Article (Scientific journals)
Biomarkers and personalised medicine in rheumatoid arthritis: a proposal for interactions between academia, industry and regulatory bodies.
Miossec, P.; Verweij, C. L.; Klareskog, L. et al.
2011In Annals of the Rheumatic Diseases, 70 (10), p. 1713-8
Peer Reviewed verified by ORBi
 

Files


Full Text
Biomarkers and personalised medicine in rheumatoid arthritis a proposal for interactions between academia, industry and regulatory bodies.pdf
Publisher postprint (212.73 kB)
Download

All documents in ORBi are protected by a user license.

Send to



Details



Keywords :
Antirheumatic Agents/therapeutic use; Arthritis, Rheumatoid/diagnosis/drug therapy; Biological Markers/analysis; Drug Industry; Drug Monitoring/methods; Humans; Individualized Medicine/methods; Prognosis; Public-Private Sector Partnerships; Specimen Handling/methods/standards
Abstract :
[en] Rheumatoid arthritis (RA) is one of the most appropriate conditions for the application of personalised medicine as a high degree of heterogeneity has been recognised, which remains to be explained. Such heterogeneity is also reflected in the large number of treatment targets and options. A growing number of biologics as well as small molecules are already in use and there are promising new drugs in development. In order to make the best use of treatment options, both targeted and non-targeted biomarkers have to be identified and validated. To this aim, new rules are needed for the interaction between academia and industry under regulatory control. Setting up multi-centre biosample collections with clear definition of access, organising early, possibly non-committing discussions with regulatory authorities, and defining a clear route for the validation, qualification and registration of the biomarker-drug combination are some of the more critical areas where effective collaboration between the drug industry, academia and regulators is needed.
Disciplines :
General & internal medicine
Author, co-author :
Miossec, P.
Verweij, C. L.
Klareskog, L.
Pitzalis, C.
Barton, A.
Lekkerkerker, F.
Reiter, S.
Laslop, A.
Breedveld, F.
Abadie, Eric 
Flamion, B.
Dere, W.
Mpofu, S.
Goel, N.
Ethgen, Olivier ;  Université de Liège - ULiège > Département des sciences de la santé publique > Santé publique : aspects spécifiques
Mitlak, B.
Ormarsdottir, S.
RAO, Rita Flora ;  Centre Hospitalier Universitaire de Liège - CHU > Néonatologie non intensive NDB
Tsouderos, Y.
Reginster, Jean-Yves  ;  Université de Liège - ULiège > Département des sciences de la santé publique > Santé publique, Epidémiologie et Economie de la santé
More authors (10 more) Less
Language :
English
Title :
Biomarkers and personalised medicine in rheumatoid arthritis: a proposal for interactions between academia, industry and regulatory bodies.
Publication date :
2011
Journal title :
Annals of the Rheumatic Diseases
ISSN :
0003-4967
eISSN :
1468-2060
Publisher :
BMJ Group, London, United Kingdom
Volume :
70
Issue :
10
Pages :
1713-8
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 23 November 2011

Statistics


Number of views
265 (19 by ULiège)
Number of downloads
397 (2 by ULiège)

Scopus citations®
 
35
Scopus citations®
without self-citations
28
OpenCitations
 
31

Bibliography


Similar publications



Contact ORBi