Research & Development

Development Organization

Global Clinical Development

While our clinical development efforts are based in Japan, we have established nerve centers for clinical development within the overseas subsidiaries - Ono Pharma USA, Inc. (OPUS) and Ono Pharma UK Ltd (OPUK). Both subsidiaries are strongly pursuing overseas clinical development of our new drug candidates. To propel drug development in Asia, the Asia Development Division, established at Head Office, is making strong contributions to our global clinical development efforts embracing Asia alongside Europe and America.

Accelerated Clinical Development Framework

We are committed to promoting clinical development with enthusiasm to deliver new drugs that meet the needs of frontline healthcare as soon as possible, for the sake of patients suffering from disease throughout the world.
We have established a Translational Medicine Center within the Development Headquarters, that scrutinizes the efficacy, safety and quality of promising new drug candidates at the basic research and nonclinical stages, and then brings together the functions necessary to bridge from research to clinical development, in an effort to enable quicker decision making in development and shorten the period from commencement of drug development to establishment of efficacy and safety (POC).
Clinical development plays a role in collecting data necessary to file applications for marketing approval for prescription drugs to Ministry of Health, Labour and Welfare. To obtain marketing approval of the drugs as quickly as possible, we are speeding up the clinical development process by advancing mutual use of results from multinational clinical trials and other overseas studies.
We are focusing on the development particularly in the oncology area as our important strategic field and continuously committed to enhancing the development framework in this area. The Immune-Oncology Exploration Unit newly established in December 2015 is promoting search of bio-markers and potential combination treatment. We also set up the Oncology Research and Development Center involving the Oncology Early Clinical Development Unit in April 2016 to strengthen the collaboration in research and development and further facilitate a speed-up of clinical development.

Development Pipeline Progress Status