- Watch the IMI Stakeholder Forum online
- IMI2 – Call 10: indicative topics published
- IMI advanced therapies consultation – outcomes published online
- IMI at the European Week of Regions and Cities
- Lancet letter spotlights EU action on antimicrobial resistance research
- ‘Without IMI this would have never happened’ – an interview with U-BIOPRED’s Peter Sterk
- News from the projects
Watch the IMI Stakeholder Forum online
The IMI Stakeholder Forum on 28-29 September will be broadcast over the internet, giving people who cannot come ot Brussels the opportunity to follow the event and submit questions.
The event starts on the afternoon of Wednesday 28 September with a keynote speech by Raju Kucherlapati of Harvard Medical School, as well as presentations on IMI’s next Calls for proposals. On the second day, 29 September, parallel consultative workshops on strategic research areas will bring together IMI stakeholders to shape together the future of IMI’s programme. The workshops will cover oncology, advanced therapies, digital health, and biopreparedness.
The webstreaming links will be published online in the days before the event. Registration to attend the Stakeholder Forum in person will close soon.
IMI2 – Call 10: indicative topics published
The following topics are under consideration for inclusion in IMI2 - Call 10, which is scheduled for launch in autumn 2016. The topics will be 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.
IMI advanced therapies consultation – outcomes published online
IMI has published the outcomes of its advanced therapies consultation. Launched earlier this year, the goal of the consultation was to identify the potential of IMI as a platform for enhancing advanced therapy medicinal products (ATMP) research and development. The consultation was open to all citizens and organisations, and the deadline for submitting contributions was 26 July 2016. Contributors were encouraged to consider in particular the following questions:
- Have the key challenges that can be addressed through collaborative, public-private initiatives been properly identified?
- Which of the proposed potential initiatives should be prioritised?
- Are any areas missing?
- What are the key European or national initiatives that IMI shall synergise with?
In total, IMI received 34 responses to the consultation. The feedback is summarised in this document. In addition, all contributions are published online, with the exception of those clearly marked as confidential.
The subject will be discussed further at the IMI Stakeholder Forum on 28-29 September 2016 in Brussels, Belgium.
IMI at the European Week of Regions and Cities
The joint undertakings, including IMI, will feature at this year’s 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)’. Held in the Committee of the Regions in Brussels on Tuesday 11 October, the event will explore 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 will see 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 represent regions, JUs, industry and research project partners in the field of electronic components and systems, health, fuel cells and hydrogen, aeronautics and bio-based industries. This workshop will be followed by a networking session.
Lancet letter spotlights EU action on antimicrobial resistance research
The EU’s diverse efforts to tackle antimicrobial resistance (AMR) are the subject of a letter published in the prestigious medical journal The Lancet. Written jointly by the European Commission, EFPIA, the European Investment Bank (EIB) and IMI, the letter notes that the EU has been ‘committed to combating AMR since 1999’ and has spent over €1 billion on AMR research. IMI’s New Drugs for Bad Bugs (ND4BB) programme is picked out as a major achievement for the EU in this area. ‘As part of the ND4BB programme, €650 million have been invested across seven projects ranging from basic science to drug discovery, and the development of new business models,’ the letter reads. The letter also highlights the work of the Joint Programming Initiative on AMR (JPIAMR), the joint EIB/EC INNOVFIN Infectious Diseases financing initiative, and the European Commission’s €1 million Horizon Prize to develop a rapid diagnostic test that should reduce unnecessary antibiotic use. The letter concludes by pointing out that these investments are starting to have a real impact in terms of new therapeutics and diagnostics, but that this momentum now needs to be sustained.
‘Without IMI this would have never happened’ – an interview with U-BIOPRED’s Peter Sterk
U-BIOPRED was one of the first IMI projects to launch back in 2009. Now the project, which focused on severe asthma, is drawing to a close. In an interview with the IMI Programme Office, the project’s scientific coordinator, Peter Sterk of the University of Amsterdam, explains how the project has increased our understanding of severe asthma and how researchers are already using this knowledge in the development of new treatments. He also talks about how the project benefited from the involvement of patients, and how they put the concept of ‘big data’ into practice to achieve their ground-breaking results. You can also read about the project’s achievements and impacts on the U-BIOPRED factsheet on the IMI website.
News from the projects
Scientists uncover gene variant that affects workings of diabetes drug
Scientists have identified a genetic variant that affects how well diabetes patients respond to the drug metformin. As well as paving the way for a more personalised approach to diabetes treatment, the findings also reveal how metformin actually works. The study, funded in part by IMI’s diabetes projects DIRECT and SUMMIT, was published in the journal Nature Genetics. For 50 years, metformin has helped type 2 diabetes patients worldwide to control their blood sugar levels and avoid the heart, eye and kidney problems that often come with diabetes. However, over a third of patients do not respond to normal doses of the drug. Furthermore, despite its widespread use, little is known about how metformin works. In this study, researchers analysed the genomes of over 13 000 people in a hunt for genetic variants associated with different responses to metformin. They found that a variant of the gene SLC2A2 is associated with a stronger response to the drug. This gene is behind the creation of a protein called GLUT2 that is involved in transporting glucose around the body, and people with the gene variant were found to have lower levels of this protein in their liver and other tissues, impairing their bodies’ ability to handle glucose. Metformin reverses this deficiency, explaining why these people respond so well to the drug. What’s more, the genetic variant had a stronger effect in overweight people. In fact, overweight people with two copies of the variant had a response that was equivalent to taking an extra 500 mg dose of metformin. ‘This is an exciting discovery that demonstrates how a patient’s genetics can determine how well, or poorly, a drug works,’ said Ewan Pearson of the University of Dundee and the DIRECT project. ‘We need to undertake further clinical studies before we can change the way we use metformin, but this finding suggests that some patients should be treated with higher doses than others to achieve the same effect. This really does move us a step closer to truly targeted therapy in the treatment of diabetes.’
- Read the University of Dundee’s press release
- Read the University of California San Francisco news item
Could a blood test offer clues to cancer gene activity?
Scientists from IMI’s CANCER-ID project have obtained unprecedented levels of information on genetic activity in cancerous tumours by analysing fragments of tumour DNA taken from blood samples. The study, published in Nature Genetics, adds to our understanding of the genetics of cancer and will aid in the development of new treatments. Ultimately, it should help to improve cancer diagnosis and treatment. Cancerous tumours regularly shed fragments of genetic material like DNA into the blood, and there is a lot of research into the best ways of capturing and analysing this material. Until now, the most advanced techniques allowed researchers to identify which mutations were present in the tumour DNA. Now, CANCER-ID researchers from the Medical University of Graz have succeeded in going a step further and identifying whether the genes are actually active or not. According to the researchers, knowing which genes are active in tumours will aid in the identification of potential drug targets and could also improve the clinical management of patients with cancer. Looking to the future, the team hopes to use their new technique to determine whether gene activity remains stable in tumours or whether it varies in response to external factors such as treatments.
- Read the project's article on the findings
- Read the Medical University of Graz’s press release (in German)
IMI scientist wins Alzheimer’s research award
Miia Kivipelto, a scientist in IMI’s Alzheimer’s disease project EPAD, has received a MetLife Foundation Award for Medical Research in Alzheimer’s Disease at the Alzheimer’s Association International Conference (AAIC) in Toronto, Canada. Dr Kivipelto was one of two scientists to win a ‘Major Award’, the other going to Guojun Bu of the Mayo Clinic in the US. ‘MetLife Foundation is proud to present the Major Awards to Dr Bu and Dr Kivipelto for their exceptional scientific research contributions, which help bring us closer to finding a cure for Alzheimer’s disease and related dementias,’ said MetLife Foundation President and Chief Executive Officer Dennis White. ‘Their outstanding contributions, recognised around the world, have helped us better understand this devastating illness, and both awardees have laid the groundwork leading to effective treatments.’ Now in their 30th year, the MetLife Foundation awards are administered by the American Federation for Aging Research. Awardees are selected by an expert advisory committee. The Major Award comes with a USD 100 000 (approx. EUR 88 300) institutional grant and a personal prize of USD 25 000 (approx. EUR 22 100). Dr Kivipelto works at Karolinska Institutet in Sweden and at the University of Eastern Finland. In EPAD, she co-leads the team responsible for setting up the EPAD cohort of 6 000 people who will undergo a range of tests that will help scientists identify early warning signs of dementia before symptoms appear.
Mofina project successfully tests new Ebola diagnostic device
Although the Ebola outbreak seems to be over, the WHO has warned that West Africa may see flare-ups of the virus. Therefore, there is still an urgent need for fast, reliable tests to determine if a patient with fever symptoms may be infected with the Ebola virus. IMI’s Mofina project is working on a new diagnostic test that will deliver results in about an hour, a device which will be crucial for diagnosis of the disease in sites where high-end laboratory infrastructure is not available. Recently the project reported a major milestone: the device designed to test for the Ebola virus and other related filoviruses has been successfully tested in three European reference labs and has also passed initial field studies in Sierra Leone. The device is now ready for product registration and the data obtained from lab and field tests is being submitted to the regulatory authorities. According to the project's coordinators, this important milestone wouldn’t have been possible without the public-private nature of IMI: for example, the industrial partners in the project couldn’t have done the work without the collaboration of public facilities which are able to handle the highly contagious Ebola virus. Further field tests, which will be conducted in Guinea and Ghana on patient samples in autumn, are expected to confirm initial results from Sierra Leone. After successful registration, the device will become available for diagnosis in patients e.g. during an outbreak or in monitoring and surveillance programs.
Drug-induced liver injury (DILI) still ranks as the leading cause of liver failure and transplantation in western countries. However, predicting which drugs will damage the liver is extremely difficult and often problems are not detected until a drug is already on the market. In pre-clinical experiments, pharmaceutical companies initially test the toxicity of drugs on various single-cell models – such as HepG2 and HepaRG cell lines and primary human hepatocytes – using basic cell health tests. But how reliable are those commonly-used tests? In the first study of its kind, recently published in the Archives of Toxicology, scientists from IMI’s MIP-DILI project selected 13 compounds, some of which are known for their potential to cause liver damage, and tested them in multiple labs across the EU. The outcome? Primary human hepatocytes are no better than cell lines in being able to predict the likely risk of DILI. Furthermore, none of the single-cell models can distinguish faithfully between DILI and non-DILI compounds in early drug discovery when using the simplest of tests. ‘This was a substantial piece of work offering clearer insight into the usability of simple cell culture tests for the pharmaceutical industry,’ said Richard Weaver of Servier. The rich data set generated from this study forms the basis from which more complex in vitro models (such as 3D micro tissues) will be developed within MIP-DILI. The ultimate aim of MIP-DILI is to enhance the tools used by the pharmaceutical industry by improving the understanding of DILI’s mechanisms.
Bipolar cell lines added to growing EBiSC catalogue
Bipolar disorder is the sixth leading cause of disability in the world, yet the discovery of new treatments has been hampered by the inability to study what is happening to an affected person’s brain cells during their lifetime. Thanks to IMI’s EBiSC project, stem cells from patients with bipolar disorder are being made available to scientists around the world to boost research into the condition. The University of Edinburgh will add 28 cell lines to the growing EBiSC catalogue of over 170 induced pluripotent stem cells. EBiSC was set up to build a robust, reliable supply chain for stem cell lines from a wide range of diseases and the new addition will enrich it further. ‘This is an excellent demonstration of how the EBiSC project collaborates with others, to make their cell lines available to the research community. The EBiSC Cell Line Catalogue already has a rich diversity of highly qualified cell lines from a multitude of diseases due to the diversity of partners providing their input. This reflects the multidisciplinary approach favoured by a public-private partnership of the IMI’, said the EBiSC project coordinator Timothy Allsopp. ‘The EFPIA partners are instrumental in assisting the consortium to select highly desirable cell lines and they work in close collaboration with the academic medical centre partners to nominate appropriate patient genotypes from diseases of interest. Finally, the SME partners have been pivotal in providing the expertise and necessary capacity to the new cell line creation and have constructed the workflow for making, banking and distributing cell lines internationally. Many more cell lines will be added this year as the collection grows.’
SAFE-T obtains FDA support for new liver biomarkers
The US Food and Drug Administration (FDA) issued a Letter of Support for five new liver safety biological markers investigated by IMI's SAFE-T project in collaboration with the Critical Path Institute’s Predictive Safety Testing Consortium (PSTC), opening the way for their clinical qualification in the future. Liver safety biomarkers are proteins that can be measured in human blood. Higher levels of these biomarkers in patients diagnosed with drug-induced liver injury (DILI) could indicate a risk for progression towards liver failure, which may result in death or the need for liver transplantation. The FDA granted the Letter of Support to encourage the use of the new biomarkers in both nonclinical and exploratory clinical studies. With this milestone, in-depth research can continue on the qualification of the new biomarkers for use in clinical trials. ‘The success of the SAFE-T/PSTC collaboration nicely demonstrates the benefits of working together across public private partnerships on a global scale. Shared scientific enthusiasm, persistence, and team-spirit were the key foundation for this achievement,’ said Michael Merz, SAFE-T project coordinator. The SAFE-T project was set up to develop improved tools for prediction, detection, and monitoring of drug-induced injuries to the kidney, the liver, and the vascular system, using markers in patients’ blood and/or urine. The ultimate goal is to identify for each of the three organ toxicities a set of biomarkers that are more specific, more sensitive and more predictive than currently available ones, and to gain regulatory acceptance for routine use of these biomarkers in drug development.