Description
Book SynopsisPharmaceutical and Biomedical Portfolio Management in a Changing Global Environment explores some of the critical forces at work today in the complex endeavour of pharmaceutical and medical product development. Written by experienced professionals, and including real-world approaches and best practice examples, this new title addresses three key areas small molecules, large molecules, and medical devices - and provides hard-to-find, consolidated information relevant to and needed by pharmaceutical, biotech, and medical device company managers.
Table of ContentsFOREWORD.
PREFACE.
ACKNOWLEDGEMENTS.
CONTRIBUTORS.
ABBREVIATIONS.
PART I: OVERVIEW.
1: Project Leadership for Biomedical Industries (Scott D. Babler).
PART II: MANAGING MEDICAL AND PHARMACEUTICAL PROJECTS.
2: Medical Devices – Components, Systems, and their Integration (Dennis F. Marr).
3: The Role of Project Management in the Development of In Vitro Diagnostics (David Kern and Diane M. Ward).
4: Drug Development Project Management (Dirk L. Raemdonck and Bradford A. Burns).
PART III: EFFECT OF BUSINESS RELATIONSHIPS ON MANAGING LARGE PROJECTS.
5: Outsourcing of Project Activities (Jonathan D. Lee and Trisha Dobson).
6: The Unique Aspects of Alliance Projects (Andrew S. Eibling).
Case Study: Management of Outsourcing for Biomedical Companies (Jeffery W. Frazier, Jennifer A. Hewitt and Andy Myslicki).
7: A Roadmap for Successful Technology Transfers (Nipun Davar, Sangita Ghosh, Nandan Oza).
8: Challenges for the Team Leader of Multifunctional Product Teams in an International Environment (Hartwig Hennekes).
9: Lessons Learned from Inter-Organizational Collaboration Projects (Andrea Jahn).
Case Study: Project Management in Non-Profit Drug Development (Autumn Ehnow).
PART IV: MANAGING UNIQUE PROJECT COMPLEXITIES.
10: Clinical Trials and Project Management (Scott E. Smith, Carol A. Connell and Dirk L. Raemdonck).
11: Role of Project Management in Quality Planning and Functions Throughout the Product Lifecycle (Thomas Dzierozynski and Ian Fleming).
12: Regulatory Strategies and Submissions in an International Product Environment (Louise Johnson).
13: Risk Management - A Practical Approach (Courtland R. LaVallee).
PART V: PORTFOLIO MANAGEMENT AND RESOURCE PLANNING.
14: Managing Successful Product Portfolio Creation and R&D Pipelines (Sue E. Steven).
15: Effective Strategies for Project Resource Planning and Utilization (Eduardo Rojas and Scott D. Babler).
16: Stage Gate Product Development Processes and Lifecycle Management (Karen E. Coulson).
PART VI: TRENDS IN BMI PROJECT MANAGEMENT.
17: The Future of Medical Devices (Ronald L. Kirschner).
18: The Next Wave of Managing Biomedical Projects (Scott D. Babler).
INDEX.
