PTI - international

Agenda: Day Two

VI. Phase I: Project Implementation, Monitoring and Control

• Develop decision-making criteria
•  Outline the decision-making process
• Conduct project review meetings
• Inform senior management and secure endorsement
• Make decisions based on risk management

Exercise: Compile a Master List of Critical Decision-Making Criteria

VII. Transition from Phase I to Phase II

• Define "handoff"
• Execute the successful "handoff"
• Determine when to begin the transition
• Define the role of the commercial group

VIII. Phase II: Project Team and Emerging Target Product Profile

• Examine possible changes in the functional composition of the team
• Form the Development Team
  • identify sub-teams (e.g., strategy sub-team)
  • develop internal and external stakeholder communication plan 
  • supply chain management 

  • technology transfer
• Review the ongoing iterative process of assessing the Target Product Profile against current data and information

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

IX. Phase II: Setting Project Objectives

• Define objectives appropriate to Phase II development 
  • publications strategy 
  • patent strategy 
  • additional work on metabolism 

  • special populations
• Apply risk management strategies

Exercise: Risk Planning

X. Phase II: Project Timeline

•  Plan for the End of Phase II meeting with regulators
• Develop Proof of Concept

XI. Phase II: Project Monitoring and Control

• Evaluate ongoing activities through Phase II
• Prepare for transition to Phase III
• Determine the brand team and key objectives related to brand management

Exercise:Review Goals and Objectives from the Beginning of Day One and Ensure All Have Been Met