EPTRI – European Paediatric Translational Research Infrastructure
Designing of a pan-European Infrastructure to promote technology-driven Paediatric research within the Infradev-1 call (Horizon 2020)
ID-EPTRI project, coordinated by CVBF-TEDDY (Consorzio per Valutazioni Biologiche e Farmacologiche – European Network of Excellence for Paediatric Clinical Research), has been submitted on March 29th, 2017, within the INFRADEV-01-2017 single-stage call for proposals with the aim to create the framework for a new Research Infrastructure (RI) intended to enhance technology-driven paediatric research in discovery and early development phases to be translated into clinical research and paediatric use of medicines.
The project arises from the need to find answers to the serious lack of medicines for children in EU and worldwide and to propose development models for paediatric medicines that integrates technology-driven aspects with clinical trials. The interest for Paediatrics was indeed mentioned in the ESFRI Road Map 2016 (http://www.esfri.eu/sites/default/files/20160309_ROADMAP_browsable.pdf) where it was recognised that a similar RI should be included into the landscape of the research in Europe.
EPTRI will be a complementary RI in the context of the existing RIs covering the current gaps in paediatric medicines. The new RI will represent a “one-stop-shop” and a paediatric common service with three already established Research Infrastructures (BBMRI, EATRIS, ECRIN) to harness efficiency and delivery of paediatric research activities and services strengthening collaboration within the scientific paediatric community.
The final result of the project will be the Conceptual Design Report to realize EPTRI, the European Paediatric Translational Research Infrastructure, describing the scientific and technical requirements as well as the key components of the new RI. To prepare the Conceptual Design Report (CDR), the project will encompasse three phases. During the Context Analysis phase, that will be performed in 5 technical and scientific domains (1-Paediatric Medicines Discovery, 2- Biomarkers, 3-Paediatric Pharmacology, 4-Formulation Science, 5-Underpinning Paediatric Studies), the perceived value and the possible gaps to be covered will be estimated, by enquiring the scientific Communities, the concerned national Authorities and many other Stakeholders. During the Operational phase, the different components of the new RI will be organised, 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. In the second year, a Feasibility phase is proposed to develop virtual exercises simulating the operations of the RI.