Neil Stevenson is the CMC / Process Chemistry Lead at BenevolentAI, covering drug substance, drug product, and all associated CDMO partnerships. With 20 years of experience within the pharmaceutical industry, he has worked on projects throughout the drug development lifecycle, from candidate selection to Phase 3 and filing. Neil has extensive experience of process chemistry, genotoxin control, analytical chemistry and regulatory strategy, with a range of publications in these fields. Prior to BenevolentAI, Neil spent a number of years within Chemical Development at GSK, and received his PhD from the University of Sheffield, within Professor Harrity’s group. He has a keen passion for people leadership, coaching and continuous development.
Presentation Title: Process Development for the Manufacture of a Topical Pan-Trk Inhibitor Incorporating Decarboxylative Sp2-Sp3 Cross-Coupling.
Abstract: In collaboration between BenevolentAI and Concept Life Sciences, the development of a synthetic route towards topical pan-Trk inhibitor 1 is described. Process improvements include development of a decarboxylative sp2-sp3 cross-coupling as part of an eight-stage synthesis. This route has been reproducibly demonstrated in two GMP campaigns on multi-gram scale delivering API in >99% area purity by HPLC. The route design, process research, and manufacture has enabled crucial First-In-Human (FIH) clinical studies, through focus on speed of delivery.