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

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