Pharmaceutical and Biomedical Project Management in a Changing Global Environment / Edition 1

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Overview

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.

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What People Are Saying

From the Publisher
"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."
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 novel!"
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

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Product Details

Meet the Author

SCOTT D. BABLER is a Senior Project Manager at IntegratedProject Management Company, Inc. (IPM). He has worked withorganizations of all sizes to successfully apply core projectmanagement practices to the dynamic life sciences and medicaldevice environment. He has led multi-functional project teams intechnology, design, development, quality, regulatory andmanufacturing.

Integrated Project Management Company, Inc. (IPM) is aleading provider of onsite project management services for the lifesciences industry. Since 1988, IPM has pioneered the application ofexcellence in project management best practices to consistentlydrive measurable results for their clients. Areas of expertiseinclude product development, alliance management, business processimprovement, technology transfer, and regulatory/qualitycompliance. IPM has offices in Boston, Chicago, St. Louis, and SanFrancisco.

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Table of Contents

FOREWORD.

PREFACE.

ACKNOWLEDGEMENTS.

CONTRIBUTORS.

ABBREVIATIONS.

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 theirIntegration (Dennis F. Marr).

3:  The Role of Project Management in the Development of InVitro Diagnostics (David Kern and Diane M. Ward).

4: Drug Development Project Management (Dirk L. Raemdonck andBradford A. Burns).

PART III: EFFECT OF BUSINESS RELATIONSHIPS ON MANAGING LARGEPROJECTS.

5: Outsourcing of Project Activities (Jonathan D. Lee andTrisha 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 AndyMyslicki).

7: A Roadmap for Successful Technology Transfers (NipunDavar, Sangita Ghosh, Nandan Oza).

8: Challenges for the Team Leader of Multifunctional ProductTeams in an International Environment (HartwigHennekes).

9: Lessons Learned from Inter-Organizational CollaborationProjects (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 andFunctions Throughout the Product Lifecycle (Thomas Dzierozynskiand Ian Fleming).

12: Regulatory Strategies and Submissions in an InternationalProduct       Environment (LouiseJohnson).

13: Risk Management - A Practical Approach (Courtland R.LaVallee).

PART V: PORTFOLIO MANAGEMENT AND RESOURCE PLANNING.

14: Managing Successful Product Portfolio Creation and R&DPipelines (Sue E. Steven).

15: Effective Strategies for Project Resource Planning andUtilization (Eduardo Rojas and Scott D. Babler).

16: Stage Gate Product Development Processes and LifecycleManagement (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).

INDEX.

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