A European public-private programme designed to tackle the bottlenecks in medicines development – the Innovative Medicines Initiative – is on track to start working on a range of research projects as early as next year.
Analogous to the Critical Path initiative in the USA, the IMI has the aim of developing ways to discover and develop better medicines, more quickly, that have fewer side effects, as well as correcting the under-funding of biomedical research that occurs in Europe relative to other parts of the world.
One of the architects of the project is Jorgen Dirach, director of corporate research affairs at Novo Nordisk. He told Pharma Times at the annual meeting of the Association of Clinical Research Professionals last week that one of the drivers for embarking on the project was the realisation that Europe is falling behind the rest of the world in biomedical research spending, in no small part because of mergers and acquisitions in the industry and the relocation of R&D activities to the more favourable operating environment in the USA.
Since 1990, R%D investment in Europe grew 2.6-fold, compared to a four-fold increase in the USA. Meanwhile, although pharmaceutical R&D budgets doubled in the period between 1992 and 2002, the number of innovative drugs reaching the market each year has been in decline.
The IMI’s newly-published Strategic Research Agenda has identified the key bottlenecks in R&D as follows: predicting drug safety, predicting efficacy, bridging the gaps in knowledge management and education and training.
“The background for the project, as laid down by the European Commission, is for industry to define the bottlenecks, and academia to come up with proposals to help solve them,” said Dirach.
One of the main objectives of the project is to increase the identification, validation and use of biomarkers which can be used as surrogates for clinical endpoints in translational medicine – the interface between preclinical and clinical research – and clinical trials themselves.
Another bottleneck is patient recruitment into studies, which in some European countries is quite easy, and in others quite a problem.
For an average Phase II or Phase III clinical trial, the patient recruitment time is around one year, while the average treatment period is just two months. “If we could reduce the recruitment period, we would save a lot of time, and also get a faster signal as to whether we should stop or proceed with the development of a compound.”
Finally, risk assessment by regulators – or pharmacovigilance – can be another bottleneck, particularly where additional data is requested to support the safety or efficacy of a new medicine. Here the IMI wants to look at ways to improve dialogue with regulators during development, as well as get them involved in the development of new biomarkers.
Underpinning the entire drug development process – from discovery through to pharmacovigilance, will be projects aimed at improving knowledge management and education and training, according to Dirach.
The IMI project is due to be debated at Europe’s Competitiveness Council this autumn and, all being well, could be approved by the end of 2006. “My personal evaluation is that this project will be flying next year,” said Dirach.
The seven-year project will combine the efforts of large and small drugmakers, academia, regulators and patient groups, and has an overall budget of 460 million euros a year or a total of 3 billion euros, half of which will be met by industry and half by the EU.
The results should be faster approval of new medicines, fewer post-marketing withdrawals and a need for fewer patients in pivotal trials, according to Dirach.