61st Edition – October 2016 | | ‘It’s been a great first year’ – an interview with Pierre Meulien One year after taking office as the Executive Director of IMI, Pierre Meulien recounts some of the year’s highlights and explains why he believes in the model of public-private partnerships more than ever. ‘I came in understanding that this was the beginning of a whole era of constructing public-private partnerships’, said Meulien. ‘They’re very new, very challenging for all the stakeholders and we’re not only pushing the boundaries in terms of what we’re learning scientifically, but we’re pushing the barriers around what kinds of partnerships can be built in terms of aligning very different views from a number of different stakeholders. That’s very exciting for me: I believe that great things are created at interfaces, and although interfaces are sometimes challenging to put together, they can be incredibly productive.’ | | Got an idea for an IMI project? We want to hear from you IMI has created an online portal where people from external organisations can submit ideas for IMI projects. All ideas submitted will be reviewed. If supported by the Strategic Governing Groups or EFPIA's IMI Strategy Group (InnoMedS), the idea may be developed and incorporated into an IMI2 topic to be launched as part of a competitive Call for proposals. Ideas can be submitted at any time, and submitters will receive feedback on their ideas. In practice, most external ideas taken on board by IMI are more likely to form just one component/aspect of a future topic. Visit the idea submission portal for more information and guidance. | | Missed the Stakeholder Forum? Catch up online! Almost 400 people attended IMI’s Stakeholder Forum in Brussels on 28-29 September, with more following the event online. All presentations and video recordings from the event are now available via the event web page. Day 1 of the event focused on IMI’s next Calls for proposals, and included a comprehensive presentation on IMI’s intellectual property policy. Day 2 saw attendees split into break-out groups to discuss IMI’s activities and plans in four key areas: advanced therapies, digital health, oncology, and preparedness for emerging diseases. | | IMI at the European Week of Regions and Cities The joint undertakings (JUs), including IMI, featured at the 2016 edition of the European Week of Regions and Cities with a session entitled ‘Enhance Regional Innovation and Growth: possibilities for integrated funding through regional cooperation with Joint Undertakings (JUs)’. The half-day session was held at the Committee of the Regions in Brussels, Belgium on Tuesday 11 October. The event explored how synergies between different funding mechanisms such as the European Structural and Investment Funds (ESIF) and the Horizon 2020 programme can help to boost innovation and growth in the regions. The event saw five JUs ( BBI, Clean Sky, ECSEL, FCH, IMI) and their regional and industrial partners (Andalucia, Carinthia, Clariant GmbH, Noord-Brabant, Scotland, Valcea) come together to exchange best practices on enhancing regional innovation by combining public and private funding, and explore new forms of cooperation. Speakers represented regions, JUs, industry, and research project partners in the fields of electronic components and systems, health, fuel cells and hydrogen, aeronautics and bio-based industries. IMI featured in the presentation of Mirjam Mol-Arts of Pivot Park, which hosts the screening centre of the European Lead Factory. The session organiser was the region of Carinthia. The JUs also jointly produced a supplement for Parliament Magazine on the contribution of public-private partnerships to economic growth in Europe's regions. | | Join IMI in the European Parliament to talk dementia On 8 November, IMI, its Alzheimer’s projects and other stakeholders will gather in the European Parliament in Brussels for a roundtable discussion. The focus of the half-day event will be on the challenges of Alzheimer’s disease for patients, the progress of the projects in IMI’s Alzheimer’s Disease Platform, the global links it has forged, and its synergies with other EU projects in the field. Between them, the projects in IMI’s Alzheimer’s Disease Platform cover many of the challenges in Alzheimer’s disease research. AETIONOMY is paving the way towards a new, mechanism-based classification of neurodegenerative diseases, particularly Alzheimer’s and Parkinson’s diseases. EMIF is developing a common information framework of patient-level data that will link up and facilitate access to diverse medical and research data sources, opening up new avenues of research. EPAD is creating a pan-European platform to identify and follow up patients identified as being at risk of developing dementia symptoms. EPAD will then draw on the platform to test a number of novel treatments designed to prevent the onset of Alzheimer’s dementia. | | IMI 2 – Call 10 – coming soon The following topics are under consideration for inclusion in IMI2 - Call 10, which is scheduled for launch in autumn 2016. The topics were presented at the IMI Stakeholder Forum on 28-29 September, along with IMI's rules and procedures. - Understanding hypoglycaemia: the underlying mechanisms and addressing clinical determinants as well as consequences for people with diabetes by combining databases from clinical trials
- How big data could support better diagnosis and treatment outcomes for prostate cancer
Note: topic forms part of the IMI Big Data for Better Outcomes (BD4BO) programme - Improving the care of patients suffering from acute or chronic pain
Note: this topic consists of three subtopics: A: Using patient reported outcome measures to improve the management of acute and chronic pain (PROMs) B: Improving the translatability of pharmacodynamic biomarkers in pain pathways of healthy subjects and preclinical species (BIOM) C: Improving translation in chronic pelvic pain (PCC) - Creation of a pan-European paediatric clinical trials network
- Biomanufacturing 2020: Development of innovative high throughput analytical tools and methods to characterize cell culture fluid during development and commercial cell culture processes
- Unlocking the solute carrier gene family for effective new therapies
- Enhanced patient voice in medicines lifecycle
- Precision medicines approaches in autism spectrum disorders
All information regarding future IMI Call topics is indicative and subject to change. Final information about future IMI Calls will be communicated after approval by the IMI Governing Board. | | AMYPAD project to focus on brain scans in Alzheimer’s disease IMI’s family of dementia projects has gained a new member with the launch of the AMYPAD project. Deposits of beta amyloid protein in the brain are a common sign of Alzheimer’s disease. AMYPAD will study the value of using positron emission tomography (PET) imaging to scan people’s brains for beta amyloid deposits. AMYPAD will carry out beta amyloid PET imaging on an unprecedented number of people who are suspected to be in the early stages of Alzheimer’s disease. The goal is to determine the clinical added value of PET imaging in diagnosis and patient monitoring, and to develop data to establish its usefulness in clinical trials. AMYPAD will work closely with IMI’s EPAD project, which is working to increase our understanding of the early stages of dementia and creating a platform to test treatments designed to prevent dementia. | | New PREFER project to give patients a voice in drug development Patient perspective is important in all medical research and particularly in drug development. A new IMI project PREFER, launched this week, will assess when and how patient preferences on benefits and risks should be incorporated into decisions on medicinal products. While industry, regulatory authorities, health technology assessment bodies, reimbursement agencies and patient organisations all agree that patient preferences are very valuable, there is little guidance on conducting and using such studies. The aim of PREFER will be to provide a set of systematic methodologies and recommendations to assess, engage and include patient perspectives during the development, approval, and post-approval of new therapies. PREFER is a is a public-private consortium of 33 partners, including 10 academic research institutions, 16 pharmaceutical companies, 4 patient organisations, 1 Health Technology Assessment body and 2 SMEs. The project has a total budget of about €12 million. Half of this comes from the EU’s Horizon 2020 programme; the other half comes in the form of in-kind contributions from the EFPIA companies. | | News from the projects BTCure takes major step toward detecting risk of arthritis Scientists in IMI’s BTCure project have uncovered a new mechanism which triggers rheumatoid arthritis, opening the way for the development of more targeted treatments which could prevent or delay the onset of this debilitating disease. By investigating events responsible for changing a healthy person into a rheumatoid arthritis patient, the researchers discovered that antibodies, which can be detected in the blood of some individuals years before disease onset, contribute to the development of the disease. According to the results of the study, these antibodies are able to induce joint pain and signs of bone loss before chronic inflammation in the joints occurs. These events might make joints very sensitive to relatively small challenges (such as minor trauma, infections, etc) and promote chronic inflammation, which eventually leads to the development of rheumatoid arthritis. ‘Our findings contribute to the early detection of not only people who already have rheumatoid arthritis but also of individuals at risk for developing the disease.’ said Anca Catrina, a professor at Karolinska University Hospital and one of the lead scientists in this study. These findings, she adds, could help researchers develop specific treatments to target early stages of the disease, delaying or preventing the disease onset. The results of this multi-centre study have been published in the Annals of the Rheumatic Diseases and, according to Catrina, wouldn’t have been possible without IMI. ‘The public-private nature of IMI has largely contributed to achieving these results’, she said. ‘For example, private sector companies have provided the academic partners with the possibilities of developing unique tools for this research, such as high quality and expensive technologies.’ EbolaMoDRAD finds way to inactivate Ebola virus When it comes to Ebola, one of the major challenges in the field is rapid diagnostics without having to transport suspected patients to major hospitals. Processing blood samples in the field or in small hospitals was not a good option until now because transporting blood tubes with the virus is a biosafety hazard and laboratories handling these samples need to have high containment facilities. Now there might be a new solution. Researchers working on IMI’s EbolaMoDRAD project found a way to inactivate the Ebola virus so it can be safely handled and transported. They did this by adapting the commonly used vacutainer tubes in a way which deactivates the virus during the sampling procedure, while preserving the virus RNA for at least 5 weeks independently of the storage temperature. The new invention, which was recently published in the Journal of Clinical Microbiology, reduces the risk of disease transmission during the handling of the samples; makes it possible to perform diagnostics in basic laboratories which may lack the high containment facilities; and makes it safer to transport patients’ samples from smaller hospitals to reference diagnostic laboratories. Although this method was developed in a lab, it is ready to be used in the field and can be validated quickly in the early stages of the next outbreak. In the long run, the EbolaMoDRAD project aims to develop and validate in the field rapid diagnostic tools that will be both simple and safe to use in low resource settings by people who may not have had specialist training. eTRIKS inspires a spin-off for scientific data analysis IMI projects not only deliver great results, but sometimes also inspire the creation of spin-off projects, providing indirect economic benefits. The latest proof of that is ITTM (Information Technology for Translational Medicine, S.A.), a Luxembourg company, which was built on the knowledge and expertise gained during the eTRIKS project. While working on eTRIKS, researchers from the University of Luxembourg realised that there is really high demand for cleaning, filtering, hosting and standardising data in the pharmaceutical sector. Those services were outside the scope of the eTRIKS project which mainly focuses on providing an open source platform for knowledge management. So, the Luxembourg partners involved in the project started a new company, ITTM. ‘The expertise we gained during eTRIKS regarding curation and standardisation of data are the building blocks of ITTM’s service offers,’ said Reinhard Schneider, Head of the Bioinformatics Core facility at the University of Luxembourg’s Centre for Systems Biomedicine. ‘In addition we were lucky to get the POST group of Luxembourg as a strategic investor. They own big very secure data centres, which gives ITTM a very professional hosting infrastructure.’ ULTRA-DD paves way for stronger cooperation with patients Patients already have a big role in many IMI projects, for example by helping with patient recruitment or advising on best practices in clinical trials. Now the ULTRA-DD project is taking it one step further. In the past year, several patient organisations, including Myeloma UK and The Brain Tumour Charity, have committed to sponsoring postdoctoral researchers, whose scientific outputs will contribute directly to the ULTRA-DD project. The sponsorship of about €1.5 million for the next two years will be done through the Structural Genomics Consortium (SGC), one of the partners in ULTRA-DD. With this step, these organisations will become directly involved in the scientific aspects of the project, helping to speed up the development of medicines for diseases which they are most interested in. ‘There are more and more patient organisations taking the matter into their own hands from the early stage drug discovery to the clinical studies’, said Wen Hwa Lee of the SGC. ‘At the moment every foundation is trying to do something on their own, for their own disease. In our view, the best option would be to give these disease foundations access to an open research platform so they could be clustered around the ULTRA-DD project. We believe that could be the foundation of a completely different way of working that could enable faster drug discovery.’ The main goal of the ULTRA-DD project is to speed up the development of truly innovative medicines, especially in the areas of autoimmune and inflammatory diseases. Through the SGC, ULTRA-DD has strong ties with similar initiatives elsewhere in the world, and this, coupled with the project’s strong open access policy, will ensure that the tools generated by the project will benefit the entire scientific community. GetReal to host a closing meeting in Brussels Before it draws to a close at the end of this year, IMI’s GetReal project will hold a closing event to showcase its results and discuss its future legacy. The event, titled ‘Delivering tools for real-world evidence development’, will take place on 24 November 2016 at the Royal Flemish Academy of Belgium for Science and Arts in Brussels. Registrations are on a first-come, first-served basis. This event comes five months after a big stakeholder conference in London which aimed to gather perspectives on the potential value of GetReal in decision-making within industry, regulatory authorities, and patient groups. The report from that event is now available online. Launched in October 2013, GetReal is a three-year project which aims to show how robust new methods for real-world evidence collection and synthesis could be adopted earlier in pharmaceutical research and the healthcare decision-making process. It brings together 29 organisations representing pharmaceutical companies, academia, regulators, patient organisations and SMEs. | | The Innovative Medicines Initiative is the largest public-private partnership aiming to boost pharmaceutical innovation in Europe and to speed up the development of better and safer medicines for patients. IMI is a joint undertaking between the European Union and the pharmaceutical industry association EFPIA. www.imi.europa.eu |
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