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

SPH IH 800

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.

SPRG 2015 Schedule

Section Instructor Location Schedule Notes
A1 Gill F 10:00 am-1:00 pm Prereqs: MPH
Epi & Biostats
core courses.
Requires grp
& outside work
MED Campus

Note that this information may change at any time. Please visit the Student Link for the most up-to-date course information.