[euro]2 billion IMI launched with European pharma

Abstract

By July 15, the organizers of the Innovative Medicines Initiative (IMI)—one of the largest pharmaceutical research projects ever—can start to judge whether their project has a chance of success. Heralded as an approach that will “reduce the risk of clinical trials” and “remove the major bottlenecks in drug development,” the launch of IMI represents not only a significant investment—€2 ($3.1) billion in total between 2008 and 2013—but also a significant departure in policy for the European Commission (EC), in Brussels. In virtually all previous EU-funded research, the EC has both designed the research agenda and funded it. This time, the EC only funds the research; the research agenda has been set by industry, specifically by the directors of research of the member companies of the European Federation of Pharmaceutical Industry Associations (EFPIA), in Brussels. Industry steers while the European taxpayer fuels the venture. Mid-July is the closing date for applications for the first €123 ($190) million stage of the project, launched on April 30. The level of response to the first call and the quality of the research consortia applying for grants will give the EC and EFPIA partnership a clear idea of whether this effort is likely to take off. The hope is that IMI will provide a general fillip for the drug development sector in Europe, including small and medium-sized biotech enterprises, although technology platform companies are likely to gain more than product companies in the near term. To say that expectations of IMI are high is an understatement. It will be a “major step in changing the European research landscape,” according to Alain Vanvossel, IMI’s interim chief executive. “It will put Europe on the map as the most progressive and innovative place for pharmaceutical research,” he claims. Jonathan Knowles, head of Global Research at Roche, of Basel, Switzerland, and chair of the EFPIA Research Directors’ group, is equally effusive. “There is nothing like IMI anywhere on this planet. It is innovative and I believe that it is the key to our creating absolutely breakthrough therapies to change totally the practice of medicine.” And European Science and Research Commissioner Janez Potočnik, clearly a soccer fan, says that he wants Europe “to be the best in the world and become a Champion’s League for biopharmaceutical research by moving [with IMI] from individual project funding, to joint program funding involving industry and public stakeholders.” Ian Ragan, who through his London-based consultancy firm CIR Consultancy is acting as an advisor to EFPIA on IMI, sees the involvement of industry as the key differentiating factor for IMI. “There have been several successful consortium approaches in pharmaceutical research,” explains Ragan, a former research manager at Indianapolis-based Eli Lilly and Whitehouse Station, New Jersey–based Merck, citing Critical Path in the US as an example. “But whereas Critical Path was instigated by the US Food and Drug Administration, IMI is driven by industry,” he says. The change in direction of research policy has required considerable political machination. It has been over four years since the notion of the scheme was first put forward by the EC. The European Parliament in Strasbourg, France, established IMI in December 2007, along with three other large-scale industry-driven initiatives: environmentally friendly aviation (Clean Sky), embedded computing systems (Artemis) and the Nanoelectronics 2020 Initiative (ENIAC). The regulation came into force in February, and IMI’s governing board met in March to approve the work plan that led to the call for proposals on April 30. The scope of IMI is broad and reflects the interests of the large and mid-sized companies that are members of EFPIA (see Table 1). The proposals fall into four principal areas: predicting drug safety, predicting efficacy, knowledge management, and education and training. For each call, a group of EFPIA companies has prepared a detailed outline of the research objectives. In call 4, for instance, which concerns the assessment of animal model systems for toxicity prediction, it is Bayer Healthcare of Leverkusen, Germany; Boehringer-Ingelheim of Ingelheim, Germany; Merck Serono of Geneva; Novartis of Basel, Switzerland; Orion Pharma of Espoo, Finland; Roche; Sanofi Aventis of Paris; Servier of Neuilly-sur-Seine, France; Solvay of Brussels; and UCB of Brussels that have set the agenda. In other projects, different combinations of pharma firms participate. But in every case, the EFPIA companies are not eligible for IMI funding and in fact contribute resources to the project. In the animal toxicity project, for instance, an estimated €10 In this section

DOI: 10.1038/nbt0708-717

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Cite this paper

@article{Hodgson2008euro2BI, title={[euro]2 billion IMI launched with European pharma}, author={John Mc B Hodgson}, journal={Nature Biotechnology}, year={2008}, volume={26}, pages={717-718} }