RT Journal Article
SR Electronic
T1 Biomarkers and personalised medicine in rheumatoid arthritis: a proposal for interactions between academia, industry and regulatory bodies
JF Annals of the Rheumatic Diseases
JO Ann Rheum Dis
FD BMJ Publishing Group Ltd and European League Against Rheumatism
SP 1713
OP 1718
DO 10.1136/ard.2011.154252
VO 70
IS 10
A1 Miossec, P
A1 Verweij, C L
A1 Klareskog, L
A1 Pitzalis, C
A1 Barton, A
A1 Lekkerkerker, F
A1 Reiter, S
A1 Laslop, A
A1 Breedveld, F
A1 Abadie, E
A1 Flamion, B
A1 Dere, W
A1 Mpofu, S
A1 Goel, N
A1 Ethgen, D
A1 Mitlak, B
A1 Ormarsdóttir, S
A1 Rao, R
A1 Tsouderos, Y
A1 Reginster, J-Y
YR 2011
UL http://ard.bmj.com/content/70/10/1713.abstract
AB 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.