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Project Management for the Pharmaceutical Industry

Description: The pharmaceutical industry has encountered major shifts in recent years, both within the industry, and in its external environment. The cost of healthcare rising due to an ageing population, the intensification of regulatory requirements and mergers within the industry have led to an increased need for restructuring, cost reduction and culture change projects. Project management is the key to addressing these needs, and also to effective drug development. Given the costs of development and the critical issue of 'time to market', project management techniques - appropriately used - are a key factor in bringing a drug to market. In this book, Laura Brown and Tony Grundy's pharmaceutical expertise and experience offers the reader a guide to the most relevant project management tools and techniques and how to rigorously apply them in the pharmaceutical industry. The authors cover the technical, strategic and human aspects of project management, including contingency planning, simulation techniques and different project options. Complete with decision-tree diagrams, checklists, exercises and a full glossary, Project Management for the Pharmaceutical Industry provides clinical research, drug development and quality assurance managers or directors with a one-stop reference for successfully managing pharmaceutical projects. The text has been revised for this edition and now includes some additional material on risk management. Reviews: "A comprehensive set of tools and techniques...The techniques and advice can be applied to many projects in the pharmaceutical industry, including drug development. This is particularly useful for managers who are looking to gain a new perspective for maximising project success...The importance of taking account of behavioural aspects for the successful running of pharmaceutical projects, often overlooked, is included...Above all, the case studies illustrate excellent techniques and principles to help the reader understand, and learn to use, modern tools and techniques for maximising management success." ­ Dr Carol Casman, Group Head, Transnational, Clinical Pharmacology and Discovery Medicine, GSK


List of Figures List of Tables Preface 1. Managing Pharmaceutical Projects Strategically Introduction Deficiencies in Conventional Project Management The Relevance of Strategic Thinking to Pharmaceutical Project Management The Pharmaceutical Project Management Process Conclusion 2. Linking Pharmaceutical Projects with Business Strategy Introduction Defining Strategy The Strategy Mix The Role of Incrementalism Understanding the Internal Competitive Environment Project Programmes, Interdependencies and Breakthroughs Conclusion 3. Defining Pharmaceutical Projects Introduction

Scoping the Pharmaceutical Project Defining the Key Issues Identifying the Project's Key Objectives Resourcing the Project ­ to CRO or not to CRO? Identifying the Project's Key Stakeholders ­ and its Difficulty Conclusion 4. Developing Pharmaceutical Project Strategy and Plans Introduction Developing Project Options and Strategies Attractiveness­Implementation Difficulty Analysis Force-field Analysis Stakeholder Analysis `How­how' and Work Breakdown Structure Analysis Critical Path (and Uncertainty) Analysis Project Management Software Conclusion 5. Evaluating Pharmaceutical Projects Introduction Understanding the Business Value System Stages in Pharmaceutical Project Appraisal Exploring the `Do-Nothing' Or Base Case Intangibles and Interdependencies Business Case Portfolio Management Conclusion 6. Pharmaceutical Project Mobilisation, Control and Learning Introduction Project Mobilisation and Roles Project Milestones and Indicators Project Systems Project Learning Project Dynamics Conclusion 7. Influencing People and Behaviour Introduction Exploring Project Behaviour Diagnosing Team Roles Specific Techniques for Understanding Behaviour Conclusion 8. Project Management Checklists and Cost-management Project Case Study Introduction Checklist for Multicentre Clinical Research Trials Checklists for Organic Business Development Projects Checklists for Organisational Change Projects Checklists for Acquisitions and Alliances (Joint Venture) Projects Checklists for Operational Projects Note 9. Conclusion Summary of Key Lessons Implementation and Next Steps For further information Glossary of Key Project Management Definitions Bibliography Index List of Figures

P.1 Perspectives on pharmaceutical project management 1.1 Helicopter vision 1.2 The pharmaceutical project management process 2.1 The strategy mix 2.2 Project forces analysis 2.3 Business strategy as a stream of projects 3.1 Strategic project scope 3.2 Fishbone analysis ­ patient recruitment 3.3 Piranha analysis ­ Year 2000 problem 3.4 Performance driver analysis ­ regulatory department 3.5 Wishbone analysis ­ success for clinical trials 3.6 Strategic gap analysis 3.7 Using `from­to' analysis 3.8 The stakeholder periscope 4.1 Project option grid 4.2 Project option grid ­ using a CRO 4.3 Economic criteria 4.4 AID analysis 4.5 Feasibility criteria 4.6 Force-field analysis 4.7 Stakeholder analysis 4.8 Stakeholder analysis ­ an example 4.9 Stakeholder attitude and influence over time curves 4.10 Stakeholder agenda analysis of a new job 4.11 `How­how' analysis 4.12 Gantt chart: Pharmaceutical business turnaround 4.13 Urgency­importance grid 4.14 Project network: A business turnaround 4.15 Uncertainty­importance grid 4.16 Risk register 4.17 Project interdependency map 5.1 Pharmaceutical project evaluation 5.2 Business value system: IT project for data capture 5.3 Defining the pharmaceutical project set 5.4 Uncertainty­importance grid 5.5 Risk matrix 5.6 Uncertainty­importance grid: New product launch 5.7 Net cash flow and sales in the pharmaceutical industry 5.8 The uncertainty tunnel 5.9 Decision tree 5.10 Portfolio management: Decision trees 5.11 Risks in the drug development process 5.12 The effects of the declining base case 5.13 R&D management 5.14 Return versus risk 5.15 Attractiveness/positioning grid 6.1 Energy over time curve 6.2 Commitment over time curve 6.3 Project plan 6.4 Project plan: Resources, assumptions, interdependencies and constraints 6.5 Project plan: Key activities and milestones 6.6 Project plan: Communication plan 6.7 Project plan: Organisation chart 6.8 Project plan: Clinical trial milestones schedule 6.9 Progress monitor report 6.10 Progress monitor report: Outstanding issues 6.11 Progress monitor report: Outstanding issues continued 6.12 Action meeting list 6.13 Clinical discovery decision tree for drug development case study 7.1 The system of pharmaceutical project behaviour 7.2 A behavioural uncertainty­importance grid 7.3 Cause-of-behaviour analysis

7.4 8.1 8.2 8.3 8.4

Levels of discussion Decision tree (1) of (3) Decision tree (2) of (3) Decision tree (3) of (3) Interdependencies: Implementation and project management tools

List of Tables 1.1 3.1 4.1 5.1 5.2 Traditional versus contemporary project management Request for proposal: responsibilities for study services Project management software An example of a financial appraisal of a new drug Types of intangibles and possible measures


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