IMI is designed to fight the many bottlenecks that hinder new drug development in Europe and improve the region's competitiveness with the US and other areas of the world.
Subject to formal adoption by the EU Competitiveness Council that will hopefully arrive by the end of this year, IMI will launch its first calls for proposals in early 2008.
"We hope to be able to start the first research projects by the end of 2008. Depending on the projects we hope to see the first scientific results by the middle of 2009," said Christophe de Callatay, the spokesperson for the EFPIA.
After the approval, the Innovative Medicines Initiative will become a separate body, totally independent from the European Commission despite receiving half of its funds from the EU via its Seventh Framework Programme (FP7).
The other half of the funding will come from the industry, adding up to a total of €2bn. This will be the first time that competitors within the pharmaceutical sector will share resources for a common aim. But the architects of the IMI, including Jorgen Dirach of Novo Nordisk, believe that there was no other option left, since the scientific challenges that IMI wants to tackle are too complex for organisations to address in isolation.
25 of the biggest Europe-based companies will be involved in IMI, working through collaborative projects with public organisations that will be carefully selected through open calls for proposals and peer review processes.
The challenging European innovative wants to reinvigorate the biopharmaceuticals sector in Europe by developing new methodologies and tools that are better at predicting the safety and efficacy of possible new drugs and medicines.
IMI is expected to bring innovative medicines on stream more quickly and with 'greater certainty' about their use. For this, IMI will be working on four main areas, which are summarised in the Strategic Research Agenda Executive Report: safety evaluation, efficacy evaluation, knowledge management and education and training.
The industry will benefit from IMI in many different ways. For example, they will share the risk of implementing new technologies, and the process of interpretation of safety findings will be accelerated through sharing pre-competitive toxicology data. The IMI also expects to be able accelerate approvals through better collaboration with EMEA, the European Medicines Agency
Other initiatives include establishing a European Medicines Research Academy (EMRA) and the creation of a European Centre of Drug Safety Research (ECDSR), as well as establishing a framework to develop biomarkers that will indicate the human relevance and regulatory utility of early laboratory findings.
If nothing is done to fight the current situation of drug development process in Europe, other economies such as the US, Singapore, India and particularly China will be prepared to attract new industry investment as they have already launched competing initiatives, such as the FDA Critical Path and the Biomarker Consortium in the US or the Translational Medicine Centre recently established in Kobe, Japan.