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. 2015 Apr;174(4):481-91.
doi: 10.1007/s00431-014-2398-z. Epub 2014 Sep 23.

Successful private-public funding of paediatric medicines research: lessons from the EU programme to fund research into off-patent medicines

L Ruggieri  1 , V Giannuzzi, P Baiardi, F Bonifazi, E H Davies, C Giaquinto, D Bonifazi, M Felisi, C Chiron, R Pressler, H Rabe, M J Whitaker, A Neubert, E Jacqz-Aigrain, I Eichler, M A Turner, A Ceci; GRiP Consortium
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Successful private-public funding of paediatric medicines research: lessons from the EU programme to fund research into off-patent medicines

L Ruggieri et al. Eur J Pediatr. 2015 Apr.

Abstract

The European Paediatric Regulation mandated the European Commission to fund research on off-patent medicines with demonstrated therapeutic interest for children. Responding to this mandate, five FP7 project calls were launched and 20 projects were granted. This paper aims to detail the funded projects and their preliminary results. Publicly available sources have been consulted and a descriptive analysis has been performed. Twenty Research Consortia including 246 partners in 29 European and non-European countries were created (involving 129 universities or public-funded research organisations, 51 private companies with 40 SMEs, 7 patient associations). The funded projects investigate 24 medicines, covering 10 therapeutic areas in all paediatric age groups. In response to the Paediatric Regulation and to apply for a Paediatric Use Marketing Authorisation, 15 Paediatric Investigation Plans have been granted by the EMA-Paediatric Committee, including 71 studies of whom 29 paediatric clinical trials, leading to a total of 7,300 children to be recruited in more than 380 investigational centres.

Conclusion: Notwithstanding the EU contribution for each study is lower than similar publicly funded projects, and also considering the complexity of paediatric research, these projects are performing high-quality research and are progressing towards the increase of new paediatric medicines on the market. Private-public partnerships have been effectively implemented, providing a good example for future collaborative actions. Since these projects cover a limited number of off-patent drugs and many unmet therapeutic needs in paediatrics remain, it is crucial foreseeing new similar initiatives in forthcoming European funding programmes.

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Figures

Fig. 1
Fig. 1
Number of participants in research consortia and number of project for each country
Fig. 2
Fig. 2
Details of paediatric age subgroups included in the clinical trials for each project
Fig. 3
Fig. 3
Details on the completion date of the agreed PIP
See this image and copyright information in PMC

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