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 |
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ix | |
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| Preface |
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xi | |
| Acknowledgments |
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xiii | |
| Contributors |
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xv | |
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xvii | |
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1 | (32) |
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1 Project Leadership for Biomedical Industries |
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3 | (30) |
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PART II MANAGING MEDICAL AND PHARMACEUTICAL PROJECTS |
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33 | (70) |
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2 Medical Devices---Components, Systems, and Their Integration |
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35 | (18) |
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3 The Role of Project Management in the Development of in Vitro Diagnostics |
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53 | (28) |
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4 Drug Development Project Management |
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81 | (22) |
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PART III EFFECT OF BUSINESS RELATIONSHIPS ON MANAGING LARGE PROJECTS |
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103 | (112) |
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5 Outsourcing of Project Activities |
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105 | (10) |
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6 The Unique Aspects of Alliance Projects |
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115 | (34) |
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Management of Outsourcing for Biomedical Companies: An Outsourcing Case Study |
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135 | (14) |
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7 A Roadmap for Successful Technology Transfers |
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149 | (26) |
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8 Challenges for the Team Leader of Multifunctional Product Teams in an International Environment |
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175 | (12) |
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9 Lessons Learned from Inter-Organizational Collaboration Projects |
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187 | (28) |
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Case Study: Project Management in Non-Profit Drug Development |
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209 | (6) |
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PART IV MANAGING UNIQUE PROJECT COMPLEXITIES |
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215 | (88) |
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10 Clinical Trials and Project Management |
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217 | (16) |
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11 Role of Project Management in Quality Planning and Functions Throughout the Product Lifecycle |
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233 | (18) |
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12 Regulatory Strategies and Submissions in an International Product Environment |
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251 | (32) |
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13 Risk Management---A Practical Approach |
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283 | (20) |
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PART V PORTFOLIO MANAGEMENT AND RESOURCE PLANNING |
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303 | (42) |
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14 Managing Successful Product Portfolio Creation and R&D Pipelines |
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305 | (22) |
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15 Effective Strategies for Project Resource Planning and Utilization |
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327 | (12) |
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16 Stage Gate Product Development Processes and Lifecycle Management |
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339 | (6) |
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PART VI TRENDS IN BMI PROJECT MANAGEMENT |
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345 | (28) |
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17 The Future of Medical Devices |
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347 | (12) |
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18 The Next Wave of Managing Biomedical Projects |
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359 | (14) |
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| Index |
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373 | |
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.
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