Shantha is a seasoned pharmaceutical executive with over 25 years of expertise in CMC development, end-to-end drug development strategy, regulatory strategy, NDA GAP assessment, and product development. Shantha has successfully led the advancement of 30+ INDs and secured regulatory approvals for 4 NDAs/MAAs, driving the commercialization of innovative therapies in hematology, oncology, and antiviral treatments, including several FDA fast-track designated products. Most recently, Shantha served as Senior Vice President of Technical Operations and Early Drug Development at CTI BioPharma (SOBi) and GlycoMimetics, where he played pivotal roles in advancing programs from preclinical development to successful regulatory approvals. Shantha’s expertise spans CMC and Drug Development strategy, technical due diligence for in-licensing and out-licensing, Quality audits and PAI preparation, differentiated formulation development, CDMO/CRO engagement, supply chain optimization, and lifecycle management strategies. Shantha holds a Ph.D. in Pharmaceutical Technology and advanced training in Drug Delivery, driven by a mission to develop safe, effective, and compliant medicines that improve lives.