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. Cover Contents 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 Attractiveness–Implementation Difficulty Analysis Force-field Analysis Stakeholder Analysis ‘How–how’ 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