IMI News
- Legislation creating Innovative Health Initiative (IHI) adopted
- IMI has been a magnet for global partnership. IHI will go even further - an opinion piece by Pierre Meulien
- RealHOPE project probes handling of protein-based drugs
- New IMI project Screen4Care to speed up diagnosis for rare disease patients
- PRIMAVERA spotlights novel treatments to fight antimicrobial resistance
- Could AI improve treatments for cancer patients? New IMI project OPTIMA thinks so
News from our projects
- Regulators tentatively endorse PREFER’s patient preference approach
- A mock ATM and a game of hide-and-seek? Testing gadgets and apps to track brain health
- Multiple important milestones advance Ebola vaccine regimen uptake
- Two-dose Ebola vaccine is safe, induces robust immune response in adults with HIV
- Quality matters: making sure research data is fit for its intended use
- Tuberculosis projects represent the biggest ever funding effort to combat the disease
Legislation creating Innovative Health Initiative (IHI) adopted
The Council of the EU has adopted legislation establishing the Innovative Health Initiative (IHI) and eight other joint undertakings under Horizon Europe, the EU’s research and innovation framework programme for 2021-2027. IHI is designed to build on the successes of, and lessons learnt from, IMI. The regulation will enter into force when it is published in the Official Journal of the European Union, so watch this space!
‘These partnerships are all about pooling research and innovation resources and ensuring that research results are turned into useful innovations for the citizens,’ said Mariya Gabriel, Commissioner for Innovation, Research, Culture, Education and Youth. ‘With Horizon Europe we are committed to emerge from the climate crisis, provide sustainable solutions to major environmental challenges, improve citizens’ health and accelerate a sustainable recovery. This will benefit all Europeans.
‘Joint undertakings will enable the joint investment of tens of billions of euros by public and private actors, at EU and national level,’ said Simona Kustec, Slovenian Minister for Education, Science, and Sport. ‘This investment will ensure a clear impact for EU citizens, will be based on the principles of openness, inclusiveness and transparency and will guide Europe in achieving the green transition, digital transformation and greater resilience in crucial areas.’
Find out more:
- Visit IMI’s web page on IHI
- Read the press releases from the Council – European Commission – IHI industry partners
IMI has been a magnet for global partnership. IHI will go even further - an opinion piece by Pierre Meulien
The Innovative Medicines Initiative organically grew into a powerhouse of international alliances. The Innovative Health Initiative’s multi-sectoral nature means that the catchment will be even wider, writes IMI Executive Director Pierre Meulien in an opinion piece on the IMI website.
IMI’s global reach is clear from a recent analysis of IMI-funded publications, which showed that over 100 countries have produced at least one IMI-funded research paper. IMI, its projects and staff are also involved in a range of initiatives.
‘There are a number of projects and programmes that come to mind when I think of IMI’s ‘connectome’, as I like to call it,’ writes Dr Meulien. ‘The Centre for Epidemic Preparedness Initiatives (CEPI) for example, contacted us requesting to take part in EBOVAC’s large-scale clinical trial of Janssen’s Ebola vaccine. Recently, I signed a grant agreement for a €180 million project on tuberculosis that attracted the attention of the Bill and Melinda Gates Foundation, among others.’
Looking to the future, he notes: ‘The new partnership that will replace IMI, the Innovative Health Initiative, will further break down research silos by offering enhanced opportunities to build on the networks that IMI has created.’
Find out more
- Read the article in full
RealHOPE project probes handling of protein-based drugs
Medicines based on proteins have dramatically improved the lives of people with a range of diseases. However, proteins can be affected by exposure to heat, sunlight or shaking. If stored or handled inappropriately during transport, or at the hospital, pharmacy or patient’s home, the proteins can break down, compromising the safety and efficacy of the product. Now a new IMI project, dubbed RealHOPE, aims to deliver knowledge and tools to address this issue.
One major project goal is to improve our understanding of how protein drugs are handled in the real world, and the effect this has on product quality. Among other things, the project will use smart tag technologies to log light, temperature and shock during real-life protein handling and analyse the proteins at different stages. They will also interview health professionals and patients to understand how they currently handle protein drugs and what limitations they face.
The project will use the data from these studies to develop teaching materials, including apps, for different target groups, namely hospital pharmacists, nurses, patients, and care givers. Ultimately, RealHOPE will aid in the development of more robust, safer protein drugs.
Find out more
- Read the article in full
New IMI project Screen4Care to speed up diagnosis for rare disease patients
Rare diseases affect up to 36 million people in the EU alone, yet getting a diagnosis takes an average of 8 years, during which the patient will go through countless consultations, tests, misdiagnoses and ineffective treatments, even as their condition continues to worsen.
The aim of new IMI project Screen4Care is to dramatically shorten the time it takes rare disease patients to get a diagnosis and treatment. The 5-year project has a total budget of EUR 25 million.
Firstly, the project will drive the genetic screening of newborn babies using genetic testing and advanced genomic technologies. The genetic testing of newborns makes sense because just over 70 % of rare diseases have a genetic cause, and a majority of rare diseases affect children.
Secondly, the project will design new artificial intelligence (AI) algorithms to identify rare disease patients early on in their disease via electronic health records. The project will also develop a repository of AI ‘symptom checkers’ to help patients who are already waiting for a diagnosis. Both AI tools will speed up the diagnosis of older rare disease patients.
Find out more
- Read the article in full
PRIMAVERA spotlights novel treatments to fight antimicrobial resistance
Vaccines and monoclonal antibodies (mAbs, laboratory-made antibodies similar to those your body makes in response to an infection) could play a key role in the fight against antimicrobial resistance (AMR). Developing vaccines and mAbs is costly and time-consuming, and so choices need to be made on which vaccines / mAbs should be prioritised for development.
The aim of new IMI project PRIMAVERA is to develop mathematical models and an epidemiological repository that will facilitate the assessment of different vaccines and mAbs in terms of their likely impact on AMR.
PRIMAVERA will set up an open access, web-based platform that will allow the wider scientific and healthcare communities to freely access and use the models and repository. For example, policy makers and healthcare authorities could use the platform to make informed decisions on which vaccines and mAbs should be prioritised.
Find out more
- Read the article in full
Could AI improve treatments for cancer patients? New IMI project OPTIMA thinks so
Advances in research mean that for many cancers, there are more treatment options than ever. However, for physicians, it is increasingly challenging to ensure each patient receives the right treatment. The aim of OPTIMA is to harness the power of artificial intelligence to advance treatments and facilitate decision-making for physicians and patients with prostate, breast and lung cancer.
At the heart of OPTIMA will be Europe’s first interoperable, large scale oncology data and evidence generation platform with data from over 200 million people. The platform, which will be GDPR (General Data Protection Regulation) compliant, will host data sets, data analysis tools, federated learning tools, and artificial intelligence (AI) tools.
The project will use the platform to drive the generation of new knowledge by developing advanced analytics and AI models to identify, prioritise and fill the main knowledge gaps in prostate, breast and lung cancer, and propose improved clinical guideline recommendations. Finally, they will develop AI-based decision support tools that can help clinicians, together with their patients, make treatment decisions based on the leading clinical practice guidelines.
Find out more
- Read the article in full
Regulators tentatively endorse PREFER’s patient preference approach
A major regulatory milestone has been reached for researchers working on the IMI-funded project PREFER, who have been investigating and testing the best ways to include patients’ voice in medicine development and decision-making. A positive draft opinion from the European Medicines Agency (EMA) on the consortium’s proposed framework for patient preference studies, as well as a document outlining points to consider when selecting methods for structured patient input to medical product decision-making, recently went through a public consultation.
The IMI-funded PREFER project is currently finalising a set of recommendations that industry, regulatory authorities and HTA bodies will be able to use to develop guidelines on how and when to include patient perspectives on the benefits and risks of medicines.
In parallel, the consortium worked out a research framework for patient preference studies, as well as a document with points to consider when selecting the methods for carrying out a patient preference study.
The project submitted an application for a qualification opinion to the EMA-EUNETHA (the first joint regulator an health technology assessment bodies joint procedure), and the EMA released a draft opinion that endorses both the framework and the points to consider document, ‘as a comprehensive reference document for planning and conducting patient preference studies’.
The draft opinion underwent a one-month consultation period so that researchers, patients, pharma companies, regulators, HTA bodies or anyone else could contribute their comments before EMA releases its final opinion.
Find out more
- Read the article in full
A mock ATM and a game of hide-and-seek? Testing gadgets and apps to track brain health
IMI’s RADAR-AD project is experimenting with different devices and software to track functional and cognitive decline in Alzheimer’s. Researchers from the project told IMI about their achievements so far and their plans for the next steps.
For example, the team is using sensors to measure how well people walk while also counting backwards from 100 to 0. For people with dementia, this is tricky. The team has refined the tests and is now bringing on board more people to expand the dataset they already have so that they can look for causal links between disease and altered walking patterns.
Other tests being assessed by RADAR-AD ask participants to play ‘hide and seek’, or mimic the experience of using an ATM to withdraw cash. Crucially, the team is linking data from some of these tests with data from ADNI, an initiative in which researchers collect data from MRI and PET images, genetics, cognitive tests, CSF and blood biomarkers to make predictions about the disease.
‘Our analysis showed that digital cognitive domains and digital task scores measured via the Altoida app offer a higher accuracy and sensitivity for diagnosing the disease at an early stage than questionnaire-based tests,’ said Meemansa Sood, of the Fraunhofer Institute for Algorithms and Scientific Computing (SCAI).
Find out more
- Read the article in full
Multiple important milestones advance Ebola vaccine regimen uptake
European marketing authorisation, WHO prequalification and an expert-backed recommendation mean the IMI-funded Johnson & Johnson Ebola vaccine regimen is closer to widespread uptake to prevent future outbreaks. The complete study results of the IMI-funded EBOVAC-Salone study were recently published in the Lancet, showing that the vaccine regimen is safe, well-tolerated and produces a strong immune response in people over the age of one, the first evaluation of the vaccine regimen in children.
The study findings had already contributed to the approval and marketing authorisation of the J&J Ebola vaccine regimen in July 2020 by the European Commission, for use in both children and adults, and to WHO prequalification in April 2021, which is a step towards formally registering the vaccine regimen in countries at risk of Ebola virus disease outbreaks.
In another important milestone, the WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization made a recommendation in support of using the regimen during outbreaks for people at risk of Ebola exposure and preventively for first responders. Focus now shifts to securing national registrations for the vaccine in Ebola-affected countries in Africa. Discussions are also ongoing with the US Food and Drug Administration regarding the approval of the vaccine regimen in the US.
Find out more
- Read the article in full
Two-dose Ebola vaccine is safe, induces robust immune response in adults with HIV
Data published in the journal PLOS Medicine demonstrates that the IMI-funded Johnson & Johnson Ebola vaccine regimen was well tolerated and induced a robust immune response in both healthy adults and adults living with HIV. The data is from a Phase 2 study conducted in Burkina Faso, Cote d’Ivoire, Kenya and Uganda that enrolled 668 healthy adults and 142 adults living with HIV.
The study also confirms that HIV infection (well-controlled via treatment with a highly-active antiretroviral therapy) did not have any apparent influence on the immune responses elicited by the vaccine regimen.
‘These data add to the growing body of evidence supporting the prophylactic use of the Johnson & Johnson Ebola vaccine regimen to protect people at risk of Ebola. This is critical to our vision of protecting some of the world’s most vulnerable and underserved people – including people living with HIV – by preventing Ebola outbreaks before they start,’ said Paul Stoffels of Johnson & Johnson.
Find out more
- Read the article in full
Quality matters: making sure research data is fit for its intended use
The EQIPD project has developed a wiki-based quality system to help increase adherence to rigorous, evidence-based practices in preclinical research. In an interview with the IMI Programme Office, the project’s Malcolm McLeod explains the replicability problem the project sought to address.
‘Often, laboratories find it difficult to replicate research findings from the published literature. When studied, this is true for at least a third of research findings subjected to a replication studies, across a wide range of research fields,’ he says. ‘This might occur because the first finding was wrong, or because of (perhaps very subtle) differences in how the research was done.’
EQIPD has come up with a range of resources to help researchers ensure their work can be replicated. A highlight here is the EQIPD Quality System, which Professor McLeod believes could be particularly useful for academic research groups. ‘The self-assessment tool, in particular, provides a means for such labs to identify their strengths and weaknesses; and by sharing that self-assessment with funders, to demonstrate their approach to research quality,’ he says.
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- Read the article in full
Tuberculosis projects represent the biggest ever funding effort to combat the disease
IMI has launched two separate projects that, when combined, represent the biggest effort to combat tuberculosis (TB) in history.
UNITE4TB, launched in 2021, is the first and only initiative of its kind in the world. The project is building a platform for carrying out clinical trials of new drug combinations for TB. They will focus on phase 2 and 'phase 3-ready' clinical trials. The partners have access to the majority of the most innovative anti-TB drugs at an advanced stage of development and will jointly test their clinical candidates and share research results.
ERA4TB, launched in 2020, has a budget of €208 million and 31 partners, and is focusing on pre-clinical development of combination therapies from pre-clinical to phase 1-ready.
The methodology for both projects is the same. They are investigating the possibility of testing TB drugs in parallel as opposed to sequentially – the ‘racetrack’ concept – an approach that will help test the safety and efficacy of drug combinations of over a dozen drug candidates at the same time.
Both projects combined bring the total investment to almost €400 million. The hope is that these efforts will produce TB treatment regimens that could ultimately become the global gold standard.
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- Read the article in full