One of the original pioneers in the red-hot personalized medicine field (HercepTest).20 years of experience in companion diagnostics and biomarker development covering all aspects – reagent licensing, development, supply chain management, manufacturing, regulatory applications and global commercialization.Most recently, our lab completed clinical trial testing supporting registration for a BRAF molecular test which received simultaneous FDA approval with a MEK and BRAF small molecule inhibitor. My other PMA experience include development of pharmDx EGFR and clinical testing of a first generation BRAF molecular assay.I offer unique companion diagnostic development perspectives, which are, established through vocations in the diagnostic manufacturing sector, service laboratory, translational biomarker development laboratories and CRO.Since 2009, I have delivered presentations on biomarker-driven oncology development in the US and China. Presentations in China include addresses at the Chinese Society of Clinical Oncology annual meetings.Led the development of four global anatomic pathology laboratories with fully networked digital pathology capabilities – the first in class for a central laboratory.