NOV 03, 2016 10:30 AM PDT

Found in Translation: ST2 From Discovery to Clinical Adoption

Speaker
  • President, Critical Diagnostics
    Biography
      Dr. James V. Snider, Ph.D., has been the President of Critical Care Diagnostics Inc. since August 2005 and serves as its Member of the Management Board. Prior to joining CCD in August 2005, Dr. Snider Served as a Executive Vice President of Business and Operations of Intelligent Medical Devices Inc. Dr. Snider joined Intelligent MD in October 2001 as Vice President of Marketing and Business Development. Prior to IMD, Dr. Snider served a series of marketing and product development positions at Applied Biosystems (ABI). In his last role at ABI, he managed the Sample Preparation Systems product line and team from genesis through product launch and successfully established it in the market. Before his eight-year tenure at AB, Dr. Snider served as Senior Scientist at Biotech Research Laboratories, a contracts and service research company specializing in retroviral technologies. He performed his post-doctoral research as a fellow in the Biological Response Modifiers Program at the Frederick Cancer Research & Development Center of the National Cancer Institute. Dr. Snider holds a BS in chemistry from Grand Valley State University, a PhD in chemistry from the University of South Carolina and an MBA in technology management from the University of Phoenix.

    Abstract

    Laboratory tests come into existence through a variety of processes but regardless of the genesis all share a certain set of requirements. These include discovery, development, validation, regulatory clearance and market adoption. ST2 is a protein biomarker that was discovered in a gene expression exploration analysis to be involved in cardiac disease and to potentially have clinical value in managing patients with cardiac disease. Following this discovery Critical Diagnostics developed an in vitro diagnostic assay to accurately measure ST2 and performed the necessary clinical studies to determine the clinical value proposition. This information was used to pursue and obtain regulatory approval and the test is now available in most of the world. This lecture will cover the processes and issues from taking a biomarker target from discovery through to commercialization.


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