Project Management for the Pharmaceutical Industry

✍ Scribed by Laura Brown, Tony Grundy

• Publisher: Routledge
• Year: 2011
• Tongue: English
• Leaves: 299
• Edition: 1
• Category: Library

✦ Synopsis

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.

✦ Table of Contents

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