Pharmaceutical and Biomedical Project Management in a Changing Global Environment
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).
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.
—Barbara Rosengren, Vice President, Strategic Product Development, Momenta Pharmaceuticals Inc
"I love this book and absolutely want to keep a copy on my
shelf. It feels like a PMO in a box – I will be able to open
it up and get my questions answered, confirm what I am thinking,
and look for other ways to approach and solve problems. The writing
across the board is consistently strong, the organization makes
sense and it reads well – almost like a fast-paced fiction
—Kathleen Monroe, Vice President, Imaging Services, Synarc
"I found the book to be practical and timely in providing
up-to-date information for project managers in this evolving area
of practice. The book provides a good view of the broad landscape
of current project management challenges in a quickly evolving
industry. It is an excellent grounding for project managers in the
biomedical industry and a highly recommended text for those who
want hands-on advice from professionals that are actively engaged
in the field. This book is valuable for project management
practitioners as well as for senior managers who seek a better
understanding of the complexities of project management in the
current biomedical environment."
—Elaine Alexander, Sr Project Manager, Global Medical Company