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 serves as Vice President, Head of CMC and Technical Operations, at ReAlta Life Sciences, where he is responsible for CMC development and manufacturing of ReAlta’s novel therapeutic peptides. Prior to joining ReAlta, he was the Chief Technology Officer at IconOVir Bio, where he led CMC activities and was the product lead for IconOVir’s lead oncolytic virotherapy candidate. Before IconOVir, John was Senior Vice President at Ring Therapeutics, developing manufacturing processes for a next-generation gene therapy platform. Prior to Ring, he was a Vice President of Gene Therapy Technical Operations at PTC Therapeutics, where he made significant contributions enabling the marketing authorization of Upstaza/Kebilidi, 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.