Department of Development Strategy

To accomplish the NCCHD's mission to facilitate pediatric and maternal drug and device development, the Department of Development Strategy supports investigators in development strategies and designing, planning, and managing clinical trials in collaboration with other departments and divisions. The department also supports drug and device development undertaken by other medical centers and research institutes. Members of the department also act as consultants to industries, advise regulatory agencies and collaborate with relevant international academic institutions.

Organization

We have two department heads and three divisions: the Division for Clinical Research Development, the Division of Clinical Research Administration and the Division of Intellectual Property and Industry-Academia Collaboration.

Functions and services

Our main task is not to conduct research but to provide administrative and project management support for drug and device development projects in collaboration with other departments and divisions. The department is responsible for:

Consultation and support for drug and device development

The department engages in projects from the preparatory phase by giving advice and support on development strategies, designing and planning preclinical and clinical studies, through to finalizing clinical study reports and new drug/device applications. These services are mainly provided to investigators and physicians, but can be offered to industries on a pay-per-service basis.

Supporting other medical centers and research institutes in drug and device development

The department also provides consultations on development strategy to other medical centers and research institutes. If continuous support is required (e.g., project management, advisory functions), our services can be provided on an as-needed basis in collaboration with other departments and divisions.

Management of standard operating procedures (SOPs) and contracts

We also handle the management of SOPs, and contracts with industries and researchers.

Intellectual property and industry-academia collaboration

We handle consultations on patent applications for products developed at the NCCHD. In addition, we authorize, manage and preserve patents by liaising with the Employee Inventions Committee.

Engaging in international collaboration and harmonization

Staff members of the department participate in discussions on ICH pre-clinical and clinical guidelines, serve as specialists for the Pharmaceuticals and Medical Devices Agency and the Ministry of Health, Labour and Welfare, Japan, and collaborate with international investigators and specialists in pediatric drug evaluation.