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.
Mục lục
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 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).
PART III: EFFECT OF BUSINESS RELATIONSHIPS ON MANAGING LARGE
PROJECTS.
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).
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 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.
La Vallee).
PART V: PORTFOLIO MANAGEMENT AND RESOURCE PLANNING.
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).
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.
Giới thiệu về tác giả
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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