Pharmaceutical and Biomedical Project Management in a Changing Global Environment (Wiley Series on Technologies for the Pharmaceutical Industry)

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. PHARMACEUTICAL AND BIOMEDICAL PROJECT MANAGEMENT IN A CHANGING GLOBAL ENVIRONMENT......Page 1 CONTENTS......Page 7 FOREWORD......Page 11 PREFACE......Page 13 ACKNOWLEDGMENTS......Page 15 CONTRIBUTORS......Page 17 LIST OF ABBREVIATIONS......Page 19 PART I: OVERVIEW......Page 23 CHAPTER 1: PROJECT LEADERSHIP FOR BIOMEDICAL INDUSTRIES......Page 25 PART II: MANAGING MEDICAL AND PHARMACEUTICAL PROJECTS......Page 55 CHAPTER 2: MEDICAL DEVICES—COMPONENTS, SYSTEMS, AND THEIR INTEGRATION......Page 57 CHAPTER 3: THE ROLE OF PROJECT MANAGEMENT IN THE DEVELOPMENT OF IN VITRO DIAGNOSTICS......Page 75 CHAPTER 4: DRUG DEVELOPMENT PROJECT MANAGEMENT......Page 103 PART III: EFFECT OF BUSINESS RELATIONSHIPS ON MANAGING LARGE PROJECTS......Page 125 CHAPTER 5: OUTSOURCING OF PROJECT ACTIVITIES......Page 127 CHAPTER 6: THE UNIQUE ASPECTS OF ALLIANCE PROJECTS......Page 137 MANAGEMENT OF OUTSOURCING FOR BIOMEDICAL COMPANIES: AN OUTSOURCING CASE STUDY......Page 157 CHAPTER 7: A ROADMAP FOR SUCCESSFUL TECHNOLOGY TRANSFERS......Page 171 CHAPTER 8: CHALLENGES FOR THE TEAM LEADER OF MULTIFUNCTIONAL PRODUCT TEAMS IN AN INTERNATIONAL ENVIRONMENT......Page 197 CHAPTER 9: LESSONS LEARNED FROM INTER-ORGANIZATIONAL COLLABORATION PROJECTS......Page 209 CASE STUDY: PROJECT MANAGEMENT IN NON-PROFIT DRUG DEVELOPMENT......Page 231 PART IV: MANAGING UNIQUE PROJECT COMPLEXITIES......Page 237 CHAPTER 10: CLINICAL TRIALS AND PROJECT MANAGEMENT......Page 239 CHAPTER 11: ROLE OF PROJECT MANAGEMENT IN QUALITY PLANNING AND FUNCTIONS THROUGHOUT THE PRODUCT LIFECYCLE......Page 255 CHAPTER 12: REGULATORY STRATEGIES AND SUBMISSIONS IN AN INTERNATIONAL PRODUCT ENVIRONMENT......Page 273 CHAPTER 13: RISK MANAGEMENT—A PRACTICAL APPROACH......Page 305 PART V: PORTFOLIO MANAGEMENT AND RESOURCE PLANNING......Page 325 CHAPTER 14: MANAGING SUCCESSFUL PRODUCT PORTFOLIO CREATION AND R&D PIPELINES......Page 327 CHAPTER 15: EFFECTIVE STRATEGIES FOR PROJECT RESOURCE PLANNING AND UTILIZATION......Page 349 CHAPTER 16: STAGE GATE PRODUCT DEVELOPMENT PROCESSES AND LIFECYCLE MANAGEMENT......Page 361 PART VI: TRENDS IN BMI PROJECT MANAGEMENT......Page 367 CHAPTER 17: THE FUTURE OF MEDICAL DEVICES......Page 369 CHAPTER 18: THE NEXT WAVE OF MANAGING BIOMEDICAL PROJECTS......Page 381 INDEX......Page 395 (Publisher-supplied data) 1: Project Leadership for Biomedical Industries Scott D. Babler 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 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 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 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 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 "This book explores some of the critical forces at work today in the complex endeavor of pharmaceutical and medical product development. Applying a structured project management framework enables companies to select and allocate the appropriate people and resources to achieve successful outcomes. The book presents chapters addressing selected issues written by experienced professionals grappling with these problems every day. Such coverage provides real-world examples of contemporary problems and their solutions"--Provided by publisher. "This book explores some of the critical forces at work today in the complex endeavor of pharmaceutical and medical product development. Applying a structured project management framework enables companies to select and allocate the appropriate people and resources to achieve successful outcomes. The book presents chapters addressing selected issues written by experienced professionals grappling with these problems every day. Such coverage provides real-world examples of contemporary problems and their solutions"--Résumé de l'éditeur