Children’s health is a major societal challenge for Europe and the world, requiring development of paediatric medicines and treatments strategies based on evidence derived from clinical trials demonstrating efficacy and safety in infants and children, rather than on uncritical extrapolation from adult data (over 50 % of the medicines used for children had not been tested in this specific age group). Conducting clinical trials in children requires specific competences and infrastructure. ECRIN-ERIC (www.ecrin.org) is a generic infrastructure for multinational trial management, in any disease area. However it does not specifically address the paediatric needs in terms of trial management capacity. In its 2016 Roadmap, ESFRI suggested an upgrade of ECRIN to develop a common infrastructure for paediatric trial management through cooperation with the European Paediatric Clinical Trial Research Infrastructure (EPCTRI). The resulting PedCRIN project is also a unique opportunity to improve ECRIN business model and financial sustainability, attracting more industry-sponsored trials and more Member and Observer countries. PedCRIN builds on five work packages : project coordination (WP1); establishment of a strategy and upgrade of the governance and business plan, through a Sustainability Board jointly involving the scientific partners and the government representatives (WP2); development of tools specific for paediatric and neonatal trials (WP3) (methodology, outcome measures, adverse event reporting, bio-sample management, ethical and regulatory database, monitoring, quality and certification); operational support provided as transnational access to a few pilot trials to test the updated organisation and tools (WP4); communication targeting user’s communities (including industry), policymakers, patient and parents’ empowerment (WP5). Two other ESFRI-landmarks, BBMRI-ERIC and EATRIS ERIC, will contribute to PedCRIN.

The ISIDORe consortium, made of the capacities of European ESFRI infrastructures and coordinated networks, proposes to assemble the largest and most diverse research and service providing instrument to study infectious diseases in Europe, from structural biology to clinical trials. Giving scientists access to the whole extent of our state of the art facilities, cutting edge services, advanced equipment and expertise, in an integrated way and with a common goal, will enable or accelerate the generation of new knowledge and intervention tools to ultimately help control SARS CoV 2 in particular, and epidemic prone pathogens in general, while avoiding fragmentation and duplication among European initiatives. Such a global and interdisciplinary approach is meant to allow the implementation of user projects that are larger, more ambitious and more impactful than the EU supported transnational activities that the consortium is used to run. Our proposition is ambitious but achievable in a timely fashion due to the relevance and previous experience of the partners that we have gathered and that have complementary fields of expertise, which addresses the need for an interdisciplinary effort. Leveraging all these existing strengths to develop synergies will create an additional value and enhance Europe capacity for controlling emerging or re emerging and epidemic infectious diseases, starting with the COVID 19 pandemic. Such a global and coordinated approach is consistent with the recommendations of the One Health concept and necessary to make significant contributions to solving complex societal problems like epidemics and pandemics.

The general objective of this project is to design the framework for the European Paediatric Translational Research Infrastructure (EPTRI), a new Research Infrastructure (RI) aimed to enhance technology-driven paediatric research in discovery and early development phases to be translated into clinical research and paediatric use of medicines. The starting point of the proposal is the serious lack of medicines for children in EU and worldwide as well as the lack of a developmental model for paediatric medicines that integrates technology-driven aspects with the methodological, ethical and regulatory framework. The design for this new RI will be based on the following main pillars: • to harness efficiency and delivery of paediatric research activities and services strengthening collaboration within the scientific paediatric community; • to be a complementary RI in the context of the existing RIs covering the current gaps, while avoiding any duplication; • to develop a one-stop-shop for advice in paediatric drug development. To prepare a valuable Conceptual Design Report (CDR), the project encompasses three phases. During the Context Analysis phase, that will be performed in 5 technical and scientific domains (1- Paediatric Medicines Discovery, 2- Paediatric Biomarkers and Biosamples, 3-Developmental Pharmacology, 4-Paediatric Medicines Formulations and Medical Devices, 5- Underpinning Medicines Development to Paediatric Clinical Studies) the perceived value and the possible gaps to be covered will be estimated by enquiring the scientific communities and many other Stakeholders. During the Operational phase, the different components of the new RI will be depicted including governance model strategies for interaction with national Authorities and the existing RIs, the IT-architecture model, services to be provided and a business plan. Finally, a Feasibility phase is proposed to develop virtual exercises simulating the operations of the RI. The final result of the project will be the CDR to realize EPTRI.

Paediatric medicines development is embedded in the European policy, legislation and in the work of the pharmaceutical industry but currently the potential of this effort is not realised. The conect4children (c4c) project will address the critical problems with the design, implementation and operational conduct of paediatric clinical trials, for example the fragmented and redundant efforts between sponsors, sites and countries. This project will generate a sustainable infrastructure that optimises the delivery of clinical trials in children through: a) a single point of contact for all sponsors, sites and investigators; b) efficient implementation of trials adopting consistent approaches, aligned quality standards and coordination of sites at national and international level; c) collaboration with specialist networks; d) high quality input to study design and preparation through rigorous strategic and operational feasibility assessment and e) the promotion of innovative methodologies. The project will be managed according to IMI2 best practice with a dedicated communications effort. The clinical trials infrastructure will be setup, implemented and tested by implementing 3-4 industry and at least 1 non-industry proof-of-viability studies. Expert advice groups will promote innovative methodologies and engagement with regulators. The business model for a sustainable infrastructure will be based on the European landscape of paediatric networks and available trial sites, the evaluation of services needs of sponsors of all kinds, and will be informed by the proof-of-viability studies. Supporting activities will include: data management (data about the trials and the network, including performance metrics for network management and promotion; handling trial data for non-industry sponsors; support for common data dictionaries); education and training. The voices of children, young people and their families will be central to the network.