C-Path, IMI sign MoU to accelerate development of safer, more effective medicines for patients

Critical Path Institute (C-Path) and the Innovative Medicines Initiative (IMI) announced today that they have signed a Memorandum of Understanding (MoU) to further the missions of both organizations.

C-Path, based in the United States, and IMI, based in the European Union, share similar objectives that accelerate the development of safer, more effective medicines for patients. Both organizations bring together scientists from the pharmaceutical industry and academic institutions, as well as representatives from patient organizations and regulatory agencies, by forming precompetitive public-private partnerships that address scientific challenges impeding the successful development of new medical products. This MoU indicates the intent of C-Path and IMI to find opportunities to leverage one another's work in order to accelerate progress and prevent duplication of efforts.

The collaboration will foster increased information sharing regarding each organization's programs and create a mechanism to exchange knowledge and develop scientific consensus regarding 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 strategic agendas, streamlined communication and complementary projects.

In the key area of drug safety, discussions for such a knowledge exchange are already ongoing. The Predictive Safety Testing Consortium (PSTC) led by C-Path and the Safer and Faster Evidence-Based Translation (SAFE-T) Consortium supported by IMI are currently working on the development of new biomarkers to predict drug-induced injury to the liver, kidney, and vascular system in the clinical setting. Increased collaboration between the international consortia could create important synergies and lead to better results for both projects, for instance in their interactions with regulatory authorities including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).

According to Former FDA Commissioner, Mark B. McClellan, MD, PhD, who currently Directs the Engelberg Center for Health Care Reform at the Brookings Institution, "Partnerships between scientists, product developers, and regulators -- like C-Path and IMI -- are an important step toward accelerating the development of innovative new medicines. I hope this collaboration will improve the efficiency of the medicine development process in bringing safe, efficacious, cost-effective treatments to patients."

Michel Goldman, MD, PhD, 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. It is clear that IMI is performing a vital role in finding better solutions for patients across Europe, and, via the collaboration with C-Path, the impact will be global."

According to Raymond Woosley, MD, PhD, President and CEO of C-Path, "C-Path and IMI's work together will benefit patients around the world by making the drug development process more efficient by decreasing the time between discovery and patient access to new therapies."