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Molecules to Medicines
Fall 2011

Course Schedule and Project Portfolio Deliverables

Date

Lecture

Activities

Week 1
Sept. 7

Introduction to the Course
Overview of Drug Development
Overview of Pharmacology
The Productivity Crisis
Lecture Slides: Week 1 Intro v4

Team Assignments
Therapeutic Area Selection

Week 2
Sept. 14

Target Identification

Pre-read:
1. Nature Reviews: How were new medicines discovered?
2. Nature Reviews: The druggable genome

Selection of Target
PP: Target Rationale

Lecture Slides:
Target ID and Validation

Activity:
Target Selection – Qualitative Assessment

Week 3
Sept. 21

Lead Identification/Lead Optimization

Discovery – Disease Models and
Pharmacology

PP: Experimental Strategy

Target to Lead - Points to Consider 2011

Lead ID Opt Exp Strategy Worksheet 2011

Week 4
Sept. 28

Phase 0 – Toxicology and Target Product Profile

Nonclinical Development

In Class Assignment: Toxicology Plan
PP: Target Product Profile

Pre-Read
FDA guidance - Non Clinical Tox

FDA Guidance - TPP 

Ambien Label

S9 Nonclinical Evaluation For Anticancer Pharmaceuticals

Week 5
Oct. 5

Technical (CMC) and Regulatory IND

Preparatory Session for MC1 Presentation

Pre-Read
IND Process

Week 6
Oct. 12

Group Presentations:   Management Committee (MC1) Presentation – Entry into Development Portfolio

Week 7
Oct. 19

Phase 1 – Objectives and Clinical Study Design

Debate Session 1: Phase 1 Trial Oversight
PP: Phase 1 Program Design

Activity: Debate Session 1 – Phase 1 Trial Oversight (TeGenero Case)

PP – Phase 1 Program Design (template)

AAR Toolkit

Week 8
Oct. 26

Scenario Development and Project Management

PP: Gantt Chart
Phase 1 data provided

Project Management for Scientists, Part 1: An Overview

Project Management for Scientists, Part 2: Getting Experience 

Week 9
Nov. 2

Phase 2 – Objectives and Clinical Study Design

Debate Session 2: Accelerated Approval Process
PP: Phase 2 Clinical Trial Design & Schedule of Assessments

PP: Phase 2 Clinical Trial Design Scenarios

Week 10
Nov. 9

Proof of Concept, Proof of Developability, Phase 3

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

Week 11
Nov. 16

Group Presentations:   MC2 Presentation  – Entry Into Phase 2

Week 12
Nov. 23
Thanksgiving

Patent Law

Catch Up Session

Project Portfolio Grading
Project Portfolio Guideline

Week 13
Nov. 30

NDA Filing

Debate Session 3: FDA Advisory Committee Meeting

Week 14
Dec. 7

Business Development and Lifecycle Management

PP: Unique Selling Points
PP: Lifecycle Strategic Plan

Week 15
Dec. 14

Future Trends
Human Resources

Submit final Project Portfolios