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The Business of Science: From Molecules to Medicines 2011
Welcome to PATHN5209: The Business of Science: From Molecules to Medicines
Course Objectives
This course is intended to provide the class with a practical, hands-on look at drug development in the Pharmaceutical/Biotech industry. The activities assigned will be real deliverables for which professionals working in Pharma are responsible throughout the research and development cycle. There are two reasons this course will be valuable for you: (1) you will get a glimpse into the activities that are common in industry, and (2) if you are considering a career in a Pharma company, this will be your opportunity not only to understand what it might entail, but also interact with professionals from the pharmaceutical industry who give the lectures and provide guidance throughout the course.
Structure of the class
The course will follow the cycle of drug research and development across three major phases: Discovery Research, Exploratory Development, and Confirmatory Development. Each session will involve 1-1.5 hours of lectures followed by 1-2 hours of activities. To enhance learning, you will be assigned to a group to create a “virtual” Project Team. Each Project Team will identify a specific disease area and therapeutic target, and develop a molecule (i.e., drug) through the phases of research and development, and up to filing a New Drug Application (NDA) and product launch. The group activities will be directly related to the course lectures and will consist of deliverables that are typically also required in the Pharma industry. Thus, you are provided an opportunity to immediately apply what you have learned. In lieu of exams, there will be two formal group presentations that are graded.
Expectations and Student Profile
This is an advanced graduate-level course, and students can register only by permission of the Course Director. As such, we have the following expectations of the students who take this course:
1. Group Work. Group work is the foundation of this course. You will be assigned to a Project Team (group) at the beginning of the course, and most of your grade is based on your Project Team’s performance. We are aware that working in a group is challenging, but this skill is absolutely required in the Pharma industry and most other professions.
2. Critical Thinking. Industry professionals are expected to be skilled in critical thinking and able to work independently. While we will provide guidance and examples of what we expect you to deliver, much of the “practicality” of this course requires you to figure out (on your own, within your group) how to apply the concepts you learn in a way that enables a business/management decision for your project.
The Project Portfolio
We have found that theory combined with practical application enables the most effective learning. Throughout the semester, each project group will develop a Project Portfolio, which is a collection of all deliverables developed by the group on a rolling basis. The Project Portfolio will include the following elements:
1. Introduction/Executive Summary
2. Target Rationale
3. Experimental Strategy
4. Target Product Profile (TPP)
5. Project Gantt Chart (Timeline for drug development)
6. Phase 1 Program Strategy
7. Phase 2 Trial Design/Schedule of Assessments
8. Decision Criteria for Entry into Confirmatory Development (Lifecycle Investment Point)
9. Unique Selling Points
10. Lifecycle Strategic Plan
Class Debates
There will be three class debates over the semester. Each student will be assigned a role in one of the debates (~6-8 students per event), and will be expected to prepare and defend a position. The debate topics will be announced at the beginning of the course.
Grading
Students will be graded on the following course elements: Final grades will be calculated as follows:
Management Committee Presentation 1 20% A: 92 - 100
Management Committee Presentation 2 25% B+: 86 - 91.9
Project Portfolio 30% B: 80 - 85.9
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