Topics Report on BioJapan 2023
Opening Ceremony, Keynote Speech and Biopharmaceutical Committee Seminar

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BioJapan 2023 was held at Pacifico Yokohama (Yokohama City, Kanagawa Prefecture) from October 11 to 13, 2023. As in previous years, "regenerative medicine JAPAN 2023" and "healthTECH JAPAN 2023" were also held in conjunction with the event. 2023 "BioJapan" was the 25th anniversary of the event and attracted approximately 16,000 more visitors than in 2022, as well as a significant number of exhibitors to the exhibition, The number of participants in partnering reached a record high of approximately 2,700. In addition, unlike in 2022, the number of participants coming to Japan from overseas increased dramatically, energizing the venue. The Pharmaceutical Manufacturers Association of Japan (PMAJ) also participated as one of the sponsoring organizations, and many of its member companies made presentations, and many companies and organizations exhibited alliance booths, where they met with academia and venture companies to actively exchange information and interact.

Opening Ceremony and Keynote Speech

Following the opening address by Mr. Minoru Yoshida, Chairman of Bioindustry Association of Japan, on behalf of the organizers, there were congratulatory speeches in English by Mr. Yasutoshi Nishimura, Minister of Economy, Trade and Industry (via video), Mr. Akihisa Shiozaki, Parliamentary Secretary of Health, Labor and Welfare, Mr. Takahiro Kamiyama, Member of the Cabinet Office Council on Science, Technology and Innovation, Mr. Yuji Kuroiwa, Governor of Kanagawa Prefecture, and Mr. Takeharu Yamanaka, Mayor of Yokohama City. Mr. Takeharu Yamanaka, Mayor of Yokohama City, delivered congratulatory speeches in English. This was followed by the following four keynote speeches

Vice Chairman, Japan Business Federation
Chairman and Representative Director, DeNA
Ms. Tomoko Nanba *1

In her presentation, Ms. Namba pointed out that the number and quality of startups in Japan are still in their infancy, and that the lack of mobility of human resources in large companies has led to a decline in engagement and labor productivity, as well as hampered the development of excellent human resources. In large companies, the lack of mobility of human resources has led to a decline in engagement and labor productivity, and has also hindered the development of excellent human resources. On the other hand, he mentioned that DeNA continues to focus on developing human resources that can accelerate innovation in Japan as a whole, without enclosing them within the company, by introducing stretch assignments, a shake-hands system, and support for employee spin-outs, in order to increase employee motivation and support independence.

Chairman and CEO, Daiichi Sankyo Company, Limited
Mr. Jun Manabe *1

In his presentation, Mr. Manabe noted that many pharmaceutical companies have been providing pharmaceuticals with the mission of providing medicines that meet diverse medical needs, and that the industry has been redefined as Healthcare as a Service (HaaS) amid the demand for a shift in thinking from industrial capitalism to digital capitalism, It was shown that the industry is expected to become a total care platform provider by utilizing big data and digital technology along with the diversification of drug discovery modalities, and by developing a data linkage and sharing system centered on genetic testing and personalized medicine. In addition to the provision of health and medical solutions, it was also noted that in this era, measures to solve social issues with a focus on patients, as well as collaboration with various stakeholders, will become increasingly important. He concluded by stating that Daiichi Sankyo, in collaboration with its partners, has launched a project to build a total care ecosystem, and that in the coming era of HaaS, the company will contribute to the transformation of healthcare and the sustainability of society.

Biopharmaceutical Committee Seminar

Development of manufacturing bases for next-generation biopharmaceuticals: Efforts to develop human resources for biomanufacturing in industry, academia, and government

The Biopharmaceutical Committee of the Pharmaceutical Manufacturers Association of Japan has been holding seminars on topics related to biopharmaceutical manufacturing processes and infrastructure for the past several years, and the FY2023 seminar was held on October 12 under the title "Development of Manufacturing Bases for Next-Generation Biopharmaceuticals: Initiatives for Human Resource Development in Biomanufacturing in Industry, Academia, and Government. The seminar was held on October 12, 2023. The seminar was coordinated by Dr. Kazuhisa Uchida, Professor of the Graduate School of Science, Technology and Innovation, Kobe University, and featured four speakers, including a remote participant from overseas, and a wide range of discussions from the perspectives of government, academia, and industry.

Introduction to the Seminar

At the beginning of the session, Dr. Uchida introduced the over view of the session and stated that while new modalities such as next-generation biopharmaceuticals and mRNA vaccines are being developed, it is necessary to strengthen the production system by establishing manufacturing sites, securing personnel, improving process efficiency, and reducing risks. While a major investment promotion through the dual-use manufacturing base development project has been decided, it was indicated that in addition to the GMP manufacturing personnel required for facility operation, there are issues in training and securing CMC (Chemistry, Manufacturing and Control) development personnel. The purpose of this session was to discuss the future direction of biotech human resource development and recruitment.

Contents of each speaker's lecture

Mr. Takuro Hori, Assistant Director of Biochemical Industry Division (Biotechnology Division), Commerce and Service Group, Ministry of Economy, Trade and Industry (METI), gave a presentation on "Direction of Human Resource Development for Biopharmaceutical Manufacturing in Japan" and explained that the government has projects totaling 1.1 trillion yen not only for AI and semiconductors but also for biotechnology and that one of them, the dual-use program, is being implemented in the biotechnology industry. The government has a 1.1 trillion yen project for biotechnology as well as AI and semiconductors, and the institutions selected for the dual-use project will manufacture biopharmaceuticals during normal times and vaccines in case of emergency. For example, it takes one year for a manufacturing operator, three years for a manufacturing process manager, and 10 years for a manufacturing manager. He mentioned that not only the training program at the Biologics Research and Training Center (BCRET) and the GMP education and training course at the Tokyo University of Science, but also the use of facilities of pharmaceutical companies for training should be considered. He touched on the point of using the facilities of pharmaceutical companies, etc. for training. In closing, he said, "The dual-use project can produce a box, but securing the human resources necessary for manufacturing will come later. We would like to analyze why we cannot do so and discuss the necessary measures, including the identification of needs such as the need for tens of thousands of workers over a number of years, as in the case of semiconductors," he summarized.

Next, Mr. Hiroshi Murata, Vice President of Life Science Company, AGC Inc. spoke on "Acquisition and Training of Biomanufacturing Human Resources in CDMO Business Utilizing Global Network. At the beginning of his presentation, he expressed his sense of the challenges in acquiring and fostering manufacturing human resources in order to expand the business from Japan to overseas, and from 2020, to import back into Japan, aiming for a tri-polar standardized operation. To this end, the company is planning to secure management personnel, formulate a grand design from backcasting for facility operation, increase the number of operations personnel following lead personnel by hiring new graduates and outside the company, and conduct on-the-job training within the company and education at BCRET outside the company, as well as cooperation with other companies. We are planning to increase the number of operations personnel by recruiting new graduates outside the company. In Japan, in-house training is required, but in Germany, the national government provides students with company training through the dual system training, and the state provides vocational schools through the dual study program. In Japan, inhouse training is necessary, but in Germany, the national government provides students with company internships through dual system training, and the state provides vocational schools through the dual study program. He concluded by stating that Japan does not have such a social system, but that the Pharmaceutical Manufacturers Association of Japan (PMAJ) announced at its president's press conference in February (1) support for human resource development in biomanufacturing for immediate employment, (2) support for human resource development in biotechnology for students, and (3) support for human resource development through BCRET, and that industry-wide efforts to develop human resources are important.

Next, Hisatoshi Ito, General Manager of the First Department, Biotechnology Business Division of Fujifilm and Fujifilm Toyama Chemical, spoke on "Biopharmaceutical Manufacturing Human Resource Development: Fujifilm Toyama Chemical's Approach". The presence of biopharmaceuticals is increasing, and the contract drug development and manufacturing organization (CDMO) market is expanding accordingly. He also introduced the plan to import from FDB (FUJIFILM Diosynth Biotechnologies) to Toyama and install a classroom-centered facility (including a laboratory and GMP in the future) since there is no training box at present. Finally, he stated that the issue of human resource development can be coordinated by each company and organization.

In addition, the Business Development Manager of Ireland's NIBRT (National Institute for Bioprocessing Research and Training), which has been producing a bioprocessing talent pool of 4,500 people per year since 2011. Barry Shortt, Business Development Manager, NIBRT (National Institute for Bioprocessing Research and Training), Ireland, noted that Industry Training continues to contribute to the growth of biopharma globally and that funding from the Irish government will provide an additional 1,800 square meters of dedicated advanced medical space in November 2023, in addition to existing space. He also emphasized that Workforce Development and Solutions is responding to customer needs and virtual workforce development.

Summary

In the final panel discussion, the panelists discussed the following human resource development issues that need to be addressed in the future: measures to acquire human resources for CMC development and GMP manufacturing, points to keep in mind when developing human resources across biologics modalities, and expectations and requests to the organizations in charge of biotech human resource development. In terms of measures to acquire human resources, there was a need to increase the number of educational opportunities and the population, and in terms of human resource development across modalities, there was a need to visualize the image of human resources required in each modality, identify them, and then take measures. Regarding expectations and requests for institutions in charge of biotech human resource development, there was an opinion that human resource development is a collaborative area and that it should be considered to utilize not only BCRET but also external initiatives such as pharmaceutical associations, etc. The general consensus was that the direction to be pursued is the same globally. Mr. Uchida, the coordinator of the forum, pointed out that the need for human resource development is dispersed among industry, academia, and government, but that "it is frustrating that the discussions are not conducted in an integrated manner among the three parties," and that "quantitative and grand design presentations have not been made" regarding the human resources needed. He summarized that human resource development should be conducted across multiple industries and educational institutions, saying, "I hope that the government, which can look at the whole picture, will take the lead.

The next BioJapan 2024 is scheduled for October 9-11, 2024, at Pacifico Yokohama.

( Junko Tsukada, Director, Pharmaceutical Affairs and Biopharmaceuticals Department, and Yoshihiro Kaneko, Chairman, Policy and Working Committee, Biopharmaceuticals Committee)

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