Project Management

for the Pharmaceutical

Industry
LAURA BROWN
and
TONY GRUNDY
http://www.gowerpublishing.com/isbn/9781409418948
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Contents
List of Figures ix
List of Tables xi
Preface xiii
1 Managing Pharmaceutical Projects Strategically 1
Introduction 1
Defciencies in Conventional Project Management 2
The Relevance of Strategic Thinking to Pharmaceutical
Project Management 5
The Pharmaceutical Project Management Process 17
Conclusion 21
2 Linking Pharmaceutical Projects with Business Strategy 23
Introduction 23
Defning Strategy 24
The Strategy Mix 27
The Role of Incrementalism 31
Understanding the Internal Competitive Environment 38
Project Programmes, Interdependencies and Breakthroughs 40
Conclusion 41
3 Defning Pharmaceutical Projects 45
Introduction 45
Scoping the Pharmaceutical Project 47
Defning the Key Issues 50
Identifying the Projects Key Objectives 71
Resourcing the Project to CRO or not to CRO? 76
Identifying the Projects Key Stakeholders and its Difculty 82
Conclusion 86
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PROJ ECT MANAGEMENT FOR THE PHARMACEUTI CAL I NDUSTRY
vi
4 Developing Pharmaceutical Project Strategy and Plans 87
Introduction 87
Developing Project Options and Strategies 88
AtractivenessImplementation Difculty Analysis 94
Force-feld Analysis 100
Stakeholder Analysis 108
Howhow and Work Breakdown Structure Analysis 114
Critical Path (and Uncertainty) Analysis 118
Project Management Software 132
Conclusion 135
5 Evaluating Pharmaceutical Projects 137
Introduction 137
Understanding the Business Value System 138
Stages in Pharmaceutical Project Appraisal 140
Exploring the Do-Nothing Or Base Case 159
Intangibles and Interdependencies 161
Business Case 165
Portfolio Management 168
Conclusion 171
6 Pharmaceutical Project Mobilisation, Control and Learning 173
Introduction 173
Project Mobilisation and Roles 173
Project Milestones and Indicators 176
Project Systems 183
Project Learning 190
Project Dynamics 191
Conclusion 192
7 Infuencing People and Behaviour 193
Introduction 193
Exploring Project Behaviour 195
Diagnosing Team Roles 198
Specifc Techniques for Understanding Behaviour 203
Conclusion 209
8 Project Management Checklists and Cost-management
Project Case Study 211
Introduction 211
Checklist for Multicentre Clinical Research Trials 212
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CONTENTS vii
Checklists for Organic Business Development Projects 220
Checklists for Organisational Change Projects 224
Checklists for Acquisitions and Alliances (Joint Venture) Projects 236
Checklists for Operational Projects 244
Note 251
9 Conclusion 255
Summary of Key Lessons 255
Implementation and Next Steps 258
For further information 260
Glossary of Key Project Management Defnitions 261
Bibliography 265
Index 267
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List of Figures
P.1 Perspectives on pharmaceutical project management xv
1.1 Helicopter vision 7
1.2 The pharmaceutical project management process 18
2.1 The strategy mix 29
2.2 Project forces analysis 39
2.3 Business strategy as a stream of projects 42
3.1 Strategic project scope 48
3.2 Fishbone analysis patient recruitment 52
3.3 Piranha analysis Year 2000 problem 53
3.4 Performance driver analysis regulatory department 54
3.5 Wishbone analysis success for clinical trials 61
3.6 Strategic gap analysis 64
3.7 Using fromto analysis 68
3.8 The stakeholder periscope 84
4.1 Project option grid 89
4.2 Project option grid using a CRO 90
4.3 Economic criteria 95
4.4 AID analysis 95
4.5 Feasibility criteria 96
4.6 Force-feld analysis 102
4.7 Stakeholder analysis 109
4.8 Stakeholder analysis an example 111
4.9 Stakeholder atitude and infuence over time curves 113
4.10 Stakeholder agenda analysis of a new job 114
4.11 Howhow analysis 115
4.12 Gant chart: Pharmaceutical business turnaround 116
4.13 Urgencyimportance grid 119
4.14 Project network: A business turnaround 120
4.15 Uncertaintyimportance grid 122
4.16 Risk register 128
4.17 Project interdependency map 132
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PROJ ECT MANAGEMENT FOR THE PHARMACEUTI CAL I NDUSTRY
x
5.1 Pharmaceutical project evaluation 138
5.2 Business value system: IT project for data capture 139
5.3 Defning the pharmaceutical project set 141
5.4 Uncertainyimportance grid 148
5.5 Risk matrix 149
5.6 Uncertaintyimportance grid: New product launch 150
5.7 Net cash fow and sales in the pharmaceutical industry 154
5.8 The uncertainty tunnel 155
5.9 Decision tree 158
5.10 Portfolio management: Decision trees 158
5.11 Risks in the drug development process 159
5.12 The efects of the declining base case 160
5.13 R&D management 168
5.14 Return versus risk 169
5.15 Atractiveness/postioning grid 170
6.1 Energy over time curve 174
6.2 Commitment over time curve 175
6.3 Project plan 177
6.4 Project plan: Resources, assumptions,
interdependencies and constraints 178
6.5 Project plan: Key activities and milestones 178
6.6 Project plan: Communication plan 179
6.7 Project plan: Organisation chart 180
6.8 Project plan: Clinical trial milestones schedule 180
6.9 Progress monitor report 181
6.10 Progress monitor report: Outstanding issues 181
6.11 Progress monitor report: Outstanding issues continued 182
6.12 Action meeting list 182
6.13 Clinical discovery decision tree for drug development
case study 185
7.1 The system of pharmaceutical project behaviour 196
7.2 A behavioural uncertaintyimportance grid 204
7.3 Cause-of-behaviour analysis 206
7.4 Levels of discussion 207
8.1 Decision tree (1) of (3) 251
8.2 Decision tree (2) of (3) 252
8.3 Decision tree (3) of (3) 252
8.4 Interdependencies: Implementation and
project management tools 253
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List of Tables
1.1 Traditional versus contemporary project management 4
3.1 Request for proposal: responsibilities for study services 80
4.1 Project management software 134
5.1 An example of a fnancial appraisal of a new drug 152
5.2 Types of intangibles and possible measures 164