Date：22 July (Thursday)
Time: 10:40 – 12:10 (GMT+8)
President and CEO
Amarex Taiwan, LLC.
Dr. Kazem Kazempour, President & CEO of Amarex Taiwan and its U.S. affiliate, co-founded Amarex Clinical Research, LLC in 1998, a full-service global contract research organization (CRO) providing clinical trial services to the pharmaceutical, biotech, and medical device communities. For over 30 years, Dr. Kazempour conducted clinical research activities with the National Institutes of Health (NIH) and numerous other research centers, participated in many DSMBs and presented to the U.S. FDA on more than 100 clinical products. He has also presented to regulatory agencies in Europe and Asia. Dr. Kazempour has worked in many therapeutic areas, including but not limited to cell and gene therapies, vaccines, anti-infectives, anti-virals, AIDS, CNS, oncology, COVID-19, and cardiovascular diseases. His expertise includes drug, biologics, medical device, diagnostic and digital health product development. Additionally, Dr. Kazempour served as Senior Staff Fellow and Mathematical Statistician at the U.S. FDA, supervising and conducting independent statistical analyses of clinical trials and reviewing statistical sections of IND/NDA submissions. During his tenure as a scientific reviewer at the U.S. FDA he received several awards for innovative problem solving and teamwork and for his contributions to the drug development process. Over the last 17 years, Dr. Kazempour has focused on international drug and device clinical development and he has significant experience with clients in the Pan-Pacific region. He has successfully helped Asian clients with FDA submissions, including IND, IDE, 505(b)2, 510k, PMA, and NDA applications for botanical, chemical, biological, and clinical device products. Dr. Kazempour received his PhD in Statistics from Colorado State University, Fort Collins. He currently teaches at George Washington University, and sits on GW’s Regulatory Affairs Advisory board.
An urgency to contain the COVID-19 pandemic led to challenges in maintaining clinical trial procedures but these challenges were later converted to advancements in trial procedures in a relatively short period of time. Now that we are approaching a post-pandemic world, there are signs that pandemic induced clinical trial changes such as remote monitoring, data collection, and auditing will become the norm. The industry and the regulatory authorities have demonstrated responsiveness and adaptability in the face of the pandemic and the result was revision in some regulatory policies, adoption to virtual procedures in clinical trials, and use of new technologies. In his presentation, “Post-Pandemic Adoption of Pandemic Revised Trial Procedures”, Dr. Kazem Kazempour, President & CEO of Amarex Taiwan, LLC will discuss the changes expected to remain. For example, the shift toward more decentralized clinical trials (DCTs) will likely continue because patient and site recruitment improved substantially in remote trials. In addition, implementation of digital technologies allows remote patient monitoring, such as using telemedicine or electronic patient reported outcome (ePRO) to collect health outcomes reported directly by the patients.