Game Delayed: Lessons from the Project Parking Lot. Joy T. Barnitz, Ph.D. PMP* and Brian D. Livingston, Ph.D. PMP*

Transcription

1 Game Delayed: Lessons from the Project Parking Lot Joy T. Barnitz, Ph.D. PMP* and Brian D. Livingston, Ph.D. PMP* Global Challenges: Succeeding with Distributed Project Teams PMI Silicon Valley Symposium October 8-9, 2011 *Statements reflect the opinions and experiences of the speakers and are not statements on behalf of MedImmune or AstraZeneca 1 Key Learning Objectives New product development in a rapidly evolving biopharmaceutical R&D environment Maintaining focus on the business objectives while meeting changing business requirements and priorities Case study demonstrating the application of key project management monitoring and close out processes to maintain transparent communication and decision making 2 1

2 In the Beginning. Project team Target product profile Timeline Budget 3 On the Mark. Get Ready. Go!! 4 2

3 And Then. CHANGE happens Business environment Competition Technical issues 5 Parked! Looking out to the goal What can we do? What lessons can we learn? How do we adapt to the change? 6 3

4 The Journey A perspective of the vaccine business A brief review of biopharma product development Case #1 MediVax A Case #2 MediVax B Key takeaways 7 Why Vaccines? Vaccines are widely attributed to increase life expectancies The incidence of several life threatening diseases have plummeted Markets for vaccines have grown substantially in the last 30 years Annual vaccine sales have gone from ~$1 billion in 1980 to >$30 billion today Eurosurveillance, Volume 15, Issue

5 Barriers to Vaccine Development Vaccines must be absolutely safe Treatment of healthy individuals necessitates the expectation of do no harm Escalating development time and cost Increased manufacturing costs and larger clinical trials Patience acceptance Education on role in public health Increasing time and economic demands Financing the Delivery of Vaccines MC Lindley et al., Pediatrics, A Project Management Perspective of the Vaccine Business Case Strengths Historic Successes Innovative Technologies Improving Heath = Cost Savings Weaknesses Expensive and lengthy R&D Process High Cost to Entry Market Consolidation Opportunities New Disease Targets Improvement of Existing Vaccines Changing Demographics Threats Anti-Vaccine Movement Developing World Accessibility Adequate Preparedness 10 5

6 Managing Weaknesses by Balancing the Triple Constraint Cost: Budget management Clarity of purpose Establishing expectations Time Organizational education Innovation in project plans Definition of decision points Scope Verification of requirements Managing change 11 Criticality of Clear Communications I know that you believe you understand what you think I said, but I'm not sure you realize that what you heard is not what I meant. Robert McCloskey 12 6

7 The Journey A bit about the vaccine business A brief review of biopharma product development Case #1 MediVax A Case #2 MediVax B Key takeaways 13 New Product Development Innovation is messy Individuals voice ideas Teams make ideas into products Complex interactions & multiple languages Different professions Different experiences Builds a corporate culture and depends on corporate culture 14 7

8 Governance: Choices and Decisions IND NDA DISCOVERY RESEARCH PRE-CLINICAL PRECLINICAL DEVELOPMENT CLINICAL DEVELOPMENT LAUNCH PRODUCT 15 Team Research & Translational Sciences Commercial & Business Project Leader, Project Manager & Regulatory CMC Clinical 16 8

9 The Journey A bit about the vaccine business A brief review of biopharma product development Case #1 MediVax A Case #2 MediVax B Key takeaways 17 MediVaxA: Fast Track! $ $ IND Target Evaluation DISCOVERY RESEARCH Lead Optimization Preclinical Development PRE-CLINICAL DEVELOPMENT 18 9

10 MediVaxA Key Acceleration Factor: Collaboration Experience and expertise 1. Key Opinion Leaders as part of the expanded team from the beginning 2. Partnership with company providing key product component 3. Product process development & product characterization leveraged global development expertise 4. Leveraged historical experience for reasons to believe 19 MediVaxA Key Acceleration Factor: Documentation Stage appropriate 1.Target Product Profile (TPP ) 2.Workplans 3.Timelines 4.Budget 20 10

11 Change Happens Corporate revenue Competitive environment R&D priorities shift Project takes a detour slows down... and parks! 21 MediVaxA: view from the parking lot 1. What can be paused? Complete prototype materials and testing Pause further development and implementation 2. How maintain relationships? Maintain team cohesion and motivation through focus on value proposition Partnerships and vendors Develop options with reduced scope ($, time) to generate data for business partnerships 22 11

12 The Journey A bit about the vaccine business A brief review of biopharma product development Case #1 MediVax A Case #2 MediVax B Key takeaways 23 Early stage projects Research stage projects often appear to be moving slowly What training for project team members can help? How can standard PM tools and techniques help to focus work and communicate progress? 24 12

13 Continuous Improvement Objectives PLAN COMMUNICATE the Plan MONITOR results DO the work W. Edwards Deming 25 MediVaxB: Key Project Factors Commercial Opportunity / Medical Need / Constraints No commercial vaccine Current therapies are not completely effective Selection of target population critical Efficient clinical development Faster time to market / lower costs Technical Complexity HIGH >2 components to produce and characterize longer time in Research stage Higher COGs than previous vaccine pipeline products Lack of predictive animal models 26 13

14 MediVaxB: Approaches & Applications Roles and Responsibilities (RACI) Governance bodies Functional management Team leadership (scientific, PM) Team members Workplans Define deliverables Identify the work, dependencies and durations Timelines, budgets and resources (people & equipt.) Flexible application of standard processes & tools Ex. Risk registers to identify and communicate technical hurdles and identify contingencies and workarounds Ex. Engage early with clinical, commercial and CMC experts 27 MediVaxB: work in - progress Reason to believe demonstrated Multiple technical approaches Component production feasible Streamlined clinical plan proposed Refined TPP in place Milestone review scheduled 28 14

15 MediVaxB: Continuity Through Change Business strategy changes Partnerships emphasized What stays the same? TPP remains same value proposition Data package for internal & external investment decisions What must change? Refine clinical strategy to select target population Adjust data packages / technical approach(es) for specific partners 29 Key Takeaway: Maintain Focus on Goal Business value is to deliver new medicine to patients: has the value proposition changed? Partnering with more than one other corporation: how do communication patterns change? The fox knows many things, but the hedgehog knows one big thing New stakeholders & new opportunities: who are our new collaborators? what new capabilities are available? Achilochus, ancient Greek poet 30 15

16 Organizational Benefits Lessons Learned and Confirmed Experience producing novel proteins Experience with multi-component products Experience with governance processes with external stakeholders Corporate Capabilities Experience with a variety production systems Experience on identifying critical product attributes for novel products 31 Putting It All Together COMMUNICATE Channels of communication may change Complexity may increase Emphasize continuity COLLABORATE Focus on linking team members to achieve key objectives Clearly state requests to stakeholders COORDINATE Change control Risk identification & mitigation Project documentation & history 32 16

17 Acknowledgements R&D Project Management Aida Bendt Jennifer Gribskov Panackal Brian Jennings Simon Lennard Ray Shackelford Julie Sharp Julia Thompson Uwe Huedepohl Key Resources Jared Cohen Mark Esser Laurie Hill Lisa Kreppel Phyllis Link Mike Washabaugh The Teams - CALIFORNIA Muralidhara Bilikallahalli Martin Chandler Greg Duke Chris Frantz Julie Hang Greg Hayes Joe Horwitz Simon Hsu Stacie Lambert Yi Liu Jason Marshall Michael J. McCarthy Louise McCormick Kirsten Schneider-Ohrum Kuldip Sra Elizabeth Stillman Roderick Tang Jennifer Woo Weiguo Zhai Fengrong Zuo The Teams - MARYLAND Brian Bishop Joelle Blakaitis Judy Falloon Bob Gasser Deb Neivert Kellie Ryan Joe Sliman Frank Sifakis Therese Takas 33 17