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. 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. 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
3
® Making project management indispensable for business results. TM

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. 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. 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. 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 the
At the start of each iteration, break the work down allocated
selected scope items to deliver
the team works to their track. Each track uses (1-4 weeks) something of value to the client at
with the client to validate this to create an iteration plan
the end of each iteration
planned iteration scope
and if needed reprioritise
or swap scope
Potentially Checkpoint
Iteration
Depoyable with
Plan
Iteration Functionality client
Scope
® Making project management indispensable for business results. TM

8. Functionality of Scrum
Agile Project Management 8
JA
- Scrum
Making project management indispensable for business results. TM
SS
®

9. Functionality of Scrum
Agile Project Management 9
JA
- Scrum
Making project management indispensable for business results. TM
SS
®

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 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
• 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. 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. 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. 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
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. Agile Tools and Techniques
Communications
Information radiator, Team space, Osmotic communications for
colocated and/or distributed teams, Agile tooling,
Daily stand-ups
Planning, monitoring, and a
Retrospectives, Task/Kanban boards,timeboxing,
dapting Iteration and release planning, WIP limits, Burn down / up
charts, cumulative flow diagrams, process tailoring
Agile estimation
Sizing / Story points, Wide band, Delphi/planning Poker, Affinity
estimating, Ideal time
Agile analysis and design Product roadmap, User stories, Maps, progressive elaboration,
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, Adaptive
leadership, Negotiation, Conflict resolution, servant leadership
14
® Making project management indispensable for business results. TM

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/ranking
Risk management Risk-adjusted backlog, Risk burn down graphs, Risk-based spike
Metrics Velocity, Cycle time, Earned value management (EVM) for agile projects, escaped
defects
Value stream analysis Value stream mapping
15
® Making project management indispensable for business results. TM

16. 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)
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
16
® Making project management indispensable for business results. TM

17. 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)
10 PMI's Code of Ethics and Professional Conduct
11 Process analysis techniques
12 Self assessment
13 Value-based analysis
17
® Making project management indispensable for business results. TM

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 compliance
11 Variance and trend analysis
12 Variations in Agile methods and approaches
13 Vendor management
18
® Making project management indispensable for business results. TM

19. PMI Agile Domains of Practice…
Domain I: Value-Driven Delivery
Domain II: Stakeholder Engagement
Domain III: Boosting Team Performance Practices
Domain IV: Adaptive Planning
Domain V: Problem Detection and Resolution
Domain VI: Continuous Improvement (Product, Process, People)
19
® Making project management indispensable for business results. TM

20. Domain I: Value-Driven Delivery
1. Define Positive Value
2. Incremental Development
3. Avoid Potential Downsides
4. Prioritization
Domain II: Stakeholder Engagement
1. Stakeholder Needs
2. Stakeholder Involvement
3. Stakeholder Expectations
20
® Making project management indispensable for business results. TM

21. Domain III: Boosting Team
Performance Practices
1. Team Formation
2. Team Empowerment
3. Team Collaboration
4. 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. 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. 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. 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. PMI References for Agile
25
® Making project management indispensable for business results. TM

26. Thank You !
Vijaya Avula
Global Program Manager CSC
Nick Lake, Director of Outreach
PMI UK Chapter
Images from :Wikimedia Commons
Licensed under Creative Commons PMI UK Chapter
Attribution ShareAlike 2.0 License
(cc-by-sa-2.0). www.pmi.org.uk
Any further use of presentation
images must be under this license
PMI 26
® Making project management indispensable for business results.
TM
www.pmi.org