Predictive biomarkers for personalised anti-cancer drug use

discovery to clinical implementation

Nayef A. Alyamani, Murray D. Smith, David J. Williams, Russell D. Petty

Research output: Contribution to journalArticle

38 Citations (Scopus)

Abstract

A priority translational research objective in cancer medicine is the discovery of novel therapeutic targets for solid tumours. Ideally, co-discovery of predictive biomarkers occurs in parallel to facilitate clinical development of agents and ultimately personalise clinical use. However, the identification of clinically useful predictive biomarkers for solid tumours has proven challenging with many initially promising biomarkers failing to translate into clinically useful applications. In particular, the 'failure' of a predictive biomarker has often only become apparent at a relatively late stage in investigation. Recently, the field has recognised the need to develop a robust clinical biomarker development methodology to facilitate the process. This review discusses the recent progress in this area focusing on the key stages in the biomarker development process: discovery, validation, qualification and implementation. Concentrating on predictive biomarkers for selecting systemic therapies for individual patients in the clinic, the advances and progress in each of these stages in biomarker development are outlined and the key remaining challenges are discussed. Specific examples are discussed to illustrate the challenges identified and how they have been addressed. Overall, we find that significant progress has been made towards a formalised biomarker developmental process. This holds considerable promise for facilitating the translation of predictive biomarkers from discovery to clinical implementation. Further enhancements could eventually be found through alignment with regulatory processes.

Original languageEnglish
Pages (from-to)869-879
Number of pages11
JournalEuropean Journal of Cancer
Volume46
Issue number5
Early online date5 Feb 2010
DOIs
Publication statusPublished - Mar 2010

Fingerprint

Drug Discovery
Biomarkers
Neoplasms
Translational Medical Research
Tumor Biomarkers
Medicine
Therapeutics

Keywords

  • Antineoplastic Agents
  • Clinical Trials as Topic
  • Drug Discovery
  • Drug Screening Assays, Antitumor
  • Humans
  • Individualized Medicine
  • Neoplasms
  • Reproducibility of Results
  • Translational Medical Research
  • Tumor Markers, Biological

Cite this

Predictive biomarkers for personalised anti-cancer drug use : discovery to clinical implementation. / Alyamani, Nayef A.; Smith, Murray D.; Williams, David J.; Petty, Russell D.

In: European Journal of Cancer, Vol. 46, No. 5, 03.2010, p. 869-879.

Research output: Contribution to journalArticle

Alyamani, Nayef A. ; Smith, Murray D. ; Williams, David J. ; Petty, Russell D. / Predictive biomarkers for personalised anti-cancer drug use : discovery to clinical implementation. In: European Journal of Cancer. 2010 ; Vol. 46, No. 5. pp. 869-879.
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