- IMI launches new Calls for proposals
- Catch up on the webinars and meet the participants
- Registration open for the IMI Scientific Symposium
- IMI Stakeholder Forum 2018 – save the date!
IMI launches new Calls for proposals
A new Antimicrobial Resistance (AMR) Accelerator Programme is part of new IMI Calls for proposals launched on 18 July. Of the other topics launched in the Calls, many address brain disorders (e.g. Alzheimer’s disease, Parkinson’s disease, Huntington’s disease, major depression) and immune-mediated diseases (e.g. rheumatoid arthritis and lupus as well as inflammatory bowel diseases such as Crohn’s and colitis, and skin diseases like dermatitis and psoriasis). Among other things, the topics aim to make clinical trials more patient-centric, contribute to medicines safety, and apply blockchain technologies to the drug development and health sectors.
Pierre Meulien, IMI Executive Director commented: ‘Our new Antimicrobial Resistance Accelerator programme represents a strategic, coordinated response to one of the biggest challenges facing the world today. Meanwhile the topics on digital health and the blockchain highlight IMI’s commitment to working with all sectors involved in healthcare.'
The two Calls for proposals (IMI2 – Calls 15 and 16) have a total budget of EUR 434 million. Around half of this comes from Horizon 2020, the EU’s framework programme for research and innovation. The other half comes from EFPIA companies and IMI Associated Partners; these do not receive any funding from IMI but contribute to projects, mainly through ‘in-kind’ contributions (e.g. researchers’ time).
Catch up on the webinars and meet the participants
During July, IMI held webinars on IMI2 – Call 16, all IMI2 – Call 15 topics, our rules and procedures, and opportunities for SMEs in the Calls. Recordings of all webinars and pdfs of the presentations are available on the webinar page of the IMI website. The page also includes the participant lists of all webinars; these represent a useful networking tool for groups looking to join or build a consortium.
More advice on building/finding a consortium can be found on our finding partners page.
Registration open for the IMI Scientific Symposium
Registration is now open for the IMI Scientific Symposium which will be held in Brussels, Belgium on 22 and 23 October 2018. The event will feature more than 80 poster displays, over 25 oral presentations and several interesting panels by young scientists on topics ranging from personalised medicine to patient-centric approaches in drug development. The oral presentations and the scientific posters were selected by a panel of top experts and they will offer a glimpse into some of the stellar science that IMI projects have been doing in various disease areas, such as severe asthma, Alzheimer’s disease, diabetes and cancer, to name but a few.
Registration is free but obligatory. A link to the registration form as well as the draft agenda are available on the event web page.
IMI Stakeholder Forum 2018 – save the date!
The IMI Stakeholder Forum 2018 will take place in Brussels, Belgium on Wednesday 24 October (the day after the Scientific Symposium). The theme this year is ’The value of cross-sectoral health research and innovation’, and as such we will be discussing the added value of cross-sector collaboration and technology convergence to address complex health challenges, especially in areas with a large public health need. In the morning, we will discuss where we could collectively collaborate, and who we need in the IMI partnership to contribute to delivering the impact expected from EU citizens. In the afternoon, we will start by looking at ways to embrace technology convergence to optimise health research, before focusing in on the neurodegenerative disease area to see how we can collectively apply the collaborative approach in practice to make a real difference to patients and healthcare systems.
iPiE releases database on environmental aspects of drugs
IMI’s iPiE project has released an online tool that summarises the properties, environmental toxicity and characteristics of active pharmaceutical ingredients (APIs). Dubbed, iPiE*SUM (‘iPiE Summary Database Search’), the tool is designed to allow public and regulatory bodies to obtain a high-level overview of what studies were collected during the iPiE project and what eco-toxicity data and studies are available. APIs can be released to the natural environment during the manufacturing process, following use by patients, or when unused medicines are disposed of inappropriately. The goal of iPiE is to develop a framework that will provide methodologies to prioritise new and existing medicinal compounds for a comprehensive environmental risk assessment. As such it will support and inform regulatory activities designed to assess and reduce the environmental impact of medicines.
RADAR-CNS MS study gets underway
The RADAR-CNS project has recruited the first participants to the multiple sclerosis (MS) component of the project. The participants will wear a Fitbit device for up to 24 hours a day. This will capture information about mobility, heart rate and sleep quality. In the following weeks, the participants will also receive a chest-worn device, the eFaros, which will be used for a week every three months to better characterise balance, gait variability, falls and heart rate variability. Professor Giancarlo Comi of the Vita-Salute San Raffaele University, Milan, Italy said: ‘We are very pleased to have recruited our first participant in Milan. It’s an exciting time for us as we enrol and recruit more people to our MS studies.’ In total, RADAR-CNS hopes to recruit 400 participants with MS to assess changes in disability and fatigue over time. In addition, the project will recruit 240 people with MS for a study on mood changes (in particular on depressive feelings) in people with a recent diagnosis of MS. Studies of patients with major depressive disorder and epilepsy got underway in 2017.
BD4BO releases toolkit to assist big data projects on outcomes work
DO>IT, the coordination project of the Big Data for Better Outcomes (BD4BO) programme, has delivered a toolkit to support the other BD4BO projects in the identification, selection and measurement of outcomes. The BD4BO programme currently has projects focusing on Alzheimer’s disease, blood cancers, prostate cancer, and heart disease. The new toolkit represents a practical guide which will help the projects to adopt a standardised approach when developing core outcome sets (COS) in their disease areas. The toolkit proposes six main stages for developing a COS, from scoping to dissemination, with a focus on stakeholder input across all stages to ensure a wide range of perspectives are taken into account. Whilst the toolkit highlights any existing best practice for developing COS, it also presents a range of methodological options which BD4BO projects can consider depending on the scope of the work and resources available. Each stage includes decision-making flowcharts, summaries of key considerations and case studies to highlight the key factors and considerations when developing COS. These typically reflect aspects that are of importance to BD4BO projects around the use of data from a range of sources from ‘real world' settings in addition to clinical trials.
ADAPT-SMART paper highlights progress on MAPPs
A new paper published in Nature Reviews Drug Discovery by the ADAPT SMART project highlights the progress made in discussions on Medicines Adaptive Pathways to Patients (MAPPs) through the project, as well as areas where bottlenecks remain. MAPPs describes the move to find ways of providing faster access to treatments for patients in urgent need, while ensuring that patients, healthcare professionals and others have sufficient information on the benefits, risks and costs of the treatment. In the paper, the authors argue that ADAPT SMART has helped to foster the evolution of an ‘adaptive mindset’, and they set out a series of ‘building blocks’ to facilitate future discussions on MAPPs. These include the need to ‘focus on speedy access for patient (sub-) populations in urgent need’; the need to use a wide range of study methods for evidence generation (including real world data), and the need to involve all stakeholders, including sponsors, patients, healthcare providers, regulators, HTA (health technology assessment) bodies and payers. The authors conclude: ‘Overall, we remain optimistic that current dynamics driven by new types of products, a more prominent patient voice and the issues of drug access and affordability will bring stakeholders together to address the challenges. We continue to believe that the building blocks of MAPPs and a shared adaptive mindset are the best option to achieving timely access for patients to transformative products in an affordable way, without compromising evidence standards.’
Join the online course on real world evidence in medicine development
Registration is open for an interactive online course developed by IMI’s GETREAL project on the current techniques, opportunities and challenges for the use of real-world evidence in medicine development. The course, which is aimed at people from pharmaceutical companies, regulatory authorities, health technology assessment bodies, patients’ organisations, consultancy companies and academia, will run in September and October. It comprises 5 learning units, each of which will require around 8 to 10 hours of student input. The units will cover the following topics: overview of the medicine development landscape; real-world evidence generation; real-world evidence synthesis; decision-making and weighing of evidence; and demonstrating relative effectiveness to decision-makers. People who complete the course successfully will receive a certificate. Previous course participants have described it as ‘comprehensive’ and ‘a great way to increase my knowledge’.