Pharmaceutical and Biomedical Project Management in a Changing Global Environment

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.

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 theirIntegration (Dennis F. Marr).3: The Role of Project Management in the Development of InVitro Diagnostics (David Kern and Diane M. Ward).4: Drug Development Project Management (Dirk L. Raemdonck andBradford A. Burns).PART III: EFFECT OF BUSINESS RELATIONSHIPS ON MANAGING LARGEPROJECTS.5: Outsourcing of Project Activities (Jonathan D. Lee andTrisha 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 AndyMyslicki).7: A Roadmap for Successful Technology Transfers (NipunDavar, Sangita Ghosh, Nandan Oza).8: Challenges for the Team Leader of Multifunctional ProductTeams in an International Environment (HartwigHennekes).9: Lessons Learned from Inter-Organizational CollaborationProjects (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. SmithCarol A. Connell and Dirk L. Raemdonck).11: Role of Project Management in Quality Planning andFunctions Throughout the Product Lifecycle (Thomas Dzierozynskiand Ian Fleming).12: Regulatory Strategies and Submissions in an InternationalProduct Environment (LouiseJohnson).13: Risk Management - A Practical Approach (Courtland R.LaVallee).PART V: PORTFOLIO MANAGEMENT AND RESOURCE PLANNING.14: Managing Successful Product Portfolio Creation and R&DPipelines (Sue E. Steven).15: Effective Strategies for Project Resource Planning andUtilization (Eduardo Rojas and Scott D. Babler).16: Stage Gate Product Development Processes and LifecycleManagement (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.