PTI - international

Agenda: Day Two

VIII. Transition from Phase III to Commercialization and Beyond

• Identify the Stakeholders
  
• Ensure a successful "hand off"

IX. Commercialization: Redefining your Project Team

• Define the role of Clinical Development
  
• Define the role of the Product Team and Medical Affairs
  

Exercise: Review Roles/Responsibilities Matrix and Revise if Necessary 

X. Commercialization: Updating the Target Product Profile

• Identify what has changed from the original TPP
  
• Identify what factors must be considered (earlier phase data, regulatory issues, the changing marketplace, the voice of the customer)
  

Exercise: Review the TPP from Day One and Revise if Necessary

XI. Commercialization: Developing Project Objectives

• Examine typical objectives of a Commercialization project
  
• Prioritize objectives
  
• Identify strengths and opportunities

XII. Commercialization: Developing the Project Plan

• Develop the Work Breakdown Structure
  • identifying activities
  • sequencing activities
  • identifying the critical path
• Resource the plan
  • identifying resource needs
  • negotiating for resources
  • manage risks
• Identify Weaknesses and Threats
  • manage risks
    

Exercise: Review and Critique an Example Commercialization Project Plan

• Create timeline
  • time: balancing what you need against what you can get
  • tools for developing timelines
  • tools for tracking timelines
• Work with budgets
  • budget: balancing what you need against what you can get
  • tools for developing budgets
  • tools for tracking budget

XIII. Phase III: Project Implementation, Monitoring and Control

• Outline the decision making process
  
• Utilize monitoring tools
  
• Assure quality
  
• Communicate progress

XIV. Summing It All Up

• Analyze the "Big Picture"- current state of project management in late-phase drug development programs
  
• Anticipate future trends in project management of late-phase drug development programs