BIO Asia–Taiwan 2022 亞洲生技大會

BIO Asia–Taiwan 2022 亞洲生技大會

TEACHER

Kazem Kazempour

Session 7 - Future Pandemic Preparedness

Date:28 July (Thursday)
Time:  10:40 – 12:00  (GMT+8)

Kazem Kazempour

President and CEO
Amarex Taiwan, LLC.

Dr. Kazem Kazempour, Amarex President & CEO, has over 40 years of experience in clinical research and is a sought-after presenter and a published and well-known clinical product development expert. 

He began his career in mathematical statistics at the Genetics Institute in 1975, publishing his first article on genetics in 1979. In 1991, he accepted a position at the U.S. FDA as a statistical reviewer, receiving awards for innovative problem solving and for building a collaborative team environment. During his tenure at the FDA, Dr. Kazempour also worked as Senior Staff Fellow and Mathematical Statistician responsible for reviewing clinical trial submissions/protocols, and for supervising and conducting independent statistical analyses.

Later, Dr. Kazempour joined an international pharmaceutical company as Global Senior Director of Biometrics and Clinical Data Systems, he was responsible for the global standardization of biostatistics, scientific programming, and data management procedures. He implemented ICH guidelines and validated programs for all biometric offices, prepared and presented the biometrical aspects of study designs for IND, NDA and PLA applications and supplements to regulatory agencies in the U.S. and Europe and directed the scope and content of Section 10, Section 8/10 and ISS/ISEs in NDAs.  

Dr. Kazempour has worked on hundreds of trials, having partnered with various institutions around the globe such as the National Institutes of Health (NIH), university research centers, hospitals, governmental agencies, and regulatory bodies. His contributions include FDA and other regulatory agency meetings, presentations to industry, and participation in FDA advisory committees and Data Safety Monitoring Boards (DSMBs). He has received multiple recognition awards from the FDA for his contributions to the drug approval process, most notably for his HIV/AIDS research. Dr. Kazempour specializes in vaccine, anti-infective, antiviral, HIV/AIDS, cardiovascular, and COVID-19 product development, but he’s worked with-in all major therapeutical areas. Dr. Kazempour has also helped several products reach market approval. 

Dr. Kazempour has authored many publications and technical reports. He currently teaches at George Washington University (GW) and sits on GW’s Regulatory Affairs Advisory Board.

Speech title & Synopsis

Post COVID-19 Pandemic Health Challenges: How to expedite such a trial for the treatment of COVID Long Haulers

As the world slowly begins to emerge from the COVID-19 pandemic, post-COVID conditions are new, returning, or ongoing health problems people can experience several weeks or even months after initial infection with COVID-19. Many of the common symptoms of the post-COVID19 syndrome are not explained by the virus-related infection alone. Similar to chronic fatigue syndrome and fibromyalgia, autoimmune-mediated autonomic nervous system dysfunction may play a significant part in the pathogenesis of such symptoms, including chronic fatigue, cognitive impairment, mood related disorders, and numerous other symptoms. Those who have continued to experience these symptoms for months, are referred here as “COVID long hauler.” These COVID long hauler conditions remain to be a primary concern for patients, health care providers, and pharmaceutical companies. 

Since COVID-19 outbreak in early 2020, there are more than 300 clinical studies associated with the COVID long hauler. Given the significant variability in symptoms and patients’ experience with post-acute COVID-19, a clearly specified endpoint may not be readily available. However, if a surrogate endpoint can be identified across symptoms — such as brain fog or anything that clinicians and regulators can agree on — researchers could potentially design such clinical trials and see the results more quickly. In addition to surrogate endpoint, using Adaptive Clinical Trials (ACTs) allow the pharmaceuticals to better work with and through a post-acute COVID-19 trial without adding months to their timeline. This is because using ACTs one can build anticipated changes into the design in order to improve power without losing the integrity of the ongoing trial. 

Having all aspect of the trial running in parallel from the very beginning makes us better prepared at the conclusion of the trial if every step was completed with precision and experience. As we have learned through the pandemic, remaining endlessly responsive and precisely coordinated is the best way to overcome and adapt to the unexpected.