Clinical development of a new medicinal: A case study about licensing a new vaccine for the developing world-SPH GH 800

Clinical development of a new medicinal: A case study about licensing a new vaccine for the developing world


Dates: All year


By: Boston University

Location: Boston

Credits: 2

Vaccines are arguably our most potent public health tools. The clinical development of a new vaccine is a massive undertaking, spanning many years, and typically costing hundreds of millions of dollars -- yet the process by which new vaccines are developed, tested, licensed, and used is poorly understood. In this course, students will participate in an extended simulation of the clinical development of a new vaccine. Students will design a Phase I through Phase III clinical development program; at each step, decisions the students take will influence future events, making the course highly iterative and flexible. The course is taught by an infectious disease specialist who recently led a clinical development team at Novartis Vaccines that led to licensure of a new meningococcal vaccine in over 33 countries. This course requires a substantial amount of time working in groups outside of the scheduled class time. www.bu.edu

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