Jack Zakowski, PhD, FACB, is the Principal of IVD Consulting LLC, which provides advanced scientific affairs guidance accumulated from his many years of experience in the in vitro diagnostics industry. Previously, he was with Beckman Coulter, Inc., in Brea, California for many years, most recently serving greater than 10 years as Director of Scientific Affairs and Professional Relations for the Diagnostics Division. Dr. Zakowski spent most of his career in the clinical diagnostics industry in research and development and product development areas, working on chemistry reagents and analyzer systems. He has also worked in technical marketing and support, development applications and clinical evaluations, and standardization and harmonization of clinical diagnostics. Dr. Zakowski has been active in various professional laboratory organizations and has served terms as Secretary, Treasurer, and President of CLSI. He has also been involved with the American Association for Clinical Chemistry (AACC), ISO Technical Committee 212 on clinical laboratory testing and in vitro diagnostic test systems, the Patient Safety Task Force of the AACC Management Sciences Division, the National Kidney Disease Education Program, and the National Glycohemoglobin Standardization Program, among other organizations.