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US and EU link faster pharma R&D initiatives

World News | June 15, 2011


Lynne Taylor

US and EU link faster pharma R&D initiatives

Europe's Innovative Medicines Initiative (IMI) and the US Critical Path Institute (C-Path) have signed a Memorandum of Understanding (MoU) to further accelerate the development of safer and more effective medicines.

Both the IMI and C-Path work to bring together scientists from the pharmaceutical industry and academic institutions - as well as representatives from patient organisations, small and medium-sized enterprises (SMEs) and regulatory agencies - to form pre-competitive partnerships. By combining their knowledge and expertise in innovative projects, the scientists in these partnerships are able to tackle challenges that are too big and complex for individual research teams to handle on their own, the groups note.

IMI is the world's largest public-private partnership in health care, with funding of 1 billion euros from the European Union (EU) matched by in-kind contributions worth at least another 1 billion euros from the member companies of the European Federation of Pharmaceutical industries and Associations (EFPIA).  C-Path is an independent, non-profit organisation set up in 2005 with US federal and private funding which has established global public-private partnerships currently including over 1,000 scientists from government regulatory agencies, academia, patient advocacy groups and 35 major pharmaceutical companies.

Under the new MoU, the IMI and C-Path will aim to find opportunities to leverage each other's work in order to accelerate progress and prevent  duplication of efforts.

The collaboration will foster increased information-sharing regarding each organisation's programmes and create a mechanism to exchange knowledge and develop scientific consensus regarding research and testing methods. It also aims to establish a platform to provide oversight and management of databases of non-competitive information, which will be made available for public use.

Discussions for knowledge exchange are already ongoing in the area of drug safety, with the SAFE-T consortium (supported by IMI) and the Predictive Safety Testing Consortium (PSTC, led by C-Path) currently working on the development of new biomarkers to predict, diagnose and monitor, in the clinical setting, drug-induced injury to the liver, kidney and vascular system. Increased collaboration between the international consortia could create important synergies and lead to better results for both projects, for example in their interaction with the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), according to the partners.

"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," said IMI executive director Michel Goldman. "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," he noted.

"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," added C-Path chief executive Raymond Woosley.

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