Once we identify the promising candidate from discovery research, we move forward the project to conduct battery of IND-enabling studies that include pharmacology studies, ADME studies and GLP-compliant toxicology studies aiming to validate the project as clinical candidate. These IND-enabling studies need to be conducted conforming to regulatory guidelines which are diverse depending on variety of modalities (e.g., small molecules, biopharmaceuticals, gene therapy, regenerative cell medicines).
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Mission of Translational Research Office (TRO), the competent team which consists of number of experts of translational research (TR) from industry, academic TR institutes, regulatory organizations, is to support projects establishing clinical development plan for the candidates and providing strategic advice to establish target product profiles and the plan for early phase clinical development and also to pave the proper plan for non-clinical studies.
Translational Research Office also provides support for the regulatory document writing and also discussions with regulatory authority like PMDA.
Please read the management team for a list and profile of members.
The business development office handles alliances for collaboration with companies, universities, and external research institutes. It is also involved in licensing intellectual property rights to companies in collaboration with RIKEN Innovation.
Mission of Translational Research Office (TRO), the competent team which consists of number of experts of translational research (TR) from industry, academic TR institutes, regulatory organizations, is to support projects establishing clinical development plan.
