TRANSVAC2 is the follow-up project to its successful predecessor project TRANSVAC, the European Network of Vaccine Research and Development funded under FP7. The TRANSVAC2 consortium comprises a comprehensive collection of leading European institutions that propose to further advance with the previous initiative towards the establishment of a fully operational and sustainable European vaccine R&D infrastructure. TRANSVAC2 will support innovation for both prophylactic and therapeutic vaccine development based on a disease-overarching and one-health approach, thereby optimising the knowledge and expertise gained during the development of both human and animal vaccines. This will be achieved by bridging the translational gap in biomedical research, and by supporting cooperation between public vaccine R&D institutions of excellence, related initiatives and networks in Europe, and industrial partners. TRANSVAC2 will complement and integrate with existing European research infrastructures in both the public and private sectors. TRANSVAC2 will function as leverage and innovation catalyst between all stakeholders involved in vaccine R&D in Europe and -by providing integrated and overarching vaccine R&D services- will contribute to the development of effective products to address European and global health challenges, to controlling the burden and spread of infectious diseases, and reinforce the economic assets represented by vaccine developers in Europe. The impact of TRANSVAC2 will be maximised by two external advisory bodies. An independent Scientific & Ethics Advisory Committee will provide recommendations surrounding scientific-technical and ethical issues, whereas the coordination of TRANSVAC2 with other related initiatives and the further promotion of the long-term stability of a European vaccine R&D infrastructure will be supported by a Board of Stakeholders comprising representatives of policy and decision makers, industry associations and European infrastructures.

In recent years there is mounting evidence that type 2 diabetes (T2D) is associated with cognitive impairment and dementia, which can be considered as a “new” long-term diabetic co-morbid complication with dramatic consequences for patients and their families and a significant impact for healthcare systems. At present there are no reported phenotypic indicators or reliable tests to identify T2D patients at risk of developing dementia. Since the retina is ontogenically a brain-derived tissue, we propose that the evaluation of retinal parameters related to either neurodegeneration or microvascular disease will be robust and valuable biomarkers to identify those T2D patients at higher risk of developing cognitive impairment and dementia. On this basis the overarching aims of the project are: 1) To investigate the common mechanisms involved in the pathogenesis of DR and cognitive impairment in the T2D. 2) To use the retina as a tool to identifying individuals with T2D at a higher risk of developing cognitive decline or dementia. Our multidisciplinary consortium (RECOGNISED) consist of top research leaders in the field belonging to 15 prestigious institutions as well as EATRIS, IDF-Europe and Alzheimer Europe and 3 SMEs. RECOGNISED will apply innovative approaches to identify the molecular mechanisms involved in the high prevalence of cognitive impairment and dementia in T2D population and will use this knowledge to characterize clinical phenotypes (personalized medicine) based on retinal functional and structural characteristics and serum biomarkers in order to stratify the risk and severity of cognitive decline. Previously collected data from registries, cohorts and biobanks will be appropriately exploited and robust new data will be generated that will guide clinical recommendations and open up new therapeutic strategies. Ultimately, RECOGNISED project will help to reduce the huge societal and economic burden associated with diabetes-related cognitive impairment.

HEAL will focus on general bottlenecks to induced pluripotent stem cell therapies with a particular focus on heart failure, which remains a major cause of morbidity and mortality with very few treatment options. HLA-homozygous cell line derived cardiomyocyte aggregates offer the prospect of a restorative heart therapy applicable to large patient populations and to overcome economic barriers associated with autologous approaches. By developing solutions for their mass-production and cryopreservation we will enable allogeneic treatment with minimum requirements for immunosuppression. Assays for assessment of immunogenicity will provide data for the development of an artificial intelligence powered algorithm to predict recipients's immune responses for personalised design of immunosuppression protocols. A potency assay to assure product effectiveness will be developed together with assays of tumorigenicity in vitro and in vivo that meet and exceed current regulatory requirements. A genetic integrity pipeline defining the most sensitive assays for rigorous assessment will be developed and a rescue tool in the form of a biallelic suicide gene for programmed cell death will add to the safety toolbox for the therapy. Optimisation of cell-product administration in terms of retention and engraftment, including catheter-based delivery as minimally invasive alternative to surgical application, and assessment of risks of graft-induced arrhythmia will be determined in a pig model. Early dialogues, via established links, to the regulatory authorities will ensure proper development according to GMP requirements. Freedom to operate and licensing strategies with a health technology and infrastructure assessment of European centres will set the scene for approval of the cell product and related assays and protocols for storage and distribution required to progress towards a first in man study of cell-based heart repair.

The social and economic challenges of ageing populations and chronic disease can only be met by translation of biomedical discoveries to new, innovative and cost effective treatments. The ESFRI Biological and Medical Research Infrastructures (BMS RI) underpin every step in this process; effectively joining scientific capabilities and shared services will transform the understanding of biological mechanisms and accelerate its translation into medical care. Biological and medical research that addresses the grand challenges of health and ageing span a broad range of scientific disciplines and user communities. The BMS RIs play a central, facilitating role in this groundbreaking research: inter-disciplinary biomedical and translational research requires resources from multiple research infrastructures such as biobank samples, and resources from multiple research infrastructures such as biobank samples, imaging facilities, molecular screening centres or animal models. Through a user-led approach CORBEL will develop the tools, services and data management required by cutting-edge European research projects: collectively the BMS RIs will establish a sustained foundation of collaborative scientific services for biomedical research in Europe and embed the combined infrastructure capabilities into the scientific workflow of advanced users. Furthermore CORBEL will enable the BMS RIs to support users throughout the execution of a scientific project: from planning and grant applications through to the long-term sustainable management and exploitation of research data. By harmonising user access, unifying data management, creating common ethical and legal services, and offering joint innovation support CORBEL will establish and support a new model for biological and medical research in Europe. The BMS RI joint platform will visibly reduce redundancy and simplify project management and transform the ability of users to deliver advanced, cross-disciplinary research.

The creation of a European Health Data Space is one of the six strategic priorities for the newly elected European Commission. The European Health Research and Innovation Cloud (HRIC) will be one of the future cornerstone pieces for this area. HealthyCloud will deliver a Strategic Agenda including a Ready-to-implement Roadmap for the HRIC ecosystem. The Strategic Agenda will incorporate the consolidated feedback of a broad range of stakeholders: the European Commission, the Member States and regional, national, European and international relevant initiatives. These agents will be invited to be part of the HealthyCloud’s Stakeholders’ Forum, designed to facilitate the dialogue among them and the Consortium, and to act as an umbrella to bring together similar efforts in specific domains. HealthyCloud has been organized around four fundamental objectives that cover 1) interactions with stakeholders to ensure their voices are included as part of the Strategic Agenda; 2) the inclusion of Ethical, Legal and Societal aspects in the design of the future HRIC ecosystem; 3) the sustainable access, use and re-use of health-related data considering a progressive adoption of the FAIR principles; and 4) the technological solutions in terms of computational facilities and mechanisms to enable distributed health data analysis across Europe. The project is driven by two real-world use-cases (Cancer and Atrial Fibrillation) to ensure that propositions by domain-specific and technological experts are technically and ethically sound and legally compliant. The ultimate goal is to propose an ecosystem that builds and reinforces the trust of patients and citizens in the use of their health data for research. HealthyCloud is a 30-month project that brings together 21 organizations with broad and yet complementary expertise, including 5 Research Infrastructures (ELIXIR, ECRIN, EATRIS, BBMRI and Euro-BioImaging) and 3 Joint Actions (InfAct, iPAAC and eHAction) related to health research.