Topics Special program held at the 8th Nikkei-FT Conference on Infectious Diseases Preparing for emerging and re-emerging infectious diseases, including drug-resistant bacteria - Unknown threats, a national response

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The preparation for emerging and reemerging infectious diseases, including drug-resistant (AMR) bacteria, is extremely important not only for the health of the public, but also from the perspective of national security and diplomacy. Key persons from industry, academia, and government specializing in infectious diseases gathered. Based on national strategies, case studies from the field, and recommendations from the drug discovery side, the participants discussed a wide range of preparedness for infectious diseases, including AMR. The importance of a command post was pointed out in the creation of a system to look not only at medical care but also at society as a whole and to realize rapid development of vaccines and therapeutics through research into new modalities (therapeutic means). The following is a transcript of the meeting.

Fig. 1 Strategy for Strengthening Vaccine Development and Production System (Overview)
*Japanese document provided by Dr. Atsuo Yagami

In 2009, a new strain of influenza became an issue, but the coronary disaster followed without progress in research and development of vaccines for other infectious diseases or new modalities. While the immediate response to coronas is of course important, the same thing could happen again 10 years from now if we are not prepared for new threats in addition to the immediate response to coronas. The strategy of this year's meeting is to prepare for possible future pandemics from normal times. One is to strengthen research and development, including the commercialization of mRNA and new modalities, and the development of vaccine prototypes against viruses that could cause a pandemic or mutate. To this end, we will establish a world-class research and development center for infectious diseases and vaccines, and strengthen the funding function to gather information on the status of research and development in Japan and abroad and strategically allocate research funds.

Although 80% of the world's new drugs originate from venture companies such as Biontec and Moderna, drug discovery ventures are not fully developed in Japan. Japan does not have enough drug discovery ventures. Support for venture research and development is also necessary. In the area of vaccine production, support should be provided for the development of dual-use facilities that can produce vaccines in times of emergency and other biopharmaceuticals in times of peace.

Investment in the development and production of vaccines in Japan will pay back double or triple in the future in the form of improved R&D capabilities, job creation, increased tax revenues, and international contributions.

The G7, led by the United Kingdom and the United States, is envisioning a strategy to develop vaccines against infectious diseases that could cause a new pandemic in 100 days. If Japan misses this trend, it will become a vaccine-backward country, and we need to work with a sense of urgency.

Fig. 2 Leading Driving Force for AMR R&D by AMED
*Japanese material provided by Dr. Katsufumi Shiro

The mission of the newly established Strategic Center for Advanced Research and Development (SCARDA), to be established in the spring of 2010, is to "strategically allocate research funds through contingencies and peacetime in order to provide effective, safe, and practical vaccines as quickly as possible. To realize this, the Preparatory Office conducted interviews with more than 20 top executives from academia and pharmaceutical companies. The roles and functions required of the Center's Director and Provost, information gathering methods, strategic fund allocation mechanisms, and specific operational methods are being studied.

The three main functions of SCARDA envisioned at this time are (1) a broad intelligence function, (2) a strategic decision-making function, and (3) a flexible funding function. First, a mechanism is needed to enable research to be initiated promptly in times of emergency, which requires (3) agile funding. For this purpose, it is necessary to strategically determine where and how much funds will be allocated even in normal times, and to publicize this information as a funding policy, which requires strategic decision-making as described in (2). As a prerequisite for this, the network should be established with overseas institutions, etc., to collect information on outbreak trends and global development trends, etc., as described in (1). Strategic research and development efforts are to prepare in this manner from normal times and operate a system that can quickly launch a development project in an emergency.

This is an example of successful government-led strategic promotion, but the case of AMR countermeasures is different from that of vaccines. While vaccines can be manufactured and sold in large quantities if R&D is successful, and there is a mechanism for the government to buy them up, which has led to expectations of marketability, antibacterial drugs for AMR control cannot be aggressively marketed to recover funds even if product development is successful, and there is no mechanism for the government to buy up such drugs.

How to ensure marketability and profitability in these areas? As with vaccines, strategic thinking is needed, but this is not the role of the government alone.

Fig. 3 Metallo-β-lactamase
*Japanese-language materials provided by Yohei Doi

We have also experienced a case of a patient with a new type of corona infection who was also infected with the fungus Mucor due to weakened resistance caused by the immunosuppressive drugs used in treatment. Mucor infections are rare in healthy individuals, but when they do occur, the mortality rate is estimated to be as high as 50%. Many of you may remember the Mucor fungus that raged in India in the spring of 2009. The problem with these fungi is that they are also becoming resistant.

While industry, government, and academia are working together globally to promote the development of new antimicrobials for AMR infections, the question of how to ensure continued access to antimicrobials has only just begun to be addressed. We hope that each country will introduce specific initiatives, such as a subscription model, to support the entire antimicrobial product cycle.

Fig. 4 Necessity of an overall strategy for crisis management
*Japanese-language materials provided by: Yasushi Okada, Chairman

We in the pharmaceutical industry have an obligation to respond to the expectations contained in the G7's 100-day strategy and the Japanese government's strategy to strengthen the vaccine development and production system. In preparation for the next pandemic, we will work to develop vaccines and therapeutics by acting as a hub for partnerships between industry, government, and academia, without being constrained by existing frameworks.

Panel Discussion

A command post is indispensable for strategy implementation.

Devise ways to support antimicrobial drug development

Mr. Shindo In September 2009, the Ministry of Health, Labour and Welfare (MHLW) released the "Pharmaceutical Industry Vision 2021. This is the first revision in eight years and serves as a guideline for mid- to long-term pharmaceutical industry policy. Noteworthy is the inclusion of the themes of "stable supply of contingency pharmaceuticals" and "fostering the vaccine and infectious disease therapeutic agent industries" as economic security issues. I would like to hear the key points, scope and priorities in addressing these issues.

Mr. Doi: As someone involved in universities and research institutes, I am concerned about the difficulty of human resource development. With the declining birth rate, the number of students who go on to study infectious diseases continues to decline. It is a very exciting field and one that can contribute to society. Furthermore, we need to show that it is also a career in which one can build a secure career.

In terms of the development of new antimicrobial agents for AMR, a major problem is that pharmaceutical companies do not see a return on their investment. If new antimicrobial agents are used, resistant strains to them will be created. Therefore, their use should be kept to a minimum, but this is a headache for pharmaceutical companies that are concerned about profitability.

In the United States, the Biomedical Advanced Research and Development Authority (BARDA) supports pharmaceutical companies by purchasing new antimicrobials in the form of a stockpile in case of anthrax or other bioterrorism. In the U.K., the National Health Service (NHS) is planning to adopt a subscription model, in which a fixed fee is paid for the right to use a drug for a certain period of time. They are creating a system whereby pharmaceutical companies receive remuneration regardless of the amount of antimicrobials used.

Mr. Shiro: Pharmaceuticals are meaningless unless they are released to the market. It is important to clarify what is to be launched and by when, and to take measures to accomplish this in the fastest possible time. This is another strong statement of the government's intention, as are the cabinet decisions and strategies in other fields such as dementia and cancer.

Just because a cabinet decision has been made on vaccines does not mean that only vaccines should be promoted. What is needed in the clinical field are therapeutic drugs, and research on these starts from the same place as a modality.

First of all, for example, it is necessary to establish a mechanism to introduce seeds, even from overseas, for prompt development and supply of vaccines and therapeutic drugs in case of emergency, and it is also necessary to establish a mechanism to foster and support domestic seeds from normal times to prevent this from happening.

I believe that our priority should be to achieve both of these goals as soon as possible.

Mr. Shindo: I agree with the idea of removing the vertical categories of vaccines and therapeutics and developing them horizontally with free thinking. As for seeds, I think the government should also play a role in fostering drug discovery ventures.

Mr. Yagami: In order to make the strategy to strengthen the vaccine development and production system actually work, the most important thing is to be prepared from normal times. Of course, the most pressing issue at the moment is the response to the new coronary disease, but we must not put off efforts to deal with the next crisis.

Economic security was mentioned, but relying on foreign countries for vaccines is still a risk when considering securing the necessary quantities, negotiating prices, and transportation. Investing in development and production in Japan will strengthen R&D capabilities, and building and operating production plants will create jobs, economic growth, and increased tax revenues. It is important to create a system that creates such a positive cycle. It is also important to develop human resources, such as researchers of infectious diseases, as you mentioned, and we will also work to nurture venture businesses.

Breakthrough without relying on other countries

Mr. Shindo: Securing a production line only for emergencies is a hurdle for companies that need to be profitable. Surge capacity to be activated in an emergency should be converted to core capacity in peacetime. Without such a system, companies will not be able to run their businesses. We would like to hear the opinions of the industry associations of pharmaceutical companies.

Chairman Okada: When we consider the vaccine strategy from the perspective of economic security, there are two perspectives: "to overcome the situation at home without depending on other countries in a crisis" and "to become a world leader by taking advantage of strengths that only the country can have. However, in the recent pandemic, even countries that had prepared for the pandemic from peacetime were in turmoil, and Japan was completely unprepared.

In view of this situation, Japan's first priority should be the former, which is how to develop and manufacture vaccines in Japan. Japan, however, has fewer patients with infectious diseases than the rest of the world and has not been active in this area. The number of infectious disease researchers is small, and Japan has few Biosafety Level 4 (BSL4) facilities that are capable of research on specific pathogens with high toxicity.

We recognize that we are lagging behind the rest of the world when it comes to infectious diseases, including AMR. Therefore, with regard to the development of vaccines for infectious diseases, it is necessary for pharmaceutical companies to come together under a vaccine strategy approved by the Cabinet and work beyond the boundaries of the companies, rather than the traditional form of government support to companies that are developing vaccines on their own initiative. For this to happen, the existence of a command post with strong authority and responsibility is indispensable, and the construction of an internationally competitive drug discovery ecosystem is critical.

At the same time, pharmaceutical companies are working to develop new antimicrobial agents that address AMR. Volunteer pharmaceutical companies affiliated with the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) have established the AMR Action Fund, which provides funding, know-how, and other support to bio ventures that are developing antimicrobial agents effective against resistant bacteria designated as targets by the WHO and other organizations.

Mr. Shindo Many opinions were raised.

First, "With regard to the economic security strategy, the strategy to strengthen the vaccine development and production system, which was approved by the Cabinet, must be put into practice without fail. In addition, it is necessary to establish a comprehensive strategy by expanding the scope of efforts to include therapeutic and diagnostic drugs. Secondly, "In order to implement the strategy, a command post with sufficient responsibility and authority is necessary, rather than simply acting as a coordinator and performing a cross-skewering function. Third, "understand that AMR could be the next threat of novel coronavirus infection ( Fig. 5 ), and work on its countermeasures through collaboration and cooperation among industry, academia, and government under the Action Plan for AMR Countermeasures. And fourth, "human resource development and the fostering of bio ventures. I would like to summarize these four points.

Fig. 5 Projected deaths by AMR in 2050

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