With stringent requirements for quality and patient safety, developing biomedical products is one of the toughest commercial endeavors a company can undertake. Companies continually strive to accelerate new product introductions by reducing development time. However, the best technologies and product concepts cannot reach patients without effective resource management planning for delivering results.
With contributions from experts in the pharmaceutical, medical device, and biotechnology industries, this multidisciplinary guide to project management offers solutions to the problems faced when bringing a highly technical and regulated product to the marketplace. Chapter–by–chapter, the book addresses the following topics:
Project leadership in the biomedical industry
The role of project management throughout the product lifecycle
Clinical trials and project management
Project management in drug and device development
Managing product risk
Challenges in an international environment
For any life sciences professional facing these daily realities, this indispensable reference is the key to maximizing resources, keeping costs and schedules in check, and transforming an idea into a safe, effective, and successful product.
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).