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allied

academies

J Pharmacol Ther Res 2017 Volume 1 Issue 2

November 02-03, 2017 Chicago, USA

4

th

International Congress on

International Conference and Exhibition on

Drug Discovery, Designing and Development

Biochemistry, Molecular Biology: R&D

&

M

ost 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 problemmainly 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.

e:

baolin.zhang@fda.hhs.gov

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

Baolin Zhang

Food and Drug Administration, USA