Industry Perspective on Biomarker Development and Qualification

Clin Pharmacol Ther. 2018 Jan;103(1):27-31. doi: 10.1002/cpt.919. Epub 2017 Nov 16.

Abstract

Pharmaceutical and biotechnology companies routinely use biomarkers to obtain quantitative metrics for drug exposure, efficacy, and safety and to inform clinical trial design with regard to patient selection, treatments, and outcomes. Biomarker science has the unique capability to catalyze precompetitive collaborations between academia, industry, regulatory agencies, and other stakeholders with the ultimate goal of accelerating the delivery of safe and effective medicines to patients, particularly in areas of high unmet need.

MeSH terms

  • Biomarkers / analysis
  • Biotechnology* / methods
  • Biotechnology* / organization & administration
  • Clinical Trials as Topic / methods*
  • Drug Industry* / methods
  • Drug Industry* / organization & administration
  • Humans
  • Interdisciplinary Communication
  • Outcome and Process Assessment, Health Care / methods
  • Technology, Pharmaceutical* / methods
  • Technology, Pharmaceutical* / organization & administration

Substances

  • Biomarkers