Report on BioJapan 2024 Opening Ceremony, Keynote Speech and Biopharmaceutical Committee Seminar
BioJapan 2024 was held at Pacifico Yokohama for three days from October 9 (Wed.) to 11 (Fri.), 2024. As in previous years, "Regenerative Medicine JAPAN 2024" and "healthTECH JAPAN 2024" were also held at the same time. As in 2023, the exhibition was energized by the large number of participants from overseas who came to Japan. Many companies and organizations exhibited alliance booths and held meetings with academia and venture companies.
Opening Ceremony and Keynote Speech
After the opening remarks by Mr. Minoru Yoshida, Chairman of BioJapan Organizing Committee, Mr. Ryo Minami, Deputy Director-General for Commerce and Services, METI; Mr. Hiroyuki Uchiyama, Deputy Director-General for Pharmaceutical Industry Promotion and Medical Information, Minister's Secretariat, MHLW; Mr. Shigekazu Matsuura, Deputy Director-General (Research Promotion Bureau and Higher Education Policy Coordination), Minister's Secretariat, MEXT; Mr. Yuji Kuroiwa, Governor, Kanagawa Pref. Mr. Yuji Kuroiwa, Governor of Kanagawa Prefecture, and others delivered congratulatory speeches.
Opening Ceremony
The keynote speeches were "The challenge of creating innovation: Clinical development and practical application of viral therapies" by Dr. Tomonori Todo, Professor, Division of Advanced Cancer Therapy, Institute of Medical Science, University of Tokyo / Department of Brain Tumor Surgery, University of Tokyo Hospital, Institute of Medical Science; "Toward strengthening Japan's drug discovery capabilities" by Dr. Hiroaki Ueno, Chairman, Japan Pharmaceutical Manufacturers Association (JPMA); and "Laying the foundations for a cancer innovation ecosystem. foundations for a cancer innovation ecosystem" by Dr. Iain Foulkes, Executive Director, Research and Innovation, Cancer Research UK: CEO Cancer Research Horizons. Iain Foulkes, Executive Director, Research and Innovation, Cancer Research UK: CEO, Cancer Research Horizons).
In his speech, Dr. Ueno, Chairman of the Pharmaceutical Manufacturers Association of Japan (PMAJ), first mentioned changes in the environment surrounding the pharmaceutical industry, such as changes in unmet medical needs, diversification of drug discovery modalities, borderless market, and progress in digital transformation (DX), and for the changes in drug discovery methods associated with these environmental changes, The importance of combining elemental technologies and the need for a drug discovery ecosystem in which multiple players collaborate were also discussed. He then presented the current status of drug discovery ecosystems around the world, citing examples from Boston, USA, and London, UK, as well as the current status of drug discovery/biotech clusters and bio-communities in Japan, and pointed out that Japan needs to establish a drug discovery ecosystem that is appropriate for its own country and that it is necessary to establish a mechanism to bring together the bio-clusters in each region to the next level. He also mentioned that Japan needs to build a drug discovery ecosystem in a form suitable for Japan, and that it is necessary to create a mechanism to bring the local bioclusters together. In addition, he mentioned the need to strengthen collaboration among regions and suppliers in each value chain in order to enhance Japan's drug discovery capabilities. He also presented examples of results achieved through such collaboration and the three important perspectives (people, products, and money) for strengthening collaboration in the drug discovery ecosystem. He concluded his remarks by mentioning the government's policies and expectations for the new administration, such as the establishment of the Drug Discovery Capability Initiative Council and the holding of the Drug Discovery Ecosystem Summit, and by saying, "Now that we are moving as one toward strengthening drug discovery capabilities with the aim of becoming a country where innovation is dynamic, let us work together to realize a "Land of Drug Discovery. He concluded with the words, "Now that we are moving as one toward strengthening drug discovery capabilities in a country where innovation is dynamic, let us work together to realize a 'land of drug discovery.
Hiroaki Ueno, Chairman, Pharmaceutical Manufacturers Association of Japan
Biopharmaceutical Committee Seminar (Organizer's Seminar)
Establishment of manufacturing bases for next-generation biopharmaceuticals: Strengthening the infrastructure for bridging new modalities in industry, academia, and government
The Biopharmaceutical Committee of the Pharmaceutical Manufacturers Association of Japan (PBCJ) has been holding seminars for the past several years on topics related to biopharmaceutical manufacturing processes and infrastructure. The seminar was held on October 10. The venue was filled to capacity as four speakers, including a remote participant from overseas, took the podium to discuss a wide range of issues from the standpoints of government, academia, and industry.
Seminar Introduction
At the beginning of the seminar, Dr. Uchida introduced the over view of the session, indicating that, as new modalities such as next-generation biopharmaceuticals and messenger RNA (mRNA) vaccines become more diverse, there are issues to be addressed not only in the expansion of manufacturing infrastructure that can handle them but also in the supply of human resources and CMC* technology to work there in order to smoothly bridge the gap to the industry. The survey showed that there are issues in the supply of human resources and CMC* technology as well as the expansion of the manufacturing infrastructure that can handle the new modalities. In addition, it is already difficult to solve a wide range of issues through the efforts of individual companies, and it should be possible to strengthen the competitiveness of domestic biologics development by abandoning the principle of self-reliance and having many stakeholders all working together toward a certain direction. He explained the purpose of this session, saying that he would like to think about the direction of future collaboration from the standpoint of industry, government, and academia, which is unlikely to continue as it is.
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CMC: Chemistry, ManufacturingCMC: Chemistry, Manufacturing and Control
An integrated concept that supports pharmaceutical manufacturing and quality
Graduate School of Science, Technology and Innovation, Kobe University
Kazuhisa Uchida, Specially Appointed Professor
Lecture by each speaker
Contribution to the Global Drug Discovery Ecosystem by Establishing a Manufacturing Base for Next-generation Biopharmaceuticals in Academia (CRDMO)
Dr. Eitoshi Tahara, Professor and Vice President (in charge of industry-academia collaboration) of Graduate School of Biomedical Sciences (Pharmaceutical), Hiroshima University, stated that since drug discovery cannot be achieved without overcoming the "valley of death," Hiroshima University, which has been selected for the METI's dual-use project, will be able to manufacture mRNA PSIExhibition Booth He also introduced the "Hiroshima GMP Education and Research Center" that was established two years ago as a preparatory step for the construction of Biologics, which is scheduled to be completed in 2026 and to be established at the Kasumi Campus in 2027, and is currently preparing documents and organizational structure. He also introduced the "Hiroshima Ikujaken Consortium," which aims to create an ecosystem in which anyone can participate and use the system free of charge. He also mentioned that the Hiroshima Venture Capital Fund supports startups.
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Exhibition BoothPSI: Peace & Science Innovation
Ecosystem to create innovation together with a spirit of peace, with Hiroshima University as the lead institution
Translational Research and Human Resource Development in Biotechnology
Mr. Satoshi Toyoshima, President of the Biologics Center for Research and Training (BCRET), said that the 2012 proposal by the Pharmaceutical Manufacturers Association of Japan (PMAJ) led to the establishment of the Japan Agency for Medical Research and Development (AMED) in April 2015, the establishment of the Next Generation Biopharmaceutical Manufacturing Technology Research Association (MAB Association), the establishment of the Pharmaceuticals Manufacturing The establishment of the Japan Biomedical Research and Development Organization (AMED) in April 2015, the establishment of the Next Generation Biopharmaceutical Manufacturing Technology Research Association (MAB Association), and the increase in the number of contract manufacturing organizations (CMOs)/contract drug manufacturing organizations (CDMOs) indicated that the domestic infrastructure was being developed. The fact that human resource development institutions such as BTEC (Biomanufacturing Training and Education Center) and Ireland's NIBRT (National Institute for Bioprocessing Research and Training), which had already achieved results overseas, were not available in Japan at the time, made it difficult for the Japanese government to establish a human resource development system. He explained that BCRET was established in August 2017 and started operation in April 2018, as there were no human resource development institutions in Japan at that time. He also mentioned that the CMC development and manufacturing human resource development through classroom lectures and practical training is not limited to companies, but also covers a wide range of subjects, including authorities, students, and academia. Lastly, he mentioned that in addition to the existing Kobe Center, the Tokyo Center will open in April 2023, and that efforts to develop human resources mainly for gene therapy and cell therapy have begun.
METI's Efforts to Establish Manufacturing Infrastructure for Industrialization of Regenerative Medicine, Cell Therapy, and Gene Therapy
Ms. Reina Kouji, Assistant Director, Biochemical Industry Division, Commerce and Service Group, Ministry of Economy, Trade and Industry (in charge of regenerative medicine, cell therapy, and gene therapy), introduced that without manufacturing, no product is produced, and that the ratio of labor costs in cell therapy is quite high at 71% (5% for small molecules), of which manufacturing costs account for 34% and quality control costs 22%. He introduced the fact that manufacturing is extremely important. He pointed out that manufacturing is extremely important, and the key points are (1) timing of attention, (2) handling of data, and (3) automation. In particular, he introduced the point (1) that venture startups in Japan tend to have less financial resources than their counterparts overseas, which tends to put off the design of costly manufacturing processes, and there are cases where the product cannot be launched or even launched without changing the manufacturing costs. In this regard, he emphasized the need for support in the initial stage. He concluded his remarks by saying, "We would like to strengthen the domestic manufacturing base, enhance drug discovery, aim to make cell manufacturing an export industry, and provide the necessary support for R&D and manufacturing that will benefit Japanese industry.
Establishing a manufacturing base for next-generation biopharmaceuticals - An Industry Perspective
Prof. Uwe Buecheler, Senior Advisor Biopharmaceuticals, Boehringer Ingelheim, indicated that the shift in presence from recombinant glycoproteins in the 1990s to antibody drugs and the recent diversification of new modalities have presented challenges for manufacturing methods and facilities. He indicated that the new modality has become While it would be good if facilities could be made applicable to multimodality, new technologies are also required. Therefore, industry and academia need to collaborate and master the technologies in order to increase manufacturing efficiency and lower costs for practical use. He concluded by saying, "In order to meet the needs of patients and implement new modalities, related stakeholders such as academia, companies, and non-profit organizations (NIBRT, etc.) must collaborate to develop life sciences, materials, platforms, and CDMOs that are adaptable to new translational technologies.
The Biopharmaceuticals Committee Seminar
Conclusion
In the final panel discussion, the panelists discussed the following issues that need to be addressed in the future: (1) critical elements for successful translational research and (2) necessary items/strategies for cooperation. Regarding (1) key factors, there is a need to integrate academia and industry (in particular, human resource development and mobility are key) and to develop CDMOs in Japan that can do "D." In addition, there is a need to provide financial support to CDMOs so that academia and ventures can outsource their work to them, as they lack money. In addition, since academia and venture companies do not have enough money, it is necessary to provide financial support to CDMOs so that they can outsource their work to them. In addition, there were opinions that (2) the human resources involved in the ecosystem are complex, and that it is necessary to create an environment that facilitates cooperation among stakeholders in terms of human resources and a coordinator who can mediate and coordinate such cooperation, and that it is necessary to build a mindset of collaboration and face-to-face relationships with all parties involved. The general consensus was that the direction to be pursued (development of a cooperative infrastructure) was the same globally. Mr. Uchida, the coordinator of the seminar, summarized the discussion on strengthening the infrastructure for new-modality bridging manufacturing by saying that it is not a common discussion, but rather, "With the ever-changing situation, we must take steps through serious discussions among industry, academia, and government, or it will be too late.
Exhibition Booth
In 2024, a booth of the Pharmaceutical Manufacturers Association of Japan (PMAJ) was set up in the exhibition hall to introduce the activities of the PMAJ, the R&D Committee, and the Biopharmaceuticals Committee. The booth has been planned and operated by the R&D Committee, but a joint task force of the R&D Committee and Biopharmaceuticals Committee was established this year to prepare the booth. In addition, personnel from both committees were assigned to the booths throughout the show to provide detailed explanations and Q&A sessions. As a result, the number of business cards exchanged at the booth doubled, and we believe that our advocacy activities had a certain effect.
Exhibition booth (first day)
The next BioJapan 2025 is scheduled for October 8-10, 2025 at Pacifico Yokohama.
(Yoshihiro Kaneko, Vice Chair of Policy and Practice, Biopharmaceuticals Committee, and Junko Tsukada, Director, Pharmaceutical Affairs and Biopharmaceuticals Department)