Connor Gallagher
Connor Gallagher has been a Process Engineer at GlaxoSmithKline since 2021. Born and raised in Havertown, Pennsylvania, he attended the University of Pennsylvania, receiving an undergraduate degree in chemical and biomolecular engineering in 2020. At GSK, Connor has been extensively involved in developing and deploying statistical process control models across both small and large molecule modalities at manufacturing sites in the United States and United Kingdom.
Bob Yule
Bob Yule is the head of the new US Engineering and Modeling group at Sanofi Cambridge Crossing. Bob is a Chemical Engineer with 40 years of experience. He started with Dupont in manufacturing and moved to R&D early in his career. He provided leadership building process engineering groups at Dupont Merck, BMS, Abbott and GSK. Before joining Sanofi, he led Global and Early Development modeling groups at GSK working on Drug Substance and Drug Product process and product development. He has partnered externally on industry, academic and government funded collaborations to advance simulation and Industry 4.0 (Digital Design). Bob’s passion is to accelerate develop and increase process understanding using simulation. This includes establishing efficient material sparing and data intensive workflows integrated with a comprehensive data infrastructure.
Ben Smith
Ben has been at Amgen since 2013, working in the applied modeling and simulation engineering team. He is currently working in process-economic and facility-fit evaluations for new manufacturing platforms and supporting automation of process modeling through digitization of process parameters and lifecycle management, as well as working as a sustainability lead in the team.
Ben Stevens
Ben Stevens is a Director of CMC Policy and Advocacy at GSK and has nearly 15 years of drug discovery and regulatory experience. Prior to GSK, Ben was a Director of Regulatory Affairs CMC at Alnylam where he led the clinical regulatory CMC development of vutrisiran prefilled syringe in over 30 countries, and the initial US NDA and EU MAA submissions. Before Ben joined Alnylam, he was a Principal Consultant at PAREXEL and an acting Branch Chief in the Office of New Drug Products (ONDP) at the FDA. At FDA, Ben worked closely with several key policy groups (OPPQ, ORP), partnered with CDRH on matters related to combination product review, and was a government liaison to USP. Before FDA, Ben spent seven years in medicinal chemistry R&D at Pfizer and Merck. Ben has broad regulatory CMC experience in small molecules, peptides, oligonucleotides, botanicals, and combination products, with recent focus CMC policy and advocacy for biologics and CGT at GSK. He received a Ph. D. in Chemistry from the University of Pittsburgh, a M.P.H. from the Johns Hopkins and is a co-author of over 30 publications and patents.
Michaela Schütz
