Session Overview: Where do you think pharmaceutical project management is heading? Is it shifting away from command and control – if you were ever lucky enough to have achieved that level of influence – or getting more deeply established as a core guarantor of value delivery? What do you think is on the radar for pharmaceutical project management of tomorrow? The old co-led (supposedly), line over project model has failed. The time is past for arcane, power-driven arguments for not adopting practices that have been long established and successful in other high technology R&D sectors. Have you heard people in your organization demand to be shown the ROI on implementing project management? The purpose of this year’s session is to further explore practices that have been long established and successful in other high technology R&D sectors and how they must be adopted by our sector so that we better understand the strategic direction and impacts we face. Project management practices in our industry still vary considerably across sectors, and between (and within) companies. A common paradigm for the industry to follow remains overdue.

1. Life Science Project Management
is Dead: A New (Old) Model for
the Future – An Update for 2020
and Beyond
Randy Dunson, MBA, PMP
Pete Harpum, MSc, MAPM
Rick Mulkey, MBA
Jann Nielsen, PhD

2. Session
Purpose
• Long established & successful practices in other high
technology R&D sectors
– Exploration of…
– Adoption by our sector so that we better understand the
strategic direction and impacts we face
• Project management practices in our industry vary
considerably across sectors
• Common paradigm for the industry to follow is way
overdue

3. Learning
Objectives
• Be able to engage with, & contribute to, dialogue
aimed at placing management at the heart of life
science organizations’ value delivery chain
• Be able to help the harmonization of corporate,
drug, & project strategy processes in your own
organizations

4. Panel
• Session Chair
– Randy Dunson, MBA, PMP
Chair
Pharmaceutical SIG
• Panelists
– Pete Harpum, MS, MAPM
Director
Harpum Consulting Ltd
– Richard Mulkey, MBA
Director, Project Management
GlaxoSmithKline
– Jann Nielsen, PhD
Executive Director, Global Project Management, Neuroscience
i3 Research

5. Introductory
Questions
• Where do you think pharmaceutical project
management is heading?
– Is it shifting away from command and control – if you were
ever lucky enough to have achieved that level of influence –
or getting more deeply established as a core guarantor of
value delivery?
• What do you think is on the radar for pharmaceutical
project management of tomorrow?
• Have you heard people in your organization demand
to be shown the ROI on implementing project
management?

6. Contact
Information
Randy Dunson
PMI Pharmaceutical SIG
chair@pharmasig.org
919.732.1707

7. Bringing Pharma
Project Management
out of the Dark Ages:
Example - Risk
Management
Jann Nielsen, PhD
Executive Director
CNS Project Management
i3 Research

8. The Best Way to Predict the
Future is to Invent It.
--Alan Kay

9. Agenda
• Pharmaceutical Industry Challenges
• Risk Management

10. Implications of a
Challenging Industry
Environment

11. Industry R&D
Productivity is
Decreasing
$50 200
$45 R&D Investments 180
Annual NME Approvals
Industry R&D Expense
$40 NME Approvals 160
$35 140
($ Billions)
$30 120
$25 100
$20 80
$15 60
$10 40
$5 20
$0 0
80
81
82
83
84
85
86
87
88
89
90
91
92
93
94
95
96
97
98
99
00
01
02
03
04
05
06
07
19
19
19
19
19
19
19
19
19
19
19
19
19
19
19
19
19
19
19
19
20
20
20
20
20
20
20
20
Source: PhRMA, FDA, Lehman Brothers;

12. A Decade to
Forget?
Other Drugs Counted as "new" by FDA
Innovative Commercial Therapies (ICTs)
70
60
50 14
40 7
2 4 8
30 5 3 1
45 4 3
20 37 4
33 32 4
25 26 26 28
10 19 16 19
14
0
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007
Source: FDA & the RPM Report, published in “The In Vivo Blog”, January 3, 2008

13. Since
June 2008
• Mergers
– Roche / Genentech
– Pfizer / Wyeth
– Merck / Schering Plough
• Layoffs
– Over 10,000
– More to come (e.g. AZ, GSK)

14. PMs Role
in the Future
• Fewer jobs
• More part-time and contracting
• More focus
– Timelines
– Quality
– Budgets
• All of these involve Risk Management

15. Risk
Management

16. Global Alignment –
Focus on
Benefit-Risk Profile
– Safety becoming more important both pre-
and post-approval
FDA – Bar set very high by first-in-class (SoC
comparisons more stringent) – Greater emphasis on
– More transparency and public scrutiny high safety bar
– More transparency and centralization in
– Approvals
submission to and assessment for EMEA
EMEA increasingly based on
– Increased emphasis on safety, with benefit/risk
significant post-approval obligations (e.g. assessment relative to
risk management plans etc.) existing therapies
– More emphasis on relative effectiveness (with growing
differentiation
– More emphasis on safety (integration of “hurdles” and post-
Japan, US and EU data)
PMDA market obligations)
– Increased emphasis on global programs
– Emphasis on strengthening clinical trials – Increased global
Other (e.g. – New reviews for patient safety alignment (FDA, EMEA
expectations and PMDA)
SFDA,
– Increased on transparency, innovation,
China) quality
– Required advantage over existing
products in China

17. Risk Management
Means
Different Things to
Different People
Risk Management
Foreign Currency Risk Mitigation
Risk & Evaluation PSUR Preparation
Patient Safety
Epidemiological
Financial Scenario
Studies
Product Positioning Planning
Outcomes Research
Signal Detection
Medication Errors Product Quality Product Liability
Drug Diversion
GMP Issues
Plant & Equipment
Management
Strategies

18. What Exactly do We
Need to do in Order
to Achieve Effective
Risk Management?
?

19. Risk Breakdown
Structure
• Hierarchical structuring of risks on the project
– Especially needed where there is a lot of data
– Similar to Work Breakdown Structure
• Standard presentation of project risks to facilitate:
– Understanding
– Communication
– Management
Hillson, Risk Doctors & Partners

20. Risk Breakdown
Structure
• Risk identification aid
• Risk assessment
• Comparison of projects
• Risk reporting
• Lessons learned for future projects
Hillson, Risk Doctors & Partners

21. Risk Breakdown
Structure - Generic
Level 0 Level 1 Level 2
Scope definition
Technical Risk
Technology
Etc.
All Risks
Proj. mgmt
Management
Risk Organisation
Etc.
Contractual terms
Commercial
Risk Procurement
Etc.
Exchange rates
External Risk
Legislation
Etc.

22. Risk Breakdown
Structure - Vaccine
Level 0 Level 1 Level 2
Regulatory Filing
Approvals
Process Formulation
Project risk Fermentation
Pre-clinical Immunoassays
Animal models
Clinical Plan
Reactogenicity
Marketing Cost
Competition
Management Team
Milestones
Hillson, Risk Doctors & Partners

23. Driving Risk
Quantitative Schedule
Risk by Register Risks
• Typical schedule risk analysis starts with the activity that
is impacted by risks
– Estimates the 3-point estimate for optimistic, most likely and
pessimistic duration
– Creates a probability distribution for activity duration
– Performs Monte Carlo simulation
• Which risks cause the most overall schedule risk? These
questions are typically answered by:
– Sensitivity
– Criticality
– Cruciality (combination of both)
Hulett and Associates, LLC

24. Simple Example of
Risk Register Risks
• Use the Risk Factors module in Pertmaster 8
• Collect probability and impact data on risks
• Load the risks
• Assign risks to schedule activities
Hulett and Associates, LLC

25. Risk Factor
Applied to a
100-day Task (2)
0040 - Technology Design : Duration
100% 130
95% 125
200
90% 122
85% 121
180
80% 119
Here the 160 75% 118
70% 117
Plan is the 140 65% 116
Cumulative Frequency
60% 115
Optimistic 120 55% 114
Hits
Value. 100
50% 113
45% 112
Probability 80
40% 111
35% 110
is 100% 30% 109
60
25% 109
20% 108
40
15% 107
20 10% 105
5% 104
0 0% 100
100 110 120 130
Distribution (start of interval)
Hulett and Associates, LLC

26. Assigning More Than
One Risk
to an Activity
• If more than one risk is acting on an activity, the resulting
ranges are the multiplication of the percentages
– Risk 1 has 90%, 100% and 115%
– Risk 2 has 100%, 110% and 130%
– The resulting risk has ranges of
• Optimistic: 90% (.9 x 1.0)
• Most Likely:110% (1.0 x 1.1)
• Pessimistic:150% (1.15 x 1.3)
Hulett and Associates, LLC

27. Two Risks Affect
One Activity
Using Factors
0040 - Technology Design : Duration
100% 144
95% 130
90% 127
140
85% 124
80% 123
120 75% 121
70% 119
Range 100
65% 118
Cumulative Frequency
60% 117
from 90 to 55% 116
Hits
150 days, 80 50% 115
45% 114
Peak about 60
40% 113
35% 111
113 days 30% 110
40 25% 109
20% 108
15% 106
20
10% 104
5% 102
0 0% 93
Hulett and Associates, LLC 100 110 120
Distribution (start of interval)
130 140

28. HyperRisk
Management
• Risk management on steroids
• Pick a system
• Demand that risk evaluation be done frequently
• Remove the Functional Leader for missing a risk
• Remove the Project Manager if 2 risks are missed
• Add bonuses for a project that is accomplished without
missing a risk
• Adapt to your culture

29. Contact
Information
Jann Nielsen
i3 Research
Jann.Nielsen@i3Research.com
610-489-3720

30. Value Delivery Using
Multidimensional
Schedule, Resources,
and Quality Trade-offs
Richard Mulkey, MBA
Director, Project Management
GlaxoSmithKline

31. Multidimensional
Trade-offs
• Pharma Pressures
• Constraints as Enablers
– Answer the Go/No Go Question
– Beginning to End Accountabilities
– Lean (Sigma) Thinking
• Project Management Trade-offs
• Conclusion

32. Pharma
Pressures
• Generic Competition Including Biosimilars
• Price Controls & US Healthcare
• Prolonged Review Cycles
• Organizational Restructuring
• Globalization

33. 33

34. Constraints

35. Constraints
as Enablers
• Answer the Go/No Go Question
• Accountability from Beginning to End
• Lean (Sigma) Thinking - Project
Managers as Efficiency Experts

36. Go/No Go
Decisions
Principles Project Plan
• Initiate only activities directly
related to the Go/No Go decision I
I
I
– May delay overall timing I
I
I
I
I I
– May increase costs for projects III
I
that progress I
• Schedule necessary activities as I
I
late as possible I
I
I
I
I
I
I
• Define your “Critical Path”
III
I
I I
I I
carefully

37. Key Decision
Critical Path
TRADITIONAL CRITICAL PATH
Stage Gate 1 Stage Gate 2
Go/No Go Activity
KEY DECISION CRITICAL PATH
Stage Gate 1 Stage Gate 2
Go/No Go Activity

38. Project Management
Measures at
Portfolio Level
 What percentage of projects planned for success
vs. projects that planned to go/no go?
 Which group of projects have the higher
progression rate?
 What was cost and cycle time impact when the
project progressed?
 What cost were saved by reducing activities for
projects that did not progress?
 How many activities and costs have been
deferred to a later phase?

39. Beginning to
End Accountability
Principles
Sponsor
Technical
Business
Manager
• Hand-offs are costly – enable
Owner
Expert
Project
experts to drive projects to Task / Activity
completion A R A R
• Redundancy is costly – ensure B A R R
teams have clear roles and C A R I C
accountabilities D A C R I
• Avoid delays – all assignments E R I A
are clear and team members are Responsible
Accountable
held accountable for deadlines Consulted
Informed

40. Lean (Sigma)
Thinking
Principles
• Identify the value drivers for the drug
development process
• Eliminate waste – waiting, rework, poor
quality
• Identify and accelerate the bottleneck –
Theory of Constraints
• Plan for both radical and continual
improvements

41. Identify Value
Drivers
• Pipeline – Filling Gaps
• Novel Targets
• Blockbusters vs. Varied Portfolio
• Globalization – Reaching New
Markets
And so many others…
unique to your company

42. Eliminate
Waste
Create a Process Map
Value Added Activities
Manufacturing, Dosing Patients
Non-value Added/Essential Activities
Auditing, Inspecting, FDA Review
Non-value Added/Non-essential Activities
Rework, Waiting, Multiple Layers of Review
VA VA VA VA
NVA - E NVA - E
NVA - NE NVA - NE NVA - NE
Months VA = 4.75 mo
NVA - E = 2.50 mo
NVA - NE = 3.75 mo

43. Theory of
Constraints
• Constraints*
– Every organization has at least one constraint, which
limits the system's performance relative to its goal
– Classified as either an internal or market constraint
– Once identified and managed correctly, constraints may
shift; process starts anew
• Critical Chain Project Management
– Method of planning that emphasizes resources required
to execute the project
– More traditional Critical Path and PERT methods
emphasize task order and rigid scheduling
*Summarized from Eliyahu M. Goldratt The Goal

44. Radical
Improvements
• When designing new processes, do NOT think of
existing procedures
• Understand the business goals and customer needs
• Commit to a process, identify an owner, and
benchmark frequently
• Standardize similar process, move towards
organization-wide definitions

45. Trade-offs

46. The Value of
Project
Management
• Schedule– interrogation of schedule,
activity durations, baseline/thresholds
• Resources – Cost per patient, deferred
spend, outsourcing options
• Quality
– Risks: competitive environment, inlicensing,
drug:drug interactions, back-up/follow-up
strategy
– Decision-making: progression criteria,
governance

47. The Value of
Project
Management
• Examples
– Reviewing and reducing redundancy in
Clinical Protocols
– Commercial Reviews of early stage drug
development candidates
– Balancing investment decisions affecting
Speed to Market

48. Conclusion
• Pharma is facing enormous pressures;
resources are constrained. Constraints
can be enablers to drive trade-off
decisions.
• Project Management is well suited to
– Provide information required for trade-off
decisions
– Manage new drivers – go/no go, resources,
and processes
– Focus teams on value drivers, eliminating
waste, and process improvements

49. Contact
Information
Rick Mulkey
GlaxoSmithKline
Richard.g.mulkey@gsk.com
610-787-5032

50. The King is Dead, Long Live
the King
Pete Harpum, MSc, MAPM
Managing Director
Harpum Consulting Ltd

51. View from 2008

52. • “Project management is the process by
which projects are defined, planned,
monitored, controlled, and delivered such
that agreed benefits are realised. Projects
are unique, transient endeavours to
achieve a desired outcome. Projects bring
about change and project management is
recognised as the most efficient way of
managing such change.”
APM Body of Knowledge, 5th edition

53. A Little
Honesty…
• Process – series of, including embedded practices: (sometimes,
often basic – quantitative risk management anyone?)
• Defined – corporate strategic goal thru project plan: (rarely)
• Planned – scope (usually), estimate (poorly), schedule (‘owned’),
budget (not often), resources (rarely, if ever), uncertainty
(sometimes – only risk, not opportunity)
• Monitored – compare actual progress to plan (sometimes, often
inaccurate, or impossible due to lack of tools)
• Controlled – action taken to take account of fact that reality
happened (and the plan was, by definition, wrong) (stop laughing)
• Delivered – handed over to the ultimate beneficiary (often
inadequately)
• Agreed benefits – agreed with panoply of stakeholders; benefits are
intangible as well as tangible, and Sponsor responsible for benefits
being accrued (value management rare, benefits realisation not
heard of, sponsor role usually misunderstood)

54. So What’s
Stopping Us?
• We’re different (yep, just like every other sector)
• Have to understand science (fundamental
misunderstanding of role of project manager)
• Attrition (completely dissimilar to software?)
• Consensus driven decision making (project management
seems to work in Japan, Sweden, China…)
• Highly regulated (unlike, for example, nuclear power,
airplanes…)
• Long project life cycles (ditto)
• Too complicated (fundamental misunderstanding of
origin of modern project management: Manhattan
Project; Polaris; Apollo; et al)

55. ∆ 2008:2010
Drug
Development
• Even less money available
• Ever higher pressure to achieve schedules
• Significantly increased market/commercial
pressure
• Establishment and stabilisation of multiple
organisational forms
• Significant increase in outsourcing

56. ∆ 2008:2010
P3M
• Increasing recognition that P3M has a role to play
– Maturity of P3M slowly increasing in some companies
– Still a relatively low level of understanding of criticality
of P3M to business success at senior executive levels
– Strong resistance to notion of ‘Project Control’ –
within and external to PM communities
– Drug Program as a collection of Line Project
Managers not yet embedded
– Full alignment and integration of [Company] Strategy,
[Therapy Area] Portfolio, [Drug] Program, and [Line] Project is
rare

57. The change of capability in portfolio,
program, and project management is not
keeping pace with the change in the
external and internal environment
Those that adapt will create even greater
competitive advantage now than would
have been the case in 2008

58. The need for high
quality P3M

59. More P3M
Please…
• Mechanical design
– JSF
– Wind turbine
– Trent 800
• Software
– North East blackout
– Ariane 5
– NASA Mars Climate Orbiter
– LAX
– A400M
– Denver airport
• New Product Development
– 787
– Examples too numerous to mention – 75% failure rate
In principle, if we had perfect knowledge, we could predict
exactly how molecules would interact with the body
Nobody else has perfect knowledge either!

60. Absolute
Minimum Need
Time
Cost Quality
• on time (NOT necessarily faster – just reliably will do)
• within budget (other molecules need the money too)
• within scope (do what is needed for project)
• meeting quality requirements (not just safety –
TPP/label)

61. Key Interventions

62. • Industry-wide acceptance
– Executive level buy-in
– Recognize need across industry
– Address need for high quality P3M at industry level
• Top down requirement for change to P3M visibility
– EVP of portfolio management, project/program management?
– Project/program management understood as core competence
in lines
• Bottom up effort
– Created and led by P3M community
– Demonstrate benefits
– Co-opt Line Reps and others to the cause
– Find a powerful ally at senior level
– Record and communicate success stories

63. The King is Dead,
Long Live the King

64. Contact
Information
Pete Harpum
Harpum Consulting Ltd
pete.harpum@harpumconsulting.com
+44 7733 107661

65. Thank You!
Q&A