John MacNair, PhD

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Spark Therapeutics, Inc.
John MacNair, PhD, is Senior Director, Head of Analytical Program Development and Management at Spark Therapeutics. Previously, over a period of 22 years, he progressed through positions of increasing responsibility in vaccine analytical development at Merck & Co., Inc. Over the last three years at Spark, John has formed a group, Analytical Program Leads, to guide leads as they design and facilitate execution of the analytical strategies associated with the gene therapy programs Spark has in development. He received a BA in chemistry from Binghamton University and a PhD in analytical chemistry from the University of North Carolina at Chapel Hill. He joined ISPE in 2022.

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Cell and gene therapy (C&GT) products address various diseases at the cellular or genetic level, offer innovative treatment approaches, and represent a significant advancement in the field of medicine. However, developers of C&GT products face unique challenges due to their complexity, such as establishing assays that show a clear link between potency, mechanism of action (MoA), and...