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Biomarkers and personalised medicine in rheumatoid arthritis: a proposal for interactions between academia, industry and regulatory bodies
  1. P Miossec1,
  2. C L Verweij2,
  3. L Klareskog3,
  4. C Pitzalis4,
  5. A Barton5,
  6. F Lekkerkerker6,
  7. S Reiter7,
  8. A Laslop8,
  9. F Breedveld9,
  10. E Abadie10,
  11. B Flamion11,
  12. W Dere12,
  13. S Mpofu13,
  14. N Goel14,
  15. D Ethgen15,
  16. B Mitlak16,
  17. S Ormarsdóttir17,
  18. R Rao18,
  19. Y Tsouderos19,
  20. J-Y Reginster20,21
  21. ; on behalf of the Group for the Respect of Ethics and Excellence in Science (GREES)
  1. 1Department of Clinical Immunology and Rheumatology, Edouard Herriot Hospital, University of Lyon, Lyon, France
  2. 2Departments of Pathology and Rheumatology, VU University Medical Center, Amsterdam, The Netherlands
  3. 3Department of Medicine, Karolinska Institute, Stockholm, Sweden
  4. 4Experimental Medicine and Rheumatology, Barts and the London School of Medicine and Dentistry, London, UK
  5. 5Arthritis Research UK Epidemiology Unit, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK
  6. 6NDA Regulatory Science Ltd, Leatherhead, Surrey, UK
  7. 7Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany
  8. 8AGES PharmMed, Institute Science and Information, Vienna, Austria
  9. 9Department of Rheumatology, Leiden University Medical Centre, Leiden, The Netherlands
  10. 10Afssaps, Saint Denis, France
  11. 11Department of Physiology and Pharmacology, University of Namur, Namur, Belgium
  12. 12Amgen Inc, Uxbridge, UK
  13. 13Novartis Pharma AG, Basel, Switzerland
  14. 14UCB Inc, Atlanta, Georgia, USA
  15. 15Medimmune Inc, Gaithersburg, Maryland, USA
  16. 16Eli Lilly, Indianapolis, Indiana, USA
  17. 17Icelandic Medicines Control Agency, Seltjarnarnes, Iceland
  18. 18Roche Products Ltd, Welwyn Garden City, UK
  19. 19Servier, Paris, France
  20. 20Department of Public Health Sciences, University of Liege, Liege, Belgium
  21. 21CHU Centre Ville, Liege, Belgium
  1. Correspondence to Professor Pierre Miossec, Department of Clinical Immunology and Rheumatology, Hospital Edouard Herriot, 69437 Lyon Cedex 03, France; pierre.miossec{at}univ-lyon1.fr

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.

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Footnotes

  • Competing interests None.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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