Beatriz da Silva Lima and Isabelle Beatrice Bekeredjian-Ding to head IMI Scientific Committee
Beatriz da Silva Lima and Isabelle Beatrice Bekeredjian-Ding have been elected as Chair and Vice-Chair respectively of IMI’s Scientific Committee. The pair were elected by their fellow committee members. Beatriz da Silva Lima, Professor of Pharmacology and Pharmacotoxicology at Lisbon University in Portugal, also served as Chair during the previous two-year mandate. Isabelle Beatrice Bekeredjian-Ding, Head of Microbiology at the Paul-Ehrlich-Institut in Germany, is new to the Scientific Committee. Meanwhile the committee has also gained a new member in the form of Zoltan Kalo, Professor of Health Economics at Eötvös Loránd University in Budapest, Hungary. The Scientific Committee provides strategic science-based recommendations to IMI and advises on the continued relevance of the Strategic Research Agenda and the scientific priorities, which are the basis for the Call topics.
‘More successful than what we thought possible’ – an interview with the Europain project coordinator
Only 30% of patients with chronic pain receive effective treatment and when it comes to neuropathic pain, which results from nerve fibres being damaged, dysfunctional or injured, this figure is even lower. By creating unprecedented levels of cooperation among industry, academia and SMEs, IMI's Europain project transformed the neuropathic pain field in a number of ways. Firstly, it generated the knowledge and tools which will make conducting pre-clinical and clinical trials more reliable and effective. Secondly, it came up with a new way of classifying patients which could lead to the development of more personalised medicines. Thirdly, the project made its mark on European regulatory guidelines and a number of its outputs are already being used by the pharmaceutical industry. In the long-term, patients could reap many benefits by gaining access to more affordable, personalised treatments. At the end of the project, we interviewed project coordinator Märta Segerdahl of H. Lundbeck A/S, and asked her to comment on the project achievements. ‘We ended up more successful than we thought possible,’ she said.
- Read the full interview
- Find out more about the project's achievements in the project factsheet
- Visit the project website
New IMI Call for proposals coming soon
IMI is currently preparing its next Calls for proposals. Although the topics are still being finalised, potential applicants can already get ahead of the game in a number of ways.
- Read IMI’s tips for applicants and advice on finding partners for your consortium.
- Familiarise yourself with IMI’s rules and procedures by watching our most recent webinar on this subject or downloading the presentation.
- Follow us on Twitter and join our LinkedIn group to get the latest updates on new Calls.
Drafts of the topics currently under consideration for inclusion in future IMI Calls for proposals can be found on our Future Topics page. Note that all information on this page is indicative; final information on the Calls will be published following Governing Board approval.
News from the projects
Of vaccines, rumours and the success of IMI’s EBODAC project
When IMI’s EBODAC project started in late 2014, Ebola had already killed over 8 000 people in just a few short months, most of them in the western African nations of Liberia, Guinea and Sierra Leone. With the outbreak continuing to devastate lives across the region, fear and anxiety were rife, and rumours spread rapidly through local communities. It was against this backdrop that IMI’s EBODAC project set out to develop a community engagement strategy to enable a clinical trial of a promising new Ebola vaccine candidate. Thanks to the many innovative methods employed, including radio and drama shows, the project is now celebrating its first big success: all of the adults in the trial have been successfully vaccinated. ‘The success of the project wouldn’t have been possible without the public-private partnership nature and the support of IMI,’ said Heidi Larson of the London School of Hygiene & Tropical Medicine, the EBODAC project coordinator. ‘Given the sensitive nature of our trust-building, community engagement, communication and rumour management, it was particularly important that the funding for that dimension of the trial was coming from the public sector rather than the industry. At the same time, the private sector partnership was crucial to the collaboration and the success.’
- Read the full success story
GetReal launches Real World Evidence Navigator
In March, the GetReal project launched the Real-World Evidence (RWE) Navigator. This is an online resource designed to help users from a broad range of research and healthcare backgrounds get to grips with RWE. RWE refers to evidence of relative effectiveness - how well medicines work in the real world, as opposed to the controlled experimental settings of clinical trials. Data to generate RWE can come from a range of sources, including patient registries, medical records, pragmatic trials, and other observational studies. The overall aim of IMI’s GetReal project was to explore how new, better ways of generating and using RWE can be incorporated earlier on in drug development and healthcare decision-making. The RWE Navigator is an educational resource to help users find out more about potential issues in demonstrating the relative effectiveness of new medicines (referred to as ‘effectiveness issues’). It also guides users to specific types of analyses or study designs that use RWE to support the development of medicines. Finally, it is a comprehensive directory of resources that support the use of RWE in medicines development. The RWE Navigator has been designed for a wide variety of users. For example, pharmaceutical companies may find it useful to increase awareness about the potential use of RWE among their medicine development teams, or patients may use it to understand concepts related to RWE and the challenges faced when of using or generating RWE.
- To find out more about the RWE Navigator, watch the launch webinar. For specific enquiries about the RWE Navigator, contact firstname.lastname@example.org
Ebola vaccine immune response lasts at least 1 year
The immune response triggered by Johnson & Johnson’s two-part ‘prime boost’ Ebola vaccine regimen appears to last at least one year, according to a new study published in the Journal of the American Medical Association (JAMA). The research was funded in part by IMI’s EBOVAC1 project. The west African Ebola outbreak, which infected 28 000 people and killed over 11 000, highlighted the urgent need for a vaccine against the disease. The vaccine regimen is being developed by Janssen Vaccines, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, in collaboration with Bavarian Nordic. It consists of an initial vaccine dose to prime the immune system, followed by a boost dose of another vaccine which is intended to enhance the immune response over time. Trials of the regimen are taking place in Europe, Africa, and the US. This latest study focuses on a Phase I trial in Oxford, UK, in which 75 healthy volunteers received the vaccine regimen. Of the 64 people who attended the one-year follow-up, all had high levels in their blood of Ebola virus glycoprotein-specific antibodies; these antibodies appear to play an important role in immunity to the disease. ‘The world needs a vaccine to help prevent or mitigate future Ebola outbreaks, and ideally it should provide sustained protection for at-risk populations,’ said Johnson & Johnson Chief Scientific Officer Paul Stoffels. ‘We are committed to helping the global community finish the job of finding an Ebola vaccine. Together with our consortium partners the London School of Hygiene & Tropical Medicine, University of Oxford, and Inserm, we are grateful for the ongoing support of Europe’s Innovative Medicines Initiative (IMI), BARDA and NIH.’
- Read Johnson & Johnson’s press release on the paper
Article highlights PROTECT’s impact on regulatory science and practice
The impacts of IMI’s PROTECT project on regulatory science and practice are spelt out in a new paper by project coordinator Xavier Kurz of the European Medicines Agency (EMA), published in the journal Pharmacoepidemiology and Drug Safety. One area where the project made an important difference in regulatory practice is in signal detection, through which medicines regulators gather information on suspected adverse drug reactions (ADRs). Based on PROTECT work, changes were made in the tools and processes used for signal detection in the EU database of reports of suspected ADRs. These changes have improved the signal detection process, with fewer false positives and more validated signals. Another area where the project has had an impact is in pharmacoepidemiology, which is the study of the use and effects of medicines in large numbers of people. According to Xavier Kurz, PROTECT’s recommendations in this area will help to improve the quality and consistency of studies, increase confidence in the results of observational studies, and strengthen regulatory decision-making. Benefit-risk assessment was another area where PROTECT delivered results, including a framework for benefit-risk assessment, greater understanding of the use of patient preferences for decision-making, and a website with training material on the subject. These deliverables also provide foundations for further methododological developments in this field. Finally, PROTECT carried out preliminary research on using the internet as a data collection tool.
OncoTrack identifies new biomarkers for colon cancer
Colorectal carcinomas are a very heterogeneous group of cancers and not all of them respond equally to different drugs. Up until now, doctors have decided on which drug to use based on the tumour gene mutations. However, the mutation status alone is not specific enough. To be able to predict a tumour’s response to certain drugs more accurately, IMI’s OncoTrack project set out to produce molecular fingerprints of different tumours and correlate the different fingerprints to how the tumours respond to various drugs. In the process, they identified two new biomarkers for colorectal cancer which could lead to more personalised and effective treatments for patients with this disease.
The study, which was recently published in the journal Nature Communications, was one of the largest public-private collaborations in this field to date. By bringing together academic institutions, SMEs and the pharmaceutical industry, OncoTrack scientists first collected tumour samples from over 100 colorectal cancer patients at different stages of the disease. They grew these tumours in tissue culture systems, as well as in special mouse strains, and proceeded to analyse them in the lab. In particular, the scientists looked for biomarkers, i.e. molecules that are typical of the different tumour sub-groups. Based on this analysis, they were able to produce molecular fingerprints for all of the tumours. Next, they tested how the tumours respond to different drugs and correlated various tumour fingerprints with their response to the different clinical compounds. Among other things, they discovered two biomarkers that can predict the effectiveness of two drugs commonly used to treat this disease: Cetuximab, which inhibits the receptor for the epidermal growth factor, and the chemotherapy drug 5FU. ‘The extensive molecular and drug sensitivity datasets generated within this study are a highly valuable resource,’ said Bodo Lange, CEO at Alacris Theranostics, one of the OncoTrack project partners. ‘Our findings provide major new insights into the molecular landscape of colorectal cancer and have the potential to guide treatment decisions.’
Meet the projects
Meet COMBACTE at ECCMID!
IMI’s COMBACTE family of antimicrobial resistance projects will have a stand at the exhibition of the 27th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Vienna, Austria on 22-25 April. The project team will be at booth 29 at the exhibition. Partners in the COMBACTE-MAGNET project will also present results from their RESCUING study at the conference. RESCUING gathered observational data on the treatment of some 1 000 patients with complicated urinary tract infections in 8 countries where the prevalence of multidrug-resistant Gram-negative bacteria is seen to be high. That includes Bulgaria, Greece, Hungary, Israel, Italy, Romania, Turkey and Spain. In a blog post on the COMBACTE website, COMBACTE-NET’s Bruno François explains why COMBACTE is going to ECCMID: ‘Since ECCMID is one of the biggest, most important microbiology and infectious diseases congresses, I would say it is really ‘the place to be’ for our project. Without a doubt it also creates more visibility. Next to that, the event itself fits with the purpose of COMBACTE.’
Registration open for European Lead Factory Stakeholder Meeting 2017
IMI’s European Lead Factory project will hold its Stakeholder Meeting 2017 on 25-26 April in Heathrow/Windsor, UK. The theme of this year’s event is ‘hitting the targets’, and there will be a focus on sharing the experiences of the project with a broad group of stakeholders from policy, science, business and health. As detailed in the agenda, partners will present the results of their collaboration, and the unique assets of the Lead Factory will be highlighted in a dedicated poster session. Additionally, attendees will have the opportunity to discuss the future of drug discovery with programme owners and other experts. Registration is free but obligatory.
Save the date: K4DD end meeting in October
In the last five years, IMI’s K4DD project has made a significant contribution to helping scientists understand how drugs bind with their targets in the body. This year the project is coming to a close and will share some of its achievements and lessons learned at a closing conference from 16 to 18 October in Berlin, Germany, which will be open to the entire scientific community. The event will feature distinguished speakers from a range of pharmaceutical companies and universities, including Leiden University, the University of Vienna and AstraZeneca. The keynote speech will be delivered by Piet van der Graaf, professor of systems pharmacology at Leiden University and one of the leaders in the field. Registration is now open via the project website.