Maybe Europe’s pharma sector can save itself

Faced with the well-rehearsed problems of rising R&D costs and falling productivity in drug discovery and development, the US National Institutes of Health recently announced plans for a National Center for Advancing Translational Science (NCATS). The centre will open in 2012 with $1 billion of funding per annum, and a brief to reinvigorate the process of taking basic science through to the clinic and into new therapies.

For once, Europe is ahead of its US counterparts, with the Innovative Medicines Initiative (IMI), the €2 billion programme, half-funded by the Commission and half by the industry, which after four years in gestation was launched late in 2007.

NCATS – and it should be said, a number of similar measures by public funders in Europe – is trying to solve the problem of low productivity by getting basic researchers to work on their compounds and projects for longer  - a move that merely shuffles the risks and costs away from pharma and onto the public sector.

IMI on the other hand, has the ambition of remodelling the discovery and development process, by pulling pharma companies, biotechs, academics and patients’ groups into broad collaborations to precisely scope the medical need and develop new tools that will address the safety, efficacy and knowledge management issues that are stifling progress.

It’s a grand – some may say grandiose – undertaking, fraught with risk, Can pharma companies truely put their competitive instincts to one side and collaborate with their rivals? Can such large-scale, cross-boundary projects really function and be productive?

Last year there were rows about intellectual property rights and the funding model, with academics and biotech industry groups saying these issues were deterring them from getting involved, suggesting the legal, administrative and scientific complexities of IMI could make it untenable.

Well, this week provided the first opportunity for the wider public to form a judgement on how the IMI is operating and progressing, when the announcement of the second tranche of projects with total funding of €172 million, was accompanied by a progress report on some of the first wave of projects, which have now been running for a year or so.

Here was news of some initial, concrete outputs. Take for example the NEWMEDS project, which has compiled the biggest database ever on schizophrenia – with more than 10,000 patients included, and has begun to pioneer research combining genetic and imaging to put this information to use in improving treatments. Nine pharma companies, seven academic teams and SMEs are involved in this project.

Similarly, the U-BIOPRED project, which has 35 participants drawn from across 13 European member states, has developed an international consensus statement on the classification of patients with severe asthma and produced a new algorithm for use in clinical research.

IMI’s education and training programmes, PharmaTrain, EMTRAIN, Eu2P and SafeSciMET have now launched new European standards for graduate and post-graduate courses in medicines research, through the collaboration of 85 public and private partners.

IMI is also providing a new and more neutral forum for the industry to interact with the regulators. In the PROTECT project the European Medicines Agency (EMA) is coordinating work to develop pharmacovigilance tools, while the SAFE-T project is talking to the US Food & Drugs Administration (FDA) and the EMA about the strategy for qualifying biomarkers of drug safety for use in clinical trials.

Perhaps more significant was the assessment of Roch Doliveux, CEO of the Belgian pharma company UCB and member of the board of the European Federation of Pharmaceutical Associations (EFPIA), the body that is coordinating the industry’s involvement in IMI, who noted that the EFPIA now views IMI as a key instrument in implementing new business models that will “ensure the sustainability” Europe’s pharmaceutical industry. “The industry has reached an inflection point where public private partnerships, based on open innovation networks, will improve the efficiency of pharmaceutical companies in bringing safe, efficacious, cost-effective treatments to patients.” Doliveux said.

The outcomes to date may be slight progress in the face of the mountain that needs to be climbed. But they do represent an important start. IMI has established based camp. Now it can begin to contemplate the ascent.