Japanese biotech ventures to compete globally even if they conduct clinical trials and obtain approval solely within Japan. We have supported cases where Japanese ventures changed their nationality, established a parent company in the U.S., raised funds from U.S. venture capital firms, and advanced their businesses. We would like to highlight this as a means for Japanese companies to spread their wings globally.

Presentation 3

Underlying this are the unstable employment environment for researchers in academia, evaluation criteria that prioritize publications, the heavy workload resulting from balancing research and teaching duties, and a lack of research funding; as a result, the number of PhD graduates remains low compared to Europe, the United States, and China.

However, the most serious issue is the gap between pharmaceutical companies and academia.Pharmaceutical companies do not have a clear enough picture of what the academic community is doing, and the academic community has not been able to fully transfer promising research leads to these companies. Therefore, recognizing the importance of a framework that enables new drug development through mutual commitment among the academic community, pharmaceutical companies, and relevant government agencies, we proposed the establishment of a consortium where opinions can be freely exchanged.We have already held meetings to exchange views with basic researchers and the Japan Pharmaceutical Manufacturers Association, as well as with the international partnership to combat drug-resistant bacteria (CARB-X), and are deepening our collaboration.

Presentation 4

Meanwhile, the pharmaceutical industry aims to strengthen investment in academia and startups, while also promoting the training and education of drug discovery talent and raising public awareness.Furthermore, in the field of infectious diseases, we will advance research and development and investment in collaboration with domestic and international organizations, including by contributing to the establishment of an Action Fund for Antimicrobial Resistance (AMR) that aims to bring two to four new antimicrobial agents to market by 2030.

Five years have already passed since the onset of the COVID-19 pandemic, and if pandemics occur once every ten years, we have already passed the halfway point of the period between pandemics.If Japan is to take the lead in distributing vaccines to its own country and neighboring nations during the next emergency, it will need an actual production capacity sufficient for hundreds of millions of people—including the necessary budget—as well as a stable production system capable of supplying adequate quantities of therapeutic drugs. To achieve this, we must discuss in advance what preparations are needed and share a concrete vision for how to act swiftly when the time comes.

Panel Discussion

Kamoto: Even in the United States, spending during the preparatory phase prior to a pandemic accounts for only 1% of the infectious disease response budget.The majority is spent after an outbreak occurs, and R&D during the preparation and initial response phases relies heavily on private funding. If Japanese startups were to attract overseas funding—such as from the U.S.—in advance, establish numerous platforms, and proceed with clinical trials, they could then make use of a large budget and get off to a flying start when the initial response phase actually begins.

Ueno: To enhance our ability to respond quickly, we need to draw up a blueprint outlining how much funding will be required during the initial response phase and who the key members involved will be.Furthermore, while it has been pointed out that academia, startups, and corporations lack a clear understanding of what each other possesses, I believe that centralizing and consolidating this information, as well as matching research leads with technologies, will be one of the major roles of the JIHS during its preparatory phase.
 

Making JIHS a Hub for Collaboration

Makihara 　As academia and industry work together to build a process for sharing information and confronting crises, isn’t it the government’s role to press the “start” button?

Sumimi: Even during the current COVID-19 pandemic, while various frameworks exist in the field of pharmaceutical regulations—such as special approvals and emergency approvals—there were instances where these were implemented appropriately and others where they were not fully utilized. We want to ensure we are thoroughly prepared so that we can implement such measures without hesitation in the event of a crisis.Furthermore, regarding R&D in the field of infectious diseases—where market mechanisms tend to be less effective—we need to seriously consider how JIHS can serve as a hub to facilitate collaboration between academia and industry, particularly how to respond during the challenging initial stages.

Ueno: I believe the pharmaceutical industry can make a human resource contribution to JIHS. We can also share practical information to facilitate collaboration, such as ideas on how to commercialize research leads and details regarding the costs and time required to establish production systems.

Kamoto: The government’s current measures, aimed at strengthening the drug discovery venture ecosystem, are among the fastest in the world. Combined with Japan’s advanced science and technology, I believe we have every reason to be confident. We intend to create a database of research leads in Japan and promote them to overseas investors.

Makihara: Based on lessons learned from the COVID-19 pandemic, as various stakeholders have conducted analyses and taken action, I believe we have taken a step forward in developing a vision for the next pandemic.
 

(Reprinted from an article in the Nikkei Electronic Edition)

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