- Big data, medicines safety and respiratory disease focus of IMI 2 – Call 6
- Missed the IMI 2 – Call 6 webinars? Catch up online!
- IMI’s guidance tool for researchers to raise awareness of regulatory requirements
- EBOVAC trial in Sierra Leone starts; boosts local health infrastructure
- DRIVE-AB highlights human costs of rising antimicrobial resistance
- U-BIOPRED releases first classifications of severe asthma
- Lancet Respiratory Diseases praises U-BIOPRED’s efforts
- Open PHACTS Foundation joins Horizon 2020 project on chemical safety
- Papers highlight quality and diversity of European Lead Factory’s compound library
- ADVANCE launches public consultation on its Code of Conduct
- Tell EBiSC which cell lines you would like to see in the stem cell catalogue
- Save the date! EUPATI webinar on 16 November
- EPAD and EU Lead Factory websites get a make-over
Big data, medicines safety and respiratory disease focus of IMI 2 – Call 6
Big data (in the areas of Alzheimer’s disease and blood cancers), medicines safety and respiratory disease are the focus of IMI 2 – Call 6, which has a total budget of €93 million. The two big data topics represent the first topics of the wider Big Data for Better Outcomes programme which was the subject of a consultation earlier this year. Further big data topics are already in the pipeline for future Calls for proposals. The Call is the sixth to be launched under the IMI 2 programme. Pierre Meulien, IMI’s new Executive Director commented: ‘These topics beautifully demonstrate why IMI is needed. They all represent major challenges in medicines development and healthcare that can only be solved by bringing together the resources and expertise of a diverse range of stakeholders in collaborative projects. The projects that emerge from these topics will also have a very real impact on both medicines research and healthcare delivery.’
- Deadline for applications: 12 January
- All Call documents and details of how to apply can be found on the Stage 1 page
- Read IMI’s press release
- Read our tips for applicants
Missed the IMI 2 – Call 6 webinars? Catch up online!
All the IMI 2 – Call 6 webinar presentations and recordings are now online and can be found on the webinars page and IMI YouTube playlist.
During October 2015 IMI held webinars on each topic of the current IMI 2 - Call 6, as well as one webinar on the IMI 2 rules and procedures. All webinars on the Call topics featured a presentation by the EFPIA topic coordinator and time for questions and answers.
The webinar on IMI’s new rules and procedures included presentations of IMI's intellectual property policy and tips on the preparation of proposals.
If you have questions on the Call topics or IMI’s rules and procedures, contact IMI at Infodesk@imi.europa.eu.
IMI’s guidance tool for researchers to raise awareness of regulatory requirements
EFPIA and IMI have published a guidance tool to inform researchers of the various opportunities to interact with regulators on science that may have an impact on public health.
Some research projects are expected to generate results that may influence regulatory decision-making, including new surrogate endpoints or biomarkers and patient reporting tools. It is therefore important to consider the potential regulatory impact of these projects at an early stage, in order build into the research plan the outputs likely to require future regulatory approval.
The guidance tool was developed to raise awareness of the existing regulatory support measures currently available in the EU and the US and is intended for use by researchers who wish to have a better understanding of these opportunities.
This guidance tool, as well as other documents designed to advise IMI projects on the mechanisms for regulatory acceptance of innovative drug development tools, can be found on the IMI web page.
EBOVAC trial in Sierra Leone starts; boosts local health infrastructure
Even in the short term, the benefits to the local community of the ‘EBOVAC-Salone’ trial are immense; new facilities had to be built to run the study, including the first emergency room at the local district hospital, and a vaccine storage facility. In addition, the project provides both jobs and training for local healthcare workers, who will also gain valuable experience by working on the trial. In the longer term, the community may also benefit if the vaccine regimen is approved.
Sierra Leone was at the epicentre of the Ebola outbreak, with 14 000 cases and 4 000 deaths, including many healthcare workers. The vaccine regimen under investigation is a ‘prime-boost’ regimen, in which two doses are given several weeks apart. The first dose ‘primes’ the immune system, while the second ‘boost’ reinforces its effects with the goal of potentially strengthening and optimising the duration of the immunity. The study is notable in that it will evaluate the vaccine regimen’s safety and immune response within the general population of Sierra Leone, including vulnerable groups such as adolescents and children. The vaccine regimen is also in trials in other parts of Africa, Europe and the US.
The EBOVAC-Salone trial is working closely with the IMI project EBODAC, which aims to ensure the prime-boost vaccine regimen is well accepted and successfully deployed. It is doing this by informing local engagement strategies, designing graphical communication aids, deploying technological solutions to increase compliance and uniquely identifying trial participants.
DRIVE-AB highlights human costs of rising antimicrobial resistance
A 30% drop in the efficacy of antibiotics could result in an additional 6 300 deaths per year in the US alone among people who undergo common surgeries and chemotherapy treatments. This is the stark finding of a study, published in the Lancet Infectious Diseases, by the IMI project DRIVE-AB. Patients who undergo surgery or immune-system suppressing chemotherapy are routinely given antibiotics to prevent infections. The DRIVE-AB team analysed the number of additional infections and deaths that would occur if these antibiotics were less effective. They focused their analysis on the 10 most common surgeries (e.g. caesarean sections, prostate biopsies, hip replacements, and appendix removals) as well as on chemotherapy treatments that suppress the immune system. They found that a 30% reduction in the efficacy of these preventive antibiotic treatments could result in 120 000 additional infections and 6 300 deaths. ‘Most of us will take antibiotics at some point in our lives and everyone should be mindful of the fact that resistance is a potential problem if we are going in for minor surgery, hip or knee replacement, transplant or chemotherapy,’ said lead author Ramanan Laxminarayan of the University of Strathclyde, the Center for Disease Dynamics, Economics & Policy, and Princeton University. ‘Our findings are likely to hold true in many other developed countries, given the common use of surgical procedures.’ The researchers conclude by noting that clinical studies are needed to determine how recommendations on the use of antibiotics should be modified as drug resistance rises.
U-BIOPRED releases first classifications of severe asthma
IMI’s severe asthma project U-BIOPRED has unveiled its first classification of severe asthma types at the European Respiratory Society’s recent international congress in Amsterdam, the Netherlands. The findings will help scientists identify and, if necessary, develop treatments best suited for each category. Severe asthma affects around half a million people in Europe. Despite taking many medicines, severe asthma patients often struggle to keep their condition in check and find it hard to go to work or school and lead normal lives. U-BIOPRED has gathered vast amounts of samples and data from severe asthma patients as well as healthy people from across Europe, in a bid to identify distinct types of the disease. In this study, scientists analysed gene activity and levels of certain proteins and lipids in sputum samples from severe asthma patients. They were able to identify three distinct patient clusters. ‘We believe that our work, dividing severe asthmatics into meaningful categories, is the first step towards being able to provide each sufferer with optimal individualised treatment, the ultimate goal of personalised medicine,’ commented Diane Lefaudeux of the European Institute of Systems Biology and Medicine, who presented the findings.
- Read the press release
- Download the ERS conference abstract via the ERS website (search for ‘Lefaudeux’ under Speaker)
Lancet Respiratory Diseases praises U-BIOPRED’s efforts
‘This ideological project has seemingly succeeded where so many others have failed, challenging the culture of how science is done by systematically collecting and analysing data in a successful pan-European collaboration involving academia, industry, and patients.’ This is how IMI’s severe asthma project U-BIOPRED is summed up in an editorial in the renowned medical journal Lancet Respiratory Diseases. The paper notes that the vast amounts of data gathered by the project, coupled with its use of knowledge management platforms like TRANSMART, will allow experts to distinguish different types of asthma that could lead to new or more effective treatment approaches. U-BIOPRED is also praised for its ‘liberal approach to data sharing’; the project has pledged to make much of its data publicly available.
Open PHACTS Foundation joins Horizon 2020 project on chemical safety
The Open PHACTS Foundation is part of a new, €30 million project on animal-free chemical safety testing funded by the EU through Horizon 2020. Dubbed EU-Tox-Risk, the project has set itself the ambition of becoming ‘the flagship in Europe for animal-free chemical safety assessment’. The Open PHACTS Foundation was born out of the IMI project of the same name. Open PHACTS has delivered a platform that links up diverse drug discovery databases, allowing researchers to rapidly find and access relevant data. The Open PHACTS Foundation was set up to maintain and further develop the platform. In EU-Tox-Risk, the Open PHACTS Foundation will contribute its expertise with interoperable data.
Papers highlight quality and diversity of European Lead Factory’s compound library
The quality and diversity of the compounds found in the European Lead Factory’s Joint European Compound Library (JECL) is highlighted in two recent publications. The project’s goal is to compile a 500 000-strong compound collection that researchers can screen (at no upfront cost) to identify compounds that could prove interesting for their own research. The pharmaceutical companies in the project have already contributed over 300 000 compounds to the library.
A paper published earlier this year in Drug Discovery Today reveals that many of these compounds are likely to be of interest for medical research. Meanwhile, ‘public’ partners (like universities and small biotechs) are adding novel compounds to the collection all the time.
A recent paper, also in Drug Discovery Today, analyses the first 55 000 compounds added to the ‘public’ collection. According to the project, ‘Both analyses reveal the high-quality and diverse nature of the compound collection, that is complementary to already existing libraries and provides access to novel chemical space.’ By January 2016, the project expects the compound collection to hit the 400 000 mark – a significant milestone.
ADVANCE launches public consultation on its Code of Conduct
Vaccine project ADVANCE has launched a public consultation on its draft Code of Conduct, which was developed to support the planning, initiation, design, conduct and reporting of observational studies in the field of vaccines.
The Code of Conduct will also support interactions between different parties involved in studies on vaccines and provide confidence to health professionals and the public about the quality of their results.
The development of this Code of Conduct is co-led by the European Medicines Agency (EMA) within the ADVANCE project.
The draft Code of Conduct and details of how to submit feedback can be found online.
The consultation closes on 15 November 2015.
Tell EBiSC which cell lines you would like to see in the stem cell catalogue
Since 2014, EBiSC has been building the European Bank for induced Pluripotent Stem Cells to make quality-assured iPSC lines and data available to both researchers in both academia and companies.
EBiSC would like to know what researchers and pharmaceutical companies wish to see included in the EBiSC iPSC catalogue to support their research now and in the future. The survey can be found here.
To learn more about the EBiSC project, to specify which cell lines should be in the catalogue or to be kept up-to-date with the cell lines from the catalogue and order them, contact firstname.lastname@example.org and visit their website.
Save the date! EUPATI webinar on 16 November
The European Patients‘ Academy on Therapeutic Innovation (EUPATI) will hold a webinar on ’Interaction between patients and other stakeholders in medicines development’ on 16 November 2015 from 17:00 to 18:30 Central European Time (CET).
This webinar will focus on the interaction between patients and the other stakeholders active in the medicines development process. More information and details of how to register will follow shortly on their website.
EUPATI is a pan-European IMI project of 33 organisations, led by the European Patients' Forum, with partners from patient organisations, universities and not-for-profit organisations, along with a number of European pharmaceutical companies.
The project focuses on education and training to improve the availability of patient-friendly information for the public as well as for more advanced patient advocates and patient experts with the capacity and capability to understand and contribute to medicines research and development. The project recently opened its second Patient Experts Training course and is looking forward to interacting with 60 highly-motivated people from more than 20 countries in Europe.
EPAD and EU Lead Factory websites get a make-over
IMI Alzheimer’s disease project EPAD launched a new website on World Alzheimer’s Day, 21 September 2015. The website aims to inform different audiences, including the scientific community, companies, people with dementia, families and carers, Alzheimer associations and the general public, about the project’s existence, its progress and its achievements. ’EPAD wants to contribute to raising awareness on Alzheimer’s disease and more specifically on the importance of the prevention of Alzheimer’s dementia,’ asserts Alzheimer Europe Executive Director Jean Georges.
The European Lead Factory has also recently given its website make over and has now a new, user-friendly look, that will make it easier for scientists to find out how they can take advantage of the project’s resources.