Pharmaceutical 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.

FOREWORD.
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.