Atsushi HASHIZUME
Director
In recent years, the development of pharmaceuticals and medical devices has been undergoing a profound transformation. New technologies and concepts are rapidly being adopted, including the use of real-world data (RWD) in regulatory approvals, the advancement of digital transformation (DX) in clinical research, and the integration of patient-reported outcomes (PROs) as evaluation metrics. Moreover, the importance of public and patient involvement (PPI) is increasing, together with the broader adoption of flexible clinical trial designs, such as master protocol studies. In this context, clinical research is advancing into a phase that emphasizes practical implementation, including regulatory approval and clinical adoption. Academic Research Organizations (AROs) are now expected to adopt a strategic and comprehensive approach to advanced medicine, providing collaborative support throughout the development process.
At Nagoya University, the Department of Advanced Medicine serves as a central organization driving these initiatives. Guided by the hospital’s mission—”We will contribute to society through medical care, education, and research”—the department aligns with one of the institution’s four core principles: “to pioneer new-generation medical technologies and practices.” Based on this vision, we are actively engaged in supporting advanced medical development daily.
The Department of Advanced Medicine consists of the Center for Advanced Medicine and Clinical Research and the Data Coordinating Center. Together, they provide end-to-end support across the entire development pathway, from basic research to regulatory approval. In the area of nucleic acid therapeutics, investigator-initiated clinical trials are currently underway targeting malignant brain tumors—a rare and difficult-to-treat condition. In the field of biomedicine, significant progress has been made through investigator-initiated trials, such as those involving CAR-T cell therapy using transposon vectors and the development of novel treatments for perinatal brain injury using Induced Pluripotent Stem cells (iPSCs). In the field of medical devices, a regenerative device designed to isolate autologous subcutaneous adipose-derived stem cells intended for the minimally invasive treatment of male stress urinary incontinence has successfully obtained regulatory approval.
We are also firmly committed to the development of ARO professionals. We offer training programs for physicians, dentists, and other professionals interested in clinical research and trials, and we actively organize seminars both within and outside the institution.
In addition, through collaboration with the Department of Clinical Research Education, established within the Graduate School of Medicine in 2021, we are working to create an educational and research environment that develops both support personnel and the next generation of clinical researchers. This department aims to cultivate individuals capable of designing and refining research questions based on clinical practice and leading them through to social implementation. By closely collaborating with the Department of Advanced Medicine, it aims to establish a model of clinical research education that is grounded in practical application.
We aim to develop a new clinical research support model based at Nagoya University Hospital—one that contributes to medical innovation, benefiting society from the Chubu region to the entire country and, ultimately, the world.
“From Chubu to Japan and the world.”
The Department of Advanced Medicine is committed to shaping and steadily realizing a model of clinical research support that meets the demands of this new era. We greatly appreciate your continued guidance and collaboration in helping us achieve this vision.