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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.
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.
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.
Inhaltsangabe
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
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
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