IMI News
- Sign up for the event on IMI’s impact on paediatric medicines
- New report highlights quality and quantity of IMI project publications
- PERSIST-SEQ to probe rare cancer cells behind drug resistance
- Vaccine trials for hospital superbugs need a radical rethink
News from our projects
- Scientists discover a highly potent antibody against SARS-CoV-2
- Closing in on COVID: results from the first year of CARE
- Data suggest four categories of trajectories in people at risk of dementia
- Antibiotics economics: rapid tests are worth it when confidence is low
- From relevance to readability: using well-defined ‘personas’ to improve the patient information journey
- INNODIA Young Scientist Award: exciting science, explained with clarity
- Surge vaccine production principles now written into EU law
- Researcher wins prestigious award for platform trial simulation study
Sign up for the event on IMI’s impact on paediatric medicines
Registration is now open for an online event on 10 November on IMI’s impact on paediatric medicine. Part of IMI’s wider Impact Series, the event will explore how IMI projects are addressing unmet needs in the field, including childhood cancers and the conduct of paediatric clinical studies.
When? Wednesday 10 November at 14:00 CET (Central European Time / Brussels time).
Where? Online – registration is free but obligatory.
Find out more
- Visit the event web page
- Learn about IMI’s impact on paediatric medicine development
New report highlights quality and quantity of IMI project publications
Two thirds of IMI project publications appeared in high-impact journals, and more than half were the result of international author collaborations. These are just two findings presented in the latest analysis of publications produced by IMI projects. The report, by Clarivate Analytics, reveals that IMI projects produced 7 177 publications between 2010 and 2020, and most research (67 %) is published in high-impact journals.
The report also looks into the 'field-normalised citation impact' of the papers – an index that is often used as a measure of research quality. The citation impact of IMI project research remains at around twice the world average, indicating that the research was internationally influential. Around a quarter of IMI project papers were highly cited; that is, the papers were in the world’s top 10 % of papers (taking journal category and year of publication into account), when ranked by number of citations.
IMI project research is also collaborative across sectors, institutions, and countries. What’s more, collaborative papers are cited more than non-collaborative papers.
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- Read the article in full
PERSIST-SEQ to probe rare cancer cells behind drug resistance
Cancer kills almost 10 million people globally every year, making it a leading cause of death. Some 90 % of these deaths occur in people who initially responded well to treatment, but whose cancer subsequently became resistant to treatment.
The aim of new IMI project PERSIST-SEQ is to shed new light on the mechanisms behind treatment resistance. To do this, they will develop a standardised approach to studying and sequencing the genetic code of individual cancer cells before, during and after treatment. In total, the project plans to use state-of-the-art technology to characterise 5 million cells and will mainly focus on lung, colorectal and breast cancer.
PERSIST-SEQ will run for 5 years and has a total budget of EUR 14 million, with around half of this funding coming from IMI, and half coming in the form of in-kind contributions from EFPIA partners in the project.
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Vaccine trials for hospital superbugs need a radical rethink
A history of failure should not discourage new research. What we need is a new strategy, says Isabelle Bekeredjian-Ding, Head of Microbiology at Paul-Ehrlich-Institut and member of the IMI Scientific Committee in a paper in Frontiers in Immunology.
Vaccines could be a valuable string in our bow in the fight against drug-resistant bacterial infections, but clinical testing of such vaccines has a long history of failure. It’s also hard to predict when and to what extent a particular pathogen is going to show up and wreak havoc. That’s why we need to rethink our tactics, learn from past failures and take advantage of new data, all while following a few guiding principles.
For example, we need to better analyse the individuals participating in a clinical study, and try to group them into sub-populations based on different biological characteristics (biomarkers), as this would help us figure out who might benefit from a vaccine and who might not. We also need to paint a more detailed picture of individual patients and patient subpopulations in future trials. Being able to identify the people most likely (and unlikely) to benefit from vaccination would be a huge advantage.
The different biology of individual patients, added to the variety of bacterial strains, disease progression and the unique situation in each hospital, have all complicated vaccine development for tackling antimicrobial resistance, leading to many vaccine development programmes getting dropped. However, the power of vaccines to prevent such infections has been demonstrated, and a renewed effort is warranted.
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- Read the article in full
Scientists discover a highly potent antibody against SARS-CoV-2
Researchers involved in IMI’s COVID project CARE have isolated a highly potent monoclonal antibody against SARS-CoV-2, one of the most powerful identified so far.
Writing in the journal Cell Reports, the scientists from Lausanne University Hospital (CHUV) and EPFL explain that the monoclonal antibody targets the SARS-CoV-2 spike protein and is effective at neutralising all variants of concern identified to date, including the delta variant.
In addition to its antiviral properties, the new antibody is designed to have a lasting effect in humans. A typical unaltered antibody provides protection for up to 3–4 weeks. But this new one can protect patients for 4–6 months. That makes it an interesting preventive-treatment option for unvaccinated, at-risk individuals or for vaccinated individuals who are unable to produce an immune response. Immunocompromised patients, organ transplant recipients and those suffering from certain kinds of cancer could be protected against SARS-CoV-2 by receiving antibody injections two or three times a year.
CHUV and EPFL now plan to build on these promising results in association with a start-up company which will perform clinical development and production of the antibody-containing drug, through cooperation and intellectual property agreements. Clinical trials of the drug should begin in late 2022.
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- Read the article in full
Closing in on COVID: results from the first year of CARE
Since its launch in 2020, IMI project CARE has published multiple studies that are teaching us more about how COVID19 wreaks havoc, and how it might be defeated. Highlights include:
- A paper in Nature demonstrated that the antimalarial drug Hydroxychloroquine didn’t show any significant effect on viral load in non-human primates, whether alone or in combination with azithromycin.
- A paper in Cell flags up a genetic link to the likelihood of someone developing severe disease.
- Another paper shows on how SARS-CoV-2 indirectly damages the endothelial cells that line the blood vessels, lymph nodes and heart.
- CARE has also produced a new assay (a test used for analysis) for understanding antibody response in natural infection versus vaccination. The team has also shed new light on the durability of different antibodies against the virus.
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- Read the article in full
Data suggest four categories of trajectories in people at risk of dementia
The EPAD project has used computational models, working on geographically-diverse, high-quality datasets, to help identify subgroups in cognitive function evolution. Writing in Frontiers in Big Data, the team describes its work on teasing out the different trajectories of people at risk of developing dementia.
The modelling suggests four distinct trajectories, from class zero, characterised by individuals having the highest levels of cognitive functioning with no signs of impairment at the beginning of the study and no decline throughout the course of the study, to class three, which describes individuals who showed the most obvious signs of early cognitive and/or functional impairment in the beginning of the study and continued to show impairment upon follow-up.
The ultimate aim of this work is to establish whether cognitive tests and biomarkers can be used to figure out who is likely to develop dementia, because early intervention offers the best chance of better outcomes.
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- Read the article in full
Antibiotics economics: rapid tests are worth it when confidence is low
Fighting drug-resistant bacteria requires prescribing fewer antibiotics. VALUE-Dx lay out the economic calculations behind decisions to use point-of-care tests.
Every doctor differs in their level of uncertainty about whether or not to prescribe an antibiotic. When they feel very certain that a patient’s symptoms are caused by a bacterial infection, an antibiotics prescription is often made promptly and confidently. The problem arises when the level of certainty dips below a certain threshold. In these cases, point-of-care tests are a worthy investment for doctors and wider society: beyond avoiding unnecessary prescriptions, they increase doctors’ confidence in their diagnosis, while also sensitising them to the risks of getting it wrong.
Those are the conclusions of a study carried out by the IMI project VALUE-Dx, as laid out in a paper in Health Economics Review. The authors’ cost-benefit calculations describe the level of uncertainty that would drive a hypothetical subset of physicians to use a point-of-care test, as well as the considerations of a hypothetical manufacturer trying to figure out how much doctors might be willing to pay for the equipment. They created an economic model that frames the dilemma in purely monetary terms, in the hope that they can once and for all demonstrate the real-world value of rapid diagnosis in primary care.
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- Read the article in full
From relevance to readability: using well-defined ‘personas’ to improve the patient information journey
The GRAVITATE-Health project has devised a set of personas to guide its work on the G-Lens, a piece of open-source software which will help people zoom in to the information on a medicine that applies to them as individuals.
Personas are fictional but realistic descriptions of typical end-users of the product based on real-world data. After collecting the raw data from multiple sources, the project partners clustered the end-users based on recurring attributes, merging similar clusters and eliminating irrelevant ones. These segments represent the entire range of diversity represented in the raw data. The result was three end-user groups and six distinct personas: Maria, Filippo, Amalia, Pedro, Peter and Antonio.
From a smoker with IBS to a child with a feeding tube and the sibling of someone with Down’s Syndrome, we meet a diverse group of people whose circumstances represent those of a wide swathe of the population.
The GRAVITATE-Health personas are being used by the project partners to give everyone a common understanding of the end-users of the G-Lens. They are just the first instalment in a suite of user research tools that will be part of a continuous, iterative, living toolkit that will evolve as more data become available.
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INNODIA Young Scientist Award: exciting science, explained with clarity
Diabetes projects INNODIA and INNODIA HARVEST have announced the winners of their Young Scientists Award. The award was open to all scientists under the age of 40 who are working in INNODIA and INNODIA HARVEST. Entrants were asked to explain the work they do in a one-minute video, and one of the most important requirements was the ability to explain their activities in lay language. The jury consisted of the patient advisory committee members.
The winner of the competition was Pieter-Jan Martens, a PhD student at KU Leuven in Belgium. In his winning video, he presents a study in which two potential diabetes treatments that work in different ways are combined. Research in mice suggests that the combination of both therapies is safe and 3-4 times more effective than either of the treatments on their own.
Second prize went to Jessica Hill of the University of Exeter in the UK, and third prize went to Gisele Silva Boos of the Helmholtz Zentrum Munich in Germany.
The project hopes that the award will encourage starting scientists to showcase their work and to name the challenges they face in diabetes research.
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- Read the article in full
Surge vaccine production principles now written into EU law
Bringing a new vaccine to market takes a long time in part because manufacturers have to prove that their vaccines are beyond reproach, safety-wise. In recent years, pharma companies have been experimenting with ‘platform technologies’ that can speed up this lengthy licensing process. Platform technologies refer to any technology, whether it’s a mechanism, delivery method, or cell line, that we can use as a base for producing different medicinal products.
IMI’s ZAPI project, recognising that such a platform is essential in the face of the threat of emerging zoonotic disease outbreaks, started working on a plug-and-play vaccine and antibody production platform in 2015. Their platform allows the immunogen of a new virus to be plugged in to produce millions of doses of new doses within months.
The ZAPI partners not only built the technical platform (and put it into practice when COVID-19 struck), they also worked the regulatory side. Now, they have influenced the updated legislative guidelines for veterinary medicine products that will be applicable in all EU countries from 28 January 2022, thus likely shaving years off future authorisation applications.
'That means that there is no need in the licensing procedure to re-discuss the safety of the platform. It’s done,' says Dr Joris Vandeputte, president of the International Alliance for Biological Standardization (IABS). The vaccine developer only has to insert the new immunogen for the new disease, and then go on with final product testing.
'This is really incommensurable, what ZAPI has done here. The big added value is not only the principle, it's also the fact that we have prepared the regulatory authorities. We are sure that thanks to this technology, in six months we can generate not millions, but billions of the antigens needed for vaccines.'
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Researcher wins prestigious award for platform trial simulation study
Elias Laurin Meyer, a scientist from IMI’s EU-PEARL project, has been awarded the Arthur-Linder-Prize for developing simulations that will help design platform trials. Meyer received the award for his paper ‘Decision rules for identifying combination therapies in open-entry, randomized controlled platform trials’. The goal of platform trials generally is to test as many investigational treatments as possible over the shortest duration. Meyer and his colleagues investigated platform trial design in the context of combination therapies, in which one of the two therapies a common, backbone monotherapy.
‘From a statistical point of view, platform trials constitute a new paradigm of clinical trial design, which in turn requires the development and/or re-calibration of statistical tools, since methods, software and quality criteria of more traditional trial designs might not be applicable,’ Meyer told the EU-PEARL project.
‘My contributions (in EU-PEARL) will be mainly in aiding development of new statistical methods and software for the simulation of complex platform trials. Ideally, the tools and software provided will aid clinical trial design and help shed light on the impact of certain design choices and assumptions on the operating characteristics of the trial. This, for example, includes the required number of patients in the trial or the required number of patients on placebo/control treatment arms.’
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