Molecular & Cancer Biomarkers

Biography

Biography: Shashwati Basak

Abstract

Biomarkers have many significant applications in oncology, including diagnosis, prognosis, risk assessment, prediction of response to treatment and screening and monitoring progression of the disease. Further, cancer biomarkers play an important role during all phases of drug discovery and development and in guiding early decision in clinical trials. Real-time quantitative polymerase chain reaction (RT-qPCR) technology has become the method of choice for clinical biomarker detection and quantification since it is accurate, sensitive, fast and relatively cheaper than other available gene expression-based technologies. Although a thorough analytical and clinical biomarker assay validation is not required for discovery-phase work, as a drug progresses into preclinical and early-phase clinical studies, it becomes important to have more rigorously qualified biomarkers. A “fit-for purpose” assay development and validation to meet the clinical requirements plays a significant role in cancer biomarker quantification. Development and use of RT-qPCR technology for robust, accurate and reliable method is required for the “fit-for-purpose” biomarker assay qualification. Few important factors influencing assay performance such as sample matrix, sample preparation, experimental precision, reproducibility, sensitivity, specificity, dilution linearity and dynamic range and their impact on the assay outcome will be discussed. Based on these, we will put forth recommendations for consideration and optimization of qPCR-based clinical cancer biomarker assays by demonstrating a few examples. Lastly, a few representative case studies of safety/efficacy and pharmacodynamic cancer biomarkers will be discussed that exemplify enabling of early decision making in Oncology and Immuno-oncology clinical trials.