IMI News
- IMI launches final IMI2 Calls for proposals
- Catch up on the webinars on IMI2 - Calls 22 & 23
- IMI Stakeholder Forum 2020 – save the date!
- ECSEL JU launches Call for proposals on decentralised clinical trials
News from our projects
- Crucial step towards EC regulatory approval of IMI-funded Ebola vaccine
- Unravelling the enigma of autoimmune diseases – an opinion piece by Pierre Meulien
- Proposed ‘clustering’ of patients offers hope for better understanding of autoimmune diseases
- New tools to help identify potential targets in autoimmune diseases
- The Patient Engagement Open Forum goes virtual
- Unprecedented study of inflammatory skin disease data gets underway
IMI launches final IMI2 Calls for proposals
IMI has launched the last Calls for proposals under the IMI2 programme. IMI2 – Call 22 is a single-stage Call for proposals designed to support research activities that will build on, and add value to, results from certain ongoing IMI2 projects. IMI2 – Call 23 is a standard, two-stage Call for proposals with the following topics:
- Returning clinical trial data to study participants within a GDPR compliant and approved ethical framework
- Modelling the impact of monoclonal antibodies and vaccines on the reduction of antimicrobial resistance
This topic is part of IMI’s Antimicrobial Resistance (AMR) Accelerator programme. - A platform for accelerating biomarker discovery and validation to
support therapeutics development for neurodegenerative diseases - Optimal treatment for patients with solid tumours in Europe through artificial intelligence
- Shortening the path to rare disease diagnosis by using new born genetic screening and digital technologies
- Behavioural model of factors affecting patient adherence
IMI will contribute a total of EUR 59 million to the projects funded under the Calls. EFPIA companies and IMI Associated Partners will contribute EUR 47 million, mostly as ‘in kind’ contributions (e.g. staff time, access to equipment, etc.).
Pierre Meulien, IMI Executive Director commented: ‘These final IMI2 Calls showcase the areas where IMI is best placed to make a difference. The topics on antimicrobial resistance, neurodegenerative disease and rare diseases demonstrate our commitment to addressing unmet medical needs that are too complex for any single organisation to solve alone. Our topics on clinical trial data and patient adherence are aligned with our principle of putting patients at the centre of our work. And the topics on artificial intelligence contribute our goal of linking up with other sectors active in health research.’
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Catch up on the webinars on IMI2 - Calls 22 & 23
As usual, IMI held webinars on all Call topics as well as IMI’s rules and procedures and opportunities for SMEs. The slides and recordings of all webinars are available on the IMI website. We have also published lists of participants, and these are a good source of leads for people looking for potential partners for their consortium.
Find out more
- Visit the webinars page of the IMI website
IMI Stakeholder Forum 2020 – save the date!
This year’s IMI Stakeholder Forum will be held on the morning of Tuesday 10 November. Due to uncertainties surrounding the COVID-19 outbreak, the event will be held online. The event will take stock of what IMI has achieved, and high level speakers will explore what has worked well and what could be improved in the potential new health partnership under Horizon 2020.
The new partnership is set to include a wider range of industrial partners, beyond the pharmaceutical industry. The event will use paediatric cancer as a case study to explore how this collaboration could work in practice.
The decision to move the event online was taken in large part due to ongoing uncertainty surrounding the evolution of the COVID-19 outbreak. Despite the ‘virtual’ setting, we are confident that we will deliver lively discussions between the panellists and with the audience. We also hope that the move will allow a wider range of stakeholders around the world to participate in the event, and reduce the greenhouse gas emissions that would otherwise be associated with the event.
Find out more
- More information on the event will be published shortly on the events page of the IMI website.
ECSEL JU launches Call for proposals on decentralised clinical trials
ECSEL JU, the joint undertaking for electronic components and systems, has launched a Call for proposals on decentralised clinical trials that would complement the work of IMI’s Trials@Home project.
In a conventional clinical trial, patients have to make regular trips to the clinic for check-ups to monitor their condition. IMI’s Trials@Home project was launched in 2019 with the goal of exploring the potential of digital technologies for use in ‘remote decentralised clinical trials’ (RDCTs). In an RDCT, patients would use digital technologies and wearable devices to assess their condition from the comfort of their own home, or while going about their daily lives. This would dramatically reduce the number of trips trial participants would need to make to a clinic. The hope is that RDCTs would therefore make it easier to recruit people to take part in trials (as many are put off by the burden of regularly travelling back and forth to the clinic), and deliver better results (as data would be collected more regularly, resulting in findings that are more representative of the real world).
The new ECSEL JU Call text explains what the JU is looking for: ‘To differentiate from the many “patch project” and initiatives that have already been running, the proposals submitted to this call should address the issues and gaps to bring all the scattered activities, technologies, platforms to a higher TRL [technology readiness level] level by addressing the technical, regulatory, compatibility and acceptability issues that at the moment block endorsement by pharma and hospitals.’
The deadline for submitting a proposal is 30 September.
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Crucial step towards EC regulatory approval of IMI-funded Ebola vaccine
Johnson & Johnson has announced that its Janssen Pharmaceutical Companies received a positive opinion from the European Medicines Agency (EMA) for its investigational Ebola vaccine regimen for the prevention of the Ebola virus disease caused by the Zaire ebolavirus.
The two-dose regimen (Ad26.ZEBOV, MVA-BN-Filo) is designed to support preventive vaccination in countries that are at risk of Ebola outbreaks, as well as for other at-risk groups such as healthcare workers and Biosafety Level 4 (BSL-4) lab workers.
To date, approximately 60 000 people have been vaccinated with the vaccine regimen in clinical studies and vaccination initiatives. Studies indicate that it is well tolerated, inducing robust and durable immune responses to the Zaire ebolavirus.
A number of organisations contributed to the development of the vaccine regimen, including IMI through the Ebola+ programme.
Janssen is collaborating with the World Health Organization (WHO) on vaccine pre-qualification to broaden access of its investigational Ebola vaccine regimen to those most in need and enable registration in African countries; European Commission approval of this regimen may help accelerate this process. The recent Ebola outbreak which started in the Democratic Republic of the Congo (DRC) in 2018 was the second worst on record. It has caused more than 3 000 cases and over 2 000 deaths.
Find out more
- Read IMI’s news story
- Read the Janssen press release
Unravelling the enigma of autoimmune diseases – an opinion piece by Pierre Meulien
We like to think of the immune system as a surveillance mechanism for the body that’s standing guard, ready to weed out and kill anything harmful. But for people with an autoimmune disorder, it doesn’t work that way; deregulated, it fights our own tissue instead of protecting it. And while we might have some success in treating the symptoms, we are largely in the dark as to why treatments work for some and not for others, as well as what triggers the disease in the first place. In an opinion piece published on the IMI website, IMI Executive Director Pierre Meulien explores IMI’s portfolio in this important disease area.
‘One of things that IMI is particularly proud of is the progress we’ve made in the reclassification of subtypes of disease, which means redefining diseases based on their biology and not just symptoms,’ he writes. ‘It’s an extremely scientifically complex area, and we’re steadily increasing the level of understanding of the molecular drivers in a number of disease areas.’
IMI is also very active in remote assessment. ‘This tech convergence is a trend, and we will see more and more sophisticated remote monitoring which will change the game in clinical trials,’ writes Dr Meulien, citing IMI’s Trials@Home and IDEA-FAST projects.
Find out more
- Read the opinion piece
- Watch our video on autoimmune disease research
Proposed ‘clustering’ of patients offers hope for better understanding of autoimmune diseases
There is evidence that many autoimmune conditions (such as rheumatoid arthritis, lupus, and Sjögren's syndrome) may share molecular mechanisms. IMI’s PRECISESADS project carried out painstaking analysis of molecular and clinical data and were able to reclassify around 2 000 individuals affected by systemic autoimmune diseases (SADs) into four different clusters of molecular groupings.
‘We were able to show that these different diseases can be joined together into groups,’ said project coordinator Marta E. Alarcón-Riquelme of the Centre for Genomics and Oncological Research in Granada, Spain. ‘There were four different groups of patients, formed by all the patients with the different autoimmune diseases. This was new.’ The four groups are inflammatory, undefined, lymphoid group and an interferon group. The interferon group was already known for lupus, and it was known that some patients with rheumatoid arthritis or scleroderma could also have the interferon signature. To go further and build on these new insights, more research is needed. ‘In another study we would need to look into whether by classifying the patients into in this way, we could actually find which treatment would be best for which patient,’ said Dr Alarcón-Riquelme.
By going beyond classical clinical signs and symptoms and grouping people by underlying drivers, the work of the team will help ensure better diagnosis and treatment for people with SADs in the future.
Find out more
- Read the full news story
New tools to help identify potential targets in autoimmune diseases
There are many proteins that could potentially be targeted in autoimmune and inflammatory diseases like rheumatoid arthritis, lupus and Sjögren’s syndrome. The problem is that a lot of research needs to be done to find out which proteins are good targets while also being amenable to treatment with molecules. The ULTRA-DD project was set up to make some headway in identifying which proteins are worthy candidates for further study, in the hope that the publicly-available knowledge they generate will lead to future clinical trials for new drugs.
The tools and data generated by the project are being made available open access, said project coordinator Michael Sundström. ‘None of our outputs are patented and there are no restrictions on its use for the research community. The industry partners won’t have exclusive rights to any of it; the databases, websites and publications are in the public domain in various open repositories, so everybody can benefit from the discoveries we’ve made and the research tools we’ve generated, long after the project ceases to exist.’
The project is already aware of widespread use of the research tools in the community. ‘We've been disseminating the chemical compounds that we developed to several hundred research groups across the globe,’ said Dr Sundström. ‘We have made arrangements with chemistry vendors that they will provide these compounds to the community for a nominal or reduced fee, long after the project is closed. With time, we will probably disseminate to several thousand research groups.’
Find out more
- Read the full news story
The Patient Engagement Open Forum goes virtual
The Patient Engagement Open Forum is organised jointly by IMI’s PARADIGM and EUPATI projects as well as Patient Focused Medicines Development (PFMD). The aim of the event is to provide a holistic perspective of patient engagement, the landscape and actors, and foster collaboration and co-creation while breaking down fragmentation and silos that are often present in patient engagement work.
This year, the event is going virtual, and will be a series of short (under two hours) online events running from June to November. Events will be recorded and published online.
Topics range from tools and recommendations for effective patient engagement, methods for monitoring and evaluation of impact and outcomes in patient engagement activities, and fair market compensation for patient input, to interactive sessions on assessing good practices in patient engagement and more.
Find out more
- Visit the event website
Unprecedented study of inflammatory skin disease data gets underway
Despite a relatively good choice of treatment options for inflammatory skin diseases like psoriasis and atopic dermatitis, finding a drug that definitely works in a given patient is still very much trial and error. The BIOMAP project, which launched in 2019, will carry out the biggest study yet of the molecular drivers of inflammatory skin diseases, with particular focus on psoriasis and atopic dermatitis, in an effort to uncover tell-tale biomarkers that will help predict the course of the disease, and the response to therapy. As a first step, BIOMAP is bringing together data from previous and ongoing clinical studies to create a large data platform capable of delivering sound results.
Having spent the first year of the project making sure their data collections adhere to stringent rules governing patient data privacy, the project partners have now started uploading the datasets to their central data platform.
‘The datasets are being harmonised according to what we call our ‘glossary’, so that the nomenclature and phrasing is the same across all cohorts, and that key information is available from all of them,’ says project coordinator Stephan Weidinger of the University Hospital in Kiel, Germany. He gives a simple example to illustrate why this is necessary: ‘It starts with the disease name itself. In some studies, the disease is called ‘atopic dermatitis’, and in other studies, it’s ‘atopic eczema’. And then there are studies where is called just ‘eczema’.’ The diagnostic criteria can also vary from study to study. ‘So, we have to check that and make it clear what criteria has been used and to which degree it is comparable.’
Find out more
- Read the full news story