Speaker Information
Speaker Bios
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Jaye Thompson, PhDSenior Vice President, Clinical Development and Regulatory Affairs, OPEXA THERAPEUTICS, INC.Jaye Thompson has more than 20 years of experience in the clinical research industry. Prior to joining Opexa, she was the Senior Vice President for Regulatory Affairs and Emerging Biotechnologies at inVentiv Clinical Solutions, LLC , a full-serve contract research organization. She assisted companies in product development by providing guidance in the areas of clinical and regulatory affairs. In addition, she was the senior executive in the office located in The Woodlands, Texas.Prior to its acquisition by inVentiv in 2006, Dr. Thompson was President and Founder of SYNERGOS, Inc, a leading contract research organization based in The Woodlands, Texas. Under her leadership, SYNERGOS (founded in 1991) grew and gained a reputation as one of the foremost clinical research organizations in the region. She started her career as a Biostatistician and Project Leader for Applied Logic Associates. Through her contract research experience, Dr. Thompson has advised a number of life science companies on strategic planning, clinical product development and regulatory affairs. She has directed and managed statistical analysis, data management, report writing, and conduct of clinical trials for a wide variety of indications. In addition, she has been actively involved in over 200 clinical trials for drugs, biologics, and devices. She has directed and managed the data management, statistical analysis and report writing for multiple FDA submissions, including 6 NDAs and 3 PMAs. Moreover, she has frequently represented Sponsor companies at FDA meetings and advisory committee meetings and teleconferences. Dr. Thompson holds a Bachelor's degree in Applied Mathematics from Texas A&M University and an MS and a PhD in Biostatistics from the University of Texas Health Science Center in Houston. She serves on the Board of Directors for Repros Therapeutics Inc, Gulf Coast Regional Center of Innovation and Commercialization Executive Board, the MD Anderson Technology Review Committee and the BioHouston Associate Advisory Board. |
