Brussels, 20 Sep 2006
The Innovative Medicines Initiative (IMI) has published a new version of its strategic research agenda (SRA), outlining strategies to overcome specific 'bottlenecks' to efficient R&D for new medicines. Central to this would be a new European Medicines Research Academy (EMRA), with some similarities to the proposed European Institute of Technology (EIT), to promote excellence in medicines research in Europe. According to the SRA, 'These bottlenecks have been identified as: predicting safety, predicting efficacy, bridging gaps in knowledge management and bridging gaps in education and training.'
The European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA) will have joint responsibility for a new organisation to overcome these bottlenecks. The body will have the power to award grants to European Public-Private Collaborations to follow the strategy laid-out in the SRA, designed to overcome the bottlenecks to efficient R&D.
Mary Baker of the European Parkinson's Disease Association said, 'Patients in Europe need faster access to better medicines so we welcome the publication of the second version of the Strategic Research Agenda. Patients across Europe look forward to working in partnership with companies and universities in the Innovative Medicines Initiative.'
The SRA lists four 'pillars' to help focus research:
- Predictivity of Safety Evaluation (Pillar I): Nine recommendations, including a European Centre of Drug Safety Research, and a framework to develop human biomarkers and a regulatory utility;
- Predictivity of Efficacy Evaluation (Pillar II): Five recommendations, each related to the five priority disease areas for Europe: Cancer; Brain disorders; Inflammatory diseases; Metabolic diseases; and Infectious diseases. Recommendations include creating disease-specific European Imaging Networks, developing regional centres of excellence, creating disease-specific centres for the validation of new biomarkers and enhancing collaborations with patients and regulatory authorities;
- Knowledge Management (Pillar III): Fifteen recommendations, including: a Translational Knowledge Management team to support Pillar I and Pillar II projects, and creating a Knowledge Management Platform to develop effective data integration and analysis tools;
- Education and Training (Pillar IV): Five recommendations, including: a EMRA, and multi-disciplinary programmes to develop skills combining biology and medicine expertise.
The EMRA would be a, 'platform for education and training, covering the whole lifecycle of a medicine,' according to the SRA. It, 'should be based on existing centres of excellence within the relevant disciplines. It is not intended to build a system for E&T [education and training] parallel to existing universities and higher education institutions.'
Jonathan Knowles, Chair of the Research Directors' Group of EFPIA said, 'The members of the Research Directors' Group are eager to start implementing the exciting research projects defined in the Strategic Research Agenda the moment we get the green-light from the EU in 2007.'
The IMI will be proposed for Joint Technology Initiative status when the Seventh Framework Programme (FP7) begins in early 2007. The IMI will need some €3 billion in investment over the length of FP7, with the European Commission and pharmaceutical investment contributing equal shares.
For further information, go to the Innovative Medicines Initiative website:
And to the EFPIS website at http://www.efpia.org/
Read the SRA document: