President & CEO
Dr. Kazempour, President & CEO of Amarex Taiwan and its US affiliate, co-founded Amarex Clinical Research in 1998, a full-service contract research organization providing services to the pharmaceutical, biotech, and device communities. Dr. Kazempour serves on the George Washington University Regulatory Affairs Advisory Board, teaching at George Washington University Medical Center and Montgomery College.
Dr. Kazempour started his career as a mathematical statistician working at Genetics Institute in 1975 and published his first article on genetics in 1979. His experience in the industry and FDA has allowed him to understand biometrics, quality assurance and quality control from both a sponsor's perspective, as the provider of the data and from a regulatory perspective, as the reviewer of the data. Dr. Kazempour has worked in many therapeutic areas including vaccines, anti-infectives, anti-virals, AIDS, and cardiovascular, as well as medical devices, as his expertise and knowledge has been a key contributor in the approval of these drugs and devices. Additionally, Dr. Kazempour has established, presented, and participated in many Data Safety Monitoring Boards (DSMB).
During his more than 30 years of experience in biomedical research, Dr. Kazempour has conducted research activities with National Institutes of Health (NIH), pharmaceutical industry and along with various universities. While at the Food and Drug Administration (FDA) as a statistical reviewer, he received several awards for innovative problem solving and teamwork along with contributions to the drug approval process. During his tenure at the FDA, Dr. Kazempour also worked as a Senior Staff Fellow and as a Mathematical Statistician responsible for supervising and conducting independent statistical analyses of clinical trials and reviewing statistical sections of submitted protocols and statistical analyses.
Dr. Kazempour has been active in the biomedical research community throughout his career as an organizer, a panel discussion member, and presenter at national and international meetings. He has made presentations to the FDA, and FDA advisory committees on more than 30 different drugs. Dr. Kazempour has authored numerous published articles, book chapters, and technical reports.
Dr. Kazempour has served as Global Biometrics Senior Director for an international pharmaceutical company. While in this position, he was responsible for the global standardization of biostatistical, scientific programming, and data management procedures. He also implemented International Council of Harmonisation (ICH) guidelines and validated the programs for all biometrics offices. Additionally, he prepared and presented the biometrical aspects of study designs of Investigational New Drug Applications (IND), New Drug Application (NDA) and Pre-Market Approval (PMA) to regulatory agencies in the US and Europe.
Dr. Kazempour received his Ph.D in Statistics from Colorado State University, Fort Collins.