title: Biomarkers and personalised medicine in rheumatoid arthritis: a proposal for interactions between academia, industry and regulatory bodies.
abstract: 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.
authors.affiliation: Department of Clinical Immunology and Rheumatology, Hospital Edouard Herriot, 69437 Lyon Cedex 03, France. pierre.miossec@univ-lyon1.fr
authors.forename: P
authors.initials: P
authors.lastname: Miossec
authors.forename: C L
authors.initials: CL
authors.lastname: Verweij
authors.forename: L
authors.initials: L
authors.lastname: Klareskog
authors.forename: C
authors.initials: C
authors.lastname: Pitzalis
authors.forename: A
authors.initials: A
authors.lastname: Barton
authors.forename: F
authors.initials: F
authors.lastname: Lekkerkerker
authors.forename: S
authors.initials: S
authors.lastname: Reiter
authors.forename: A
authors.initials: A
authors.lastname: Laslop
authors.forename: F
authors.initials: F
authors.lastname: Breedveld
authors.forename: E
authors.initials: E
authors.lastname: Abadie
authors.forename: B
authors.initials: B
authors.lastname: Flamion
authors.forename: W
authors.initials: W
authors.lastname: Dere
authors.forename: S
authors.initials: S
authors.lastname: Mpofu
authors.forename: N
authors.initials: N
authors.lastname: Goel
authors.forename: D
authors.initials: D
authors.lastname: Ethgen
authors.forename: B
authors.initials: B
authors.lastname: Mitlak
authors.forename: S
authors.initials: S
authors.lastname: Ormarsdóttir
authors.forename: R
authors.initials: R
authors.lastname: Rao
authors.forename: Y
authors.initials: Y
authors.lastname: Tsouderos
authors.forename: J-Y
authors.initials: JY
authors.lastname: Reginster
mesh_terms: D018501:Antirheumatic Agents / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000175:diagnosis* / Q000188:drug therapy; D015415:Biomarkers / Q000032:analysis*; D004345:Drug Industry; D016903:Drug Monitoring / Q000379:methods; D006801:Humans; D057285:Precision Medicine / Q000379:methods*; D011379:Prognosis; D055818:Public-Private Sector Partnerships; D013048:Specimen Handling / Q000379:methods / Q000592:standards
chemical_list: D018501:Antirheumatic Agents; D015415:Biomarkers