Multiple Sclerosis (MS) is the most frequent neuroinflammatory disease. Despite new treatments that slow the progression of the disease, patients with MS (PwMS) frequently evolve towards major disability. The pathogenesis of MS is controversially debated, but the recent discovery that infection with the Epstein-Barr virus (EBV) is a major risk factor will radically change research avenues. The BEHIND-MS consortium ambitions to understand how EBV promotes MS development. To this end, we have established a multidisciplinary team that will for the first time draw a comprehensive map of the interactions between the virus and all arms of the immune system in the blood and brain of PwMS and how they ultimately lead to neural damage, in the context of genetic risk factors. We will also develop an in vitro model of MS that integrates the virus, the immune system and brain cells reprogrammed from the blood of the same PwMS. Thus, for the first time, we will study in the laboratory the complex molecular mechanisms that give rise to MS. Finally, we will develop an animal model of prodromal MS that would be a ‘game changer’ for our understanding of MS pathogenesis and allow testing of promising new treatments. The pivotal knowledge developed in this project will empower the entire healthcare value chain to work towards better clinical management of MS. A detailed understanding of EBV-MS interactions, combined with newly identified biomarkers, and study models will open the doors for researchers, clinicians and industry to capitalize on the mechanisms underlying EBV-MS interactions, and develop new diagnostic, preventive and therapeutic tools and guidelines. Throughout the project, an open dialogue with the main stakeholder representatives will ensure a mutual understanding of patient needs and project results. Ultimately, by contributing to improved risk analysis, stratification and treatment strategies, BEHIND-MS has the potential to reduce the burden of MS on society.

IMPROVE will use Patient Generated Health Data (PGHD) gathered via m-health and e-health technologies to gain improved insights into the real-life behavior of, and challenges faced by, patients of all ages with complex, chronic diseases and comorbidities. Already today, a wealth of patient and citizen information is available, but fragmented, and therefore not coming to its full utility and value. These personal data will complement and improve existing approaches for Patient-Centered Outcome Measures beyond those currently available in state-of-the-art platforms. The IMPROVE platform that the consortium will build will enable the smart use of patient input and patient generated evidence to 1) advance the role of patient preference and patient experience in the context of treatment selection, 2) improve medical device design based on patient preferences and experiences, and 3) facilitate faster market entry of patient-centric and cost-effective advanced integrated care solutions. Improved clinical adoption of Value Based Health Care, and enhanced return on research and innovation investments will be demonstrated in different care settings across the EU, for 10 use cases in at least 5 different disease areas (e.g., ophthalmology, oncology, cardiovascular disease, chronic inflammation, and neurology). The use cases will be conducted using a large variety of implementation strategies, building on a design thinking approach, to optimally test the innovative framework of data gathering and translation into controlled change and action. In addition, a significant contribution from implementation science is planned to reach out to all stakeholders that are relevant for this initiative and maximise the impact to IMPROVE healthcare provision.

SYNTHIA is an ambitious collaboration between public and private institutions to facilitate the responsible use of Synthetic Data (SD) in healthcare applications. The project will improve the methodological and technical aspects of SD Generation (SDG) by developing new techniques and advancing established ones for different data modalities, including genomics and imaging, to improve the generation of realistic multimodal and longitudinal data. This project will provide the research community with approaches for transparent benchmarking of alternative SDG methods for specific applications, identify and establish evaluation metrics and methodologies, and contribute to the standardisation of an evaluation assessment framework for SD. Robust evidence of SD applicability in a set of use cases across a broad spectrum of medical conditions will be crucial to demonstrate the potential of SD to accelerate data-driven solutions of equivalent quality to those derived from real patient data. Furthermore, legal and regulatory implications of SD use will be analysed with the aim of delivering an assurance framework to guide secure SD utilization in healthcare. These significant breakthroughs will be implemented through the open SYNTHIA federated platform, facilitating responsible SD use by the health research community. The platform will facilitate users´ long-term access to extensively validated, reusable synthetic datasets, as well as to SDG workflows and SD assessment frameworks. The federated infrastructure will rely on extended open-source frameworks for interoperability with other data-sharing infrastructures in the context of the European Health Data Space. A multidisciplinary collaboration of SDG developers, FAIR data experts, clinical researchers, developers of therapies and data-based tools, legal experts, socio-economic analysts, regulatory, policy advocacy, and communication experts will provide a 360º vision on how to advance healthcare applications through SD use.

In the first five years of operations, EATRIS has shown strong proof of concept of the value of the services portfolio, with users ranging from academia, SMEs, large pharma, to biotech and research funding organisations. The overarching aim of EATRIS-Plus is to support the long-term sustainability (LTS) of EATRIS by delivering innovative scientific tools to the research community, strengthening the infrastructure’s financial model and reinforcing EATRIS leadership in the European Research Area (ERA), particularly in the field of Personalised Medicine (PM) research and development. Specific objectives are: (i) To consolidate EATRIS capacities in the field of PM to better serve academia and industry and augment the number of EATRIS Innovation Hubs with large pharma; (ii) To further strengthen the LTS of EATRIS financial model; (iii) To drive patient empowerment through active involvement in the infrastructure’s operations; (iv) To expand strategic partnerships with Research Infrastructures and other relevant stakeholders. The proposal relies on a scientific and technological programme combined with capacity-building activities across 16 EU countries, with the support of two umbrella organisations representing patient organisations and SMEs. EATRIS-Plus will help pooling and exploiting the translational academic capacities of the infrastructure in omic technologies to enable researchers to better address the scientific and societal challenge of PM. Additionally, the coordination office and 13 existing national nodes of the infrastructure will participate in implementing joint outreach, training, industry engagement and international collaboration activities to further build national capacity, increase users’ trust and strengthen EATRIS and the ERA global scientific leadership.