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Reflector is Pharm Exec's Brussels correspondent.
Reflector outlines the obstacles ahead for Europe's revamped Innovative Medicines Initiative.
"2016 will be an exciting and challenging year," predicted Pierre Meulien, the newly-appointed executive director of the re-vamped Innovative Medicines Initiative (IMI) in his introduction to the current workplan of this $3.5 billion flagship joint venture in European drug development.
Exciting, maybe. Challenging, certainly. IMI still has a lot to prove, and the climate is not entirely favourable. A 'stakeholder forum' it has scheduled for Brussels in late September will offer a chance to assess how the challenge is being met.
The IMI concept, now up and running for getting on for a decade, was described at its launch as a "Champions League for biomedical research" by the European commissioner for research. His remarks reflected the optimism surrounding this unprecedented public-private partnership, in which participating drug firms match European Union research grants with a mixture of cash and in-kind contributions in projects selected together on the basis of an agreed strategic agenda. The Commissioner's comparison was nonetheless ill-judged, given the reputation of top-level international soccer for bitter rivalries, professional fouls, and astronomical spending.
IMI was set up to promote cooperation among drug firms, universities and research centres. Its key aims were to speed useful new products to patients, and to achieve better value-for-money from research spending by the public and private sector. But the programme's initial focus on early-stage pre-competitive research inevitably meant there was little prospect of it delivering breakthrough innovations of the sort that would capture headlines and provide evident justification for the eye-watering budget of €2 billion for its first seven years. Alongside discernible impatience at what looked like meagre results, sniping grew from smaller firms and research organisations that felt excluded from the action, or baffled by the ponderous participation rules.
Conscious of the need for change, the IMI hierarchy – a mix of company bosses and European Commission officials – relaunched the programme in 2014. Renamed IMI2, and running until 2024 with an expanded budget, it featured an explicit move to supporting research further downstream, and made earnest commitments to greater transparency, accessibility and outreach.
It wasn't a lucky attempt at a new beginning. At this crucial juncture, the organization endured a lengthy period of interim management because of a bungled process to appoint a new executive director. Meanwhile, repeated expressions of concern from the European Parliament over lapses in financial control and failings in transparency were breeding suspicions of mismanagement and lack of focus. A leading MEP, Inge Grässle of the parliament's budgetary control committee, accused the organization of an "inherent conflict of interest". And sharp criticism in the media – notably a high-profile, albeit ill-informed, attack in Spiegel – made IMI into an easy target for suggestions that public money was being siphoned off by drug firms for their own benefit, without much value to medical progress, and with questionable implications for patient safety. "Hundreds of thousands of so-called scientists around the coffee machine on EU taxpayer dough!" was a not untypical comment at the time.
Determined to demonstrate IMI's utility, and keen to salvage its reputation, Meulien has been pushing energetically at practical improvements since he took over at the head of the organisation. IMI is expanding its existing portfolio in diabetes, infection control, immunology and neurodegeneration, and exploring new areas, including advanced therapies, oncology, and the “one health” concept. It is developing a big-data strategy across all disease areas, and creating a sustainability scheme so that assets generated by projects are preserved as project funding comes to an end. And in response to the strongly political dimension of all health-related discussions in Europe, IMI plans include "an ambitious communication strategy that aims at improving transparency and clarity of our work and objectives to various audiences, including policy makers at European and national level."
The 2016 workplan constitutes a long list of promises of remedial actions, including "working to engage with associated partners from other industry sectors and philanthropic organizations and other public funders", so that research topic selection takes account of a wider range of views and can better incorporate input from ICT, imaging or medical technology too. Targeted support and guidance will be provided to smaller firms through a dedicated helpdesk, and efforts are to be stepped up in networking with venture capital organizations and the investment arms of pharmaceutical companies. IMI is also raising its profile more widely by taking a spot at major exhibitions - such as at BIO 2016 in San Francisco last June.
To avoid duplication of effort, joint funding initiatives or schemes run in parallel with national and international funding agencies are now under consideration. A first workshop on antimicrobials and clinical trials took place with the US National Institutes of Health earlier this year, and similar ventures are in the pipeline. Developing links with healthcare professionals – to assist in meeting IMI's motto of "delivering the right treatment at the right time to the right patient" – is another priority. So too is a bid to "reinforce collaboration with patient groups, regulators and those who pay for healthcare with a view to demonstrating the value that innovation brings."
Collaboration with regulators – particularly the European Medicines Agency and the FDA - is to be stepped up so that development strategies for novel biomarkers, patient-focused clinical endpoints, innovative trial designs or alternative pathways address real needs. And crucially, IMI now sees the need to expand "dialogue with other healthcare decision makers such as health technologies assessment bodies and payers" – firmly shifting IMI interests away from the remoter reaches of the laboratory and right into the heart of Europe's hottest discussions on healthcare. At the same time, IMI's evaluation of the projects it funds is to be further tightened up, to better reflect evolving science – and to close down projects no longer relevant or no longer delivering.
In IMI's favour, the passage of time is allowing some concrete results to emerge from IMI projects, strengthening its bid for recognition and approval. A recent study from Thomson Reuters concluded that IMI-funded research measures up well in quality and quantity against research supported by other high-profile funding organizations like the Wellcome Trust and the Medical Research Council. And an evaluation in May of the "socio-economic impact" of IMI's first nine projects to be concluded expressed praise for IMI's contribution to pharmaceutical R&D and to creating new knowledge and tools, as well as to leveraging further research funding and creating collaborative networks – although it also pointed to some failings, particularly where it highlighted gaps between IMI's work and the broader healthcare world. IMI has undertaken to analyse the report's recommendations and to work out how to implement them.
IMI still faces criticism from MEPs over its audits, and much of the basis of its work – speeding drugs through development – is under open attack from researchers, consumers and healthcare campaigners in an increasingly skeptical and suspicious Europe. Adaptive pathways, the EMA-led exploration of how authorization processes might become more flexible in response to options for more targeted therapies, is one of the focuses of IMI research, with a project known as ADAPT-SMART, and IMI's impending move into closer involvement in oncology is likely to drive it further into that direction. In addition, the prospect of the research-rich UK leaving the EU amounts to a further threat to the IMI concept of collaborative research.
All of which makes IMI's September stakeholder forum of greater interest. The agenda promises a focus on recent initiatives and results, on upcoming calls for proposals, and on partnering opportunities for grant applicants. Workshops on the future shape of IMI’s programs will cover oncology, advanced therapies, digital health, and bio-preparedness. And many observers will be watching to see how far IMI2 is now firmly and confidently moving in the direction that its creators envisaged.