Kazem Kazempour, Ph.D.
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.
Chia-Hua (Maggie) Ho, DPhil.
Chief Operating Officer
Dr. Ho, Chief Operating Officer of Amarex Taiwan, LLC, oversees the organization in accordance with its affiliate, Amarex Clinical Research (USA). She is responsible for the management of Amarex Taiwan, including clinical operations, business development, and client services for the Pan Pacific region. Dr. Ho has trained under Amarex regulatory experts in the US as a Regulatory Specialist, with the purpose of creating FDA approval strategies for small molecule drugs, biologics, botanicals, and devices within a wide range of therapeutic indications.
Prior to joining Amarex, Dr. Ho served as Assistant Vice President for a biotech start-up company. She was involved in raising investment funds and developing operating plans and strategic objectives to support the company’s research and development. In this position, Dr. Ho had the opportunity to participate in the development of patentable technology and was able to investigate the feasibility of applying a wide-range of scientific principles and concepts to potential inventions and products.
Dr. Ho served as Senior Scientist for a Taiwanese biopharmaceutical company. While in this position, she generated and managed CMC documentation for a novel active immunotherapy, ensured adherence to cGMP guidelines, and lead project development planning. Additionally, Dr. Ho served as Senior Manager for a technology organization where she developed and validated analytical methods for protein drug candidates, and she prepared non-clinical pharmacology study reports of pharmacodynamics and toxicology for a wide variety of therapeutic indications.
Dr. Ho started her research career in 2002, working on different projects within the areas of infectious disease and oncology, at the National Health Research Institute and Academia Sinica in Taiwan. At the University of Oxford, Dr. Ho supervised students in the Department of Organic Chemistry and in the Department of Biochemistry, Systems Biology, while developing an advanced experimental technique module. She completed her first postdoctoral program at MIT, where she worked on RNA and DNA modifications in microbial pathogenesis. Dr. Ho completed her second postdoctoral program at Helmholtz Zentrum München (Germany), and she investigated the mechanisms of epigenetic regulation via DNA and RNA modification to discover new therapeutic opportunities. Dr. Ho has presented on a number of scientific research topics, including epigenetic mechanisms in health and disease, protein structure and function, the biological chemistry of inflammation in cancer, and the convergence of Omics and cell biology in relation to human health and disease. She published her findings in several pioneer journals, including Nature, Nature Chemical Biology, PNAS, and PLoS Pathogen.
Dr. Ho earned her BS in Chemistry from Tsing Hua University (Taiwan) and her PhD in Chemistry from Oxford University (UK).