European Journal of Cancer

Issue 2, 2008

EUROFILE

By Ian Mundell

Private-public drive to cut delays in drug development

The EU’s new Joint Technology Initiatives (JTIs), are intended to bring together EU and private funds to implement a research programme whose priorities are set by industry. Among the first to be launched will be the Innovative Medicines Initiative JTI (IMI), with a budget of €2 billion up to 2017. IMI will address bottlenecks in the drug development process, including, from 2009, cancer treatments.

Half of the funding will come from EU funds, half from the pharmaceutical industry, represented by European Federation of Pharmaceutical Industries and Association (EFPIA). If all goes to plan – the legislation is currently being scrutinised by EU ministers and European Parliament – the programme should start at the beginning of 2008.

An organisation set up in Brussels will manage funds and issue calls for proposals, a role normally reserved for the European Commission. Although the Commission will be represented on the IMI board and have a strong role in overseeing its work, this devolution of power is a radical departure for EU research programmes.

The IMI is also intended to be a change from the traditional pattern of collaboration in the pharmaceutical industry, in which companies work on a one-to-one basis with partners such as universities to develop new drugs. The EU wants to see more research and development on tools and methodologies that can be used by all companies active in the drug development process. So, rather than look for new drug targets or candidate compounds, IMI will address research bottlenecks in the drug development process. This should reduce development times, enable faster access to more targeted medicines and an earlier return on research investment.

Tools and methods will be developed to better predict the suitability, safety and efficacy of drugs early in the development process, before costly clinical trials begin. 'Intelligent infrastructures' will be established for data integration and knowledge management between industry, academia and clinical centres. This is intended to stop the duplication of research efforts in both the public and the private sector. Finally, education and training gaps will be addressed.

The EU money will be used to support academics participating in projects, clinical centres, patient organisations, public authorities and small and medium-sized enterprises. EFPIA member companies will cover the costs of their part of the research collaboration.

Projects will be selected on a yearly basis from a strategic research agenda developed by EFPIA, in consultation with researchers and other stakeholders. The content of the first call for proposals is expected in draft form in December, 2007.  Cancer research is expected to feature in the second call, in 2009, with topics aimed at improving predictivity of efficacy evaluation of cancer treatments (see http://www.imi-europe.org/).

Reaction to the IMI from the cancer research community has been generally positive. Françoise Meunier, director general of the European Organisation for Research and Treatment of Cancer (EORTC), thinks the IMI has potential. "IMI should be able to contribute to accelerating access to new drugs, and as a collaborative tool between industry and academia it can benefit both parts and bring cohesion to the European landscape," she said.

"It’s a very daring and novel thing to do," commented Gordon McVie, co-ordinator of clinical research at the European Institute of Oncology in Milan,. He is impressed by the matching of EU and industry funds, the promised reduction in bureaucracy and the transparency of the project selection processes. "All the things that you would want in a science research programme appear to be in there."

The fact that industry is setting the agenda does not pose a problem, he said: "Fostering the business of cancer research in Europe is unthinkable without the industry, so I think it's an enlightened approach".

The European Cancer Research Managers' Forum, however, has reservations about tying such a large amount of public funding to industry priorities. "We don't consider it a bad thing, but we don't necessarily consider it a good thing. You need to be very cautious with something like this," explained Seth Eckhouse, director of the ECRM secretariat and co-author of its recent report on cancer research funding in Europe.

The danger is that such public-private partnerships draw funds away from more fundamental research, instead favouring projects that industry identifies as having low-risk, predictable outcomes, he said. Meanwhile the competition for remaining funds goes up, with the risk that researcher productivity falls.

Finally, public-private partnerships tend to direct funds to centres that are already strong. "When you are using public funds to help finance private research these funds tend go to where there are significant labs already set up, where they have a really good base of highly trained researchers already in place, where pharma companies exist already," Eckhouse explained, highlighting France, the UK and Germany as the countries most likely to benefit. "You are not addressing the widening R&D gap, the haves and have-nots, East and West, that we see in Europe."

A particular concern for EORTC is the gap between the budget originally conceived for strategic research - around €3bn - and the €2bn now allocated to the IMI. "According to the IMI website, the estimated budget allocation for efficacy evaluation in drugs for cancer is still €66.7 million per year, as it was when the overall IMI budget amounted to €3.2 billion," said Françoise Meunier. "It would be appreciated if this budget allocation for cancer is confirmed as well as the distribution of the overall IMI budget within the strategic research agenda."