The Innovative Medicines Initiative (IMI), the public private partnership established between the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA) in December 2007, is expected to become an autonomous body around the middle of next month.

The Commission was given responsibility for setting up the IMI and for its initial operations until the Joint Undertaking (JU) developed the capacity to implement its own budget. The appointment of Michel Goldman as executive director of the IMI, taking up the reins on 16 September, was “an important step towards IMI’s complete autonomy from the European Commission and EFPIA”, the industry association noted.

Professor Goldman’s appointment was announced at a press conference in Brussels this week, where the IMI unveiled the research topics for the second call for project proposals from research consortia seeking funding under initiative.

“The preparatory phase in setting up the IMI JU is coming close to the end,” noted Alain Vanvossel, interim executive director of the Undertaking, while Janez Poto_nik, European Commissioner for Science and Research, said the IMI was “now ready to fly on its own wings”.

The IMI Joint Undertaking comprises a Governing Board, split 50:50 between the initiative’s two founding members (the European Commission and EFPIA) and with overall responsibility for the JU’s operations and their implementation; an executive director (i.e., Professor Goldman), responsible for the day-to-day management of the Undertaking and supported by the Executive Office staff; and a 15-member Scientific Committee that advises the Governing Board.

Speaking at the press conference, Professor Goldman said the transition to an autonomous body reflected the need for a neutral third-party to ensure fair and equitable implementation of the IMI’s programmes and activities in the common interests of patients, industry and academia; to monitor the combined use of public funds and industry investments; and to guarantee fair and reasonable conditions for optimal exploitation of the knowledge generated by the initiative.

The different stakeholders in the IMI, such as large companies, academia and small and medium-sized enterprises (SMEs), were governed by different rules even if they were pursuing the same objectives, Professor Goldman pointed out.

Collaborative culture

Roche’s Jonathan Knowles, deputy chair of the IMI board and chair of the EFPIA’s Research Directors’ Group, highlighted fostering a collaborative culture as one of the main challenges facing the IMI as it moved forward. This called for a relationship of trust and better communications, he emphasised.

There was no point in blaming everything on the pharmaceutical industry or public health systems, Professor Knowles added. The IMI was a partnership; it was not about the Commission supporting industry, which was often happier with shorter-term goals.

One example of an emerging collaborative spirit was the SAFE-T (Safer And Faster Evidence-based Translation) Consortium funded under the IMI’s first call for proposals, which resulted in 15 projects being selected for investment last May.

This particular project was approved for funding on 20 March 2009 and kicked off on 15 June, with the goal of qualifying translational biomarkers to monitor organ safety (drug-induced kidney, liver and vascular injury) in human subjects. The consortium involves 20 partners in total, including 11 pharmaceutical companies, five academic institutions and four SMEs, with the European Medicines Agency and the US Food and Drug Administration acting as external advisors.

How intellectual property rights (IPR) for research results are distributed under the IMI is another area that may need some refining. In Brussels, Vanvossel noted that the IMI had elaborated its own IPR policy after two years of discussions. Nonetheless, there were still some concerns among the stakeholders and the IMI would need to see how the IPR issue panned out with the first-call consortia, he acknowledged.

The aim was to take a highly pragmatic approach and make any necessary adjustments to IPR policy if and when needed, Vanvossel commented. For the moment, though, he added, “let’s not fix something that is not broken”.

Professor Knowles pointed out that, under the IPR policy as it stood, all stakeholders shared equally in the outcomes of an IMI programme. If one partner felt intellectual property was a sticking point, he said, the programme could not go ahead – so there would not be any IPR available anyway.

Vision, courage, conviction

Summing up his experience of the IMI in its first year, Vanvossel said it had been “a story of vision, courage and conviction”, with both private and public partners stepping outside their respective comfort zones to engage in a new form of research collaboration.

According to Professor Goldman, who hailed the atmosphere of “trust and equilibrium” that already surrounded the IMI, public-private partnerships were the “best if not only” way to overcome the current obstacles to more productive research and development (R&D) in pharmaceuticals – and especially in a new era of personalised medicine that required a deeper understanding of disease processes and the identification of potential side-effects as early as possible.

Arthur Higgins, EFPIA president and chief executive officer of Bayer HealthCare, stressed that industry and other stakeholders must maintain their commitment to the IMI at a “very difficult” time for the pharmaceutical sector. The initiative was “far, far too important to fail”, he told the press conference.

The reality, Higgins said, was that pharmaceutical companies “can’t do it alone in the current climate”. That climate was one of growing pressure on public health budgets, ageing populations, declining competitiveness in the European pharmaceutical sector, a dramatic increase in the cost of R&D, very high attrition rates in the research pipeline, a more risk-averse regulatory environment, and a volume of new chemical entities that was “at best stagnant”.

The constrained economic conditions now prevailing meant there was a real risk that the resources for innovation would be cut – and “we must not let this happen”, Higgins warned.