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J Med Oncl Ther 2017 | Volume 2 Issue 4
Oncology and Biomarkers Summit
November 27-28, 2017 | Atlanta, USA
Annual Congress on
T
he utility of various types of clinical biomarkers is to aid
decision-making in drug development. After a pre-clinical
candidate is approved for development in clinical studies,
biomarker activities are transitioned from discovery to
clinical biomarker development and implementation. Clinical
biomarker development includes clinical biomarker assay
development, fit-for-purpose assay validation, and clinical
biomarker qualification in clinical studies. After a clinical
biomarker is qualified, it will then be implemented in clinical
studies to aid decision-making. Overcoming challenges of
clinical biomarker development such as preanalytics, assay
selectivity, and matrix effect will be discussed.
e:
xuemei_zhao@merck.comOvercoming challenges of clinical biomarker development
Xuemei Zhao
Merck Research Laboratories, USA