ID-EPTRI a new research infrastructure that will facilitate the future development of better paediatric medicines
Rome, January 2018 - The first Research Infrastructre entirely dedicated to paediatrics has been officially kicked-off. ID-EPTRI (European Paediatric Translational Research Infrastructure), is a EU-funded project coordinated by the Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF), and lasting 24 months, which is aimed to design the framework for a new European Paediatric Research Infrastructure (RI), acting as a paediatric common service in the context of the existing RIs.
New products and technologies
Minors represent 20% of the European population and their care is one of the most important priorities and challenges for Europe. It's essential the development of evidence-based paediatric medicines and treatment strategies. Nowadays around the 50% of the medicines addressed to children and young patients have not been tested specifically for them. For this reason, it's strategic the development of the suitable research infrastructure that can solve this problem, studying the paediatric research from the early phases to the paediatric formulation. Children and young patients cannot be never compared with adults as they are growing up and their metabolism is different. For this reason, the only way to develop better medicines for children and young patients is studying them specifically for this type of "special" population. A dedicated infrastructure integrating the different basic research networks addressed to paediatric population will help in the process to reduce time and increase the number of projects. On the other hand, it also can help to a fast translation into the clinical practice. "The project arises from the need to cover the gap in paediatric medicines availability by enhancing innovative technologies and reconnecting all the drug development phases from discovery and preclinical to clinical research", explained the project Coordinator, Donato Bonifazi. "EPTRI will be a "one-stop-shop" for advice in paediatric medicines research with demonstrated capacity to bridge the existing gaps".
This new research infrastructure, EPTRI is complementary to the other existing Biomed Research Infrastructures acting as a 'Paediatric Common Service' in the ESFRI (European Strategy Forum on Research Infrastructures) Scenario. The project involves 26 partners from EU and non-EU countries including consolidated research infrastructures, top-level universities, scientific and clinical centers of excellence in Europe and aims to create a Conceptual Design Report (CDR) to set-up the European Paediatric RI.
In order to set up the new RI within the European landscape, there will be three different phases: 1. a context analysis, aiming to acquire the information needed to complete a consistent CDR; 2. an operational phase focused more specifically on the design of the whole RI; 3. a feasibility phase in which selected pilot experiences will allow testing a limited number of services and tools delivered by EPTRI.
The involvement of children and young people is included in the development of the project, with the aim to ensure that their needs are addressed in the conceptual design report for the development of the new infrastructure, that will join and cover all the different domains previous to the clinical research in drug development: 1. Pediatric Medicines Discovery and Preclinical Studies; 2. Biomarkers; 3. Paediatric Pharmacology, 4. Formulation Science, 5. Underpinning Paediatric Studies.
EPTRI will allow to: " Cover the current existing gaps connecting the different steps in research from early stage. " Enable and prepare researchers in many methodological areas to conduct research that effectively underpins the development of paediatric medicines. " Increase the global competitiveness of the European RI also in favor of children, young people and their families.
To test this new RI, in the second year a feasibility phase is proposed to develop virtual exercises simulating the operation of the RI. In this phase four types of experiments will be developed: 1. Feasibility studies with scientists; 2. Feasibility studies with governments; 3. To test the interest of patients' associations and YPAGs and 4. Commons services with RI feasibility studies.
The Kick-off Meeting of the project was held in Rome on 15th and 16th of January, with the involvement of all the partners, at the Ministry of Education, University and Research.
Research Infrastructure, paediatrics, research, children, paediatric drug development
Albania, Austria, Switzerland, Cyprus, Czechia, Germany, Estonia, Greece, Spain, France, Israel, Italy, Netherlands, Poland, Romania, Russia, Sweden, Ukraine, United Kingdom