SlideShare a Scribd company logo

Life Science Project Management Is Dead A New (Old) Model For The Future – An Update For 2020 And Beyond

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 of 65
Download to read offline
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
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
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
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
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?
Contact
Information




    Randy Dunson
PMI Pharmaceutical SIG
 chair@pharmasig.org
     919.732.1707
Bringing Pharma
Project Management
out of the Dark Ages:
Example - Risk
Management
Jann Nielsen, PhD
Executive Director
CNS Project Management
i3 Research
The Best Way to Predict the
   Future is to Invent It.
        --Alan Kay
Agenda


• Pharmaceutical Industry Challenges
• Risk Management
Implications of a
Challenging Industry
   Environment
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;
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
Since
            June 2008

• Mergers
  – Roche / Genentech
  – Pfizer / Wyeth
  – Merck / Schering Plough
• Layoffs
  – Over 10,000
  – More to come (e.g. AZ, GSK)
PMs Role
         in the Future

• Fewer jobs
• More part-time and contracting
• More focus
  – Timelines
  – Quality
  – Budgets
• All of these involve Risk Management
Risk
Management
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
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
What Exactly do We
Need to do in Order
to Achieve Effective
Risk Management?




  ?
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
Risk Breakdown
                       Structure


 •   Risk identification aid
 •   Risk assessment
 •   Comparison of projects
 •   Risk reporting
 •   Lessons learned for future projects




Hillson, Risk Doctors & Partners
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.
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
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
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
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
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
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
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
Contact
  Information


         Jann Nielsen
         i3 Research
Jann.Nielsen@i3Research.com
        610-489-3720
Value Delivery Using
Multidimensional
Schedule, Resources,
and Quality Trade-offs

Richard Mulkey, MBA
Director, Project Management
GlaxoSmithKline
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
Pharma
             Pressures

• Generic Competition Including Biosimilars
• Price Controls & US Healthcare
• Prolonged Review Cycles
• Organizational Restructuring
• Globalization
33
Constraints
Constraints
        as Enablers


• Answer the Go/No Go Question
• Accountability from Beginning to End
• Lean (Sigma) Thinking - Project
  Managers as Efficiency Experts
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
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
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?
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
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
Identify Value
               Drivers

•   Pipeline – Filling Gaps
•   Novel Targets
•   Blockbusters vs. Varied Portfolio
•   Globalization – Reaching New
    Markets

                     And so many others…
                     unique to your company
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
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
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
Trade-offs
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
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
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
Contact
 Information



       Rick Mulkey
     GlaxoSmithKline
Richard.g.mulkey@gsk.com
      610-787-5032
The King is Dead, Long Live
the King



Pete Harpum, MSc, MAPM
Managing Director
Harpum Consulting Ltd
View from 2008
• “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
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)
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)
∆ 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
∆ 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
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
The need for high
  quality P3M
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!
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)
Key Interventions
• 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
The King is Dead,
Long Live the King
Contact
    Information



           Pete Harpum
       Harpum Consulting Ltd
pete.harpum@harpumconsulting.com
         +44 7733 107661
Thank You!

  Q&A

Recommended

marriott international 2000 Annual Report
marriott international 2000 Annual Reportmarriott international 2000 Annual Report
marriott international 2000 Annual Reportfinance20
 
Recovery And Crisis Presentation 20090914
Recovery And Crisis Presentation 20090914Recovery And Crisis Presentation 20090914
Recovery And Crisis Presentation 20090914Sammy Hsieh
 
Top 5 Investment Mistakes
Top 5 Investment MistakesTop 5 Investment Mistakes
Top 5 Investment Mistakesgallas2
 
Marketing action plan
Marketing action planMarketing action plan
Marketing action planguestb13ebe3
 
Carl Emmerson: The outlook for NHS funding to 2021/22
Carl Emmerson: The outlook for NHS funding to 2021/22Carl Emmerson: The outlook for NHS funding to 2021/22
Carl Emmerson: The outlook for NHS funding to 2021/22Nuffield Trust
 
amgen Investors_2000_AnnualReport
amgen Investors_2000_AnnualReportamgen Investors_2000_AnnualReport
amgen Investors_2000_AnnualReportfinance18
 
marriott international 2001 Annual Report
marriott international 2001 Annual Reportmarriott international 2001 Annual Report
marriott international 2001 Annual Reportfinance20
 

More Related Content

What's hot

MGMM_2005_Annual_Report
MGMM_2005_Annual_ReportMGMM_2005_Annual_Report
MGMM_2005_Annual_Reportfinance29
 
Fortune Minerals LTD Corporate Presentation
Fortune Minerals LTD Corporate PresentationFortune Minerals LTD Corporate Presentation
Fortune Minerals LTD Corporate PresentationCompany Spotlight
 
InterTrade Ireland Challenge Programme Workshop II
InterTrade Ireland Challenge Programme Workshop IIInterTrade Ireland Challenge Programme Workshop II
InterTrade Ireland Challenge Programme Workshop IIJamie McCallum
 
Kauffman fellows 2010-ssp
Kauffman fellows 2010-sspKauffman fellows 2010-ssp
Kauffman fellows 2010-sspSanjaySubhedar
 
Wagner Business Improvement Approach 4 18 09
Wagner Business Improvement Approach 4 18 09Wagner Business Improvement Approach 4 18 09
Wagner Business Improvement Approach 4 18 09mikewagner426
 
12 slides Pitch Deck
12 slides Pitch Deck12 slides Pitch Deck
12 slides Pitch Deckh_lenna
 
Schiller Lecture
Schiller LectureSchiller Lecture
Schiller Lecturegm2240
 
Employment Tracker DC Metro: March 2012
Employment Tracker DC Metro: March 2012Employment Tracker DC Metro: March 2012
Employment Tracker DC Metro: March 2012kottmeier
 

What's hot (10)

MGMM_2005_Annual_Report
MGMM_2005_Annual_ReportMGMM_2005_Annual_Report
MGMM_2005_Annual_Report
 
Fortune Minerals LTD Corporate Presentation
Fortune Minerals LTD Corporate PresentationFortune Minerals LTD Corporate Presentation
Fortune Minerals LTD Corporate Presentation
 
InterTrade Ireland Challenge Programme Workshop II
InterTrade Ireland Challenge Programme Workshop IIInterTrade Ireland Challenge Programme Workshop II
InterTrade Ireland Challenge Programme Workshop II
 
Kauffman fellows 2010-ssp
Kauffman fellows 2010-sspKauffman fellows 2010-ssp
Kauffman fellows 2010-ssp
 
Wagner Business Improvement Approach 4 18 09
Wagner Business Improvement Approach 4 18 09Wagner Business Improvement Approach 4 18 09
Wagner Business Improvement Approach 4 18 09
 
Final Presentation Yogo
Final Presentation  YogoFinal Presentation  Yogo
Final Presentation Yogo
 
Presentation Two
Presentation TwoPresentation Two
Presentation Two
 
12 slides Pitch Deck
12 slides Pitch Deck12 slides Pitch Deck
12 slides Pitch Deck
 
Schiller Lecture
Schiller LectureSchiller Lecture
Schiller Lecture
 
Employment Tracker DC Metro: March 2012
Employment Tracker DC Metro: March 2012Employment Tracker DC Metro: March 2012
Employment Tracker DC Metro: March 2012
 

Viewers also liked

GSK Project Management for the Academy of Logistics
GSK Project Management for the Academy of LogisticsGSK Project Management for the Academy of Logistics
GSK Project Management for the Academy of LogisticsMargaret D.
 
ATMS Marine Transportation Training Management System
ATMS Marine Transportation Training Management SystemATMS Marine Transportation Training Management System
ATMS Marine Transportation Training Management Systeminsidersatms
 
Atlas Logistics Project
Atlas Logistics ProjectAtlas Logistics Project
Atlas Logistics ProjectOsama Ahl
 
Tata project scm logistics offereing scc part 2
Tata project scm logistics offereing scc part 2Tata project scm logistics offereing scc part 2
Tata project scm logistics offereing scc part 2Zubin Poonawalla
 
STRUCTURE DESIGN AND ANALYSIS OF HYDRAULIC TRANSPORTER FOR LIFTING AND SHIFTI...
STRUCTURE DESIGN AND ANALYSIS OF HYDRAULIC TRANSPORTER FOR LIFTING AND SHIFTI...STRUCTURE DESIGN AND ANALYSIS OF HYDRAULIC TRANSPORTER FOR LIFTING AND SHIFTI...
STRUCTURE DESIGN AND ANALYSIS OF HYDRAULIC TRANSPORTER FOR LIFTING AND SHIFTI...NISHANTH H D
 
Lifting and handling solutions for heavy wind turbine components - Fyns Kran ...
Lifting and handling solutions for heavy wind turbine components - Fyns Kran ...Lifting and handling solutions for heavy wind turbine components - Fyns Kran ...
Lifting and handling solutions for heavy wind turbine components - Fyns Kran ...Fyns Kran Udstyr A/S
 
Pharma project risk management
Pharma project risk managementPharma project risk management
Pharma project risk managementMegha Kotak, PMP
 
Project lifecycle management @ Pharma Project Management Conference - 2014, M...
Project lifecycle management @ Pharma Project Management Conference - 2014, M...Project lifecycle management @ Pharma Project Management Conference - 2014, M...
Project lifecycle management @ Pharma Project Management Conference - 2014, M...Megha Kotak, PMP
 
Project Management In Pharmaceutical Industry
Project Management In Pharmaceutical IndustryProject Management In Pharmaceutical Industry
Project Management In Pharmaceutical IndustryMegha Kotak, PMP
 
C:\Users\Alumne\Desktop\Xarxes1
C:\Users\Alumne\Desktop\Xarxes1C:\Users\Alumne\Desktop\Xarxes1
C:\Users\Alumne\Desktop\Xarxes1Lorena Tortosa
 
Juan Madrid v. The State of Texas - The State's Reply Brief - Bryant Francis ...
Juan Madrid v. The State of Texas - The State's Reply Brief - Bryant Francis ...Juan Madrid v. The State of Texas - The State's Reply Brief - Bryant Francis ...
Juan Madrid v. The State of Texas - The State's Reply Brief - Bryant Francis ...Bryant "Beef" Cabrera
 
Walter Joaquin Acosta Bejarano
Walter Joaquin Acosta BejaranoWalter Joaquin Acosta Bejarano
Walter Joaquin Acosta BejaranoWalter Acosta
 
Technology question 3
Technology question 3Technology question 3
Technology question 3emma-steer123
 
IT Security: What an In-Plant Print Center Needs to Know
IT Security: What an In-Plant Print Center Needs to KnowIT Security: What an In-Plant Print Center Needs to Know
IT Security: What an In-Plant Print Center Needs to KnowRochester Software Associates
 
Fun and games
Fun and gamesFun and games
Fun and gamessmsandra
 

Viewers also liked (20)

GSK Project Management for the Academy of Logistics
GSK Project Management for the Academy of LogisticsGSK Project Management for the Academy of Logistics
GSK Project Management for the Academy of Logistics
 
ATMS Marine Transportation Training Management System
ATMS Marine Transportation Training Management SystemATMS Marine Transportation Training Management System
ATMS Marine Transportation Training Management System
 
Atlas Logistics Project
Atlas Logistics ProjectAtlas Logistics Project
Atlas Logistics Project
 
Tata project scm logistics offereing scc part 2
Tata project scm logistics offereing scc part 2Tata project scm logistics offereing scc part 2
Tata project scm logistics offereing scc part 2
 
CEA Project Logistics Myanmar
CEA Project Logistics MyanmarCEA Project Logistics Myanmar
CEA Project Logistics Myanmar
 
STRUCTURE DESIGN AND ANALYSIS OF HYDRAULIC TRANSPORTER FOR LIFTING AND SHIFTI...
STRUCTURE DESIGN AND ANALYSIS OF HYDRAULIC TRANSPORTER FOR LIFTING AND SHIFTI...STRUCTURE DESIGN AND ANALYSIS OF HYDRAULIC TRANSPORTER FOR LIFTING AND SHIFTI...
STRUCTURE DESIGN AND ANALYSIS OF HYDRAULIC TRANSPORTER FOR LIFTING AND SHIFTI...
 
Lifting and handling solutions for heavy wind turbine components - Fyns Kran ...
Lifting and handling solutions for heavy wind turbine components - Fyns Kran ...Lifting and handling solutions for heavy wind turbine components - Fyns Kran ...
Lifting and handling solutions for heavy wind turbine components - Fyns Kran ...
 
Pharma project risk management
Pharma project risk managementPharma project risk management
Pharma project risk management
 
Project lifecycle management @ Pharma Project Management Conference - 2014, M...
Project lifecycle management @ Pharma Project Management Conference - 2014, M...Project lifecycle management @ Pharma Project Management Conference - 2014, M...
Project lifecycle management @ Pharma Project Management Conference - 2014, M...
 
Project Management In Pharmaceutical Industry
Project Management In Pharmaceutical IndustryProject Management In Pharmaceutical Industry
Project Management In Pharmaceutical Industry
 
Ingresar a scolartic Fundación telefónica
Ingresar a scolartic Fundación telefónica Ingresar a scolartic Fundación telefónica
Ingresar a scolartic Fundación telefónica
 
C:\Users\Alumne\Desktop\Xarxes1
C:\Users\Alumne\Desktop\Xarxes1C:\Users\Alumne\Desktop\Xarxes1
C:\Users\Alumne\Desktop\Xarxes1
 
Juan Madrid v. The State of Texas - The State's Reply Brief - Bryant Francis ...
Juan Madrid v. The State of Texas - The State's Reply Brief - Bryant Francis ...Juan Madrid v. The State of Texas - The State's Reply Brief - Bryant Francis ...
Juan Madrid v. The State of Texas - The State's Reply Brief - Bryant Francis ...
 
Walter Joaquin Acosta Bejarano
Walter Joaquin Acosta BejaranoWalter Joaquin Acosta Bejarano
Walter Joaquin Acosta Bejarano
 
Ls ans 12 12-13
Ls ans  12 12-13Ls ans  12 12-13
Ls ans 12 12-13
 
Technology question 3
Technology question 3Technology question 3
Technology question 3
 
67 69
67 6967 69
67 69
 
Andrulius
AndruliusAndrulius
Andrulius
 
IT Security: What an In-Plant Print Center Needs to Know
IT Security: What an In-Plant Print Center Needs to KnowIT Security: What an In-Plant Print Center Needs to Know
IT Security: What an In-Plant Print Center Needs to Know
 
Fun and games
Fun and gamesFun and games
Fun and games
 

Similar to Life Science Project Management Is Dead A New (Old) Model For The Future – An Update For 2020 And Beyond

Recovery And Crisis Presentation 20090914
Recovery And Crisis Presentation 20090914Recovery And Crisis Presentation 20090914
Recovery And Crisis Presentation 20090914Sammy Hsieh
 
TFM Search Engine Marketing Benchmark Report
TFM Search Engine Marketing Benchmark ReportTFM Search Engine Marketing Benchmark Report
TFM Search Engine Marketing Benchmark ReportEconsultancy
 
Advanced Traffic Analysis Yields Profitable Workforce Insights
Advanced Traffic Analysis Yields Profitable Workforce InsightsAdvanced Traffic Analysis Yields Profitable Workforce Insights
Advanced Traffic Analysis Yields Profitable Workforce InsightsG3 Communications
 
Annual report ivona poyntz
Annual report ivona poyntzAnnual report ivona poyntz
Annual report ivona poyntzIvonaPoyntz
 
Corporate Presentation
Corporate PresentationCorporate Presentation
Corporate PresentationSySallard
 
Energy Savings A Measured Success 051110
Energy Savings A Measured Success 051110Energy Savings A Measured Success 051110
Energy Savings A Measured Success 051110psighi
 

Similar to Life Science Project Management Is Dead A New (Old) Model For The Future – An Update For 2020 And Beyond (16)

Agricultural adaptation during times of change - Thilak Mallawaarachchi
Agricultural adaptation during times of change - Thilak MallawaarachchiAgricultural adaptation during times of change - Thilak Mallawaarachchi
Agricultural adaptation during times of change - Thilak Mallawaarachchi
 
Recovery And Crisis Presentation 20090914
Recovery And Crisis Presentation 20090914Recovery And Crisis Presentation 20090914
Recovery And Crisis Presentation 20090914
 
Avast-NOAH12 London
Avast-NOAH12 LondonAvast-NOAH12 London
Avast-NOAH12 London
 
Avast - NOAH12 London
Avast - NOAH12 LondonAvast - NOAH12 London
Avast - NOAH12 London
 
TFM Search Engine Marketing Benchmark Report
TFM Search Engine Marketing Benchmark ReportTFM Search Engine Marketing Benchmark Report
TFM Search Engine Marketing Benchmark Report
 
Corporate Presentation
Corporate PresentationCorporate Presentation
Corporate Presentation
 
Advanced Traffic Analysis Yields Profitable Workforce Insights
Advanced Traffic Analysis Yields Profitable Workforce InsightsAdvanced Traffic Analysis Yields Profitable Workforce Insights
Advanced Traffic Analysis Yields Profitable Workforce Insights
 
Mobile
MobileMobile
Mobile
 
Annual report ivona poyntz
Annual report ivona poyntzAnnual report ivona poyntz
Annual report ivona poyntz
 
Corporate Presentation
Corporate PresentationCorporate Presentation
Corporate Presentation
 
Energy Savings A Measured Success 051110
Energy Savings A Measured Success 051110Energy Savings A Measured Success 051110
Energy Savings A Measured Success 051110
 
TOL_2005_AR
TOL_2005_ARTOL_2005_AR
TOL_2005_AR
 
TOL_2005_AR
TOL_2005_ARTOL_2005_AR
TOL_2005_AR
 
TOL_2005_AR
TOL_2005_ARTOL_2005_AR
TOL_2005_AR
 
TOL_2005_AR
TOL_2005_ARTOL_2005_AR
TOL_2005_AR
 
TOL_2005_AR
TOL_2005_ARTOL_2005_AR
TOL_2005_AR
 

Life Science Project Management Is Dead A New (Old) Model For The Future – An Update For 2020 And Beyond

  • 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
  • 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
  • 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
  • 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
  • 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)
  • 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