Presentation on “The Role of Academia in Creating Medical Innovation” at the 13th Annual Meeting of the ARO Council

We are pleased to announce that on Friday, September 25, 2026, at the 13th Annual Meeting of the ARO Council¹⁾, held at the Hiroshima City Culture and Exchange Hall, Toshio Miyata, President and Representative Director of our company and Professor at Tohoku University Graduate School of Medicine, delivered a presentation entitled “The Role of Academia in Creating Medical Innovation” at Symposium 4, “What Kind of ARO Can Support First-in-Human Trials?”²⁾.

This symposium focused on First-in-Human (FIH) trials, a critical step in translating research discoveries originating in academia into innovative pharmaceuticals and medical devices for societal implementation. Researchers and ARO professionals with experience in FIH trials discussed past challenges, the support infrastructure required, and the future role of AROs.

Our drug development efforts, which began approximately 30 years ago in the field of kidney disease, have progressed from basic research and translational research through investigator-initiated clinical trials and have now reached multiple Phase III investigator-initiated trials in oncology. To date, we have conducted 31 investigator-initiated clinical trials involving unapproved drugs and other investigational products. Drawing on this long-term R&D experience, the presentation highlighted the distinctive features of drug discovery originating in academia and the challenges involved in translating such discoveries into practical applications.

In particular, Dr. Miyata explained that, unlike drug development conducted within a single company, open collaborative research that draws on the diverse resources of universities and research institutions can lead to the discovery of previously unanticipated pharmacological effects and expansion into new disease areas. He also described the ability to rapidly advance these findings from basic research to clinical research and clinical trials as a key strength of academia-driven drug development.

At the same time, significant challenges remain in bringing promising academic discoveries to patients as new medicines. These include the need for an integrated clinical development framework that extends beyond FIH trials to subsequent Phase III trials and international collaborative trials. Going forward, we will continue to leverage the drug discovery and clinical development experience and networks cultivated over many years by academic researchers. By further strengthening collaboration with universities, research institutions, medical institutions, and companies in Japan and overseas, we will advance programs in an integrated manner from basic research through clinical development and ultimately into societal implementation, with the aim of creating new treatment options and enhancing corporate value.

1) ARO (Academic Research Organization): An organization based at a university, medical institution, or similar entity that specializes in supporting investigator-initiated clinical trials and clinical research. AROs provide a broad range of functions necessary for clinical development, including study planning, regulatory support, project management, data management, statistical analysis, and monitoring.

2) First-in-Human (FIH) trial: A clinical trial in which a newly developed drug or medical technology is administered to or used in humans for the first time. Such trials primarily assess safety, tolerability, and pharmacokinetics and represent a critical step in subsequent clinical development.