Online Program

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Thursday, September 13
Thu, Sep 13, 2:45 PM - 4:00 PM
Thurgood Marshall West
Study Design and Statistical Considerations in Precision Medicine Product Development

Use of Biomarkers in Oncology Clinical Development (300765)

*Li Liu, Sanofi 

Keywords: biomarker, oncology, predictive biomarker

With the development of targeted anticancer treatments that block or stimulate certain pathways of tumor cells, it is quite common to incorporate the biomarkers in the different phases of the drug development. The biomarkers can be used to prove the drug mechanism of actions, support the optimal dose selection, and identify subgroups that are more likely to have a favorable response to treatment. The biomarker strategy can be different depending on the objectives and phases of the study. Recent developments in this area will be discussed.