Pharmaceutical Chemistry - Rd Map Dvlpmnt&Reg Ap New Drug

Catalog description

This special topics course will cover key steps in developing and bringing a new drug through pharmaceutical development and regulatory approval and into commercial use. Development of both traditional small-molecule chemical drugs and biotechnology-based protein drugs will be discussed. Example topics include: (1) how does a drug candidate move from its discovery at the lab bench into clinical trials? (2) what are the key hurdles in developing a new medicine that can be produced at large-scale in a manufacturing facility? (3) why are patents and venture capital so important in drug development? Guest lecturers will provide real world perspectives including case studies. This is two-hour class that meets 8 times during the semester. Prerequisite: Graduate standing in Pharmaceutical Chemistry or a trainee of the NIH Biotech Training Grant.