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A perspective on challenges and issues in biomarker development and drug and biomarker codevelopment

Sheila E Taube1, Gary M Clark, Janet E Dancey

  • 1ST-Consulting, PO Box 260, Glen Echo, MD 20812-0260, USA. taubese63@alumni.brandeis.edu

Journal of the National Cancer Institute
|October 27, 2009
PubMed

Insights

Biomarker development requires understanding target biology and assay performance. Rigorous scientific approaches and early regulatory interaction streamline drug and biomarker codevelopment for clinical practice.

Area of Science:

  • Biomarker discovery and development
  • Translational science
  • Regulatory science

Background:

  • Workshop convened by National Cancer Institute and US Food and Drug Administration to discuss biomarker development challenges.
  • Addressed lessons learned and ongoing issues in biomarker and drug codevelopment.

Framework:

  • Product development hinges on understanding target biology, drug interactions, and disease processes.
  • Stronger biological understanding and validated analytical signals reduce development risks and increase efficiency.

Implementation:

  • Emphasized rigorous scientific methods, including meticulous specimen collection and standardized, quality-controlled data acquisition.
  • Highlighted the importance of early engagement with regulatory bodies for appropriate study design.

Implications:

  • Accelerated clinical adoption of novel diagnostics and therapeutics through optimized development pathways.
  • Ensuring robust biomarker assay performance and well-characterized test results for reliable clinical application.

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