Sheila E Taube

Summary

Affiliation: Brandeis University
Country: USA

Publications

  1. pmc A perspective on challenges and issues in biomarker development and drug and biomarker codevelopment
    Sheila E Taube
    ST Consulting, PO Box 260, Glen Echo, MD 20812 0260, USA
    J Natl Cancer Inst 101:1453-63. 2009
  2. doi request reprint Biomarkers in oncology: trials and tribulations
    Sheila E Taube
    ST Consulting, Glen Echo, Maryland 20812 0260, USA
    Ann N Y Acad Sci 1180:111-8. 2009
  3. doi request reprint Challenges in drug and biomarker co-development
    Sheila E Taube
    ST Consulting, Bethesda, MD, USA
    Recent Results Cancer Res 195:229-39. 2012

Collaborators

Detail Information

Publications3

  1. pmc A perspective on challenges and issues in biomarker development and drug and biomarker codevelopment
    Sheila E Taube
    ST Consulting, PO Box 260, Glen Echo, MD 20812 0260, USA
    J Natl Cancer Inst 101:1453-63. 2009
    ..Early interaction with appropriate regulatory bodies will ensure studies are appropriately designed and biomarker test performance is well characterized...
  2. doi request reprint Biomarkers in oncology: trials and tribulations
    Sheila E Taube
    ST Consulting, Glen Echo, Maryland 20812 0260, USA
    Ann N Y Acad Sci 1180:111-8. 2009
    ..A development pathway is proposed that defines the steps required for evaluation of a biomarker assay's analytical and clinical performance. Several pilot projects are ongoing to test the process, and these are described...
  3. doi request reprint Challenges in drug and biomarker co-development
    Sheila E Taube
    ST Consulting, Bethesda, MD, USA
    Recent Results Cancer Res 195:229-39. 2012
    ..kit), the designs of trials for evaluation of clinical utility, and the regulatory pathway. Successful co-development requires planning very early in the process and assembling the appropriate multi-disciplinary team...