September 30 (Mon) - October 2 (Wed), 2019

September 30 (Mon), 11:50-12:40, Rm. 308

Precision medicine (also known as personalized medicine) is an innovative approach to consider differences in people's genes, environments, and lifestyles for right treatments to the right patients at the right time. To realize this in the real world, companion diagnostics is a "regulatory science-based toolkit" to provides information for the identification of the risk and benefit of targeted therapeutics for stratified patient population. We have established analytically-validated and compliant tools which is composed of droplet digital PCR, next generation sequencing and multiplex immunohistochemistry using liquid biopsy samples including circulating tumor DNA, platelet-rich plasma, circulating tumor cells, and exosome, and formalin-fixed paraffin-embedded tissue or biopsy samples to support prospective biomarker clinical trials or exploratory study for clinical trials. In this symposium, we will introduce three sponsor-initiated clinical trials co-developed with companion diagnostics and two exploratory studies using our biomarker development toolkits for investigator-initiated clinical trial.