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Informationen zum Autor 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. Klappentext The expansive, all-in-one guide tosuccessful pharmaceutical project managementTo 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 processesCarefully 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. Zusammenfassung 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. Inhaltsverzeichnis 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 S...
List of contents
List of Contributors.
Acknowledgements.
Introduction.
SECTION I.
The Life Science Industry Context for Portfolio, Program, and Project Management.
Introduction.
1 A Review of Project Management in Life Science Industry Sectors (Thomas R. Dunson).
2 The Impact of Organizational Size on Drug Project Management (Eric Morfin).
3 Drug Development in Biotech and How We Can Do It Better (Susan Linna).
SECTION II.
The Portfolio, Program, and Project Management Approaches and Processes.
Introduction.
4 An Overview of the Organization and Processes of Portfolio, Program and Project Management (Pete Harpum).
5 Portfolio Management in the Pharmaceutical Industry: Balancing Corporate Need with the Reality of Delivering Products to the Market (John Bennett).
6 Program Management in Drug Development (Pauline Stewart-Long).
7 Project Control (Martin Powell).
8 Managing Uncertainty in Drug Projects (Pete Harpum and Thomas R. Dunson).
9 Managing Drug Safety Risk (Thomas R. Dunson and Eric Morfin).
10 Developing Program Strategy (Pete Harpum).
11 Project Value Management: Ensuring the Development of Added Value Drug Products (Trevor Brown and Stephen Allport).
SECTION III.
Integrating the Processes.
Introduction.
12 Integrated Business Process to Support Cross-Functional Drug Development (Martin D. Hynes III).
13 Integrated Drug Development From Cradle to Grave and From Lab to Market (Stephen Allport and Terry Cook-Davies).
14 The Development of P3M Capability in Drug Development Organizations (John Arrowsmith, Patrick Grogan and Bob Moore).
15 Implementing Portfolio, Program, and Project Management Best Practices in Drug Development Organizations (Pete Harpum, Ashley Jamieson and Inge Fisher).
Bibliography.
