OrphaDev4Kids is a 3 year Project aiming to address the issue of Orphan medical devices (MDs) for the paediatric population. Paediatric MDs development faces unique challenges as children often differ from adults in size, growth, development, body composition, and disease features. Paediatric MDs development is more complex and riskier for developers and only a small number of approved MDs are available, few designed specifically for children and others readapted from adult applications.
OrphaDev4Kids will grant access to a complex ecosystem including tools, facilities, and supportive services (e.g. regulatory advice, assistance for prototype development, certification and marketing authorization, etc.) aimed to maximise the value-for-patients of the research and development of paediatric MDs projects.
Project’s Work Plan
Partners
The OrphaDev4Kids consortium brings together a multidisciplinary group of nine partners from across Europe:
Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) acts as the Project’s Coordinator. CVBF is a not-for profit organisation providing clinical research services to all type of sponsors and leading research in national and international projects. CVBF focuses on proposing models for paediatric medicines integrating technology-driven in several scientific domais, such as: Drug Discovery and Early Development; Preclinical Studies; Biomarkers; Paediatric Pharmacology and Formulations. CBF has also extensive experience in Project Coordination.
TEDDY – European Network of Excellence for Paediatric Clinical Research is an independent multidisciplinary, multinational Network, founded in 2005, composed of partners from more than 20 countries aimed at facilitating the performance of good quality paediatric studies and research. TEDDY is strongly proactive in the promotion and implementation of adequate health policies and a social awareness on the importance of the paediatric medicines across Europe.
Instytut Pomnik Centrum Zdrowia Dziecka (IPCZD), an EPTRI member, is the largest and best-equipped institute of paediatric healthcare in Poland, also serving as one of the leading teaching hospitals. IPCZD has experience in identifying the needs and challenges associated with paediatric healthcare and leveraging collective groups to ideate solutions.
Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus, an EPTRI member, is a scientific research organisation, registered as a private, not-for-profit foundation in 2007, with the aim to promote research in biological, medical and pharmaceutical areas in Europe. The Foundation promotes research in biological, medical and pharmaceutical areas with strict and continuous attention to the innovations and opportunities resulting from the scientific progress as a guide for introducing substantial methodological innovation and new fields of action.
Universitá Degli Studi de Bari Aldo Moro, an EPTRI member, is a public higher education institution founded in 1925 with a student population of around 40,000. The university is also focused on scientific research at the doctorate level. Its research centres are highly-interactive, having connections among different departments, universities, and other research centres. The university is one of the 48 Italian higher education institutions in the CWUR list of the top 1000 universities in the world for 2016. It has been ranked between 151st and 200th in the world for Physics by Academic Ranking of World Universities (ARWU) – Shanghai Jiao Tong University (2015).
RCCS – Associazione La Nostra Famiglia “Instituto Scientifico Eugenio Medea” is a Scientific Institute for Research, Hospitalization and Health Care. It was officially recognized in 1985 and it specializes in neurological and neuropsychological diseases of the developmental age, focusing on research, treatment and training. Its goal is to promote the dignity and the quality of life of our young patients and their families.
Mediziwische Universitat Graz is a center of innovative, cutting-edge medicine in southern Austria in which over 2,500 academic and general staff members and around 5,000 students conduct research, teach and learn with a spirit of innovation.
J.E.M Tech is an Italian company developed to solve the problem of the lack of imaging technology during open heart surgeries. After a 5 years’ experience in Verona’s (Italy) cardiac operating rooms: we developed the Videocardiograph (VCG), an industry-first non-invasive, A.I. based medical support system able to assess the mechanical function of the heart in real time with just one camera.
EPTRI, European Paediatric Translational Research Infrastructure, is a non-profit research organisation aiming at implementing competences, research strategies, access to key technologies, standardised models, and analytical tools and offering public and private stakeholders qualified basic, preclinical and translational research services covering paediatric medicines discovery and development.
With the support of:
This Project has received funding from the European Union’s Horizon Europe Framework Programme under grant agreement No 101161377.
