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FOREWORD. <p>PREFACE.</p> <p>ACKNOWLEDGEMENTS.</p> <p>CONTRIBUTORS.</p> <p>ABBREVIATIONS.</p> <p><b>PART I: OVERVIEW.</b></p> <p>1: Project Leadership for Biomedical Industries (<i>Scott D. Babler</i>).</p> <p>PART II: MANAGING MEDICAL AND PHARMACEUTICAL PROJECTS.</p> <p>2: Medical Devices – Components, Systems, and their Integration (<i>Dennis F. Marr</i>).</p> <p>3:  The Role of Project Management in the Development of In Vitro Diagnostics (<i>David Kern and Diane M. Ward</i>).</p> <p>4: Drug Development Project Management (<i>Dirk L. Raemdonck and Bradford A. Burns</i>).</p> <p><b>PART III: EFFECT OF BUSINESS RELATIONSHIPS ON MANAGING LARGE PROJECTS.</b></p> <p>5: Outsourcing of Project Activities (<i>Jonathan D. Lee and Trisha Dobson</i>).</p> <p>6: The Unique Aspects of Alliance Projects (<i>Andrew S. Eibling</i>).</p> <p>Case Study: Management of Outsourcing for Biomedical Companies (<i>Jeffery W. Frazier, Jennifer A. Hewitt and Andy Myslicki</i>).</p> <p>7: A Roadmap for Successful Technology Transfers (<i>Nipun Davar, Sangita Ghosh, Nandan Oza</i>).</p> <p>8: Challenges for the Team Leader of Multifunctional Product Teams in an International Environment (<i>Hartwig Hennekes</i>).</p> <p>9: Lessons Learned from Inter-Organizational Collaboration Projects (<i>Andrea Jahn</i>).</p> <p>Case Study: Project Management in Non-Profit Drug Development (<i>Autumn Ehnow</i>).</p> <p><b>PART IV: MANAGING UNIQUE PROJECT COMPLEXITIES.</b></p> <p>10: Clinical Trials and Project Management (<i>Scott E. Smith, Carol A. Connell and Dirk L. Raemdonck</i>).</p> <p>11:  Role of Project Management in Quality Planning and Functions Throughout the Product Lifecycle (<i>Thomas Dzierozynski and Ian Fleming</i>).</p> <p>12: Regulatory Strategies and Submissions in an International Product       Environment (<i>Louise Johnson</i>).</p> <p>13: Risk Management - A Practical Approach (<i>Courtland R. LaVallee</i>).</p> <p><b>PART V: PORTFOLIO MANAGEMENT AND RESOURCE PLANNING.</b></p> <p>14: Managing Successful Product Portfolio Creation and R&D Pipelines (<i>Sue E. Steven</i>).</p> <p>15: Effective Strategies for Project Resource Planning and Utilization (<i>Eduardo Rojas and Scott D. Babler</i>).</p> <p>16: Stage Gate Product Development Processes and Lifecycle Management (<i>Karen E. Coulson</i>).</p> <p><b>PART VI: TRENDS IN BMI PROJECT MANAGEMENT.</b></p> <p>17: The Future of Medical Devices (<i>Ronald L. Kirschner</i>).</p> <p>18: The Next Wave of Managing Biomedical Projects (<i>Scott D. Babler</i>).</p> <p>INDEX.</p>

<b>SCOTT D. BABLER</b> 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. <p><b>Integrated Project Management Company, Inc. (IPM)</b> 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.</p>

<b>A best practices guide to bringing new pharmaceutical or biomedical innovations to market</b> <p>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.</p> <p>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:</p> <ul> <li> <p>Project leadership in the biomedical industry</p> </li> <li> <p>The role of project management throughout the product lifecycle</p> </li> <li> <p>Clinical trials and project management</p> </li> <li> <p>Project management in drug and device development</p> </li> <li> <p>Managing product risk</p> </li> <li> <p>Building alliances</p> </li> <li> <p>Technology transfer</p> </li> <li> <p>Challenges in an international environment</p> </li> </ul> <p>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.</p>

"The book is an excellent primer and "hands on" reference text focused on the unique aspects of managing projects in the life sciences. Practical tips and tools are offered for wide ranging topics relevant to those working in both large pharma and small biotech, in both US focused and global settings."<br /> —<b>Barbara Rosengren</b>, Vice President, Strategic Product Development, Momenta Pharmaceuticals Inc <p>"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 novel!"<br /> —<b>Kathleen Monroe</b>, Vice President, Imaging Services, Synarc</p> <p>"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."<br /> —<b>Elaine Alexander</b>, Sr Project Manager, Global Medical Company</p>

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