RISCAPE will provide systematic, focused, high quality, comprehensive, consistent and peer-reviewed international landscape analysis report on the position and complementarities of the major European research infrastructures in the international research infrastructure landscape. To achieve this, RISCAPE will establish a close links with a stakeholder panel representing the main user groups of the report, including representatives from ESFRI, the OECD and Member state funding agencies to ensure usability and the focus of the Report. It will also benefit from close co-operation with other projects and initiatives in the European research infrastructures development to ensure consistency with the existing landscape work. Particularly, RISCAPE builds on the European Research Infrastructures (RIs) in the ESFRI landscape report (2016) and on the landscape analysis done or currently underway in the H2020 cluster projects. RISCAPE leverages the experts on the European RIs with extensive knowledge on the disciplines involved and RI development in Europe and the project benefits from the contacts and tools developed in the cluster- and international RI collaboration projects to maximize the discipline-specific usability of the results. A key factor in the RISCAPE analysis is that the complementarities will be analyzed in a way which is natural and suitable for the discipline and RI in question. The resulting Report and the used methods will be independently peer reviewed to maximize the usability and objectivity of the information provided for the EU strategic RI development and policy. The project answers directly to the European Commission strategy on EU international cooperation in research and innovation, particularly on the need to obtain objective information in order to help implement the (EC) strategic approach.

Recent pandemics showed Europe how serious health threats can be to society. Proactive approaches are needed to ensure that medical countermeasures are available during pandemics. PROACT EU-Response’s overarching objective is to prepare Europe for future pandemics by strengthening upon existing networks of experts and civil society focused on clinical therapeutic platform trials within hospital inpatient settings across Europe. In case of an outbreak, this network will provide capacity to pivot rapidly to implement large, multi-country platform trials studying therapeutics and diagnostic-tool performance. Underpinned by strong community involvement and further strengthened by the inclusion of social and implementation scientists, PROACT EU-Response centres on six objectives: expand a solid network of clinical centres across Europe that will implement a clinical trial assessing a syndromic approach for respiratory viral infections; strengthen a laboratory network to identify pathogens and biomarkers of disease monitoring for routine surveillance; support a network of methodologists and trialists who will ensure the trials’ logistical and methodological aspects; initiate a network of professionals to work on preparedness tools to ensure a smooth pivot from inter-pandemic to the pandemic period in case of an outbreak; build a network of social science researchers who will provide nuanced understanding of the social contexts; and establish a community group to work on activities that will empower patients and citizens in Europe regarding their own health and educate them about science and health issues. By bringing together scientists, social science researchers, and civil society members, PROACT EU-Response will benefit the entire European population and beyond through decreased mortality and morbidity associated with emerging diseases, lower societal economic costs of morbidity, strengthened research and innovation expertise, human capacities, and know-how for combatting communicable diseases.

The evaluation of new medicines for rare diseases (RD) including rare paediatric RDs is challenging for several reasons, among which are the small patient sample sizes, heterogeneity of patients and diseases and heterogeneity in disease knowledge. Due to these difficulties, access to effective treatments and the number of treatment options are often limited in RDs. INVENTS aims to provide clinical trial trialists, researchers and regulators with a global framework encompassing methods, workflows and evidence assessment tools to be implemented in orphan and paediatric drug development. Our ambition is to significantly improve the evaluation of evidence and regulatory decision-making through the development and validation of: refined longitudinal model-based diseases trajectories and treatment effect, improved extrapolation models, in silico trials (e.g., virtual patient cohorts), optimised model-based clinical trial designs and evidence synthesis methods. These will be evaluated through simulation studies and tested on extensive data from a range of use cases provided by our industrial partners Roche and Novartis and Real World data (RWD) from RD registry. The INVENTS framework will improve consistency and efficiency of the drug evaluation process for RD by augmenting clinical evidence without compromising its scientific integrity and providing regulators assessment credibility criteria. At the end of this 5 years project, the European industry will be able to exploit novel and improved clinical trial designs, in silico trials and RWD analysis approaches supporting drug development in RD. The European Medicine Agency and European national regulators (including Health Technology Assessment bodies) will be supplied with a general framework allowing better informed decision-making. Most importantly, RD patients will benefit from an increased and faster access to efficacious and safe treatments.

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.