Pharmaceutical and Biomedical Project Management in a Changing Global Environment

SCOTT D. BABLER is a Senior Project Manager at Integrated Project Management Company, Inc. (IPM). He has worked with organizations of all sizes to successfully apply core project management practices to the dynamic life sciences and medical device environment. He has led multi-functional project teams in technology, design, development, quality, regulatory and manufacturing. Integrated Project Management Company, Inc. (IPM) is a leading provider of onsite project management services for the life sciences industry. Since 1988, IPM has pioneered the application of excellence in project management best practices to consistently drive measurable results for their clients. Areas of expertise include product development, alliance management, business process improvement, technology transfer, and regulatory/quality compliance. IPM has offices in Boston, Chicago, St. Louis, and San Francisco.

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.