Dip your toe in

IT’S NOT OFTEN these days that you hear about large sums of money being made available to fund research in Ireland. And with a squeeze on national resources, Irish researchers are being encouraged to look to Brussels to help keep operations going.

So a €2 billion European funding programme that encourages academic groups, small enterprises and not-for-profit agencies to join forces with multinational pharmaceutical companies and lay the groundwork for new therapies, sounds like just the ticket.

Yet as the dust settles on the first call for the Innovative Medicines Initiative, only three participants from Ireland were involved in the successful consortia.

There hasn’t been much uptake of the IMI’s funding scheme in Ireland to date, according to Dr Ciarán Duffy from Enterprise Ireland. One contributing factor, he suggests, could be that our academics have a relative lack of experience in research interactions with big pharmaceutical companies compared to other countries.

“A lot of the Irish researchers are perhaps not connected in with the large pharma – we don’t have the large RD-based pharma here,” says Duffy, who is Ireland’s national representative for the IMI. But getting more involved with big companies in Europe could help showcase our skills, improve our contacts and stimulate innovation in RD here, he argues.

“In Ireland we have the capability, the research, we have invested heavily for the last seven or eight years and it’s time to reap the benefits of that and let the corporate sector see what expertise we have on the ground here. This has to be of benefit to us.” But Irish researchers and companies may also still need to become more aware of the scheme, he adds, which had its first call in 2008.

So what is the IMI about? “Essentially it’s a €2 billion investment, a public-private partnership between the European pharma industries and the European Commission,” says Duffy.

“The EFPIA has said there is a problem here: Europe is losing the battle in terms of innovation, our researchers are going to the US and China, RD is being transferred out of Europe – and this is one of the mechanisms they are putting in place.” The idea is to improve early-stage research into drug discovery, development and testing and thereby help to reduce failures at the later (and expensive) clinical trials stage.

“The cost of bringing a new drug from discovery to market ranges from €800 million to €2 billion. And if you look at the numbers of compounds that are discovered and the numbers of drugs that make it to the shelf, there’s a huge difference there, a massive number of them fail at ,” says Duffy.

“So we need to predict better which compounds are going to succeed and so reduce the overall number of clinical trials – that is a huge part of where the money is lost.”

With that in mind, and very much defined by industry needs, the IMI is homing in on “pre-commercial” enabling technologies such as platforms to screen for molecules that act as biomarkers of disease or that could be targeted by a drug therapy. Knowing more about such molecules at an early stage of discovery could help cut down on those expensive failures later on.

Máire Geoghegan-Quinn, the new European Commissioner for Research, Innovation and Science, is positive about European uptake of the scheme so far. “The initiative has been received enthusiastically,” she says, noting that by the second call’s deadline last month, 1,120 participants had joined forces in a total of 124 finalised expressions of interest, which she describes as “a very good outcome”.

That said, there are some potential minefields that need to be carefully navigated, such as the intellectual property rights arising from the research. “That needs to be carefully looked at, although the people I have engaged with have been satisfied with the agreements put in place,” says Duffy.

“And the IMI has a working group looking at that to amend and constantly update it as the feedback comes back from the first call.”

But one of the most glaring teething problems is the relatively low financial support for overhead costs, which can be a potential barrier for cash-strapped applicants from the public side, according to Duffy.

“One of the core differences between the IMI and Framework 7 is in the level of overhead funding,” he says. “Framework 7 will give you 75 per cent for research costs and 60 per cent for overheads.

IMI will give you the same for research costs, but only 20 per cent for overheads. So we have a situation where universities are in difficulty and they ask, ‘can we afford to be involved?’”

Duffy has raised the issue of overheads, as have representatives of other states, and Geoghegan-Quinn told Innovationthat the matter was currently being examined.

“We are aware of the concerns regarding the overhead provisions, and are looking deeper into it. The overhead provisions are part of a set of rules created before I became a commissioner and before IMI became an autonomous body. We will explore what can be done to alleviate the concern.”

Overall, the outcomes of the initiative should benefit patients, notes Geoghegan-Quinn, with the target of “better and safer drugs and progress towards cures for diseases such as diabetes, chronic pain and certain cancers, where no effective cure is yet available”.

And, by improving the research environment in Europe, the initiative also hopes to help reverse the brain drain and help prevent pharmaceutical companies relocating to the US and Asia, she adds. “That will benefit all member states, including Ireland.”

Smaller enterprises should reap the rewards too. “It is important to stress that this is not just about large and established pharmaceutical companies,” she says.

“IMI can strengthen the competitive position of smaller players, which over time will help them to flourish and grow. Indeed, greater participation of SMEs is a major priority for me across all of the EUs research and innovation activities.”

Innovation medicines initiative at a glance

What is it?A €2 billion investment into public-private partnership between the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA), which represents 24 companies. The Commission provides €1 billion (using FP7 funding) and another €1 billion comes from EFPIA members through in-kind contributions.

What does it do?The initiative is looking to fund academic researchers, small businesses and not-for-profit agencies to form research partnerships with multi-national pharma companies

Why?The IMI aims to boost early-stage research in biopharma in the hope it will make RD in Europe more competitive; slow brain drain out of the region; help minimise expensive failures at later stages of clinical testing and ultimately get better drugs to patients.

How?It's designed to reduce research bottlenecks and meet the needs of the biopharmaceutical industry by improving tools to identify and screen molecules in the early stages of drug development and testing. The main pillars are prediction of safety, prediction of efficacy, knowledge management, education and training. The focus areas are cancer, inflammatory diseases, brain disorders, metabolic diseases and infectious diseases.

What are the issues?The relative lack of funding provisions for overheads in IMI grants is a concern for applicants such as universities, which may not be able to afford to take on the projects as a result.

How is Ireland doing?Three participants from Ireland were in consortia that successfully applied for funding through the first call of the IMI – Argutus Medical, Trinity College Dublin and Hibernia College.

The Commission has not yet released information on the number of Irish participants that responded with expressions of interest to the second call, which closed in February.