Former Director of the FDA’s Office of In Vitro Diagnostics with an extensive background, spanning more than 25 years, in executive leadership, innovation, companion diagnostics, molecular diagnostics, molecular genetics, immunology, infectious diseases, surgical pathology, laboratory medicine, basic and applied research and development, commercial operations, manufacturing, contract negotiations, mergers and acquisitions, FDA regulations, dozens of successful FDA submissions and scores of regulated products launched outside the US, and worldwide clinical laboratory operations at Duke University, then Industry and finally at the FDA. He received his M.D. and Ph.D. in Microbiology and Immunology from Duke University after graduating with Honors in Chemistry from Grinnell College and is board certified in Pathology and Genetics following a residency, a clinical fellowship, and an NIH funded research fellowship at Duke University. He founded the Duke Clinical Molecular Diagnostics laboratory, clinical and research laboratories in Japan and China, respectively, and Molecular Diagnostics at QuidelOrtho.