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Molecules to Medicines - Fall 2006

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, Ph.D.
973-972-5238
ponzio@umdnj.edu

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

Structure of the class
The course will follow the cycle of drug research and development.  The first half of the course will focus on drug discovery and early research.  The second half of the course will focus on clinical development through marketing.  Each class will involve 1-1.5 hours of lectures (didactic) followed by 1-2 hours of group activities.  The activities will be directly targeted to the lecture; students are provided an opportunity to apply what they have learned. 

Course Material
Each week, students will be expected to read the selected course material, posted to the M2M website.  Reading material will be available in advance of the class.  The material will include journal articles and other papers that will support the lecture and activities planned for that week.

The Project Portfolio
Each project group will be tasked with identifying a target and developing a molecule through non-clinical and clinical development.  Throughout the semester, the 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:

1. Target Product Profile (TPP)
2. Project Gantt Chart (Timeline)
3. Target selected, with rationale
4. Experimental Strategy 1: Screening to hits
5. Experimental Strategy 2: Hits to lead
6. Toxicology Plan
7. Technical (CMC) Strategy Presentation
8. MC Presentation 1 (Entry into Development Portfolio)
9. Phase 1 Plan
10. MC Presentation 2 (Entry into Phase 2)

Class Debates
There will be three class debates over the semester, each student will be assigned a role in one of the debates
(~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:

• Students will be graded on the following:
  
• In class participation and homework assignments - 15%
  
• The Management Committee Presentation 1 - 20%
  
• The Management Committee Presentation 2 - 20%
  
• The Project Portfolio- 30%
• Participation in one of the three class debates - 15%