Sheila E Taube
Affiliation: Brandeis University
- A perspective on challenges and issues in biomarker development and drug and biomarker codevelopmentSheila 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...
- Biomarkers in oncology: trials and tribulationsSheila 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...
- Challenges in drug and biomarker co-developmentSheila 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...