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The Business of Science: From Molecules to Medicines

Welcome to PATHN5209: The Business of Science: From Molecules to Medicines

Molecules to Medicines - Fall 2008

Course Objectives
This course is intended to provide the class with a practical, hands-on look at drug development. The activities we will be assigning will be real deliverables for which professionals working in the Pharma industry are responsible throughout the research and development cycle.  There are two reasons this course will be valuable for you: (1) if you are considering a career in a Pharma company, this will be your opportunity to understand what it might entail, and (2) we have found that theory combined with practical application enables the most effective learning.

Classes are held on Wednesday evenings (6 - 9pm) on the UMDNJ Newark campus;
Medical Sciences Building Room C-555.

Course Directors:

Nicholas M. Ponzio
973-972-5238
ponzio@umdnj.edu

Steve R. Ritland
973-325-5245
steve_r.ritland@roche.com

Shanon Hunt
shanon.hunt@roche.com

Holly Hilton
holly.hilton@roche.com

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 class will involve 1-1.5 hours of lectures followed by 1-2 hours of activities. To enhance your learning, students will be assigned to a group to create a “virtual” project team. Each project team will identify a therapeutic area and a target and develop a molecule through research and development up to filing a New Drug Application (NDA).  The group activities will be directly targeted to the lecture and will consist of deliverables that are typically required in the Pharma industry; students are provided an opportunity to apply what they have learned.

The Project Portfolio
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:

Target Product Profile (TPP)
Project Gantt Chart (Timeline)
Target Rationale
Experimental Strategy
Toxicology Strategy
Management Committee-1 (MC1) Presentation (Entry into Development Portfolio)
Chemistry, Manufacturing & Controls (CMC) Strategy Management Presentation
MC2 Presentation (Entry into Phase 2)
Decision Criteria for Entry into Confirmatory Development
Unique Selling Points

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 forthcoming.

Grading
Students will be graded on the following:

Management Committee Presentation 1        20%
Management Committee Presentation 2        20%
Project Portfolio                                             30%
Participation in one of three debates             15%
Group Participation – Peer Feedback             15%

Project Portfolio Teams