Syllabus

Course Description

Welcome to the Drug Development Course. This course will provide an overview of the drug development process, focusing on drug development science, regulation, and industry from the U.S. perspective. Most sessions will consist of a brief didactic overview of the day's topic, followed by discussion of a primary scientific publication that emphasizes the most important principles covered.

Course Objectives

At the conclusion of this course, students should be able to:

• Describe how new drugs and devices are taken from the laboratory to the marketplace in the U.S.
• Differentiate Phase I, II, III, and IV studies.
• Understand the balance between medical benefit, medical risk, economic reward, and economic risk in the decision making process as it relates to drugs and devices in development.

Prerequisites

This course is required for students in the Graduate Training Program in Clinical Investigation, and is appropriate for others interested in the topic.

Course Requirements

Assessment of performance is based on 3 factors: (1) participation in class discussions, including attendance; (2) a small group project presented during the final session; (3) a brief (500-word limit) written summary of the group project.

Students are assigned to small groups to prepare a response to a fictional drug development scenario. Each group is asked to evaluate and prepare a response to a different assignment and will present their response to the class during the final session.

Student are asked to provide a brief critical written overview of their assigned drug development project in the form of a typed, double-spaced narrative of no more than 2 pages (500 words). Each student is randomly assigned to take a different perspective on the desired outcome of the project (i.e. industry, consumer, academic, or regulatory perspective). Thus every student will be writing a unique final paper.

> The written summary constitutes 75% of your grade, with discussion and presentation consituting the balance.