Development of Pharmaceuticals and Medical Devices

As the “leading company in IV solutions,” we are engaged in research and development with the mission of creating better products and delivering them quickly to actual medical practice around the world.
The Research and Development Center oversees the entire research and development process—from creating new pharmaceuticals and medical devices through postmarketing—with three divisions: the Naruto Research Institute, the Clinical Development Department, and the Medical Affairs Department, working in close collaboration.
The Naruto Research Institute is responsible for generating concepts for new pharmaceuticals and medical devices and evaluating them through nonclinical studies, while the Clinical Development Department builds on those results and conducts scientific verification of efficacy and safety through clinical studies (clinical trials). Furthermore, the Medical Affairs Department works to maximize product value in actual medical practice by developing medical plans for postmarketing products, generating evidence, and collaborating with external medical and scientific experts. To create products that will be the best partner in actual medical practice, each department takes the initiative from the early stages of research and development, and by integrating knowledge and ideas across departmental boundaries, we foster creativity across all departments and further enhance our research and development capabilities.
In addition, the Research and Development Center includes project managers who oversee entire development programs, as well as specialists who plan global product strategies and work to improve the quality of regulatory submission documents, and they drive research and development activities by leveraging their respective expertise and skills.
In recent years, using Otsuka Pharmaceutical Factory America as our base, we have sought to expand our global business centered on the United States and have actively taken on the challenge of providing innovative therapies.

Our mission is to discover new product concepts and substantiate them scientifically. To do so, we must first accurately identify the issues and problems that lie hidden in the clinical setting and create the best treatment methods. Seeds of innovation may emerge in the daily course of research and development or be discovered within vast amounts of data. That is why it is essential for all departments of the Research and Development Center, with their wide range of functions and expertise, to act as one.
To generate distinctive innovation, each researcher’s keen powers of observation and the passion and tenacity to make it happen are indispensable. We provide strong, organization-wide backup for such passionate individual challenges. By leveraging the advantage covering the fields from basic research to MA and supporting each activity as one team, we believe we can powerfully blaze a trail in product development.

To pioneer next-generation healthcare, some R&D pipeline programs with innovative concepts have already begun clinical studies overseas. To deliver these to actual medical practice worldwide, we must overcome diverse barriers such as national regulations, cultures, and medical practices. In response to these product-specific barriers, we are tackling global expansion by building new platforms in collaboration not only within the Research and Development Center but also with various departments across the company.

One specific initiative is “bioengineered pancreatic islet.” This unique therapy encapsulates pancreatic islets from pigs raised in environments free of infectious pathogens and transplants them into patients with diabetes to supplement insulin. It is expected to offer a new option for severe, difficult-to-treat type 1 diabetes.
Furthermore, regarding obesity, which is a global issue, Otsuka Pharmaceutical Factory, whose long-standing focus has been nutrition, has created a compound with an entirely new mechanism and has initiated development in the United States.

We believe that innovation is born from each researcher’s rich creativity and relentless drive to solve problems, and that it takes shape when the research and development organization that supports them creates the conditions for success.
As the founding company of the Otsuka Group, we have passed down the spirit of our predecessors as our “Otsuka DNA.” We hope that the researchers who will shape the future will approach their daily research with a mindset that is unconstrained by past conventions, always mindful of creativity, and bold in continuing to take on challenges.