Innovative Medicines Initiative moves up a gear

Now that the Innovative Medicines Initiative has entered its second phase, a recent Stakeholder Forum in Brussels offered the occasion to take stock of past achievements and look forward to future opportunities

The EU’s Innovative Medicines Initiative (IMI) public-private partnership (PPP) – now in its second phase – has demonstrated how it can deliver medical solutions to complex disease issues.

At a Stakeholder Forum in Brussels in June, Rudolf Strohmeier, Deputy Director General of the European Commission's research and innovation directorate-general, said the aim of the forum, the first since the launch of IMI’s second phase last year, was to assess how far the initiative has come and what new opportunities might be available to different member groups. The IMI is a joint undertaking between the EU and the European Federation of Pharmaceutical Industries and Associations (EFPIA). The first phase began in 2008 and it is Europe’s largest PPP, with a €3.3bn budget for the period 2014–2024.

This is a chance to take stock of what we have achieved and to look to the future

‘This is a chance to take stock of what we have achieved and to look to the future. The health sector faces many challenges, including tightening national health budgets and I am convinced that the only way forward is more research innovation,’ said Strohemeier, who is also Deputy Chair of IMI. The IMI had, he told a 500-strong audience, brought ‘new insight’ and sought to cultivate ‘new breakthroughs’ in medical research.

The IMI currently oversees 60 projects, involving around 7,000 researchers from universities, pharma companies, patient groups and regulatory authorities. Data presented at the forum shows that by the end of 2014, IMI projects had delivered more than 1,134 scientific publications and that the citation of IMI papers is twice the world average.

According to Pierre Meulien, IMI’s newly appointed Executive Director, this is further evidence of the power of collaboration on health research. Canada-based Meulien, who will take up his new post in December 2015, describes IMI as a ‘unique’ joint venture that will ‘continue to deliver health innovation’.

The forum focused on some of its success stories. These include the European Lead Factory (ELF), which provides access to data on some 326,000 compounds that could potentially be developed into new medicines. Launched in 2013 and funded by €200m (US$225m) through the IMI, the factory won the prestigious Bio-IT World Best Practices Award in April 2015 for a software tool it developed to protect the IP of compounds.

In the past there was a huge gap between academia and the pharma industry. Ours is a great example of how this gap can be bridged

Dimitrios Tzalis, CEO of Taros Chemicals and the leader of ELF’s chemistry consortium, told the forum the collection will rise to 500,000 compounds by the end of 2017, adding: ‘In the past, and this is still the case to a certain extent, there was a huge gap between academia and the pharma industry. The two were not connected. Ours is a great example of how this gap can be bridged by bringing together the best minds on one problem. The project is a blueprint for successful partnership in early drug discovery.’

Another success story highlighted was the Novel Methods leading to New Medications in Depression and Schizophrenia (NEWMEDS) project, where companies have pooled their data to create the largest-known database of studies on schizophrenia, including information on more then 23,000 patients in at least 25 countries. By analysing their immense database, NEWMEDS researchers found that clinical trials could be shortened by up to two weeks. Mike Hardman, Project Co-ordinator of the European Medicines Research Training Network (EMTRAIN) project, said IMI’s educational and training work was particularly important. It includes the SafeSciMET project, which he said will develop a ‘comprehensive modular education and training programme’ teaching safety in the development and research of medicines.

Another success story, said Hardman, is the European Autism Interventions – A Multicentre Study for Developing New Medications (EU-AIMS) project, which generates tools to enhance understanding of autism and develop new, safe and effective treatments for use in both children and adults. Stressing the need for IMI to link EU academia and industry, Hardman said: ‘Europe has a very sophisticated system of higher education and European research area but there is still a gap in terms of movement between the two.’

His comments were partly echoed by Ferran Sanz, Project Co-ordinator of the IMI-funded eTOX project, which develops innovative strategies and novel software tools to better predict the safety and the side-effects of new medicines. He said there was ‘still much to be done’ in utilising the potential of toxicity data available in the archives of many pharma companies.

Through its work and projects IMI brings tremendous leveraging opportunities

Another keynote speaker, Sanjoy Dutta, Assistant Vice President of the Juvenile Diabetes Research Foundation (JDRF), which researches type 1 diabetes, believes IMI is already ‘bridging the gap’ between academia and research, adding, ‘through its work and projects IMI brings tremendous leveraging opportunities’.

‘At JDRF we work with everyone, from small biotechs to large pharma companies, and the unique patient voice we bring to the table enriches IMI’s own initiatives,’ said Dutta.

The conference was told that the IMI’s recently-launched €215m ($242m) project on Ebola is helping research into the disease that, according to the World Health Organisation in March, killed more than 10,000 people in Western Africa. One planned deliverable is developing rapid diagnostic tests, delivering reliable results at the point of care in 15 minutes.

It is an example of how the IMI is able to respond rapidly to emerging healthcare emergencies, noted Richard Bergstrom, Director General of EFPIA, who added: ‘Thanks to its collaborative spirit, IMI’s Ebola programme allows us to work towards solutions efficiently, in a way that no single body could alone. The next “frontier” is to link what we are doing with other disciplines so that there is more convergence.’

IMI was supposed to run until 2017 and launch its last ‘call for proposals’ under this programme in December 2013. As it was so successful, the European Commission persuaded EU ministers to keep IMI going (as ‘IMI 2’) and the first ‘call for proposals’ under IMI 2 was launched last July. The stakeholder forum heard that although the first IMI projects are only now drawing to a close, IMI is already assessing its impact on areas of unmet medical need, public health and the competitiveness of Europe’s medicines R&D sector. IMI’s Acting Executive Director Irene Norstedt claimed: ‘The first analyses of IMI project results are promising and show that IMI is delivering fantastic results.’

To bring these highly innovative technologies to the market requires passion, great collaboration, knowledge transfer, and early dialogue with all stakeholders

Speaking on a panel on biomedicines, Samantha Parker, Chief Patient Affairs Health Policies Officer at France-based Lysogene, which specialises in gene therapy for rare neurodegenerative diseases, agreed. She said: ‘IMI’s involvement in advanced therapies is extremely timely and appropriate. To bring these highly innovative technologies to the market in very severe diseases requires passion, great collaboration, knowledge transfer, and early dialogue with all stakeholders, including regulators, health technology assessment bodies, and patient groups.’

She stressed how the European Commission and the US FDA and other international agencies founded the International Rare Diseases Research Consortium (IRDiRC), adding that its work could be enhanced by IMI members generating ‘greater efficiency in furthering collaboration and research’.

One of the concluding sessions formed part of a wider consultation on big data and health outcomes, and EFPIA has proposed an IMI 2 programme focused on ‘maximising the potential of big data in healthcare’. A consultation paper on a ‘Big Data for Better Outcomes’ project was circulated at the forum.

Looking to the future, it was noted that as recently as April, the IMI had agreed with the World Anti-Doping Agency (WADA) to collaborate on areas of ‘common interest’, including ageing, frailty, lung function and blood supply. Tests developed through IMI to analyse the effect of medicines in patients could in turn be useful for WADA in its efforts to identify athletes who have abused substances in an attempt to enhance their performance, the forum heard.

Further comment came from Magda Chlebus, the EFPIA's Director of Science Policy, who welcomed the IMI’s collaborative work, noting that this had been done in the past but that it is the scale of the collaboration now that is new.

In a session entitled ‘Where are we going?’, Belgian Liberal MEP Philippe De Backer called for the creation of a dedicated European fund for research into rare diseases, adding: ‘At a time when the perceived high cost of developing new drugs is putting a strain on national health budgets this should be a no-brainer.’

The main benefits of partnership are not so much financial but the networking opportunities and access to experts and expertise that it offers

Ultimately, the success of IMI 2 will depend on upcoming proposal ideas and Bergstrom stressed the value of its open and competitive calls, with small-and-medium-sized enterprises (SMEs), universities and patient groups benefiting from funding and major companies gaining from access to brains and talent in other organisations through the creation of consortia.

An IMI spokesman stressed later that despite its significant funding – in EU cash and in resources and staffing from major pharma companies – ‘the main benefits of partnership are not so much financial but the networking opportunities and access to experts and expertise that it offers’. During its first phase (2008–2013), IMI had a budget of €2bn ($2.25bn), half of which came from the EU’s Seventh Framework Programme for research (FP7), and half from contributions in kind by EFPIA companies.

In its second phase, IMI 2 has a €3.3bn ($3.72bn) budget for 2014–2024. Of this, €1.63bn ($1.84bn) – nearly half the budget – comes from Horizon 2020, the EU's latest framework programme for research and innovation; €1.425bn ($1.609bn) from EFPIA companies; and up to €213m ($240m) from other life science industries or organisations that contribute to IMI 2 as members in individual projects.

One key element of the IMI, the forum was told, was its funding of around 170 small-and-medium-sized enterprises (SMEs), who account for 16% of funding beneficiaries and 15.8% of its budget. Under IMI’s rules, SMEs sufficiently small to meet the EU legal definition of SMEs when a project starts remain eligible for IMI funding throughout the project, even if they become larger during its term.

For projects funded under the IMI 2 programme, IMI provides funding to eligible organisations as follows: direct eligible costs up to 100% of eligible costs (up to 70% for innovation projects) and 25% of indirect eligible costs (overheads). The organisation holds a stakeholder forum every year to inform investors of its activities and receive feedback.