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An evaluation of regulatory and commercial barriers to stratified medicine development and adoption

The Pharmacogenomics Journal volume 15, pages 6–12 (2015)Cite this article

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Abstract

Today, a range of products based on genomics, proteomics and metabolomics have facilitated the development of ‘stratified’ medicines and companion diagnostics. This investigation profiles a series of targeted medicines and corresponding diagnostics, and their role(s) in supporting evidence-based medicine. Despite their potential benefits we found that scientific, financial and regulatory barriers impede the development and adoption of companion diagnostics. Therefore, in order to realise improvements to the risk/benefit profiles of health-care interventions—notably reducing clinical uncertainty—conferred by the use of companion diagnostics, industry representatives, health-care providers and regulators will need a coordinated response to overcome these barriers.

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Acknowledgements

We thank members of the research subgroup for the regulatory environment of stratified medicines who provided key inputs and expert opinion to the paper: Dr Ian Hudson (Medicines and Healthcare products Regulatory Agency, UK), Mr Kent Kost (Roche Diagnostics), Dr Thomas Lönngren (NDA Advisory Service Ltd), Dr Marisa Papaluca Amati (European Medicines Agency) and Dr Stephen Spielberg (Food and Drug Administration). This work was supported by the Oxford Partnership Comprehensive Biomedical Research Centre with funding from the Department of Health’s NIHR Biomedical Research Centres funding scheme. DAB gratefully acknowledges support from the SENS Research Foundation (Mountain View, CA, USA). The views expressed herein represent those of the authors and do not necessarily represent the views or practices of the authors’ employers or any other party. DAB is subject to the CFA Institute and CAIA Association’s Codes, Standards, and Guidelines, and as such must stress that this article is provided for academic interest only and must not be construed in any way as an investment recommendation.

Author information

Authors and Affiliations

  1. Kinapse, Wimbledon, London, UK

    N A Meadows

  2. Amgen, Cambridge, UK

    A Morrison

  3. Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK

    D A Brindley

  4. Harvard Stem Cell Institute, Holyoke Centre, Cambridge, MA, USA

    D A Brindley

  5. UCL Centre for Behavioural Medicine, UCL School of Pharmacy, BMA House, London, UK

    D A Brindley

  6. Oxford-UCL Centre for the Advancement of Sustainable Medical Innovation, University of Oxford, Oxford, UK and University College London, London, UK

    D A Brindley & R W Barker

  7. Oxford National Institute of Health Research (NIHR), Biomedical Research Centre (BRC), Molecular Diagnostic Centre (MDC), Oxford University Hospitals, Oxford, UK

    A Schuh

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  1. N A Meadows
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Correspondence to N A Meadows.

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Meadows, N., Morrison, A., Brindley, D. et al. An evaluation of regulatory and commercial barriers to stratified medicine development and adoption. Pharmacogenomics J 15, 6–12 (2015). https://doi.org/10.1038/tpj.2014.51

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