Today the second version of the Strategic Research Agenda of the Innovative Medicines Initiative (IMI) was published by the European Federation of Pharmaceutical Industries and Associations (EFPIA).
The Innovative Medicines Initiative is a unique pan-European public and private sector collaboration between: patient organisations, universities, hospitals, regulatory authorities as well as small and large biopharmaceutical and healthcare companies. The objective of IMI is to support the faster discovery and development of better medicines.
Over 350 senior representatives of: patient organisations, universities, hospitals, regulatory authorities as well as small and large biopharmaceutical companies worked together to produce the Strategic Research Agenda. This document describes recommendations on predicting safety and efficacy of new medicines as well as plans to bridge gaps in knowledge management and in education and training. These are the principal causes of delays in the complex process of developing new medicines.
The Strategic Research Agenda is also a roadmap to guide the rapid implementation of IMI. The European Commission and EFPIA are proposing to create and operate a new Public Private Partnership to lead and co-ordinate the development of Patient Centred Projects to accelerate the discovery and development of more effective innovative medicines. Building this organisation is pending a favourable decision by the EU Institutions.
Speaking for patients, 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.”
Rodolfo Paoletti, Professor of Pharmacology and Dean of the School of Pharmacy at the University of Milan said, “The opportunities in the Innovative Medicines Initiative for academia to participate in high-quality collaborative research projects are immense and I encourage academia to participate fully in this exciting development of biomedical research in Europe.”
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.”
Creating biomedical R&D leadership for Europe to benefit patients and society is the vision of IMI, which is a powerful strategic partnership between the European Commission and EFPIA, who are supporting the Innovative Medicines Initiative with strategic and financial resources.
About the Innovative Medicines Initiative (IMI)
IMI is a unique pan-European public and private sector collaboration between large and small biopharmaceutical and healthcare companies, regulators, academia and patients and represents a coordinated joint public and private collaboration to boost Europe’s biomedical R&D base, correcting the relative under-funding of biomedical R&D in Europe compared to other regions of the world.
The aim of IMI is to support the faster discovery and development of better medicines for patients and enhance Europe’s competitiveness by ensuring that its biopharmaceutical sector remains a dynamic high-technology sector. IMI will ensure that Europe’s biopharmaceutical sector receives targeted strategic support for the benefit of patients, scientists and citizens of Europe. IMI proposes a number of clear, practical paths that will accelerate the discovery and development of more effective innovative medicines with fewer side-effects.
IMI will implement innovative patient centred research projects that address the principles causes of delay or bottlenecks in the current process of discovering and developing new medicines through powerful public-private collaborations. These bottlenecks have been identified as predicting safety, predicting efficacy, bridging gaps in knowledge management and bridging gaps in education and training. The Strategic Research Agenda, a living document and will be up-dated based on scientific advances, describes the recommendations to address these bottlenecks and provides a plan to guide their implementation.
Enhanced European Competitiveness:
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The Innovative Medicines Initiative is important for Europe because it contributes to the European Union’s Lisbon Objective of building the most competitive and dynamic knowledge-based economy in the world by 2010;
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The Innovative Medicines Initiative is important for Europe because the scientific challenges facing Europe are too complex for organisations to address in isolation. Therefore pan-European public and private sector collaboration and co-ordination is essential to ensure that patients benefit from advances in biotechnology, such as the decoding of the human genome;
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The Innovative Medicines Initiative is important for Europe because it secures long-term prosperity for Europe through biotechnology, which the European Union considers to be essential for developing a dynamic and innovative knowledge based economy.
Distinct Benefits for Patients, Scientists and Europe:
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Faster discovery and development of better medicines will benefit patients;
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A more attractive professional environment will benefit scientists, addressing the brain-drain;
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The creation of European expertise and know-how in new technologies will attract biomedical R&D investment in Europe;
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The creation and support of sustainable competitive advantage for Micro, Small and Medium-Sized Enterprises (SME), spin-offs and start-ups will enhance Europe’s economy.
Implementation
To fully implement IMI would require an investment of about €460 million per year for an initial seven year period, starting in 2007, shared between the European Commission and the European Federation of Pharmaceutical Industries and Associations. A potential overall injection of over €3 billion of new funding to boost Europe’s science base and stimulate the faster discovery and development of better medicines. As part of the European Union’s 7th Research Framework Programme, IMI will be proposed for Joint Technology Initiative status — subject to approval by the European Competitiveness Council in 2007.
The European Commission and European Federation of Pharmaceutical Industries and Associations will take joint responsibility for creating and operating a new international not-for-profit organisation based on article 171 of the Treaty establishing the European Community. This organisation will have a legal mandate to award significant research grants to European Public-Private Collaborations to conduct innovative patient centred research projects focused on the principal causes of delay or bottlenecks in discovering and developing new medicines. The European Union’s 7th Research Framework Programme will fund academic participants of Public-Private Collaborations and support SMEs, while the biopharmaceutical companies will fund their own contributions to 100%. Other types of organisations participating in Public-Private Collaborations will be supported on a case-by-case basis. With this structure, public money will be used to exclusively boost the R&D capabilities of the public sector and small biotech companies and not biopharmaceutical companies. The biopharmaceutical industry partner(s) will match the funds from the European Union’s 7th Research Framework Programme with R&D resources such as staff, laboratories, materials and clinical research capabilities.
About EFPIA and the Research Directors Group (RDG)
The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the research-based pharmaceutical industry operating in Europe. EFPIA’s Research Directors’ Group (RDG), in which European Biopharmaceutical Enterprises (EBE) — a specialised group within EFPIA — also participates, brings together the European heads of research from the world’s leading pharmaceutical companies to address the issues facing research and development of (bio)pharmaceuticals in Europe.