Project for Regenerative Medicine and Cell and Gene Therapies
Overview
This project aims to promote the discovery and development of innovative research in regenerative medicine and cell and gene therapy. The project supports basic research and foundational technologies for future clinical applications. The project also advances clinical research and trials of emerging medical technologies and facilitates their commercialization. In addition, the project strengthens manufacturing infrastructure for cells and vectors, including domestically developed viral vector producer cell lines. The project further supports platform technologies, CDMO capability development, human resource development, and market creation initiatives. Through these integrated efforts, the project accelerates the practical application of promising technologies. The project also advances the development of drug discovery tools that use regenerative medicine technologies to evaluate the safety, efficacy, and other key properties of pharmaceutical products.
List of our Programs
| Programs | Overview |
|---|---|
| Acceleration Program of R&D and implementation for Regenerative Medicine and Cell and Gene Therapy | This program supports the generation of innovative early-stage research, the promotion of clinical translation, commercialization, and technology transfer to industry, the advancement of interdisciplinary research, the elucidation of disease mechanisms, and drug discovery research. Through these efforts, the program aims to advance regenerative medicine and cell and gene therapy and address unmet medical needs while maintaining and strengthening international competitiveness. |
| Research Project for Practical Applications of Regenerative Medicine | This program supports the practical application of regenerative medicine and cell and gene therapy developed by academia and other research institutions. The program provides seamless support from the nonclinical through clinical stages for investigator-initiated clinical trials conducted under the Act on the Pharmaceuticals and Medical Devices and for clinical research conducted under the Act on the Safety of Regenerative Medicine. It also supports research to address development challenges, platform technologies for commercialization, and drug discovery research utilizing regenerative medicine technologies, including iPS cells, ES cells, organoids, and related technologies. |
| Project to Promote the Foundation for Practical Application of Regenerative Medicine | This program supports the establishment of translational research infrastructure to facilitate the practical application of regenerative medicine and cell and gene therapy. The program promotes collaboration among consortia comprising experts in translational research, research institutions, medical institutions, and manufacturing organizations. Through these efforts, the program aims to improve research efficiency, promote standardization, and reduce development costs. |
| A Project Focused on Developing Basic Technology Aiming at Industrialization of Regenerative Medicine and Gene Therapy/Program for the Industrialization of Cell and Gene Therapy Products | This program supports research and development to promote the commercialization of regenerative medical products in the field of regenerative medicine and cell and gene therapy. The program provides support to companies, including start-ups and venture companies, that lead product development. It covers the activities required to advance to company-sponsored clinical trials, including regulatory-compliant nonclinical studies, product quality establishment, and manufacturing process development. |
| A Project Focused on Developing Basic Technology Aiming at Industrialization of Regenerative Medicine and Gene Therapy/ Development of Advanced Drug Discovery Tools Based on Regenerative Medicine Technology | This program supports the development of drug discovery support tools that utilize regenerative medicine technologies, including differentiation induction from iPS cells and other stem cells, as well as organoids. These tools are used to evaluate safety, efficacy, pharmacokinetics, and other characteristics through microphysiological systems (MPS). Through these efforts, the program aims to promote the practical application and broader implementation of MPS. |
| A Project Focused on Developing Basic Technology Aiming at Industrialization of Regenerative Medicine and Gene Therapy/ Development of next-generation manufacturing technology for Regenerative Medicine and Cell Therapy | This program supports the development and improvement of manufacturing and analytical technologies for regenerative medicine products (human cell-based processed products) based on the quality by design (QbD) concept. The program promotes automation of manufacturing and quality control processes, development of broadly applicable automation platforms, and integration of manufacturing equipment and systems. It also supports data standardization, data management systems, and compatible manufacturing and analytical equipment to enable stable and efficient commercial manufacturing of regenerative medicine and cell therapy products. |
| A Project Focused on Developing Basic Technology Aiming at Industrialization of Regenerative Medicine and Gene Therapy/ Accelerated Development Research Project for Gene Therapy | This program supports the development of technologies that advance both in vivo and ex vivo gene therapy, including the establishment of domestic cell lines for AAV vector production and innovative technologies such as gene delivery and genome editing. The program promotes the development of highly useful and cost-competitive domestic manufacturing technologies for gene therapy and cell therapy, thereby driving their dissemination and industrialization. The establishment of manufacturing platforms through collaboration among industry, academia, and government, and the development of highly skilled personnel to support the field. Furthermore, through horizontal division of labor and collaboration among industry, academia and government, we promote the establishment of a domestic manufacturing platform whilst supporting the development of highly skilled personnel in this area. |
| Practical Research for Innovative Cancer Control | This research program promotes development of technologies for the prevention and early detection of cancer. |
| Practical Research Project for Rare / Intractable Diseases | The goal of this project is to promote the elucidation of the causes of intractable diseases. |
Last updated 07/24/26