Annual Report 2023

Preface

Focus Areas of EPOC

In 2022, with the appointment of Toshihiko Doi as Director of the Exploratory Oncology Research and Clinical Trial Center (EPOC), which had focused on TR/rTR since its establishment, the center reassessed its direction to further strengthen its research and development efforts aimed at practical applications. Key areas of focus were identified to ensure the successful clinical development of innovative medical technologies: (1) the importance of evidence from basic research, (2) collaboration between hospitals and laboratories, and (3) the technologies and systems required for the transition from pre-clinical to clinical phases, including investigational drug manufacturing. EPOC defined its focus area as the "near-clinical" phase, seamlessly spanning applied research to early clinical trials seamlessly. This approach was shared across all divisions, and R&D activities were carried out in line with this policy in FY2023.

Activities of EPOC

In academic drug discovery, it is crucial to emphasize the uniqueness of the seeds and the "strength" of the science itself. Furthermore, recent trends in drug discovery highlight the importance of not only identifying new therapeutic targets based on biological mechanisms but also of developing modalities that address both new and existing targets. Such modalities involve technologies that demonstrate how therapeutic agents approach and attack cancer cells. In each division of EPOC, technology development has progressed in areas that are particularly notable as recent drug discovery modalities, such as biologics, cell therapies, and radiopharmaceuticals, with visible advances from basic research to the near-clinical domain. To further strengthen EPOC's unique R&D environment, efforts in the cell therapy and regenerative medicine fields are being pursued in collaboration with contract development and manufacturing organizations (CDMOs) adjacent to the Kashiwa Campus to establish the Kashiwa-no-ha Regenerative Medicine Platform. This project was also selected as part of AMED's Program for Accelerating Research in Regenerative Medicine, Cell Therapy, and Gene Therapy (Support for Practical Research on Regenerative Medicine, Cell Therapy, and Gene Therapy). For radiopharmaceuticals, a cooperative agreement was concluded with the Japan Atomic Energy Agency to promote R&D of radioactive isotope-labeled drugs and the construction of a related supply chain. This collaboration is developing a framework for joint research to promote the domestic production and use of medical radioisotopes.

Challenges and Prospects for EPOC

Advancing R&D focused on modality requires a collaborative system involving the expertise from basic research, pharmaceutical development, and medical device development. EPOC aims to be a flexible organization that can respond to changes in the current development environment. In addition to building a collaborative system within and outside the center, a fundamental review of EPOC’s internal organizational structure will be essential in the near future.

Katsuya Tsuchihara

Director,

Exploratory Oncology Research and Clinical Trial Center