Partners

The ENSEMBLExJ Project builds a network of domestic partners in Japan to support each stage of development, approval, and commercialization. Depending on the nature and objectives of each project, the ENSEMBLExJ Project envisages collaboration with partners in the following categories.

Pharmaceutical companies

These partners support development advancement, regulatory approval, business partnerships, and post-launch activities in Japan.
They are important partners for companies considering medium- to long-term expansion in the Japanese market.

“Co-development,” “in-licensing,” “licensing,” “regulatory submission,” “commercial collaboration,” “post-launch support,” “pharmacovigilance,” “business partnership,” and “market expansion”

CRO

These partners support the practical aspects of clinical development in Japan, including clinical trial start-up, site selection, regulatory coordination, and safety management.
They provide implementation support for overseas companies advancing drug development in Japan. CROs with CDMO capabilities, whether in-house, within their corporate group, or through partner networks, as well as CDMOs, are also included in this category.

“Clinical trial support,” “development operations,” “site start-up,” “site selection,” “regulatory support,” “PMDA interactions,” “safety management,” “CDMO,” and “commercial support”

Clinical Study Group

These are groups of physicians or medical institutions specializing in specific disease areas.
They support the introduction of medicines, including investigational products, that are needed by patients in Japan by conducting clinical trials, including investigator-initiated trials, in collaboration with medical institutions within their networks.

“Investigator-initiated trials,” “clinical trial conduct,” and “clinical trial site network”

Others

This category covers a wide range of activities, including analyses to communicate an accurate understanding of the Japanese market to overseas stakeholders, as well as support for overseas BioTech companies entering Japan in collaboration with ENSEMBLExJ.

“Venture incubation,” “market research,” and “inbound support”