Kate Simon
Biologics Consulting Group,USA
Biography
Simon came to Biologics Consulting with over eleven years of experience at the FDA. During her time at FDA she served as a Master Scientific Reviewer in the Office of In Vitro Diagnostics and Radiological Health (OIR). Dr. Simon has been a lead reviewer of many pre-market applications for IVD devices including PMA, 510(k), Pre-IDE, IDE and Pre-submissions. She has served as an FDA speaker in public forums on a diverse array of topics, including the de novo process, pharmacogenomics and personalized medicine, and premarket IVD submissions. Dr. Simon holds a Ph.D. in Microbiology from the University of Virginia.
Abstract
Abstract : Bringing New Biomarkers to Market