First call for proposals under the Innovative Medicines Initiative presented today in the presence of Commissioner Janez Potoènik and EFPIA President Arthur Higgins.
Brussels, Belgium-April 30, 2008-The decline in biopharmaceutical innovation is multi-factorial. Scientific challenges are increasingly complex and R&D costs are higher than ever before. At the same time, higher regulatory hurdles are slowing down new product approvals, while the downward pressure on prices continues and framework conditions in Europe are not innovation-friendly. In this context, only a partnership-based approach can help to accelerate the discovery and development of new medicines, according to Arthur J. Higgins, EFPIA president and chief executive officer of Bayer HealthCare.
Higgins was speaking on the occasion of a high-level event in Brussels marking the first call for proposals under the Innovative Medicines Initiative (IMI). This Joint Undertaking-a unique public–private partnership between the European community and the pharmaceutical industry represented by EFPIA-will dedicate €2 billion over the next five years to boosting biomedical innovation.
“Challenges in biomedical sciences have become so complex that no single research-based pharmaceutical company is able to face them alone,” said Higgins. “We as an industry fully accept our responsibility and are ready to play our part in bringing forward medical innovation. At the same time, we have no problem to admit that we cannot solve all these issues by ourselves-but rather, we need to join forces with partners to address the main causes of delays, or bottlenecks, in drug discovery.”
IMI will fund projects involving a variety of stakeholders, and in particular small and medium-sized enterprises, academia, research centres, patient groups, public authorities (including regulators), and the research-based pharmaceutical industry.
In his address, European Commissioner for Science and Research Janez Potoènik joined the EFPIA president in underlining the importance of collaborative efforts to help Europe regain a leadership role in biopharmaceutical innovation.
According to Jonathan Knowles, chairman of IMI’s governing board, EFPIA’s research director’s group, and head of group research at Hoffmann-la Roche, “Europe has great potential for innovation because of its excellent science base. However, it is lagging behind other global players such as the US. The Innovative Medicines Initiative will ensure that Europe’s biomedical sciences receive targeted strategic support for the benefit of patients, scientists, and citizens. This in turn will help to improve Europe’s competitiveness in biopharmaceutical innovation and make it a more attractive place for pharmaceutical R&D.”
Innovative patient centered projects that aim to address the causes of delay or bottlenecks in the biomedical R&D process are eligible for funding under the Innovative Medicines Initiative. The bottlenecks identified in the IMI Strategic Research Agenda are safety evaluation, the prediction of efficacy, knowledge management, and gaps in education and training. Better tools are required in these four areas in order to speed up the discovery and development of better medicines.
Improving safety evaluation will enable scientists to identify at an early stage of research those products with the best benefit–risk ratios and a greater likelihood of success. It will lead to a reduction in adverse reactions in patients; a more rational use of experimental animals and, possibly, a reduction in the number required; more adequate regulatory requirements; and faster medicine development.
Research to improve the prediction of efficacy will focus among others on the development of biomarkers. Biomarkers can be used as tools to understand the biology of a disease, but also to understand the effects of a new compound. Biomarkers may provide information on patient sub-populations that might respond to a new molecule or be susceptible to side effects-an approach that is the basis of the future concept of personalized medicine.
The knowledge management pillar under IMI will support safety and efficacy projects and communities of experts with their information management and information sharing, modelling, and simulation tasks (data pooling, data processing, etc).
As regards education and training in support of the medicines development process, a number of gaps have been identified. For specialists, there is a profound need in Europe for qualified personnel within the natural, technical, pharmaceutical, and medical sciences. Furthermore, there is a need for ongoing training to keep them updated with scientific and technology developments. The “vision for the future” outlined in the IMI Strategic Research Agenda is to establish by 2013 a European Medicines Research Academy, a pan-European platform for educating and training current and future professionals involved in biomedical R&D, including regulatory officers.
Research projects under IMI will focus on five disease areas. These are cancer, brain disorders, inflammatory diseases, metabolic diseases, and infectious diseases. These diseases have been chosen because they are, primarily, important areas of unmet medical need, affecting the lives of millions of European citizens. It is to be noted that findings in these areas will have a positive impact in other disease areas too.
In particular, the successful improvement of the R&D process through IMI will be directly applicable to the development of medicines for rare or orphan diseases, a diverse group of diseases affecting between 20 and 30 million Europeans today. Thousands of rare diseases are known. They are often severe, life-threatening, and chronically debilitating.