Overview of Research

Dr. Itoh is a health policy researcher at The University of Tokyo, specializing in incentive design for high-need therapeutics such as rare diseases, pediatric indications, and antimicrobial-resistant infections. His work bridges regulatory science, economic policy and business model to address systemic barriers in drug innovation. He proposed the Transferrable Regulatory Privilege (TRP), a Japan-specific version of the U.S. Priority Review Voucher, enabling tradable regulatory incentives within Japan’s unique framework. Dr. Itoh also developed pricing models for TRP transactions based on domestic pharmaceutical benchmarks, offering a foundation for financial options market of regulatory privileges. His broader research explores mission-oriented public procurement for innovation, aiming to reengineer innovation eco-systems. By integrating stakeholder networks and policy design, Dr. Itoh’s work provides actionable pathways for governments and investors to accelerate development of economically challenging but socially critical therapeutics. His research is especially relevant for those seeking scalable, policy-enabled innovation in Japan’s evolving life sciences ecosystem.

Profile

Dr. Itoh holds a Ph.D. in Health Policy from The University of Tokyo and a Master’s from Kyoto University. With 17+years in a major Japanese pharmaceutical company, he led corporate strategy, R&D planning, and biologics development, including CDMO and regulatory affairs. He contributed rare disease initiatives, such as a nucleic acid therapy for DMD at Kyoto University. At The University of Tokyo, he proposed Japan’s Transferrable Regulatory Privilege (TRP) system and modeled its market value. His career integrates business and policy to drive innovation in high-need, small-market therapeutics, offering scalable solutions for investors and public health stakeholders.

Overview of Research

A urine-based screen that catches frailty–metabolic risk before patients fall through the cracks. We address a costly gap: mental and metabolic disease often co-occur, yet clinics lack a noninvasive combined-risk screen. Our solution reads metabolic “fingerprints” from one urine sample—volatile organic compounds (VOCs)—to detect patterns linked to epilepsy, depression, anxiety, and sarcopenia. Invalidated mouse models we identified VOC signatures and translated them into a low-cost assay. We have filed four patents; two cover biomarkers for late-life depression/anxiety and sarcopenia, with a JST-supported PCT for sarcopenia entering U.S. national phase. In older adults, sarcopenia often co-occurs with, and can trigger or result from, depression and anxiety; this interdependence motivated our sarcopenia VOC program. Initial markets: primary care and cardiology/diabetes clinics, where early triage and monitoring can reduce hospitalizations. We seek investment to complete clinical validation, finalize an easy central-lab analysis, and build longitudinal risk-scoring pipelines. This VOC screen enables earlier detection, optimized treatment, and frailty prevention.

Profile

Keiko Kato, DVM, PhD, DJCLAM, is Professor and Dean of the Graduate Schools at Kyoto Sangyo University. A neurochemist and glycobiologist, I investigate how glycosylation and metabolism regulate limbic circuits in epilepsy, depression, and anxiety. My laboratory has delineated roles for sialyltransferase ST3GAL4 in epileptogenesis and affective behaviors, linking thalamic dynamics to metabolic signaling. Work integrates circuit-resolved mouse models and glycoproteomics with behavioral readouts to map pathways from molecular modification to network excitability and mood phenotypes. I trained at Osaka Prefecture University(DMV), Osaka University (PhD), and Caltech (HFSP), and actively collaborates with TMIG. Mission: educate future talent and extend healthy life expectancy worldwide.

Overview of Research

We hold an international patent for titanium peroxide nanoparticles as radiation sensitizers, which is unparalleled worldwide. Building on this, we have proposed an innovative cancer vaccine therapy that combines radiation therapy with immune checkpoint inhibitors (ICIs). Since titanium peroxide nanoparticles induce explosive anti-tumor effects upon radiation exposure, we have named this combination therapy “Burst Therapy” and have also filed a patent application for it as a pharmaceutical product. For social implementation, we have established a venture company and are raising funds from AMED and venture capitalists, with the ultimate goal of conducting phase II/III clinical trials. Our target customers are major pharmaceutical companies that sell ICIs, as this therapy offers them significant advantages by overcoming the early loss of efficacy—a major limitation—associated with ICIs through a novel therapeutic strategy. The targeted diseases include head and neck cancer, sarcoma, and colorectal cancer, and this next-generation therapy is expected to have a significant ripple effect as it has the potential to break through the limitations of current treatments.

Profile

Ryohei Sasaki, M.D., Ph.D. is Professor and Chair of Radiation Oncology at Kobe University Graduate School of Medicine. His research focuses on advanced radiotherapy, radiosensitizers, and translational oncology. He pioneered bioabsorbable spacers for particle therapy and developed “Burst Therapy,” a novel titanium peroxide nanoparticle–based radio-immunotherapy with strong potential for clinical and industrial application. Prof. Sasaki actively promotes collaborations bridging medicine, veterinary oncology, and nanotechnology, and is committed to accelerating social implementation of innovative cancer treatments. He has been recognized with major national awards in Japan, including the Minister of Education, Culture, Sports, Science and Technology Award.

Overview of Research

The general cell injection requires a sufficient amount of suspension solution and speedy injection to allow the cells to enter the tissue. I found this process makes tissue and graft cell injuries. General injection requires some appropriate amount of cell suspension solution and appropriate injection speed for tearing the tissue. This leads to an on-site inflammatory response, which eventually results in fibrosis to isolate the grafted cells from the host tissue. This also makes significant shear stress in the needle, which affects the viability. Our new injection method consisted of two factors: slow injection and a body-temperature-sensitive cell suspension solution. The gel-state cell suspension solution can push the cells in the syringe and needle out to the tissue; at the same time, the body temperature converts it from gel to sol, and then it can be washed by tissue micro-fluid flow. This method could widely contribute to next-generation cell therapies.

Profile

Since2002, I have been researching new technologies for heart regenerative medicine using human pluripotent stem cells at Keio University. Representatively, I invented the “metabolic purification method of cardiomyocytes” and the “transplantation method of cardiomyocyte balls”; these are the core technologies of HeartSeedInc., a Keio University-derived venture company. Especially, the metabolic purification method has become the golden standard method for cardiomyocyte purification, which is adopted by Professor Wolfram-Hubertus Zimmermann for the human clinical study of engineered heart muscle. Heart regenerative medicine is wonderful because the heart cannot be regenerated naturally. However, in turn, it holds many evolutionarily established obstacles to reaching more effective therapy. One of such obstacles, the heart has the high ability quickly making fibrotic scar tissue after the injury. I noted that cell injection itself is the cause the fibrotic isolation of the donor cells to avoid the host graft interactions.

Overview of Research

Warfarin is an anticoagulant requiring strict dosage control, as overdosing increases bleeding risk while underdosing raises thrombosis risk. However, inter- and intra-individual variability due to diet and other factors makes routine monitoring of blood coagulation (PT-INR) burdensome. Although various prediction formulas, including those using genetic data, have been proposed, their accuracy remains limited. To address this, I have developed a novel program that predicts the optimal daily dose using only routinely available clinical data such as prior dosing, PT-INR, and patient background. This approach enables accurate dose adjustments to maintain PT-INR within the therapeutic range. Designed for mobile platforms such as smartphones and tablets, the system is suitable for both hospital and outpatient use. It also incorporates a patient education function that delivers drug information and promotes adherence. The system can support pharmacists in providing medication guidance and enable patients or caregivers to manage therapy after discharge, thereby improving the safety and adherence of anticoagulation treatment.

Profile

I am a clinical pharmacologist with expertise in pharmacogenomics and the integration of pharmacokinetics and pharmacodynamics. I draw on my involvement in multiple clinical studies and my experience as a reviewer at the Pharmaceuticals and Medical Devices Agency (PMDA, the Japanese counterpart of the FDA). These experiences give me a strong translational perspective on drug development and clinical practice, which I now apply to developing innovative systems that enhance the safe and effective use of drugs.

Profile

I am engaged in promoting collaboration among academia, industry, and government, with a focus on fostering startups and creating joint research initiatives. My work centers on supporting innovation, building partnerships, and developing ecosystems that connect diverse stakeholders. Drawing on my research and clinical experience in the life sciences, I am working on projects that aim to address challenges in healthcare. At this stage, I am refining our concept through this program, with the vision of contributing to healthcare solutions and realizing their social implementation.