Portfolio, Program, and Project Management in the Pharmaceutical and Biotechnology Industries

This book describes the way that pharmaceutical projects and programs are currently managed, and offers views from many highly experienced practitioners from within the industry on future directions for drug program management. The book integrates portfolio, program, and project management processes as fundamental for effective and efficient drug product development. Contributing expert authors provide their view of how the projectization approach can be taken forward by the drug industry over the coming years.

Preface ix

Acknowledgments xi

About the Authors xiii

Part One The Life Science Industry Context for Portfolio, Program, and Project Management

1. A Review of Project Management in Life Science Industry Sectors 3
Thomas R. Dunson

2. The Impact of Organizational Size on Drug Project Management 21
Eric Morfin

3. Drug Development in Biotechnology and How We Can Do It Better 33
Susan Linna

Part Two The Portfolio, Program, and Project Management Approaches and Processes

4. An Overview of the Organization and Processes of Portfolio, Program, and Project Management 53
Pete Harpum

5. Portfolio Management in the Pharmaceutical Industry: Balancing Corporate Need with the Reality of Delivering Products to the Market 59
John Bennett

6. Program Management in Drug Development 85
Pauline Stewart-Long

7. Project Control 101
Martin Powell

8. Managing Uncertainty in Drug Projects 135
Pete Harpum and Thomas R. Dunson

9. Managing Drug Safety Risk 155
Thomas R. Dunson and Eric Morfin

10. Developing Program Strategy 175
Pete Harpum

11. Developing Products with “Added Value” 197
Trevor J. Brown and Stephen Allport

Part Three Integrating the Processes

12. Integrated Business Processes to Support Cross-Functional Drug Development 227
Martin D. Hynes III

13. Integrated Drug Development: From Cradle to Grave and from Lab to Market 239
Stephen Allport and Terry Cooke-Davies

14. The Development of P3M Capability in Drug Development Organizations 259
John Arrowsmith, Patrick Grogan, and Bob Moore

15. Implementing Portfolio, Program, and Project Management Best Practices in Drug Development Organizations 287
Pete Harpum, Ashley Jamieson, and Inge Fisher

Bibliography 311

Index 313

PETE HARPUM is a Director of Harpum Consulting and has been consulting on Portfolio, Program, and Project Management (P3M) for some ten years. He chairs and contributes to many conferences and symposiums on P3M. Mr. Harpum's other activities include postgraduate lecturing and research on P3M for three world-class universities, and supporting the Association for Project Management, Project Management Institute, and the Drug Information Association in various ways.

The EXPANSIVE, ALL-IN-ONE GUIDE to SUCCESSFUL PHARMACEUTICAL PROJECT MANAGEMENT

To improve the ways they currently manage projects and programs, pharmaceutical and biotechnology companies need reliable stewardship to direct future strategies. Unlike other industry sectors, they have yet to fully embrace the effective integrated processes of Portfolio, Program, and Project Management, otherwise referred to as P3M, to position themselves favorably in meeting challenges unique to the drug development business.

Portfolio, Program, and Project Management in the Pharmaceutical and Biotechnology Industries illustrates how high-quality program and project management is crucial for drug companies to remain competitive, to deliver good returns to investors, and ultimately to bring novel personalized medicine to patients with:

• A combination of theoretical insights and pragmatic examples from professionals who are all working in the industry
• Case studies with very detailed, real-life examples of how the management of drug development is actually done
• Answers the pharmaceutical industry needs to streamline and make the drug development process more efficient
• The full spectrum of management processes needed from the operational-ization of corporate strategy by portfolio management processes through to practical project control processes

Carefully divided into three main sections to cover topics such as the impact of organizational size on P3M; planning and control; and reducing product safety risk, this informative reference is structured to align both novices and professionals in drug program management with success in the wake of emerging trends.