Report on the Organization and Participation in “BioJapan 2024” Highlights of the Opening Ceremony, Keynote Speeches, and the Biopharmaceutical Committee Seminar

"BioJapan 2024" was held for three days from Wednesday, October 9, to Friday, October 11, 2024, at Pacifico Yokohama. As in previous years, "Regenerative Medicine JAPAN 2024" and "healthTECH JAPAN 2024" were also held concurrently, andThis year saw a record-high attendance of 18,003 visitors. In addition, the number of exhibitors was exceptionally high, and a record 22,045 partnering meetings were held.As in 2023, there were many international attendees, which added to the vibrant atmosphere at the venue. The JPMA participated as one of the organizing bodies, and member companies delivered numerous presentations. Many companies and organizations set up alliance booths and held meetings with academia and startups, fostering active information exchange and networking.

Opening Ceremony and Keynote Speeches

Following opening remarks by Mr. Minoru Yoshida, Chair of the BioJapan Organizing Committee, on behalf of the organizers, congratulatory speeches were delivered by Mr. Ryo Minami, Deputy Director-General for Commerce and Services at the Ministry of Economy, Trade and Industry; Mr. Hiroyuki Uchiyama, Deputy Director-General for Pharmaceutical Industry Promotion and Medical Information at the Minister’s Secretariat of the Ministry of Health, Labor and Welfare;Mr. Shigekazu Matsuura, Deputy Director-General of the Minister’s Secretariat at the Ministry of Education, Culture, Sports, Science and Technology (in charge of the Bureau of Research Promotion and Higher Education Policy Coordination), and Mr. Yuji Kuroiwa, Governor of Kanagawa Prefecture, among others, delivered congratulatory remarks.

Scenes from the Opening Ceremony

This was followed by a keynote lecture titled “Challenges That Drive Innovation: Clinical Development and Commercialization of Viral Therapies” (Department of Advanced Cancer Therapy, Institute of Medical Science, The University of Tokyo / Professor Tomoki Todo, Department of Brain Tumor Surgery, Institute of Medical Science Hospital, The University of Tokyo), “Toward Strengthening Japan’s Drug Discovery Capabilities” (Hiroaki Ueno, Chairman, Japan Pharmaceutical Manufacturers Association), and “Laying the Foundations for a Cancer Innovation Ecosystem” (Executive Director, Research and Innovation, Cancer Research UK:Dr. Iain Foulkes, CEO of Cancer Research Horizons).

In his lecture, Mr. Ueno, Chairman of the JPMA, began by citing changes in the environment surrounding the pharmaceutical industry, including shifts in unmet medical needs, the diversification of drug discovery modalities, the elimination of market borders, andthe advancement of digital transformation (DX). He emphasized that combining core technologies is crucial in response to the shifts in drug discovery methods driven by these changes, and highlighted the need for a drug discovery ecosystem where multiple players collaborate.He then discussed the current state of global drug discovery ecosystems, citing examples from Boston, U.S., and London, U.K., while also outlining the current status of Japan’s drug discovery and biotech clusters and bio-communities. He noted that Japan needs to build a drug discovery ecosystem tailored to its own circumstances and that mechanisms are required to elevate and consolidate regional biotech clusters to the next level.Furthermore, to strengthen Japan’s drug discovery capabilities, the speaker highlighted the need to enhance collaboration between regions and among suppliers across each value chain, presented examples of achievements resulting from such collaboration, and identified three key perspectives (people, resources, and funding) for strengthening collaboration within the drug discovery ecosystem.Finally, he touched upon national initiatives—such as the establishment of the Drug Discovery Capability Vision Council and the hosting of the Drug Discovery Ecosystem Summit—as well as expectations for the new administration. He concluded by stating, “Aiming to become a nation where innovation thrives, now that we have begun moving forward as one to strengthen our drug discovery capabilities, let us work together to realize a ‘Land of Drug Discovery.’”

Hiroaki Ueno, Chairman of the JPMA

Biopharmaceutical Committee Seminar (Organizer-Hosted Seminar)

Establishing a Manufacturing Hub for Next-Generation Biopharmaceuticals: Strengthening the Bridge Manufacturing Infrastructure for New Modalities Across Industry, Academia, and Government

The JPMA Biopharmaceutical Committee has been hosting seminars over the past several years on topics related to biopharmaceutical manufacturing processes and infrastructure. In fiscal year 2024, a seminar titled “Establishing Manufacturing Hubs for Next-Generation Biopharmaceuticals: Strengthening the Manufacturing Infrastructure for Bridging New Modalities Across Industry, Academia, and Government” was held on October 10.Kazuhisa Uchida, Specially Appointed Professor at the Graduate School of Science and Technology Innovation, Kobe University, served as the coordinator. Four speakers, including some participating remotely from overseas, took the stage, and a wide-ranging discussion took place from the perspectives of government agencies, academia, and industry. The venue was filled to capacity.

Seminar Introduction


At the outset, Mr. Uchida presented an overview of the session. He pointed out that as new modalities—such as next-generation biopharmaceuticals and messenger RNA (mRNA) vaccines—become increasingly diverse, ensuring a smooth transition to the industry requires not only expanding the manufacturing infrastructure to accommodate these needs but also addressing challenges related to the supply of skilled personnel
and CMC* technologies
.He also noted that it is already difficult for individual companies to resolve these wide-ranging challenges on their own; by abandoning a self-reliant approach and having numerous stakeholders work together toward a common goal, it should be possible to strengthen Japan’s competitive edge in biologics development.The purpose of this session was explained as an opportunity to consider future directions for collaboration—from the perspectives of industry, government, and academia—given that the outlook remains bleak if the current situation continues.
  • *　
    CMC: Chemistry, Manufacturing, and Control
    • —an integrated concept underpinning pharmaceutical manufacturing and quality


Kazuhisa Uchida, Specially Appointed Professor, Graduate School of Science and Technology Innovation, Kobe University

Presentations by Each Speaker

Contributions to the Global Drug Discovery Ecosystem Brought About by Academia-Based CRDMO Manufacturing Hubs
Eishun Tahara, Professor and Vice President (in charge of Industry-Academia Collaboration) at the Graduate School of Medical Sciences (Pharmacy), Hiroshima University, stated that drug discovery is impossible without overcoming the “Valley of Death.” Therefore, Hiroshima University—which has been selected for METI’s Dual-Use Project—is developing the PSI
*
He explained that the biologics facility is scheduled for completion in 2026, with operations set to begin at the Kasumi Campus in 2027; as part of the preparatory phase, the PSI GMP Education and Research Center was established two years ago, and work is underway to develop the necessary documentation and organizational structure; and that the “Hiroshima Suki-jaken Consortium” was formed with the goal of creating an ecosystem that anyone can join and use free of charge.He also touched on how Hiroshima Venture Capital’s fund supports startups.
  • *　

    PSI: Peace & Science Innovation
    An ecosystem that fosters innovation in the spirit of peace, with Hiroshima University as the lead institution

Translational Research and Biopharmaceutical Talent Development

Satoshi Toyoshima, Representative Director of the Biologics Research and Training Center (BCRET), pointed out that, following the 2012 proposal by the JPMA, the Japan Agency for Medical Research and Development (AMED) was established in April 2015. He highlighted that domestic infrastructure is gradually being developed, as evidenced by the establishment of the Next-Generation Biopharmaceutical Manufacturing Technology Research Association(MAB Consortium) and the rise in Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs). He noted that, at that time, Japan lacked human resource development institutions comparable to the BTEC (Biomanufacturing Training and Education Center), which had a proven track record overseas, and Ireland’s NIBRT (National Institute for Bioprocessing Research and Training), were not available in Japan at the time; therefore, BCRET was established in August 2017 and began operations in April 2018.He also noted that the scope of the CMC development and manufacturing training program—delivered through both classroom instruction and hands-on training—is broad, targeting not only companies but also regulatory authorities, students, and academia. Finally, he mentioned that in addition to the existing Kobe facility, a Tokyo facility was opened in April 2023, marking the start of initiatives focused on training personnel in gene therapy and cell therapy.

METI’s Initiatives Regarding the Development of Manufacturing Infrastructure for the Commercialization of Regenerative, Cell, and Gene Therapies

Ms. Reina Kōdera, Assistant Director of the Biochemical Industry Division, Commerce and Services Group, Ministry of Economy, Trade and Industry (in charge of regenerative, cell, and gene therapies), noted that without manufacturing, there can be no product, and that labor costs account for a significantly high 71% of cell therapy costs (compared to 5% for small molecules).of which manufacturing costs account for 34% and quality control costs account for as much as 22%. She emphasized that manufacturing is of the utmost importance and highlighted the following key points: (1) the timing of focus, (2) data handling, and (3) automation.Regarding point (1) in particular, she noted that compared to overseas markets, venture capital and startup funding in Japan is limited. Consequently, the costly process of designing manufacturing processes tends to be postponed. This leads to cases where companies are forced to bring products to market with high manufacturing costs that cannot be reduced, or where products never even reach the market at all; she emphasized the need for support during the early stages.In conclusion, he stated, “We aim to strengthen the domestic manufacturing infrastructure, enhance drug discovery, and develop the cell therapy industry into an export-oriented sector; to this end, we intend to 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 for Biopharmaceuticals at Boehringer Ingelheim, pointed out that the industry’s focus shifted from recombinant glycoproteins in the 1990s to antibody therapeutics, and that recently, with the diversification of new modalities, challenges have arisen regarding manufacturing processes and equipment.While it would be ideal to have facilities applicable to multiple modalities, new technologies are also required; therefore, to increase manufacturing efficiency and reduce costs for practical implementation, industry and academia must collaborate to refine these technologies.In conclusion, he stated, “To meet patient needs and implement new modalities, relevant stakeholders—including academic societies, companies, and nonprofit organizations (such as NIBRT)—must collaborate to establish the necessary infrastructure in life sciences, materials, platforms, and CDMO services adapted to new translational approaches.” Scenes from the Biopharmaceutical Committee Seminar

Summary

During the concluding panel discussion, participants debated the challenges that need to be addressed moving forward, focusing on (1) key factors for the success of translational research and (2) what is needed and what measures should be taken to foster a collaborative framework.Regarding (1) key elements, opinions included the need for integration between academia and industry (with talent development and mobility being particularly crucial) and the necessity of fostering CDMOs capable of “D” (development) within Japan. Additionally, it was noted that since academia and startups lack funding, financial measures must be put in place to enable them to outsource work to CDMOs and similar entities.Furthermore, regarding (2) measures, it was noted that the talent pool within the ecosystem is complex; therefore, an environment must be established to facilitate collaboration among relevant stakeholders in terms of human resources, along with the need for coordinators capable of mediating and managing these relationships.and that a mindset of “shared destiny” and the building of face-to-face relationships are essential. Overall, there was a consensus that the desired direction—the development of a collaboration infrastructure—is common across the global landscape.Mr. Uchida, the coordinator, summarized the discussion on strengthening the manufacturing infrastructure for bridging new modalities by stating that this was not just a routine discussion: “As the situation is changing by the minute, if we do not take concrete measures through serious, integrated discussions among industry, academia, and government, it will be too late.”

Exhibition Booths

In 2024, the JPMA once again set up a booth within the exhibition hall to introduce the activities of the JPMA, the R & D Committee, and the Biopharmaceutical Committee. While the R & D Committee had previously been responsible for planning and operating the exhibition booth, this year a joint task force comprising the R & D Committee and the Biopharmaceutical Committee was established to oversee preparations.In 2024, we made greater efforts than ever before to enhance the materials and video presentations related to the JPMA, the R & D Committee, and the Biopharmaceutical Committee, as well as to optimize the booth layout. Furthermore, staff from both committees were stationed at the booth throughout the event to ensure attentive and detailed responses to inquiries and questions.As a result, the number of business cards exchanged at the booth doubled, and we believe this achieved a certain level of success as part of the JPMA’s advocacy efforts. Exhibition Booths (First Day)


The next “BioJapan 2025” is scheduled to be held from Wednesday, October 8, to Friday, October 10, 2025, at Pacifico Yokohama.
 

(Yoshihiro Kaneko, Vice Chairperson of Policy and Operations, Biopharmaceutical Committee; Junko Tsukada, Director, Regulatory Affairs and Biopharmaceuticals Department)

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