This course introduces students to the concepts, approaches and methods to develop scalable manufacturing processes for both pharmaceutical active ingredient and the optimal dosage form, the clinical studies and regulatory requirements and submissions necessary to gain marketing approval, and the manufacturing supply chain and distribution system to market the drug in commercial markets. The course builds upon concepts introduced in the previous semester, describing development from the initial Phase 1 clinical trial to marketing approval and commercialization, and providing for some illustrating case studies. Requires senior undergraduate standing or graduate standing. Prerequisite: BIOL 647.