Biopharmaceuticals Committee
Interview with Dr. Kuraczar, Chairman, Biopharmaceuticals Committee

The mission of the Biopharmaceuticals Committee is to promote the development of an environmental infrastructure for the creation of all innovative biopharmaceuticals, including preventive vaccines, therapeutic vaccines, regenerative medicine/cell therapy, and gene therapy, in addition to recombinant and cell culture protein pharmaceuticals. To this end, we conduct extensive research on issues ranging from research and development to production and post-marketing activities, and make policy recommendations and other proposals.

In the course of these activities, one of the major issues we recognize is the "human resource development" of biopharmaceuticals in Japan. In particular, there is a critical shortage of human resources not only for manufacturing, but also for those who are responsible for the "back end" of the drug discovery process, that is, for linking promising seeds discovered in academia to products. Specifically, there is a wide range of areas including process design, manufacturing method development, test method development, personnel to build quality assurance for the entire process, and even specialized personnel who can handle domestic and international regulatory filings.

With support from the Ministry of Economy, Trade and Industry (METI), large-scale capital investment is underway to enable the switch to vaccine production in the event of an emergency. However, even when the facilities are ready to go into operation, there are not enough "people" to operate them. Solving this structural problem is our urgent task.

To address this shortage of human resources, we are taking concrete steps along two axes. The first is the "development of biomanufacturing personnel who can be immediately effective. In anticipation of the launch of domestic manufacturing infrastructure in the next few years, we have already begun a practical educational program that utilizes actual production facilities owned by pharmaceutical companies to train young personnel from other companies. The Biologics Center for Research and Training (BCRET), a general incorporated association, is taking the role of coordinator of this initiative and is working in cooperation with the Ministry of Health, Labour and Welfare (MHLW).

The second is "educational support for future biomanufacturers," which is designed to create opportunities for students to learn about biopharmaceutical production five to ten years from now, and to provide them with opportunities to become aware of the appeal of biopharmaceutical production to students who have difficulty imagining development and production sites as potential employment opportunities due to lack of learning opportunities in this field. This human resource development support program is designed to provide students with opportunities to learn about biopharmaceutical production.

This human resource development support program is a challenge to expand the base of the Japanese biopharmaceutical industry as a whole, beyond the benefit of individual companies. The more domestic human resources we have, the more we will be able to complete manufacturing in Japan without having to outsource overseas, which in turn will lead to increased international competitiveness. The Ministry of Economy, Trade and Industry (METI) estimates that 1,000 biopharmaceutical workers need to be trained by 2030, and we will support the efforts of each company to achieve this goal.

In parallel with human resource development, we are also engaged in more specialized surveys and research to raise the level of the drug discovery environment. For example, we are examining measures to support start-ups by strengthening cooperation between industry, academia, and government, researching what should be included in applications for approval of new drugs, and holding monthly working-level discussions with the PMDA and related organizations on issues related to the regulation of regenerative medicine products.

Another important pillar of our activities is the "resolution of issues related to vaccines. In light of the issues that have emerged after the new coronas and the shrinking market for routine childhood vaccinations due to the declining birthrate, there is an urgent need for companies to make stable and continuous investments in facilities and establish a system to ensure a stable supply of vaccines in Japan. In addition, the current system does not provide sufficient incentives to encourage research and development of high value-added vaccines using new technologies. To this end, it is essential to increase market predictability by promptly incorporating vaccines with high development priority into the routine vaccination program, and to support the development of a supply system to ensure stable supply and improve productivity.

It is also necessary to actively promote the concept of "life course immunization" in Japan, in which all people are vaccinated at appropriate times throughout their lives according to their individual risk of infectious diseases. Under the current framework of the Immunization Law, the current Class B routine immunization and voluntary immunization vaccines impose a heavy burden on local governments and vaccine recipients, among other issues. For example, while many G7 countries provide the new corona vaccine to the recommended age group free of charge, Japan has shifted to a system that requires a partial co-payment. It has been pointed out that this increase in co-payment may lead to a decline in the vaccination rate. In order to create a sustainable environment in which the public can receive vaccinations with peace of mind, we are proposing to strengthen the vaccine industry infrastructure and reform the vaccination business.

We believe it is important to always have a global perspective: Japan has high potential in areas such as iPS cells and regenerative medicine, but we must always look overseas as a benchmark and develop a world-class infrastructure.

The human resource development support program we have initiated is a "spark" for this purpose. I am convinced that the way to enhance the value of Japan's biopharmaceutical industry is to create a "positive cycle" in which human resources are nurtured, the industry is revitalized, and new human resources are attracted to the industry. We believe that the Japanese biopharmaceutical industry can achieve a future in which it leads the world by working together as an industry to ensure that this trend is not halted.

The structure and activities of the Biopharmaceutical Committee are posted on the website of the Pharmaceutical Manufacturers Association of Japan (PMAJ). Please visit the site.

Biopharmaceuticals Committee Website]
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