- IMI Stakeholder Forum 2016 – registration open
- IMI research remains top-notch, while output grows rapidly
- Next deadline approaching for IMI’s open Call on Ebola
- Capturing cancer’s complexity – PREDECT models show the way
- Luxembourg joins ELIXIR, sustainability of eTRIKS ensured
- CHEM21 launches a new online training platform
- ENABLE project seeks antibiotic experts to join project
- ADAPT SMART makes the case for early access
- Contribute to WEB-RADR’s surveys on apps
- EUPATI wants your views on patient involvement in R&D
- Sign up for SafeSciMET’s courses on clinical safety and in vitro models
IMI Stakeholder Forum 2016 – registration open
Registration is now open for the IMI Stakeholder Forum 2016, which will take place on 28 and 29 September in Brussels, Belgium. The first day will feature a keynote speech by Raju Kucherlapati of Harvard Medical School, as well as presentations on, and networking opportunities for, IMI’s next Calls for proposals. On the second day, parallel consultative workshops on strategic research areas will bring together IMI stakeholders to shape together the future of IMI’s programme. The workshops will cover oncology, advanced therapies, digital health, and biopreparedness.
Registration is free but obligatory. To register, simply fill in the form on the event web page.
IMI research remains top-notch, while output grows rapidly
In only one year, the total number of scientific papers produced by IMI projects grew by 48%, while the quality remained high, reveals a new analysis carried out by Thomson Reuters. The study demonstrates that IMI-funded research is world class, and measures up well against research supported by other high-profile funding organisations like the Wellcome Trust and the Medical Research Council. Key findings in the latest report:
- By the end of 2015, IMI projects had produced 1 678 scientific papers – a 48% increase compared to the total number of papers published by the end of 2014.
- IMI research has a citation impact of 1.93 - almost twice the world average (baseline of 1.0) and nearly twice the EU average (1.10).
- Around a quarter (23.5%) of IMI papers are ‘highly cited’, meaning they are in the top 10% of papers for that journal category and year, when ranked by number of citations received.
- IMI research is published in some of the most prestigious journals in the world, including the New England Journal of Medicine, Nature, and the Lancet.
- IMI research is collaborative. More than half (58.5%) of all papers feature authors from different sectors (e.g. universities, pharmaceutical companies, small companies, patient organisations). More than half (53.3%) include authors from more than one country.
Read the full report
Next deadline approaching for IMI’s open Call on Ebola
The next cut-off date for submitting proposals for IMI’s open Call on Ebola and related diseases (IMI 2 - Call 8) is 15 September 2016. Following the first cut-off date in March of this year, €55 million is left in the pot for future projects. The Call was launched to capture emerging scientific advances and to progress those rapidly into health care interventions. Projects funded under this Call should ensure fast development and a wide deployment of sustainable innovative solutions that will result in an increased readiness to respond to future outbreaks. Applicants should pay particular attention to exploiting support from different stakeholders, including the mobilisation of funds through the inclusion of contributing partners under the IMI scheme of public-private consortia. Proposals may address aspects of pre-clinical development and/or clinical development of vaccines, treatments and diagnosis of Ebola or other filovirus infections. Manufacturing strategies, vaccine stability during transport and storage, and/or deployment of vaccines and treatments are also in scope. There are a number of cut-off dates for this open Call, with the final cut-off date set for March 2018.
Capturing cancer’s complexity – PREDECT models show the way
During the earlier stages of cancer drug development, researchers study cancer cells in the laboratory, for example in petri dishes. These two-dimensional models of cancer are relatively cheap and easy to use, so they are still widely used in research, yet they do not accurately replicate real tumours in the body. This hinders the ability of researchers to study cancer in detail and develop new treatments. IMI’s PREDECT project has developed and analysed a number of more complex, three-dimensional models of prostate, breast and lung cancer that may more accurately mimic the behaviour of tumours in the body. According to Boehringer Ingelheim’s Ralph Graeser, there is no single perfect model that fits all purposes. To help scientists pick the right model for the right situation, the project team has written a paper in the journal Scientific Reports. The article sets out the strengths and weaknesses of the different models and provides detailed protocols for their use as well as advice on when and how to use them. ‘Although people have called for an end to use of 2D cultures, these models are still predominantly used, even though they poorly represent human tumours,’ explained Dr Graeser. ‘The robust protocols for the set-up and analysis of 3D cultures, as well as the cross-comparison of the platforms presented in this paper, should help scientists both in academia and industry to better incorporate these complex models in the drug discovery pipeline.’
Luxembourg joins ELIXIR, sustainability of eTRIKS ensured
IMI projects gather vast amounts of data during their lifespan, and once they end, there is usually the question – how to ensure that this data becomes available to the public, benefiting society in the long run? Thanks to the work of the Luxembourg Centre of Systems Biomedicine (LCSB) at the University of Luxembourg and their involvement in IMI’s eTRIKS project, now there is a solution. The LCSB, one of eTRIKS project partners, was appointed by the Luxembourg state to host the latest node of ELIXIR, a European network for the sharing of scientific data. While eTRIKS provides projects with an open-source platform for knowledge management, ELIXIR provides an infrastructure, a kind of a highway system, which integrates research data from all corners of Europe and ensures a seamless service provision that is easily accessible to all. Luxembourg is the newest member in a network of 18 European countries and they are also the first node of ELIXIR, which will become a data repository for translational research, the interdisciplinary branch of the biomedical field. The inspiration to specialise in translational data came from IMI’s eTRIKS project, said Reinhard Schneider, Head of the Bioinformatics Core facility at the University of Luxembourg’s Centre for Systems Biomedicine, who is also involved in eTRIKS. 'The sustainability of eTRIKS is now secured,' he added. 'All IMI projects which will open their data are welcome to deposit their data on the Luxembourg ELIXIR node.'
CHEM21 launches a new online training platform
Interested in the greening of the drug development process? Don’t miss the new online training platform which was launched by IMI’s CHEM21 project as part of their recent workshop ‘Practical Aspects of Green Chemistry in the Pharmaceutical Industry’. The platform comprises a range of free, shareable, and interactive educational and training materials created to promote the uptake of green and sustainable methodologies, with a particular focus on the synthesis of pharmaceuticals. This online resource is supplemented by a book, Green and Sustainable Medicinal Chemistry, edited and authored by CHEM21 consortium members and collaborating external experts. Available in both hardcopy and electronic format, the book addresses current challenges in modern green chemical technologies and sustainability thinking. It covers a broad range of CHEM21 topics, providing an overview of the key green chemistry tools, guidance and considerations aimed at developing greener processes, as well as cutting-edge synthetic methodologies. IMI’s CHEM 21 project is Europe’s largest public-private partnership dedicated to the development of manufacturing sustainable pharmaceuticals. One of the primary aims of this project is to promote the uptake of green and sustainable methodologies and to embed them in everyday practice.
ENABLE project seeks antibiotic experts to join project
IMI antimicrobial resistance project ENABLE is looking for partners to join its consortium. Specifically, the team is looking for organisations with expertise in bacterial potentiation or small molecule uptake. Details of the expertise required, the types of organisations that are eligible for funding, and information on how to apply, can be found on the project website. The project will also hold a webinar on the process on 31 August. The deadline for submitting expressions of interest is 9 September 2016.
Meanwhile, ENABLE’s open Call for innovative anti-infective programmes remains open. The Call provides early stage anti-infective programmes with an exciting opportunity to progress through the challenging, earlier stages of drug development and draw on the extensive expertise of the ENABLE consortium.
ADAPT SMART makes the case for early access
The question of whether, and how, patients with serious diseases should be allowed early access to promising new treatments is hotly debated. Now IMI’s ADAPT SMART project has put together a simple guide to early access that begins with the story of two fictional patients. Jane has advanced cancer and has at best a year or two to live. John has a family history of cancer, but is currently fit and healthy. If both are told about an experimental new treatment that looks promising but needs more testing, their responses will likely be very different. John hopes that if he is diagnosed with cancer in several years’ time, the treatment will be thoroughly tested. Jane cannot wait so long, and is willing to accept the uncertainties that come with the experimental treatment. However, as the project notes, ‘healthcare decision-makers have an obligation to cater to the needs of both Jane and John’. The project goes on to explain how Medicines Adaptive Pathways to Patients (MAPPs) seek to foster access to beneficial treatments for the right patient groups at the earliest appropriate time and in a sustainable fashion. The key features of MAPPs are:
- focuses on the promise to address a high unmet need;
- provides timely access for the target population in need;
- uses an iterative development and assessment plan with evidence generation over the entire life-span of the drug;
- harnesses real world data to inform follow-on licensing and reimbursement decisions and to manage risks;
- provides for the adjustment of the treatment-eligible population;
- manages utilisation;
- facilitates the collaboration of all stakeholders (pharmaceutical companies, patients, regulators, HTAs, payers, health care providers);
- ensures the sustainability of the innovation and healthcare systems.
Contribute to WEB-RADR’s surveys on apps
IMI project WEB-RADR has launched a pair of surveys, one for healthcare professionals and one for patients and consumers of medicines. The goal of the surveys is to gather opinions on an app that people can use to report adverse drug reactions (side effects) and receive safety information about medicines. The results will help the project to improve the app they have already developed and raise awareness about reporting side effects and receiving safety information. The project will also use the results to quantify the main facilitators and barriers for a mobile app as a tool of two-way risk communication, and determine whether there are differences in preferences and expectations between stakeholder groups (type of patient, healthcare professionals, countries). The surveys are available in seven languages: Croatian, Dutch, English, French, German, Portuguese, and Spanish. The deadline for contributing to the survey is early September.
EUPATI wants your views on patient involvement in R&D
Patient education project EUPATI has launched a public consultation to review the guidance it has developed on patient involvement in the medicines research and development process. The guidance is divided into four distinct frameworks:
- patient involvement in industry-led R&D
- patient involvement in health technology assessment (HTA) bodies
- patient involvement in regulatory processes
- patient involvement in ethics committees (to follow by end of July 2016)
They were developed in response to the growing need to draw on the experience and specific knowledge of patients, and their day-to-day use of medicines, in order to improve medicines development and evaluation. The frameworks suggest approaches to allow structured interaction with patients, and thereby facilitate the exchange of information and constructive dialogue at national and European level where the views from users of medicines can and should be considered.
The four frameworks have already received feedback from a number of partners of the EUPATI consortium (including patient organisations), but further evaluation and feedback from patient organisations and other key stakeholders are essential in order to validate the guidance. Individuals and groups are invited to contribute to the review by commenting directly on the framework documents, which can be downloaded from the EUPATI website. The consultation will close on 15 September.
Sign up for SafeSciMET’s courses on clinical safety and in vitro models
Registrations are open for two SafeSciMET courses which will be held in September this year.
- Clinical safety: post-approval – 12-16 September 2016, Paris (France)
- Innovative in vitro models in drug safety assessments – 13-16 September 2016, Liverpool (UK)
IMI’s SafeSciMET consortium offers a variety of custom-tailored solutions to education and training needs for drug safety specialists. For current developments within the project and planning for the future, read the project’s InBrief newsletter.