This strategic proposal defines the direction that Japan should promote research and development of "designer cells". The main cell modality that have been researched and developed so far have been regenerative medicine, which is replacement therapy aiming at regeneration by transplanting stem cells to the site of organ/tissue injury. "designer cells" is a completely new type of cell modality that artificially modifies cells and aims to control diseases. It is expected that Japan's clinical development seeds and products will be created by combining Japan's strengths. In 2017, CD19 CAR-T cell therapy was launched on the market with its overwhelming therapeutic effect on patients. The advent of CAR-T is a historic turning point demonstrating that cell modality has been established as a breakthrough therapy.

CAR-T is an important success story. But it is just one of the potentials of the cell modality. In the short term (5 years later), clinical trials and launches of improved CAR-T/TCR-T/NK/NKT cell therapies are expected to make significant progress. Over the medium to long term (10 to 15 years later), a wide variety of immune cells (regulatory T cells, γδT cells, macrophages, etc.), stem cells (iPS cells, ES cells, MSCs, tissue stem cells, hematopoietic stem cells, etc.). It is expected that disease control and treatment will be realized one after another by applying various designs to (bacteria, phages, etc.). In Japan, it is important to promote four pillars as follows.

• [Pillar 1: Basic research] Search for new design policies
• [Pillar 2: Basic technology] Development of design technology
• [Pillar 3: Seed refinement] Realization and refinement of "designer cells" and construction of manufacturing base
• [Pillar 4: Evaluation & Implementation] Promotion of clinical trials and social implementation

We will set up a headquarter and will allocate budget according to the progress of [Pillar 1] to [Pillar 4]. [Pillar 1] implements small-scale funding and idea fusion for researchers in various fields. [Pillar 2] will build a base for technological advancement and technical support for domestic researchers. [Pillar 3] will implement medium-scale funding for research groups that can implement the development-evaluation-improvement development cycle and build a manufacturing base. [Pillar 4] will utilize and expand existing clinical trial-related businesses and conduct small-scale research and research on ELSI.