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