Journal of Pharmacology and Therapeutic Research

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Biomarker-directed drug development in oncology-20 years and counting

4th International Congress on Drug Discovery, Designing and Development & International Conference and Exhibition on Biochemistry, Molecular Biology: R&D
November 02-03, 2017 Chicago, USA

Baolin Zhang

Food and Drug Administration, USA

Posters & Accepted Abstracts : J Pharmacol Ther Res


Most recently approved oncology drugs target discrete molecular aberrations or pathways in tumor cells and consequently are active on a subset of the patient population. The problem mainly lies in the vast heterogeneity that exists between tumor types, individuals with the same type of tumor, and within one tumor of a patient at any given time. The Predictive biomarkers, measured using in vitro companion diagnostics (IVD), help identify patients likely to respond to treatment and are increasingly integrated into drug development programs. This presentation will provide an update of biomarker-directed oncology drugs approved by the US Food and Drug Administration. Case studies will be presented on therapeutic monoclonal antibodies selectively targeting HER2, EGFR, or PD-1/PD-L1 signaling pathways. This information will be further discussed with respect to biomarker qualification in the development of novel cancer therapeutics.


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