Systemic lupus erythematosus (SLE) is a systemic autoimmune connective disease in which the immune system attacks its own structures, causing widespread inflammation and tissue damage in the affected organs. The kidney is one of the main organs affected by SLE, and lupus nephritis (LN) concerns 3060% of adult SLE patients, being significantly associated with an increase in morbidity and mortality. The definitive diagnosis of LN can only be achieved by histological analysis of renal biopsies, but the invasiveness of this technique is an obstacle for early diagnosis of renal involvement and a proper follow-up of LN patients under treatment. Our aim to identify minimally invasive biomarkers of renal involvement and non-response to therapy in SLE using body fluid (urine and blood), using cutting-edge technologies related with flow cytometry: blood mass cytometry, urinary inflammatory mediators, extracellular vesicle analysis and urinary microbiome. The tissue/fluid correlation will be assessed using kidney biopsy samples following a liquid biopsy approach. We will apply this analysis to longitudinal samples of LN patients recruited in 3TR consortium, and finally design a prototype kit for LN diagnosis and prognosis. With this project EARLINESS participate in the efforts of the scientific community to develop effective strategies for personalized rheumatology.

CORE–MD will translate expert scientific and clinical evidence on study designs for evaluating high-risk medical devices into advice for EU regulators, to achieve an appropriate balance between innovation, safety, and effectiveness. A unique collaboration between medical associations, regulatory agencies, notified bodies, academic institutions, patients’ groups, and health technology assessment agencies, will systematically review methodologies for the clinical investigation of high-risk medical devices (Work Package 1), recommend how new trial designs can contribute (Work Package 2), and advise on methods for aggregating real-world data from medical device registries with experience from clinical practice (Work Package 3). Multidisciplinary workshops will propose a hierarchy of levels of evidence from clinical investigations; educational and training objectives for all stakeholders, to build expertise in regulatory science in Europe; and an ethics charter for medical device innovation (Work Package 4). Industry participation will be invited. Specific CORE–MD tasks will advise on optimal statistical methods, the utility of patient-reported outcomes, the conduct of registry trials, clinical criteria for evaluating artificial intelligence as a medical device, and how to evaluate medical devices used in children. The essential principles of medical device trials will be considered jointly with the Good Clinical Trials Collaborative. Links between CORE–MD partners will catalyse sustainable networks for research. The consortium is led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, and involves all 33 specialist medical associations that are members of the Biomedical Alliance in Europe. Final recommendations will be submitted to the Working Group on Clinical Investigation and Evaluation of the European Commission to be considered when developing EU guidance or common specifications.

Age-related macular degeneration (AMD) is the world’s most important age-related blinding disorder. The current proposal utilises epidemiological data describing clinical phenotype, molecular genetics, lifestyle, nutrition, and in-depth retinal imaging derived from existing longitudinal European epidemiological cohorts and biobanks to provide three major insights needed for long-lasting prevention and therapy for AMD: (a) the development of robust algorithms utilising genetic and non-genetic risk factors to identify personalised risks of developing advanced wet and dry AMD; (b) the identification of novel biomarkers for further stratification of disease risks. New insights from (a)+(b) will be used to elaborate preventive medical recommendations for highrisk subgroups of AMD patients; and (c) the identification of molecular drivers/biological pathways relevant for onset and progression of advanced AMD that will be used to identify and validate new therapeutic targets. Key deliverables are: 1. Determination of AMD frequency in Europe, and assessment of AMD risk for phenotypical, genetic, environmental, and biochemical risk factors and their interaction. (WP1-3) 2. Development of a web-based prediction model for personalised risk assessment of AMD based on integration of risk profiles derived from retinal imaging, molecular genetics, assessment of lifestyle, and biochemical testing. (WP4) 3. Modelling and functional characterisation of pathophysiological pathways identified from integrated analysis of current knowledge and the above risk profiles. (WP5) 4. Experimental testing and interpretation of pathophysiological consequences of risks at the molecular level. (WP6) 5. An extension and refinement of the prediction model (WP4) based on work in WP5 and WP6 to generate clinical guidelines for the medical management of high-risk subgroups of patients with AMD. (WP7) 6. Promotion and dissemination of newly gained knowledge towards AMD prevention and therapy development