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Project Risk Management

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An integrative view of how risk management can be effectively utilized by project managers in drug development and commercialization.

1 of 26
Finding Opportunities for Fully Integrated Risk Management in Biopharmaceutical Projects John Franc, BS, MBA, PMP
Key Concepts ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],J. Franc, Slide
Agenda ,[object Object],[object Object],[object Object],[object Object],J. Franc, Slide
Typical Large Pharma Project Management Model ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],J. Franc, Slide
Guideposts for Effective Project Risk Management ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],J. Franc, Slide
General Project Risk Management Process J. Franc, Slide Initiate Project Risk Management Process Step1 . Risk Assessment Risk Identification Risk Analysis Risk Assessment Step 2. Risk Control Risk Reduction Plan Risk Response Expected Effectiveness Risk Management Tools Step 3. Risk Communication Risk Communication Output: Results of the Project Risk Management Process Step 4. Risk Review Risk Review Plan found Acceptable Further assessment required
Sample Project Objective ,[object Object],J. Franc, Slide
Scope Considerations ,[object Object],[object Object],[object Object],[object Object],[object Object],J. Franc, Slide
R&D Project Risk Management ,[object Object],J. Franc, Slide Phase 3 Approval/ Launch File NDA/MAA Regulatory Milestones Decision Points T – 1 mo T – 1 mo Risk Management Planning T – 6 mo Prep for Decision Prep for Decision Prep for Decision Monitor, Control to Filing Phase 2 Filing Target Reality Phase 1b/2a Initial topline data
R&D Project Risk Management Example ,[object Object],[object Object],[object Object],J. Franc, Slide
R&D Project Risk Management Example ,[object Object],J. Franc, Slide Example: New to company manufacturing process. Different EMEA vs FDA comparator requirements
R&D Project Risk Management Example ,[object Object],J. Franc, Slide ,[object Object],[object Object],Example: New to company manufacturing process . Different EMEA vs FDA comparator requirements
Integrating R&D and Manufacturing Risk Management J. Franc, Slide Phase 3 Approval/ Launch File NDA/MAA Regulatory Milestones Decision Points T – 1 mo T – 1 mo R&D Risk Management Planning T – 6 mo Prep for Decision Prep for Decision Prep for Decision Monitor, Control to Filing Phase 2 Filing Target Reality Phase 1b/2a Initial topline data Manufacturing Risk Management Planning Monitor, Control to Launch
Manufacturing Risk Management Example ,[object Object],[object Object],J. Franc, Slide
Manufacturing Risk Management Example ,[object Object],[object Object],J. Franc, Slide
Manufacturing Risk Management Example ,[object Object],[object Object],J. Franc, Slide
Manufacturing Risk Management Example ,[object Object],[object Object],J. Franc, Slide
Integrating Commercialization or Brand Risk Management ,[object Object],J. Franc, Slide Phase 3 Approval/ Launch File NDA/MAA Regulatory Milestones Decision Points T – 1 mo T – 1 mo T – 6 mo Prep for Decision Prep for Decision Prep for Decision Monitor, Control to Filing Phase 2 Filing Target Reality Phase 1b/2a Initial topline data Monitor, Control to Launch Refined Brand Risk Management Monitor, Control to Launch Early Draft Brand Plans Brand Risk Management R&D Risk Management Planning Manufacturing Risk Management Planning
Brand Risk Management ,[object Object],[object Object],[object Object],[object Object],J. Franc, Slide
Brand Risk Management Example ,[object Object],[object Object],J. Franc, Slide ,[object Object],[object Object],[object Object],Opportunities Threats
Brand Risk Management Example ,[object Object],[object Object],[object Object],[object Object],J. Franc, Slide
Example: Risk Management Maturity by Function ,[object Object],J. Franc, Slide Unawareness Buy-in Ownership Awareness Understanding Self-concern Tryout Adoption Institutionalization Internalization Time Sales& Marketing Phase I/IIa Phase III R&D Manufacturing PP&M
Managing to See Value J. Franc, Slide ,[object Object],[object Object],[object Object],[object Object],Value Were risks avoided? Predicted? Impact Was the output used to set expectations and manage risk? Scope Did participants feel time was well spent? Was the plan improved? A long-term proposition
Beating the Odds: What Can Happen When Risks Are Owned and Managed J. Franc, Slide 15 16 17 10 11 12 13 18 19 20 21 Phase III Start to Filing (months) 14 22 23 24 Initial Proposed Timeline ,[object Object],[object Object],[object Object],[object Object],Schedule Risk Assessment 10% 50% 90% ,[object Object],[object Object],[object Object],[object Object],Actual Performance ,[object Object],[object Object],5% Likely? Ok, but we’ll show them how it’s done!
Key Concepts ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],J. Franc, Slide
[object Object],J. Franc, Slide

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Project Risk Management

  • 1. Finding Opportunities for Fully Integrated Risk Management in Biopharmaceutical Projects John Franc, BS, MBA, PMP
  • 2.
  • 3.
  • 4.
  • 5.
  • 6. General Project Risk Management Process J. Franc, Slide Initiate Project Risk Management Process Step1 . Risk Assessment Risk Identification Risk Analysis Risk Assessment Step 2. Risk Control Risk Reduction Plan Risk Response Expected Effectiveness Risk Management Tools Step 3. Risk Communication Risk Communication Output: Results of the Project Risk Management Process Step 4. Risk Review Risk Review Plan found Acceptable Further assessment required
  • 7.
  • 8.
  • 9.
  • 10.
  • 11.
  • 12.
  • 13. Integrating R&D and Manufacturing Risk Management J. Franc, Slide Phase 3 Approval/ Launch File NDA/MAA Regulatory Milestones Decision Points T – 1 mo T – 1 mo R&D Risk Management Planning T – 6 mo Prep for Decision Prep for Decision Prep for Decision Monitor, Control to Filing Phase 2 Filing Target Reality Phase 1b/2a Initial topline data Manufacturing Risk Management Planning Monitor, Control to Launch
  • 14.
  • 15.
  • 16.
  • 17.
  • 18.
  • 19.
  • 20.
  • 21.
  • 22.
  • 23.
  • 24.
  • 25.
  • 26.

Editor's Notes

  1. From immediate, to near term, to long term…moving up