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 a drug discovery ecosystem in the field of infectious diseases. Below is a transcript of the seminar.

Presentation 1

Furthermore, as a cross-cutting priority in the action plan, we are placing great emphasis on strengthening R&D through the promotion of digital transformation (DX).We want to expedite the creation of systems that enable the rapid sharing of information—such as electronic health records—and utilize it in clinical trials and other areas. As another key pillar, we are also 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 cover a wide range of diseases, not just COVID-19 and novel influenza. Along with revising 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: startup → fundraising from venture capital (VC) → product development → raising substantial capital through an initial public offering (IPO) → further development of expertise and talent cultivation → launch of 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 startups established in Japan is by no means small, the amount of investment per company stands at only 160 million yen in Japan, compared to 2.5 billion yen in the United States; it is difficult to believe 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 legal domicile, 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 academia is doing, and academia has not been able to fully transfer its research leads to these companies. Therefore, recognizing the importance of a system where academia, pharmaceutical companies, and relevant government agencies can develop new drugs through mutual commitment, 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 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 assuming a pandemic occurs once every ten years, we have already passed the halfway point of the period between pandemics.If Japan is to take the lead in deploying vaccines to its own country and neighboring nations during the next emergency, it will need an actual production capacity for hundreds of millions of doses—including the necessary budget—as well as a stable production system capable of supplying sufficient quantities of therapeutic drugs. To achieve this, we must discuss what preparations are needed during peacetime and share a concrete vision for how to respond swiftly when the time comes.

Panel Discussion

Kamoto: Even in the United States, spending during the preparation 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.—and establish numerous platforms and advance clinical trials in advance, 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 personnel 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 these resources, 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?

Sumii: Even during the current COVID-19 pandemic, while various frameworks such as special approvals and emergency approvals exist in the field of pharmaceutical regulations, there were instances where these were either implemented appropriately or 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, in the field of infectious disease R&D—where market forces are less effective—we need to seriously consider how JIHS can serve as a hub to facilitate collaboration between academia and industry, and specifically how to respond during the challenging initial stages.

Ueno: I believe the pharmaceutical industry can make a significant contribution to JIHS in terms of human resources. We can also share practical information to facilitate collaboration, such as ideas on how to commercialize research findings and 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 proceeded with analysis and response measures, 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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