BME7900 Seminar: John Huynh (IconOVir Bio)

Description

The Science of Manufacturing: The recipe to making a quality drug

Everyone knows that it takes years and multiple clinical trial phases to develop and ultimately receive marketing approval for a new drug. What is less publicized is the level of scientific rigor and understanding required to ensure drug safety and efficacy, and the controls that must be in place to consistently manufacture drugs that meet the expectations of health and regulatory authorities. Today’s seminar will provide insight into the role Chemistry, Manufacturing, and Controls (CMC) plays across the drug development cycle, such as manufacturing process development, analytical validation, drug formulation, specifications, and stability.
 

Bio:
John Huynh is the Chief Technology Officer at IconOVir Bio, responsible for CMC development and manufacturing of oncolytic virotherapies. Prior to IconOVir, he served as Senior Vice President of Technical Operations at Ring Therapeutics, developing manufacturing processes for a next-generation gene therapy platform. Before Ring, he was a Vice President of Gene Therapy Technical Operations at PTC Therapeutics, where he helped establish and grow their gene therapy CMC group and made significant contributions to enable the marketing authorization of Upstaza, only the fourth in vivo gene therapy ever approved. Earlier in his career, John held positions of increasing responsibilities at Merck, WuXi AppTec, and the University of Pennsylvania Gene Therapy Program, focusing his career on process and analytical development and life-cycle management of viral vaccines and vectors.

John holds a Ph.D. in biomedical engineering from Cornell University and a B.S. in biomedical engineering from the University of Texas at Austin.