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10 - EUROPEAN NEW SAFE AND INNOVATIVE MEDICINES INITIATIVES: HISTORY AND PROGRESS (THROUGH DECEMBER 2009)

Published online by Cambridge University Press:  04 April 2011

Ole J. Bjerrum
Affiliation:
University of Copenhagen
Hans H. Linden
Affiliation:
European Federation of Pharmaceutical Sciences
Bruce H. Littman
Affiliation:
Translational Medicine Associates
Rajesh Krishna
Affiliation:
Merck Research Laboratories
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Summary

Introduction

On April 30, 2008, the Innovative Medicines Initiative (IMI), worth 2 billion euros, was launched in Brussels, Belgium, as a joint undertaking (JU) by the European Union (EU) and the European Federation of Pharmaceutical Industries and Associations (EFPIA). The initiative is meant to boost the funding of research of the drug development process in Europe, by addressing the key bottlenecks in the drug development value chain.

The IMI focuses on clinical safety concerns, and it is seeking to improve the efficacy of new pharmacological interventions in areas such as cancer and brain disorders, as well as inflammatory, metabolic, and infectious diseases. Projects to be funded through the IMI will also address current deficits in knowledge management and education and training for pharmaceutical research and development (R&D) in Europe. Strengthening these four pillars (efficacy, safety, information management, and education and training) is foreseen to lead to new discoveries and faster development of better therapies.

Such a program and its associated investment has a long history. In Section 10.2, we also report on the history of earlier initiatives with the involvement of many stakeholders over several years and how they have led to this successful outcome. The EU research funding system and the many European stakeholders of it should first be briefly described.

The EU Research Funding System

When the EU was established, there was also the intention to create a central funding system for research with the purpose of facilitating and supporting research collaboration between its member states.

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Publisher: Cambridge University Press
Print publication year: 2011

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References

Innovation Medicines Initiative (IMI), http://www.IMI.Europa.eu
European Federation of Pharmaceutical Sciences, http://www.EUFEPS.org
Bjerrum, OJ. (2000). New safe medicines faster: A proposal for a key action within the European Union's 6th framework programme. Pharmacol. Toxicol. 86(Suppl 1), 23–26.CrossRefGoogle ScholarPubMed
Alderborn, G, Bjerrum, OJ, Lehr, CM, Linden, H, Nilsson, M-I, Reden, J et al.(2000). New medicines faster: Proposals for research topics, methodologies, techniques and other means promoting the drug development process to the benefit of European citizens. March 15–16, Brussels. European Federation for Pharmaceutical Sciences (EUFEPS) workshop. Available at: http://www.eufeps.org/document/pdfs/nsmf.pdf
The Innovative Medicines Initiative (IMI) research agenda. (February 15, 2008). Creating biomedical R&D leadership for Europe to benefit patients and society (version 2.0). Available at: http://imi.europa.eu/docs/imi-gb-006v2–15022008-research-agenda_en.pdf
Bjerrum, OJ. (2002). New safe medicines faster: A proposition for a pan-European research effort. Nat. Rev. Drug Discovery. 1, 395–398.CrossRefGoogle ScholarPubMed
Donnelly, F, & Jehenson, P. (2005). European technology platform on innovative medicines. Int. J. Pharm. Med. 19, 153–161.CrossRefGoogle Scholar
FP6 Workprogramme. Integrating and strengthening the European Research Area in Life sciences, genomics and biotechnology for health Call 1–4, 2002–2006. January 2002. Available at: http://ec.europa/research/fp6/pdf/fp6-in-brief_en.pdf
Bjerrum, OJ, Demotes, J, Odysseos, A, Sanz, F, Seiler, J, Strandgaard, K (2005). New medicines faster: How to establish a European technology platform for innovative medicines. April 21–22, Barcelona. European Federation for Pharmaceutical Sciences (EUFEPS). Available at: http://www.eufeps.org/document/pdfs/nsmf_III_final_report.pdf
Ainsworth, MA, Bjerrum, OJ, Bühler, FR, Dencker, L, Dirach, J, Hansen, JG, et al. (2003). New medicines faster: How to rethink and accelerate the development and approval of innovative, new medicines for faster patient relief. April 28–29, Copenhagen. European Federation for Pharmaceutical Sciences (EUFEPS). Available at: http://www.eufeps.org/document/pdfs/nsmf_II_report.pdf
Bjerrum, OJ, Caldwell, J, Claude, N, Linden, H, Mulder, GJ, Seiler, JP, et al. (2004). Report from European Federation for Pharmaceutical Sciences (EUFEPS) brainstorm workshop on safety sciences. April 2–3. Available at: http://www.eufeps.org/document/pdfs/safetysciences_report.pdf
U.S. Department of Health and Human Services, Food and Drug Administration. (March 2004). Innovation or stagnation: Challenge and opportunity on the critical path to new medical products. Available at: http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm077262.htm
The European Federation of Pharmaceutical Industries and Associations (EFPIA). Vision paper. Innovative Medicines Initiative. October 2010. Available at: http://www.imi.europa.eu/sites/default/files/uploads/documents/vision-document_en.pdf14. Innovative Medicines Initiative. InnoMed project. 27 Sept. 2007. Available at: http://www.imi.europa.eu/innomed_en.html

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