Bryan Castle, Ph.D., is a twenty plus year veteran of the pharmaceutical industry, who has a solid grounding in analytical sciences. He has experience in drug substance and drug product analytical development from both a technical and an administrative view point. He is passionate about quality and has led the redevelopment of laboratory quality system used for all of product development. Bryan is experienced with continuous manufacturing and was part of the team that commercialized the first product using this technology at Eli Lilly and Company, which included a real time release (RTR) approach leveraging near-infrared spectroscopy. He also has experience with regulatory submissions in major markets (US, EU, Japan and Brazil) and responses to questions. In addition, Bryan has been active in IQ and AAPS workgroups for process analytical technology (PAT), and with the Allotrope foundation for data standards (regulatory working group). He holds a Ph.D. in Analytical Chemistry from the University of Florida.