EU’S Innovative Medicines Initiative to collaborate with FDA’s Critical Path

Europe’s Innovative Medicines Initiative (IMI) is joining forces with its US counterpart, the Critical Path Institute (C-Path) to further their shared mission of reshaping the drug development process to improve the productivity of pharmaceutical industry R&D.

Both organisations bring together scientists from the industry and academic institutions, with representatives from patient organisations, small companies and regulatory agencies, in precompetitive public-private partnerships.

By combining knowledge and expertise, these partnerships aim to tackle challenges that are too big and complex for individual research teams to handle alone. Now IMI and

C-Path have agreed to look for opportunities to leverage one another’s work, to further accelerate progress and prevent duplication.

The collaboration will foster increased information sharing and create a mechanism to exchange knowledge and develop scientific consensus on research and testing methods. It also aims at establishing a platform to provide oversight and management of databases of non-competitive information to be made available for public use.

This will occur under the formal collaborative agreement via joint meetings, shared agendas, streamlined communication, and complementary projects.

In the key area of drug safety, discussions for such information exchange are already taking place. The SAFE-T consortium supported by IMI and the Predictive Safety Testing Consortium led by C-Path are currently working on the development of biomarkers to predict, diagnose and monitor drug-induced injury to the liver, kidneys and the vascular system.

Increased collaboration between the two partners could create important synergies and lead to better results for both projects.

Michel Goldman, Executive Director of IMI said, “The uniqueness of what IMI is doing is the scale and the innovative approach of the collaborative research now being undertaken and how it is transforming drug development […..]. Via the collaboration with CPath, the impact will be global.”

The IMI is the world’s largest public-private partnership in health care. The EU is contributing  €1 billion to the programme, which is matched by in-kind contributions worth at least another €1 billion euro from the member companies. At present, IMI is funding 23 projects, many of which are already producing impressive results.