Agile Importance in Pharmaceuticals Industry

Agile in Pharmaceutical Industry

© 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.

Vijaya Avula

MSD, 14th June 2012

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

® Making project management indispensable for business results. TM2

• 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

How we can adapt ?• Develop the best quality products in the shortest possible time.• Accelerate innovation• Design for supply• Rapidly commercialize


Adapting “Agile” is the key for all above to Fosters the Business Transition & Sustained Growth

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


• Packaging and Drug Handling Management• Global Product Delivery & Partner Management

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


• PMI References

Waterfall vs. Agile

Discovery Design Implementation Manage

Waterfall

Release 1 Release 2

Agile

Release 3 Release 4

Go Live

® Making project management indispensable for business results. TM

• 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

DefineRelease 1 Release 2

It 1 It 2 It 3 It 4 It 5 It 6

Release 3

It 7 It 8 It 9

Release 4

It 10 It 11 It 12

Iteration N

MonLocal team: acts as interface to client, does some dev work

team: develops and tests Fri

Mon: Iteration kick-off with client

Fri: End-of-iteration checkpoint with client

Go Live

Agile Delivery Model

(3) Daily teamMeetingThe team meets daily to report status and address roadblocks

Short Iterations

24 hours

(1) Validate/Reprioritize scope

(2) Build iteration planThe team works with the client to gain a deeper understanding of the iteration requirements and be able to

(4) Deliver potentially deployable functionalityThe team performs Analysis & Design, Requirements detailing,


Short Iterations

(1-4 weeks)

(1) Validate/Reprioritize scopeAt the start of each iteration,the team works with the client to validate planned iteration scope and if needed reprioritise or swap scope

requirements and be able to break the work down allocated to their track. Each track uses this to create an iteration plan

IterationScope

Design, Requirements detailing, Development and testing of the selected scope items to deliver something of value to the client at the end of each iteration

Potentially DepoyableFunctionality

IterationPlan

Checkpoint with client

Functionality of Scrum

® Making project management indispensable for business results. TMJASS

Agile Project Management - Scrum

8

Functionality of Scrum

® Making project management indispensable for business results. TMJASS

Agile Project Management - Scrum

9

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 customer's competitive advantage

• Deliver working software frequently, from a couple of weeks to a couple of months, with a preference to the shorter timescale


• 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

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


• 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

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


▫ 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

The War Room

• Team Structure - the basic "who's 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


the team who is responsible

• Story Board - The stories for this iteration, what is complete, in-progress, and not started

• Client Deliverables - This may seem straight forward, but a reminder as too what we as a team are trying to deliver

• Client Phase Exit Criteria - What are we marching toward to complete the current phase and achieve signoff

• Story Stack - The scope of the project

• Meeting Agenda - The standard daily team stand-up meeting has a strict, short agenda so we can complete it within 30 minutes

• Issues and Next Steps - The whiteboard list of next steps, dates, owners, to be checked during each team meeting

• Risks - The whiteboard list of risks, impact, and mitigation that needs to be taken (with owner)

• Recognition Awards - Some place to call out great work by the team or individuals.

• Ground Rules - The team derived rules for respecting each other

Agile Tools and TechniquesCommunications

Information radiator, Team space, Osmotic communications forcolocated and/or distributed teams, Agile tooling,Daily stand-ups

Planning,monitoring, and adapting

Retrospectives, Task/Kanban boards,timeboxing,Iteration and release planning,WIP limits, Burn down / upcharts, cumulative flowdiagrams, process tailoring

Agile estimationSizing / Story points, Wide band, Delphi/planning Poker, Affinityestimating, Ideal time

Agile analysis and design Product roadmap, User stories,Maps, progressive elaboration,Wireframes, chartering, personas, agile Modeling, Story Maps


Wireframes, chartering, personas, agile Modeling, Story Maps

Product quality Frequent Verification and Validation, Test-driven development,Acceptance test-driven development,Definition of done, Continuous Integration

Soft skills negotiation Emotional intelligence, Collaboration, Adaptiveleadership, Negotiation, Conflict resolution, servant leadership

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,minimallymarketablefeature (MMF), relativeprioritization/ranking

Riskmanagement Risk-adjustedbacklog, Risk burn downgraphs, Risk-based spike

Metrics Velocity, Cycle time, Earned value management (EVM) for agile projects, escaped

defects

Value stream analysis Value streammapping


Agile Knowledge & Skills (Level 1)1 Active listening

2 Agile Manifesto values and principles

3 Assessing and incorporating community and stakeholder values

4 Brainstorming techniques

5 Building empowered teams

6 Coaching and mentoring within teams

7 Communications management

8 Feedback techniques for product (e.g., prototyping, simulation,

9 demonstrations, evaluations)


9 demonstrations, evaluations)

10 Incremental delivery

11 Knowledge sharing

12 Leadership tools and techniques

13 Prioritization

14 Problem-solving strategies, tools, and techniques

15 Project and quality standards for Agile projects

16 Stakeholder management

17 Team motivation

Agile Knowledge & Skills (Level 2)1 Agile frameworks and terminology

2 Building high-performance teams

3 Business case development

4 Colocation (geographic proximity)/distributed teams

5 Continuous improvement processes

6 Elements of a project charter for an Agile project

7 Facilitation methods

8 Participatory decision models (e.g., input-based, shared collaboration,

9 command)


9 command)

10 PMI's Code of Ethics and Professional Conduct

11 Process analysis techniques

12 Self assessment

13 Value-based analysis

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 compliance

11 Variance and trend analysis

12 Variations in Agile methods and approaches

13 Vendor management

PMI Agile Domains of Practice…

Domain I: Value-Driven Delivery

Domain II: Stakeholder Engagement

Domain III: Boosting Team Performance Practices


Domain III: Boosting Team Performance Practices

Domain IV: Adaptive Planning

Domain V: Problem Detection and Resolution

Domain VI: Continuous Improvement (Product, Process, People)

Domain I: Value-Driven Delivery1. Define Positive Value2. Incremental Development3. Avoid Potential Downsides4. Prioritization




1. Stakeholder Needs2. Stakeholder Involvement3. Stakeholder Expectations

Domain III: Boosting TeamPerformance Practices

1. Team Formation2. Team Empowerment3. Team Collaboration4. Team Commitment




1. Levels of Planning2. Adaption3. Estimation4. Velocity/Throughput/Cycle Time

Domain V: Problem Detection and Resolution

Task 1 Create an open and safe environment to surface problemsand impediments that are slowing the team down orpreventing its ability to deliver value.

Task 2 Proactively engage the team at various points in the projectto identify risks and createmitigation strategies.

Task 3 Ensure impediments are resolved and/or reset expectationsin view of impediments that cannot be resolved.


Task 4 Maintain a visible list of risks and impediments in order toelevate accountability and track ownership and resolutionstatus.

Task 5 Communicate status of risk and impediments in order tomanage the expectations of the impacted stakeholders.

Domain VI:Continuous Improvement(Product, Process, People)

Task 1 Tailor the process to the project by adapting practices forthe team, organization culture, and delivery goals in orderto ensure that the team is effective within establishedorganizational norms.

Task 2 Incorporate feedback by conducting frequent retrospectivesin order to improve process, individual, and teameffectiveness.

Task 3 Adjust team composition and work practices to improveefficiencywithin the existing process with a goal of keepinga team together long term.

Task 4 Remove wasteful process elements by challenging existing


Task 4 Remove wasteful process elements by challenging existingprocess elements in order becomemore efficient.

Task 5 Create systemic improvements by disseminatingknowledge and practices across project and organizationalboundaries in order to avoid re-occurrence of problemsidentified, improving the effectiveness of the organizationas a whole.

Task 6 Improve teammember knowledge and skills by pairing teammembers in order to improve overall team effectiveness andlowering risk around knowledge silos.

Task 7 Evaluate work efficiency in order to identify opportunities toreduce waste.

Task 8 Experimentwith new techniques and process ideas forshort periods in order to discovermore efficient andeffective ways of working.

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


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.

PMI References for Agile


Thank You !

Vijaya AvulaGlobal Program Manager CSC

Nick Lake, Director of Outreach


Nick Lake, Director of OutreachPMI UK Chapter

PMI UK Chapterwww.pmi.org.uk

PMIwww.pmi.org

Images from :Wikimedia Commons Licensed under Creative CommonsAttribution ShareAlike 2.0 License (cc-by-sa-2.0).Any further use of presentation images must be under this license

Agile Importance in Pharmaceuticals Industry

Business

Transcript of Agile Importance in Pharmaceuticals Industry