Agile Importance in Pharmaceuticals Industry

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Agile Importance in Pharmaceuticals Industry

  1. 1. Agile in Pharmaceutical Industry Vijaya Avula MSD, 14th June 2012 © 2001 to 2012 PMInst (UK) Ltd. All rights reserved. “PMI” and the PMI logo are service and trademarks registered in the United States and other nations; “PMP” and the PMP logo are certification marks registered in the United States and other nations; and “Building professionalism in project management.” and “Making project management indispensable for business results” are trademarks of the Project Management Institute, Inc.
  2. 2. Pharmaceutical Industry in Transition• $60 billion of US pharma patent revenue will expire in 2012• Decline in FDA drug approvals• Surge of the generics which now accounts for 3 in 4 pills• Shift to the stakeholder payer model puts market access at centre stage• R&D Shift• Leaner and more agile pharma companies• 50,000+ senior level redundancies in the US alone• Even more pressure on those retained• Huge opportunities in emerging markets 2 ® Making project management indispensable for business results. TM
  3. 3. How we can adapt ?• Develop the best quality products in the shortestpossible time.• Accelerate innovation• Design for supply• Rapidly commercialize Adapting “Agile” is the key for all above to Fosters the Business Transition & Sustained Growth 3 ® Making project management indispensable for business results. TM
  4. 4. Areas where Agile works….• Drug development portfolio Management• Comprehensive drug development records Management• Clinical Supply Management• Technology Transfer and Knowledge Management• Quality and Risk Management• Packaging and Drug Handling Management• Global Product Delivery & Partner Management 4 ® Making project management indispensable for business results. TM
  5. 5. A Brief Journey to Agile• Waterfall vs Agile• Agile Delivery Model• Agile Principles & Benefits• Agile Tools – Skills & Knowledge• PMI Agile Domains of Practice• PMI References 5 ® Making project management indispensable for business results. TM
  6. 6. Waterfall vs. Agile Waterfall Discovery Design Implementation Manage Go Live Agile Release 1 Release 2 Release 3 Release 4 Define It 1 It 2 It 3 It 4 It 5 It 6 It 7 It 8 It 9 It 10 It 11 It 12 Go Live Iteration N Local team: acts as interface to client, does some dev work Mon Fri team: develops and tests Fri: End-of-iteration Mon: Iteration kick- checkpoint with client off with client• A project is broken into releases (a release should occur no less frequently than every 4 months)• Releases are broken into short (1-4 week) iterations ® Making project management indispensable for business results. TM
  7. 7. Agile Delivery Model (3) Daily team Meeting 24 hours The team meets daily to report status and address roadblocks (2) Build iteration plan (4) Deliver potentially The team works with the deployable functionality client to gain a deeper The team performs Analysis & understanding of the iteration Design, Requirements detailing,(1) Validate/Reprioritize scope requirements and be able to Short Iterations Development and testing of theAt the start of each iteration, break the work down allocated selected scope items to deliverthe team works to their track. Each track uses (1-4 weeks) something of value to the client atwith the client to validate this to create an iteration plan the end of each iterationplanned iteration scopeand if needed reprioritiseor swap scope Potentially Checkpoint Iteration Depoyable with Plan Iteration Functionality client Scope ® Making project management indispensable for business results. TM
  8. 8. Functionality of Scrum Agile Project Management 8 JA - Scrum Making project management indispensable for business results. TM SS ®
  9. 9. Functionality of Scrum Agile Project Management 9 JA - Scrum Making project management indispensable for business results. TM SS ®
  10. 10. Agile principles• Highest priority is to satisfy the customer through early and continuous delivery of valuable software• Welcome changing requirements, even late in development and focus on the customers competitive advantage• Deliver working software frequently, from a couple of weeks to a couple of months, with a preference to the shorter timescale• Business people and developers must work together daily throughout the project• Build projects around motivated individuals. Give them the environment and support they need, and trust them to get the job done• The most efficient and effective method of conveying information to and within a development team is face-to-face conversation ® Making project management indispensable for business results. TM
  11. 11. Agile principles (contd…)• Working software is the primary measure of progress• Agile processes promote sustainable development. The sponsors, developers, and users should be able to maintain a constant pace indefinitely• Continuous attention to technical excellence and good design enhances agility• Simplicity – the art of maximizing the amount of work not done – is essential• The best architectures, requirements, and designs emerge from self- organising teams• At regular intervals, the team reflects on how to become more effective, then tunes and adjusts its behaviour accordingly ® Making project management indispensable for business results. TM
  12. 12. The Four Main Benefits of Agile (if done right!)• Increases Flexibility ▫ It minimizes up front investment and maximizes return on investment (ROI) by creating an efficient IT development process• Delivers the Right Solution ▫ It aligns users and stakeholders with the right people to deliver the solution that the business actually needs• Accelerates Delivery ▫ Iterations get to the right solution faster• Reduces Risk and Increases Quality ▫ Greater stakeholder visibility and control ® Making project management indispensable for business results. TM
  13. 13. The War Room• Team Structure - the basic "whos on the team", including contact information• High level plan, Mid Level Plan - The overall project milestones, and the key iterations and release dates, with the anticipated objectives or deliverables for each• Roles and Responsibilities - A RACI style chart with the internal and external roles and the person on the team who is responsible • Meeting Agenda - The standard daily team stand-up meeting has a strict, short agenda so we can• Story Board - The stories for this iteration, what is complete it within 30 minutes complete, in-progress, and not started • Issues and Next Steps - The whiteboard list of next• Client Deliverables - This may seem straight steps, dates, owners, to be checked during each forward, but a reminder as too what we as a team are team meeting trying to deliver • Risks - The whiteboard list of risks, impact, and• Client Phase Exit Criteria - What are we marching mitigation that needs to be taken (with owner) toward to complete the current phase and achieve signoff • Recognition Awards - Some place to call out great work by the team or individuals.• Story Stack - The scope of the project • Ground Rules - The team derived rules for respecting each other ® Making project management indispensable for business results. TM
  14. 14. Agile Tools and TechniquesCommunications Information radiator, Team space, Osmotic communications for colocated and/or distributed teams, Agile tooling, Daily stand-upsPlanning, monitoring, and a Retrospectives, Task/Kanban boards,timeboxing,dapting Iteration and release planning, WIP limits, Burn down / up charts, cumulative flow diagrams, process tailoringAgile estimation Sizing / Story points, Wide band, Delphi/planning Poker, Affinity estimating, Ideal timeAgile analysis and design Product roadmap, User stories, Maps, progressive elaboration, Wireframes, chartering, personas, agile Modeling, Story MapsProduct quality Frequent Verification and Validation, Test-driven development, Acceptance test-driven development, Definition of done, Continuous IntegrationSoft skills negotiation Emotional intelligence, Collaboration, Adaptive leadership, Negotiation, Conflict resolution, servant leadership 14 ® Making project management indispensable for business results. TM
  15. 15. Agile Tools and Techniques (Contd…)Value-based prioritization Return on investment (ROI)/net present value (NPV)/internal rate of return (IRR), compliance, customer-valued prioritization, minimally marketablefeature (MMF), relative prioritization/rankingRisk management Risk-adjusted backlog, Risk burn down graphs, Risk-based spikeMetrics Velocity, Cycle time, Earned value management (EVM) for agile projects, escaped defectsValue stream analysis Value stream mapping 15 ® Making project management indispensable for business results. TM
  16. 16. Agile Knowledge & Skills (Level 1)1 Active listening2 Agile Manifesto values and principles3 Assessing and incorporating community and stakeholder values4 Brainstorming techniques5 Building empowered teams6 Coaching and mentoring within teams7 Communications management8 Feedback techniques for product (e.g., prototyping, simulation,9 demonstrations, evaluations)10 Incremental delivery11 Knowledge sharing12 Leadership tools and techniques13 Prioritization14 Problem-solving strategies, tools, and techniques15 Project and quality standards for Agile projects16 Stakeholder management17 Team motivation 16 ® Making project management indispensable for business results. TM
  17. 17. Agile Knowledge & Skills (Level 2)1 Agile frameworks and terminology2 Building high-performance teams3 Business case development4 Colocation (geographic proximity)/distributed teams5 Continuous improvement processes6 Elements of a project charter for an Agile project7 Facilitation methods8 Participatory decision models (e.g., input-based, shared collaboration,9 command)10 PMIs Code of Ethics and Professional Conduct11 Process analysis techniques12 Self assessment13 Value-based analysis 17 ® Making project management indispensable for business results. TM
  18. 18. Agile Knowledge & Skills (Level 3) 1 Agile contracting methods 2 Agile project accounting principles 3 Applying new Agile practices 4 Compliance (organization) 5 Control limits for Agile projects 6 Failure modes and alternatives 7 Globalization, culture, and team diversity 8 Agile games 9 Principles of systems thinking (e.g., complex adaptive, chaos)10 Regulatory compliance11 Variance and trend analysis12 Variations in Agile methods and approaches13 Vendor management 18 ® Making project management indispensable for business results. TM
  19. 19. PMI Agile Domains of Practice…Domain I: Value-Driven DeliveryDomain II: Stakeholder EngagementDomain III: Boosting Team Performance PracticesDomain IV: Adaptive PlanningDomain V: Problem Detection and ResolutionDomain VI: Continuous Improvement (Product, Process, People) 19 ® Making project management indispensable for business results. TM
  20. 20. Domain I: Value-Driven Delivery 1. Define Positive Value 2. Incremental Development 3. Avoid Potential Downsides 4. PrioritizationDomain II: Stakeholder Engagement 1. Stakeholder Needs 2. Stakeholder Involvement 3. Stakeholder Expectations 20 ® Making project management indispensable for business results. TM
  21. 21. Domain III: Boosting Team Performance Practices1. Team Formation2. Team Empowerment3. Team Collaboration4. Team Commitment Domain IV: Adaptive Planning 1. Levels of Planning 2. Adaption 3. Estimation 4. Velocity/Throughput/Cycle Time 21 ® Making project management indispensable for business results. TM
  22. 22. Domain V: Problem Detection and Resolution Task 1 Create an open and safe environment to surface problems and impediments that are slowing the team down or preventing its ability to deliver value. Task 2 Proactively engage the team at various points in the project to identify risks and create mitigation strategies. Task 3 Ensure impediments are resolved and/or reset expectations in view of impediments that cannot be resolved. Task 4 Maintain a visible list of risks and impediments in order to elevate accountability and track ownership and resolution status. Task 5 Communicate status of risk and impediments in order to manage the expectations of the impacted stakeholders. 22 ® Making project management indispensable for business results. TM
  23. 23. Domain VI:Continuous Improvement (Product, Process, People) Task 1 Tailor the process to the project by adapting practices for the team, organization culture, and delivery goals in order to ensure that the team is effective within established organizational norms. Task 2 Incorporate feedback by conducting frequent retrospectives in order to improve process, individual, and team effectiveness. Task 3 Adjust team composition and work practices to improve efficiency within the existing process with a goal of keeping a team together long term. Task 4 Remove wasteful process elements by challenging existing process elements in order become more efficient. Task 5 Create systemic improvements by disseminating knowledge and practices across project and organizational boundaries in order to avoid re-occurrence of problems identified, improving the effectiveness of the organization as a whole. Task 6 Improve team member knowledge and skills by pairing team members in order to improve overall team effectiveness and lowering risk around knowledge silos. Task 7 Evaluate work efficiency in order to identify opportunities to reduce waste. Task 8 Experiment with new techniques and process ideas for short periods in order to discover more efficient and effective ways of working. 23 ® Making project management indispensable for business results. TM
  24. 24. Are We Ready For Agile?...• Trust pervades the culture of the organization, the interactions between its people, and its clients• Individuals demonstrate a high level of enthusiasm for or openness toward change• Management empowers individuals to take risks without fear of repercussions• Disciplined execution is representative of the organization’s delivery practices or broadly viewed as a goal worth of striving for• Teams and management alike evidence the commitment and patience necessary to seeing through changes despite challenges and disappointments along the way• A willingness exists to make reasonable investments in tools, training, coaching and mentoring to facilitate successful adoption and sustained change. ® Making project management indispensable for business results. TM
  25. 25. PMI References for Agile 25 ® Making project management indispensable for business results. TM
  26. 26. Thank You ! Vijaya Avula Global Program Manager CSC Nick Lake, Director of Outreach PMI UK ChapterImages from :Wikimedia CommonsLicensed under Creative Commons PMI UK ChapterAttribution ShareAlike 2.0 License(cc-by-sa-2.0). www.pmi.org.ukAny further use of presentationimages must be under this license PMI 26 ® Making project management indispensable for business results. TM www.pmi.org

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