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Lessons for tumor biomarker trials: vicious cycles, scientific method & developing guidelines.

Daniel Hayes1, Claire Raison

  • 1Comprehensive Cancer Center, University of Michigan, Ann Arbor, MI, USA.

Expert Review of Molecular Diagnostics
|December 31, 2014
PubMed
Summary

Dr. Daniel Hayes pioneered circulating breast tumor biomarker CA15-3 discovery. His career focuses on integrating clinical trials with breast cancer biomarker research and drug development.

Keywords:
biomarker validationbreast cancerclinical validitycompanion diagnosticsoncologyregulatory

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Area of Science:

  • Oncology
  • Biomarker Research
  • Clinical Trials

Background:

  • Dr. Daniel Hayes, Professor of Breast Cancer Research at the University of Michigan, has a distinguished career in breast cancer research.
  • His work spans clinical and translational research, focusing on breast cancer biomarkers and drug development.
  • He led the discovery of the circulating breast tumor biomarker CA15-3 approximately 30 years ago.

Discussion:

  • The core of Dr. Hayes's research integrates clinical trials with tumor biomarker studies.
  • He chairs the Correlative Sciences Committee of the Breast Cancer Steering Committee.
  • He also co-chairs the Expert Panel for Tumor Biomarker Practice Guidelines for the American Society of Clinical Oncology.

Key Insights:

  • Pioneering discovery of the CA15-3 biomarker.
  • Extensive experience in breast cancer drug development and clinical trial design.
  • Significant contributions to establishing practice guidelines for tumor biomarkers.

Outlook:

  • Continued integration of biomarker research into clinical trials for improved breast cancer treatment.
  • Advancing the understanding and application of biomarkers in oncology.
  • Shaping future breast cancer care through guideline development and research leadership.