Kaiser J. Aziz, Ph.D., (Biochemistry – American University), Post-Doctorate (Health Sciences – University of Southern California), Graduate Certificate (Business Administration) – Georgetown University). Kaiser completed a 29-year career with FDA as a clinical regulatory scientist and manager of drug and device evaluations, approvals, reengineering, standards, good manufacturing and quality system applications. Kaiser worked with individual and industry organizations in design and total product life cycle (TPLC) approaches to premarket applications for medical devices, pharmaceuticals, and combination products PMAs and NDAs. Prior to joining FDA, he developed and implemented quality assurance standard operating procedures and protocols for medical diagnostic systems in hospitals, physicians’ offices, and clinical reference laboratories.
During his tenure at FDA, he served as an adjunct faculty in the Department of Medicine and Physiology, NIH Graduate School, where he developed and taught courses in Clinical Pharmacology, Toxicology, Therapeutic Drug Monitoring, and Clinical Laboratory Medicine. Currently he serves as an adjunct faculty at Virginia Tech’s Medical HACCP Alliance Program, where he teaches Risk Management Using HACCP Principles for the Pharmaceutical Industry. He has published numerous scientific and regulatory articles in professional and trade journals and serves as a member of editorial advisory boards of professional journals performing various functions such as writing editorials, evaluating manuscripts for suitability for publication, and technical review. He was an invited guest editor on Nanotechnology and Clinical Trials in the Journal of Clinical Ligand Assay in 2006.