Pharmaceutical and Biomedical Project Management in a Changing Global Environment

ISBN-13: 9780470293416 / Angielski / Twarda / 2010 / 400 str.

Scott D. Babler; Sean Ekins

Opis

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.

Spis treści

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. LaVallee).

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.

O autorze

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.

Blurb

A best practices guide to bringing new pharmaceutical or biomedical innovations to market

With stringent requirements for quality and patient safety, developing biomedical products is one of the toughest commercial endeavors a company can undertake. Companies continually strive to accelerate new product introductions by reducing development time. However, the best technologies and product concepts cannot reach patients without effective resource management planning for delivering results.

With contributions from experts in the pharmaceutical, medical device, and biotechnology industries, this multidisciplinary guide to project management offers solutions to the problems faced when bringing a highly technical and regulated product to the marketplace. Chapter–by–chapter, the book addresses the following topics:

• Project leadership in the biomedical industry

• The role of project management throughout the product lifecycle

• Clinical trials and project management

• Project management in drug and device development

• Managing product risk

• Building alliances

• Technology transfer

• Challenges in an international environment

For any life sciences professional facing these daily realities, this indispensable reference is the key to maximizing resources, keeping costs and schedules in check, and transforming an idea into a safe, effective, and successful product.