Innovative Medicines Initiative
This article was originally published in SRA
Executive Summary
EFPIA proposes public private partnership
EFPIA proposes public private partnership
The European pharmaceutical industry federation, EFPIA, has proposed setting up a public private partnership with the European Commission to investigate new methods for developing drugs. But it still is unclear how much community funding the proposed partnership will receive, or whether it will be mostly financed by industry.
The future of the initiative was discussed at a 7 March 2006 meeting of the Drug Information Association in Paris, France. Octavi Quintana-Trias, director of health research at the commission, explained how the initiative fits in with the commission's objective of increasing research and development spending in Europe by promoting partnerships with the private sector, while Ian Ragan of Eli Lilly outlined the structure of the project. Known as the Innovative Medicines Initiative (IMI), the project has been included in the European Union's Seventh Research Framework Programme 2007-2013 (FP7). If it receives community funding, the IMI would involve the setting up of a new secretariat to coordinate work on drug development tools such as biomarkers1. The work would be undertaken by companies and academics working together to make the drug development process more efficient. In this respect, the IMI is very similar to the US Food and Drug Administration's critical path initiative.
Improving the productivity of industry
Mr Quintana-Trias said the initiative would help industry become more productive while boosting research in health. For example, it would stimulate new research into infectious diseases and into the causes of antimicrobial resistance. And it could provide new models for testing the safety of drugs without the use of animals. “Europe has a comparative advantage for this type of research because our public health systems are regulated and allow a central collection of data,” he said. While the overall aim of the initiative is to help raise the share of research and development to 3% of European gross domestic product, it has the added advantage of promoting cooperation between the public and private sectors.
A pilot project, InnoMed, has already been organised to test the IMI concept. Some 42 partners are working on tools for predicting toxicology, 18 of which are biopharmaceutical companies. The public sector is represented by universities in Würzburg, Germany, Dublin, Ireland and Istanbul, Turkey, while the companies include Bayer, Boehringer-Ingelheim, GlaxoSmithKline, Johnson & Johnson and Roche2.
EFPIA has also prepared a report, the strategic research agenda, that essentially outlines the work plan of a future IMI. The proposed work plan includes developing tools for predicting the suitability, safety and efficacy of drugs, developing infrastructures for data integration and knowledge management3. The IMI is expected to focus on “pre-competitive” research, which means that the participants will investigate tools that could be used across the drug development sector, irrespective of individual products. Pre-competitive research relates to studies of disease mechanisms, as well as the setting up of networks, Mr Ragan explained.
Like the FDA's critical path initiative, the IMI would try to bridge the gap between pure research and development by showing how new drug concepts could be confirmed at an earlier stage, and then validated in the clinic. New biomarkers developed by industry would have to be shared and tested. The information derived from this process could then be incorporated into regulatory standards4. “The problems [being addressed by the IMI] are similar to those being looked at by the critical path initiative. The key issue is how quickly this whole project will be launched,” Mr Ragan said.
Funding the Innovative Medicines Initiative
The IMI is one of six “joint technology initiatives” that have been proposed as part of the EU's seventh research framework programme. The other initiatives involve energy research, nanotechnology, research into global warming, embedded systems and aeronautics and air transport. Initially, the commission proposed to spend about €70 billion on the entire research framework. But in December 2005, the Council of Ministers decided to reduce the size of the entire EU budget for the coming financial year, thus leaving less money for research and other things. As of mid-March 2006, the council and the European Parliament were in talks about reducing the research budget. Once a new spending figure is decided, then the commission will need to reallocate the proposed funds within the various research projects. This process could take several more months5.
References
1. Ian Ragan comments at 18th Annual DIA EuroMeeting, Paris, France, 7 March 2006
2. Ian Ragan presentation to the Royal College of Physicians, London, UK, 11 November 2005
3. Annex III, Specific Programmes Implementing the Seventh Framework Programme, 21 September 2005
4. Mr Ragan comments at DIA EuroMeeting, 7 March 2006
5. Personal communication, European Commission, 15 March 2006