One of 5 JU, others in energy, aeronautics, IT and electronics New approach to financing R&D Long term public-private partnerships in research at European Level Co-ordinated research efforts responding to industry needs Implemented through new legal entities – Joint Undertakings , established under European Law
IMI funded from the FP7 pot Topics are complementary to the health call themes IMI JU consults with health Directorate to ensuer no overlaps
Only one drug candidate in 10,000 will reach the market/patient. It takes up to 10 -13 years to develop a drug and bring it to the market. It requires an investment of around €1 billion on average for each new drug Make drug discovery and development process in Europe more efficient Enhance European competitiveness in the pharmaceutical sector Drug development process is getting harder and harder – create an environment of open innovation to overcome key issues
Safety : this addresses bottlenecks related to accurately evaluating the safety of a compound during the pre-clinical phase of the development process, but also impacts the later phases in clinical development. Efficacy : this addresses bottlenecks in the ability to predict how a drug will interact in humans and how it may produce a change in function. Knowledge Management : this addresses the more effective utilisation of information and data for predicting safety and efficacy. Training + Education : this closes existing training gaps in the drug development process.
Projects must include at least two EFPIA member companies, and two legal entities who are not members of EFPIA and who are eligible to receive IMI funding Any organisation carrying out activities relating to IMI objectives, in EU MS or AC can participate Others may participate if agreed by IMI governing board Participants must have the capacity to carry out the work themselves Project budgets will aim at a 50:50 ratio between in-kind contributions from EFPIA Members and the financial contribution from IMI. In kind contributions from EFPIA members will be in the form of R&D resources such as personnel, laboratories, materials and clinical research
STAGE 1 Document on official forms and submission procedure Scientific /technological case (3 pages) Partnership case (I page plus ½ page per participant) Summary of workplan (2 pages including indicative budget plan) Ethical Issues (1/2 page) No involvement from EFPIA companies at this stage Evaluation Panels Independent experts and EFPIA coordinators Evaluation criteria; science technology, partnership, work plan Outcome Ranking and selection of the best EoIs EFPIA coordinators do not contribute to the final ranking Only one project per topic will be funded STAGE 2 Highest ranked EoI will be invited to jointly develop a full Project Proposal with the EFPIA consortium associated with the topic. Full proposal is subject to a final review by independent experts Successful consortia invited to conclude a Grant Agreement with the IMI.
IMI Graham Hughes
Innovative Medicines Initiative Graham Hughes UK National Contact Point Health "By joining the best academic teams with high-level industry scientists, IMI is building the research capacity needed to cure the major diseases of our time." Michel Goldman, IMI Executive Director
IMI in the Health Theme Activity 1: Biotechnology, generic tools & technologies for health Activity 2: Translating research for human health Activity 3: Optimising the delivery of health care cross-cutting issues: international cooperation, SMEs, child health, ageing populations, gender -related health issues Activity 4: Support actions & response to policy needs The Innovative Medicines Initiative
What are the Expected Results? <ul><li>To modernise the development process of medicines; </li></ul><ul><li>To drive the development of innovative medicines with a high level of safety and efficacy, for millions of patients; </li></ul><ul><li>To generate more and better quality jobs for scientists , reversing the European brain drain; </li></ul><ul><li>To enhance European expertise and know-how in new technologies to attract pharmaceutical R&D investment to Europe; </li></ul><ul><li>To create a stronger competitive advantage for smaller companies (SMEs, spin-offs and start-ups) and public organisations by collaborating with a multitude of stakeholders. </li></ul>
How to Achieve Results <ul><li>Support “pre-competitive pharmaceutical research and development ” – accelerate the development of safer and more effective medicines for patients </li></ul><ul><li>Modernization of the drug development process , via new approaches, methods and technologies, better use of research results and data and more skilled staff </li></ul><ul><li>Foster collaboration between stakeholders , e.g industry, academia, patient organisations, public authorities (inc regulators) , clinical centres etc </li></ul><ul><li>Addresses the challenges in the development process of drugs rather than aiming to deliver new medicine s </li></ul>
How is it funded? <ul><li>EFPIA members fully fund their own participation and provide R&D resources such as staff, laboratories, materials and clinical research . </li></ul><ul><li>EU funds exclusively public organisations or nonprofit organisations and small and medium-sized enterprises (SMEs). </li></ul>
IMI Projects: Key facts <ul><li>Open and competitive calls with a peer review process by independent experts </li></ul><ul><li>Average project size €15 - 20 million </li></ul><ul><li>Average consortium size in the range of: </li></ul><ul><ul><li>9 – 16 pharmaceutical companies </li></ul></ul><ul><ul><li>9 – 37 academic, SME, regulatory, patient organisations </li></ul></ul><ul><li>EU funding to academic, SME and other partners is </li></ul><ul><ul><li>75% of total eligible research costs </li></ul></ul><ul><ul><li>100% of total eligible management and training costs </li></ul></ul><ul><li>Total eligible costs include direct eligible costs plus 20% overheads </li></ul>