The Innovative Medicines Initiative, IMI, finally has been approved by the European Parliament and becomes operative. The IMI, a unique partnership between the European Community and the European Federation of Pharmaceutical Industries and Associations (EFPIA) has been established as a Joint Technology Initiative, a major new element of the EU's 7th Research Framework Programme (2007-2013). Through the IMI Joint Undertaking, the IMI will manage €2 billion in research funds, with €1 billion coming from the FP7 funds and €1 billion in-kind from the member companies of EFPIA. In the first week of March the Governing Board, the decision-making body of IMI, has been constituted. The Governing Board of the IMI is composed of 10 members, representing equally its two Founding Members: the European Community, represented by the Commission and the EFPIA, the European Federation of Pharmaceutical Industry and Associations. The Governing Board shall have the overall responsibility for the operations of the Joint Undertaking. Decisions in the first meeting concentrated on two key priorities for IMI in 2008: launching the first call for project proposals and progressing towards making the IMI JU autonomous. The Governing Board therefore approved the draft scientific priorities for the first IMI call, full details of which will shortly be published on the IMI website www.imi-europe.org. A lot of useful documents, such as the statutes of IMI, the IPR policy and the workflow for calls and their review can be found under http://imi.europa.eu/documents_en.html
According to information gathered from several national kick-off meetings and presentations given at the member states group meeting, the topics of the first call will most likely be:
- Efficacy – Diabetes
- Islett cell research
- Surrogate markers for micro- or macrovascular hard endpoints
- Genomic and genetic studies for stratification of responders and non-responders
- Efficacy - Brain
- Pain Research
- Psychiatric disorders
- Neurodegenerative disorders
- Efficacy – COPD & Asthma
- Establishment of a European network on Asthma & COPD
- Translational medicine network for Asthma & COPD
- Health outcome network for Asthma & COPD
- Safety - Preclinical
- PredTox II
- Qualification of translational biomarkers from non clinical to early clinical studies
- Immunogenicity
- Non-genotoxic carcinogens
- Development of expert system for in silico toxicity prediction
- Safety – Pharmacovigilance
- Education and Training
- European Medicines Research Network
- Safety Sciences Training Programme
- Pharmaceutical Medicine Programme
- Integrated Medicines Development Training Programme
- Pharmacovigilance Training Programme
On Wednesday, April 30, an information day will be organised in Brussels to inform all key stakeholders on the details of the first call. The event will provide potential stakeholders with initial guidance on the application procedures.
In parallel the European Commission launched a call for nominations for the Scientific Advisory Board of IMI. This is composed of 15 scientists who should have a broad expertise on the whole drug discovery and development process. Each country is asked to nominate 10 scientists, 5 of which must be from other outside the country. Nominations are due at March 31st.
By Gerhard F. Ecker, University of Vienna
