Date

Lecture

Activities

Week 1
Sept. 3

Introduction to the Course
Overview of Drug Development
Overview of Pharmacology

Team Assignments
Therapeutic Area Selection

Week 2
Sept. 10

Target Identification

Selection of Target
Project Portfolio (PP): Target Rationale

Week 3
Sept. 17

Lead Identification/Lead Optimization

PP: Experimental Strategy

Week 4
Sept. 24

Phase 0 – Toxicology and Target Product Profile

PP: Toxicology Strategy
PP: Target Product Profile

Week 5
Oct. 1

Working Session:  Preparation of the Management Committee Presentation 1 (MC1) - Entry into Development Portfolio (PP)

Week 6
Oct. 8

Group Presentations: MC1 – Entry into Development Portfolio (PP)

Week 7
Oct. 15

Technical (CMC) and Regulatory IND

PP: CMC Strategy Presentation

Week 8
Oct. 22

Phase 1 – Objectives and Clinical Study Design

Debate Session 1: Phase 1 Trial Oversight (case study: TeGenero)

Week 9
Oct. 29

Phase 2 – Objectives and Clinical Study Design

Debate Session 2: Accelerated Approval Process (case studies: Iressa, Gleevec)

Week 10
Nov. 5

Scenario Development and Project Management

PP: Gantt Chart
Prepare for MC2 Presentations

Week 11
Nov. 12

Group Presentations: MC2 - Entry Into Phase 2 (PP)

Week 12
Nov. 19

Proof of Concept, Proof of Developability, Phase 3

PP: Decision Criteria for Entry into Confirmatory Development (Phase 3)
PP: Unique Selling Points

Week 13
Nov. 26
Thanksgiving

Patent Law

Catch up Session

Week 14
Dec. 3

NDA and Business Development

Debate Session 3: FDA Advisory Committee Meeting (case study: TBD)

Week 15
Dec. 10

Future Trends
Human Resources

Submit final Project Portfolios