COMPANY PROFILE

 NameCONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE (CVBF) - TEDDY
 RegionApulia
StatusConsortium

 
 PROPOSAL 

TitleNot-for-profit Pan-European Paediatric Research Management Model (Pan European R2M)
Project id.114
Reference sectorBIOTECHNOLOGY
IP Protection LevelNo patents foreseen yet. CVBF-TEDDY developed a not-for-profit Research Management Model based on: a) paediatric scientific networking; b) IT tools; c) interoperability of different paediatric medicines databases; d) interoperability of Research Infrastructures (RIs). The model is intended to connect RIs and to implement good practices and innovative methodologies to develop studies and research on medicinal products in children.
Description of the innovation projectA Research Infrastructure (RI) refers to facilities, resources, services to conduct top level research. The Pan European Paediatric Research Management Model is intended to be transferred to EU and non-EU Mediterranean Countries. It will help in providing an integrated system model for the conduct of paediatric clinical trials about medicines by facilitating the delivery and design of these trials and developing tools and methods to catalyse research, improve and sustain quality, lower costs and harmonize practice. It will also foster the interoperability with the RIs.
State of dev.Model
Industrial applicationThe Pan European PCT-RI model will contribute to enhance industrial capacities and business in the field of paediatric medicines. The presence of the Excellence Centres and networks in different specialized paediatric areas would represent a strong support and incentive to conduct research in industrial sectors of major interest for industry. It will also establish operative standards for developing biological and biotechnological medicines taking into account the paediatric specificities.
Market segmentThe model addresses the market of paediatric medicines with the aim to improve high quality clinical trials delivery by well-equipped sites and the development of appropriate medicines.It will allow Pharma Industries to displace paediatric research in Europe and particularly in Mediterranean Countries,thus increasing the paediatric medicines market
Advantage factorIt will enable researchers to manage paediatric clinical trials and implement important research activities through the creation of innovative platforms. There will be many advantages: aggregation and growth of scientific structures in the field of innovation and life sciences; development of industrial processes; integration with existing ESFRI infrastructures; international effort sharing to enhance the efficiency of the development and delivery of medicines to develop new business.
Commercial challengeThe implementation of the model will speed up the completion of pediatric clinical trials and studies, advantaging companies operating in the Member States participating in the RI. Researchers, patients and Goverments will benefit in terms of increased critical mass of expertise, and growth of workforce in the specific field. Pan-European coordination will provide a one-stop shop across the continent for study funders and sponsors to identify sites and receive quality assurance about the sites.
Publications and Customer ReferecesRuggieri L, et all; on behalf of the GRiP Consortium. Successful private-public funding of paediatric medicines research. Eur J Pediatr. 2015; Giannuzzi V, et all. Clinical Trial Application in Europe. Sci Eng Ethics. 2015; Baiardi P et all. Innovative study design for paediatric clinical trials. Eur J Clin Ph. 2011 May;67 Suppl 1:109-15; Sturkenboom MC et all. Drug use in children: cohort study in three EU countries. BMJ. 2008 Nov 24;337:a2245.