Pharmaceutical and Biomedical Project Management in a Changing Global Environment
Published on 13. January 2011
400 pages
978-1-118-05821-3 (ISBN)
Description
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.
Reviews / Votes
"The book is an excellent primer and "hands on" reference textfocused on the unique aspects of managing projects in the lifesciences. Practical tips and tools are offered for wide rangingtopics relevant to those working in both large pharma and smallbiotech, in both US focused and global settings." --Barbara Rosengren, Vice President, Strategic ProductDevelopment, Momenta Pharmaceuticals Inc "I love this book and absolutely want to keep a copy on myshelf. It feels like a PMO in a box - I will be able to openit up and get my questions answered, confirm what I am thinking,and look for other ways to approach and solve problems. The writingacross the board is consistently strong, the organization makessense and it reads well - almost like a fast-paced fictionnovel!" --Kathleen Monroe, Vice President, Imaging Services,Synarc "I found the book to be practical and timely in providingup-to-date information for project managers in this evolving areaof practice. The book provides a good view of the broad landscapeof current project management challenges in a quickly evolvingindustry. It is an excellent grounding for project managers in thebiomedical industry and a highly recommended text for those whowant hands-on advice from professionals that are actively engagedin the field. This book is valuable for project managementpractitioners as well as for senior managers who seek a betterunderstanding of the complexities of project management in thecurrent biomedical environment." --Elaine Alexander, Sr Project Manager, Global MedicalCompanyMore details
Other editions
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Book
08/2010
Wiley
€120.50
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Software
07/2010
Wiley
€168.72
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Persons
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.
Content
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.
