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Beschreibung

This book describes the way that pharmaceutical projects and programs are currently managed, and offers views from many highly experienced practitioners from within the industry on future directions for drug program management. The book integrates portfolio, program, and project management processes as fundamental for effective and efficient drug product development. Contributing expert authors provide their view of how the projectization approach can be taken forward by the drug industry over the coming years.

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Veröffentlichungsjahr: 2011

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Contents

Preface

Acknowledgments

About the Authors

Part One The Life Science Industry Context for Portfolio, Program, and Project Management

1. A Review of Project Management in Life Science Industry Sectors

PROJECTS AND PROJECT MANAGEMENT

LIFE SCIENCES NEW PRODUCT DEVELOPMENT PROJECTS

OVERVIEW OF PORTFOLIO MANAGEMENT IN LIFE SCIENCE ORGANIZATIONS

MANAGING VALUE

BUILDING CORE COMPETENCIES TO REDUCE RISK

PROJECT MANAGEMENT AT CROS

SUMMARY

REFERENCES

2. The Impact of Organizational Size on Drug Project Management

INTRODUCTION

ORGANIZATIONAL CULTURE

PRIORITIZING PROJECTS

PROJECT LEADERSHIP

DECISION MAKING

SUMMARY

NOTES

APPENDIX

3. Drug Development in Biotechnology and How We Can Do It Better

INTRODUCTION

ORGANIZATIONAL LEADERSHIP

MANAGING THE PIPELINE OF NEW DRUGS

DECISION MAKING

DEFINING THE ROLE AND VALUE OF PROJECT MANAGEMENT

CAPACITY MANAGEMENT

CONCLUSIONS

REFERENCES AND NOTES

FURTHER READINGS

Part Two The Portfolio, Program, and Project Management Approaches and Processes

4. An Overview of the Organization and Processes of Portfolio, Program, and Project Management

INTRODUCTION

DEFINITIONS

THE RELATIONSHIP BETWEEN THE PROCESSES

ENSURING PROCESS INTEGRATION

5. Portfolio Management in the Pharmaceutical Industry: Balancing Corporate Need with the Reality of Delivering Products to the Market

INTRODUCTION

BRIDGING THE GAP FROM THE CORPORATE STRATEGY TO THE CANDIDATE PLANS

SUMMARY

REFERENCE

6. Program Management in Drug Development

INTRODUCTION

PORTFOLIO, PROGRAM, OR PROJECT MANAGEMENT?

STRUCTURE AND GOVERNANCE OF PROGRAMS

PROGRAM RISK MANAGEMENT

PROGRAM CHARTERS AND MANAGEMENT RESPONSIBILITIES

TOOLS

SUMMARY

REFERENCES

7. Project Control

INTRODUCTION

OVERVIEW OF PROJECT CONTROL

DEVELOPING PROJECT CONTROL METHODS IN LIFE SCIENCE ORGANIZATIONS

CONTROL PROCESSES

ENHANCING PROJECT CONTROL

EVA

SUMMARY

REFERENCES AND NOTES

8. Managing Uncertainty in Drug Projects

INTRODUCTION

OVERVIEW OF UNCERTAINTY MANAGEMENT

THE UNCERTAINTY MANAGEMENT PROCESS IN THE LIFE SCIENCES

COMMUNICATING UNCERTAINTY

CONCLUSION

REFERENCES AND NOTES

9. Managing Drug Safety Risk

INTRODUCTION

PRODUCT RISK

LEARNING FROM HISTORY

RECENT REGULATORY DEVELOPMENTS

FACTORS AFFECTING SUCCESSFUL DRUG SAFETY RISK MANAGEMENT PROCESSES

PREPARING FOR THE FUTURE

CONCLUSION

REFERENCES

10. Developing Program Strategy

INTRODUCTION

OVERVIEW OF STRATEGY

DEVELOPMENT OF PROGRAM STRATEGY

SUMMARY

REFERENCES AND NOTES

11. Developing Products with “Added Value”

INTRODUCTION

THE NEW PARADIGM OF VALUE CREATION

UNDERSTANDING STAKEHOLDERS PERCEPTIONS OF VALUE

THE QUESTION OF PRICE

PROJECT MANAGING DRUG DEVELOPMENT TO MAXIMIZE CUSTOMER VALUE

CONCLUSIONS

REFERENCES

Part Three Integrating the Processes

12. Integrated Business Processes to Support Cross-Functional Drug Development

INTRODUCTION

BUSINESS PROCESS INTEGRATION: PORTFOLIO MANAGEMENT PROCESS

INTEGRATION BUSINESS PROCESSES THAT SUPPORT CROSS-FUNCTIONAL DRUG DEVELOPMENT: PROJECTMANAGEMENT PROCESS

BUSINESS PROCESS INTEGRATION THAT SUPPORT CROSS-FUNCTIONAL DRUG DEVELOPMENT: THE CAPACITY MANAGEMENT PROCESS

INTEGRATED BUSINESS PROCESSES THAT SUPPORT CROSS-FUNCTIONAL DRUG DEVELOPMENT: FINANCIAL

PROJECT MANAGEMENT INFORMATION SYSTEM

REPORTING

CONCLUSION

REFERENCES

13. Integrated Drug Development: From Cradle to Grave and from Lab to Market

INTRODUCTION

LIFE-CYCLE MANAGEMENT

TRUE INTEGRATION ACROSS FUNCTIONS AND GEOGRAPHICAL BOUNDARIES

ALIGNMENT OF STRATEGY, PORTFOLIO, PROGRAM, AND PROJECT ACTIVITY

IMPLICATIONS OF INTEGRATION

WORKING IN THE INTEGRATED ORGANIZATION

THE FUTURE OF INTEGRATED DRUG DEVELOPMENT

REFERENCES

14. The Development of P3M Capability in Drug Development Organizations

INTRODUCTION

STRATEGIC DRIVERS TO DEVELOP INTEGRATED P3M IN LIFE SCIENCES

MANAGING THE TENSION BETWEEN CURRENT OPERATIONS AND FUTURE CAPABILITY

SCALING P3M CAPABILITY TO MATCH ORGANIZATIONAL SIZE

COMPETENCIES REQUIRED TO ACHIEVE P3M CAPABILITY

DEVELOPING AND IMPLEMENTING SYSTEM CAPABILITY

CONCLUSION

REFERENCES AND NOTES

15. Implementing Portfolio, Program, and Project Management Best Practices in Drug Development Organizations

INTRODUCTION

THE CONCEPT OF BEST PRACTICE

PROJECT MANAGEMENT BEST PRACTICE IN DRUG DEVELOPMENT

ACHIEVING BEST PRACTICE IN DRUG DEVELOPMENT PROJECT MANAGEMENT

CONCLUSIONS

REFERENCES AND NOTE

Bibliography

Index

Copyright © 2010 by John Wiley & Sons, Inc. All rights reserved.

Published by John Wiley & Sons, Inc., Hoboken, New Jersey.Published simultaneously in Canada.

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Library of Congress Cataloging-in-Publication Data

Portfolio, program, and project management in the pharmaceutical and biotechnology industries/[edited by] Pete Harpum.p. cm.Includes index.ISBN 978-0-470-04966-2 (cloth)1. Pharmaceutical industry–Management. 2. Biotechnology industries–Management. 3. Project management. I. Harpum, Pete.HD9665.5.P67 2010615.1068′4–dc222009041793

For the six diamonds in my life:Inge, Emily, Bill, Alex, Alex, Hendrik

Preface

Integrated Portfolio, Program, and Project Management (P3M) is recognized across industry sectors as the most effective way to get things done. This is as true for large capital projects, found in civil engineering, defense-aerospace, and building, as it is for new product development, and organizational change initiatives. Driven by the need for well-controlled delivery of work, the art and science of P3M has been developing inexorably since the late 1950s, when the idea of project management as a distinct discipline began to become accepted by government and commercial organizations.

Project management in the life science sector did not become established as a credible approach to managing product development work until the early 1980s. The adoption of project management across the sector has been patchy and inconsistent, despite the huge business benefit that this approach has brought to almost every other industry. The number of books available on P3M as applied to drug development is very limited. Few journal articles are available on the subject, and there is almost no research published. Medical device project management fares better. This is unsurprising given the established project approach to managing product design with strong engineering and technical content.

The book is about the current and future way that the life science sector (pharmaceutical, biopharmaceutical, biotechnology, and biotherapeutic) projects and programs can be managed. All application of P3M is context dependent, and the pharmaceutical and biotechnology sector has a more challenging context than many others. There is, however, increasing appetite within the industry to embrace the advantages that a project-oriented approach to managing drug development work can bring.

Driving the move toward further and deeper projectization of product development in the sector are several factors. The industry is struggling to provide sufficient numbers of people with the knowledge and experience required to develop enough of the compounds coming out of discovery to meet patients’ needs. This lack of capacity is arguably one of the biggest inhibitors to development of new drugs and devices. There are tremendous revenue pressures on the industry, coming from both generics competition, and Government and other payers. The time scales for products to reach market have not decreased significantly, especially not when viewed in comparison to other new product development sectors. Many of these same factors led other sectors to adopt P3M as a core organizational competence to manage product development. As the industry faces up to the need for more efficient usage of resources (people and materials), better control of development cost, and reduced timelines, the adoption of high-quality P3M is bound to accelerate.

This book brings together the views of many experts on P3M in life science product development. Some have been, or currently are, academics. Some are practitioners, working to deliver drugs and devices to patients. Some are consultants, working as trusted advisors to life science companies, large and small, to help develop world class P3M. Yet others have held executive-level positions and write with authority as internal customers of drug program and project teams. When bringing together such a group of writers, with such a wide range of experiences, it is inevitable that there will be a mixture of writing styles. The editing has been deliberately kept to a minimum to ensure that the authenticity of the authors’ voices has been retained. This allows the writers’ authority in their fields to shine through.

The book is formed of three parts. Part One with three chapters sets the scene for the rest of the book by providing the context for P3M in the life science sector. There are reflections on the current state of project management in life science organizations, the impact of organizational size on P3M, as well as the specific subsector (pharmaceutical, biotechnology, etc.). Part Two of the book, comprising eight chapters, addresses the major organizational aspects of portfolio and program management, as well as covering the important processes of planning and control, managing program uncertainty, controlling product safety risk, developing program strategy, and managing value throughout the product development life cycle. In Part Three of the book, the final four chapters cover two themes. Two chapters discuss alternative perspectives of the integration of the work for product development. The two final chapters provide insight on the approaches needed to bring about high-quality, high-effectiveness P3M in life science companies. A bibliography is provided to direct the reader to the literature available, for P3M generally.

This book can be viewed as the end of the beginning of the application of consistent, formal project management in the life sciences sector. Steady progress over the last 20 years has been made, albeit uneven and often localized. The fact is that other industry sectors with very high levels of uncertainty in their product development processes have adopted P3M successfully. The outcomes for these sectors include increased profit margins, reduced overall life-cycle time, and more efficient utilization of people and resources. This leads to more products reaching the market. Translated to the drug development sector, this means more diseases can be treated, and more people with the diseases are able to receive drugs. Best practice P3M will also lead to increased reliability of timelines to deliver products to market, reducing company stock price volatility due to missing promised launch dates.

Life science companies that embrace best practice P3M will gain significant competitive advantage. The authors in this book provide the knowledge and insight to help create that competitive advantage.

PETE HARPUM

Acknowledgments

First and foremost, I would like to thank all the authors for their contributions to the book. They all work hard in their different roles within the life sciences sector, and they have each made significant contributions of knowledge, insight, thought, and much effort with their chapters. This book project has taken a great deal of time to put together (with much schedule slippage!), and all the authors have shown great patience with me as I have worked through the editing process. My naïve belief that adopting a “less is more” approach to the editing would keep the book to Wiley’s original deadlines has been cruelly exposed to all involved. I have also had the pleasure of working with an equally patient editor from Wiley-Blackwell, Jonathan Rose, who has remained polite and reassuring at all times, despite my constant requests for just another few months. Lauren Hilger, Editorial Assistant at Wiley-Blackwell, also deserves many thanks for her continuous advice and support as the manuscript was finalized.

Marianne Pendred, my personal assistant, has been invaluable as the project manager. At once supportive and demanding, she has kept us all, me and authors alike, steadily moving toward manuscript submission. Ruth Welsh has worked long and hard to format the chapters, chasing us all for clarifications, obtaining copyright approval, and checking references. Alex Fisher spent hours transforming diagrams and other graphics into useable formats. I thank you all.

For permission to use copyrighted material, I wish to thank the following: John Wiley & Sons Inc., for the reproduction of Figures 7.1, 7.2, and 7.12; Merriam-Webster Inc., for the definition of “uncertainty”; INSEAD, Fontainebleau, France for the reproduction of a Case Study: The Development of Nopane, and Macmillan Publisher Ltd., for the license to use Figure 11.14.

Also, grateful thanks to Philip Baylis and Dr. Donald Grosset for permission to use their unpublished illustrations – Figure 7.17 and Figure 11.11, respectively.

Finally, for permission to reproduce Figures 6.8 and 6.9, my thanks go to GlaxoSmithKline.

About the Authors

Stephen Allport

Stephen has over 30 years of experience in the pharmaceutical and health-care sector, latterly working with GlaxoSmithKline (GSK). A pharmacologist by training, he has extensive international operational, project management, and portfolio management experience.

After leaving GSK, Allport established his own independent consultancy, SWA Consulting Ltd., undertaking interim management roles and working with leading pharmaceutical, biotechnology, and IT companies on improving project management, portfolio management, and research and development (R & D) productivity. As well as managing his own company, Allport is Director of the R & D Society, an Associate of Premark Services Ltd., Program and Project Director for Pronus Ltd., and Director of the Pharma and Biotech Practice for Human Systems.

John Arrowsmith, BSc, PhD

Arrowsmith is Executive Director, Head of Competitive Intelligence with Pfizer Global R & D, Connecticut. During his 30-year career in Biopharmaceutical R & D with Pfizer in the United Kingdom, the United States, and Japan, he has gained skill and experience in drug discovery and development, intellectual property, competitive intelligence, project management excellence, portfolio information systems, portfolio prioritization, continuous improvement processes, performance measures, and scorecards. He is also an author/contributor to 16 publications and 18 patents, and is co-inventor of Tikosyn®, an anti-arrhythmic drug.

John Bennett, BSc, PhD

Dr. Bennett worked for Pfizer Global Research and Development for 21 years, starting in the research laboratories before moving to project management where he shepherded many candidates at all stages of development. He then spent a period designing and implementing project management processes and systems, knowledge management, risk and resource management systems, as well as making significant contributions to a number of global process improvement initiatives as Head of Project Management Operations and Development. He spent the last 9 years as a portfolio manager, initially looking after exploratory development candidates and, more recently, the pain, allergy and respiratory, genitourinary, and gastrointestinal therapeutic areas. He is currently an independent pharmaceutical consultant specializing in the design of drug development programs, project, portfolio, and risk management.

Trevor J. Brown, MBA, FCIM

Trevor J. Brown is the Managing Director of Premark Services Limited, which he formed in 1994 after 25 years in the industry. Over the past 20 years, he has developed an expertise in the creation of disease area strategies designed to add value to products in early stages of development. Particular areas of expertise are the research and evaluation of patient-centric health-care needs, liaison with clinical opinion leaders and health-care payers, and the organization and management of market development programs.

Terry Cooke-Davies

Cook-Davies is the founder and Executive Chairman of Human Systems International, Visiting Professor at ESC, Lille, a Visiting Fellow at Cranfield University, and co-author of The Right Projects, Done Right. He has a PhD in Project Management, a bachelor’s degree in Theology, and qualificiations in electrical engineering, management accounting, and counselling. Cook-Davies is the recipient of the Association for Project Management’s Sir Monty Finneston Award for his outstanding contribution to the development of project management. He is also an Association for Project Management (APM) Honorary Fellow.

Thomas R. Dunson

Dunson has over 20 years of combined project management and clinical development experience at both public and private pharmaceutical and contract research organization companies. Dunson possesses a strong working knowledge of contemporary project management standards and practices, and is a certified Project Management Professional. He has authored or co-authored over 30 peer-reviewed manuscripts, book chapters, and monographs on a wide variety of topics as well as delivered numerous project management training sessions. Randy has served as First Vice Chair of the Project Management Institute (PMI) Pharmaceutical Specific Interest Group since 2004.

Inge Fisher

Fisher is a seasoned management consultant, with specialist expertise in the assessment and development of people, across a wide range of industries, in both private and public sectors. She has led interventions at all levels of the organization, from restructure, through team development activities, to individual coaching assignment with senior managers. Fisher’s approach to supporting organizational success is to emphasize the critical role of individual employee’s motivation and competence in achieving the desired outcomes of structures and processes.

Patrick Grogan

Grogan is currently Senior Director, Strategic Planning, for Becton Dickinson’s bioscience division in San Jose, California. He is responsible for strategic planning, portfolio management, and strategic marketing for their pharmaceutical and software businesses. Grogan’s earlier experience includes bench scientist, university research associate, biotechnology marketing consulting, and later, portfolio management at Genentech, Parke Davis, and Pfizer. Grogan received his BS honors degree from National University of Ireland Galway and completed his MBA in Finance at St. Mary’s College, Moraga, California.

Martin D. Hynes III, PhD

Hynes is director of product research and development, six sigma champion at Lilly Research Laboratories. He has authored or co-authored numerous scientific articles, abstracts, books, and patents. He has also edited books on FDA preapproval inspection published by Marcel Dekker, Inc.

Ashley Jamieson, MSc, MBA

Jamieson has many years of project management experience in global aerospace. He has worked with Professor Peter Morris on research projects including translating corporate strategy to project strategy, and revising the APM Body of Knowledge. In 2009, he completed a research project in best practice project management life science R & D. Jamieson is a consultant with Harpum Consulting. He contributed to the Wiley Guide to Managing Projects (2004), the Gower Handbook of Project Management (2007), and co-authored Translating Corporate Strategy into Project Strategy: Achieving Corporate Strategy through Project Management (2004).

Susan Linna

Susan is currently Executive Director, Global Project Management at Novavax, Inc., with responsibility for integrating planning and operations across discovery, preclinical, clinical, manufacturing, and commercial development. Linna’s prior experience includes Vice President of Project Management Office at Emergent BioSolutions; Director of Project Management, Human Genome Sciences; and Project Manager at Merck. Susan has worked on many drug compounds, including Aggrastat®, Trusopt®, Vaqta®, Varivax®, Merck’s Hepatitis A and Varicella vaccines, as well as alliance projects for LymphoStat-B and Albuferon.

Robert (Bob) Moore

Moore has spent over 30 years in a broad spectrum of Clinical Research and Development areas, from the Cardiovascular Lab, to Clinical Information and IT, to Project and Portfolio Management. He retired from Pfizer Global Research & Development as Executive Director, Worldwide Project Management in 2007. After relocating to the southern coast of North Carolina, he continues to provide consulting assistance to other pharmaceutical companies, carefully balanced with boating and golfing recreation.

Eric Morfin, PMP, PhD

Morfin is a drug and device project executive, and has been a life sciences project manager since 1987. Morfin has been published many times in project management magazines and pharmaceutical publications, and founded the independent BioPharmaPM network. As Chief Partner at Critical Skills, Eric has worked and consulted with small start-up biotechnologies as well as global pharmaceuticals for over 20 years, making him well qualified to compare project management for drug development best practices across a wide range of companies and countries.

Martin Powell

Martin Powell is Director of Projects at the London Development Agency, the Mayor of London’s agency for economic development. He is responsible for the delivery of the agency’s capital projects, ranging from physical infrastructure projects to environmental and climate change initiatives, and also for the agency’s project management improvement program. He is also Managing Director of Cambridge Management & Research Ltd., which specializes in a range of project management solutions from process gap analyses through to project reviews and hands-on project delivery.

Pauline Stewart-Long

Pauline Stewart-Long is Vice President of Global Project Management for GSK R & D. She is responsible for the long-term capability development of project management as a professional discipline at the company. Prior to this role, Stewart-Long’s work has included positions as a portfolio manager and project manager, and early on in her career, as a clinical research assistant. She has a PhD in Biochemical Nutrition from Cambridge University. She is a member of the Pharmaceutical Industry Project Management Group, the Drug Information Association, and PMI, and represents GSK on the Human Systems Project Management Knowledge Network.

Part One

The Life Science Industry Context for Portfolio, Program, and Project Management

Since context is vital to understanding the application of portfolio, program, and project management (P3M) - in any sector - the first three chapters in this section provide this background. The authors remind us of the complexities of the product development environment, including:

Great uncertainty of the outcome of experimentsHigh rates of attrition, particularly in the early stages of the life cycle for drugsFluidity of the regulatory environmentHigh costs of development through the life cycle to launchLong time frames from new chemical entities (NCEs) coming out of discovery to new drug application (NDA) submissionGreat variation in size of firms in the sector, from “big pharmaceutical” companies with tens of thousands of employees, to start-ups and virtual biotechnologies with less than 10Significant differences between pharmaceutical, biotechnology, biopharmaceutical, biotherapeutics, medical devices, and diagnostic and imaging subsectors.

In Chapter 1, Thomas R. Dunson provides a comprehensive overview of the application of P3M across the different life science sectors. He also discusses the fundamentals underpinning the notion of project management itself, in the process describing the two most well-established bodies of knowledge for project management.

Eric Morfin follows with a chapter that presents the implications of organizational size on the way P3M is operationalized. He covers the impact of organizational culture, styles of leadership, the impact of the need to prioritize resources in larger companies with bigger pipelines of products, and the way in which different organizational structures intersect with P3M processes.

The final chapter in the section by Susan Linna looks specifically at the challenges of bringing effective P3M to product development in the biotechnology sector. Linna covers the specifics of the transition from research to development (regulatory regimes, manufacturing and control, routes of administration, and others). She also describes how P3M can support decision making and capacity management. The need for senior management support for effective P3M is also described, with a detailed explanation of why this is so important.

Chapter 1

A Review of Project Management in Life Science Industry Sectors

Thomas R. Dunson

This chapter aims to provide an overview of the way project management differs in its application across the pharmaceutical, biotechnology, and contract research organization (CRO) sectors.

Considering the complex nature of drug development projects and the high cost of being late to market (or failing late in the development life cycle), it would seem intuitive that project management would flourish in the life science sector. However, the industry has been slow to implement project management practices and is thus behind other industries in this area [1, 2].

Still, the importance of project management is recognized: it is seen by many companies as a pivotal contributor to getting products to market and achieving excellence in drug development [2, 3], and more emphasis is being placed on the application and development of project management practices in the industry than at any previous time.

PROJECTS AND PROJECT MANAGEMENT

Projects have a definitive start and end, and their end products should be different from other products and services.

A project is a temporary endeavor undertaken to create a unique product or service [4].

Many organizations use projects to do those activities that cannot be performed with normal operations or processes (often referred to as “business as usual” ). By definition, as projects are unique, there is more uncertainty, and thus, risk and opportunity in project-oriented work compared with normal operations. Turner [5] states that organizations use projects when their business objectives are achieved more effectively by projects, that is, when benefits are bigger than the risks associated with the work.

Figure 1.1 Goals and methods matrix (adapted from Turner) [9] .

Changes in the business environment generally have promoted the use of projects. Rapid technological change has made the future of businesses unpredictable, globalization has changed market structures, and deregulation has transformed industry structures [6]. Organizational structures need to be flexible to enable fast responses to changes, and projectization is a key way to create flexibility in organizations [7]. In addition, in a networked business environment, projects support knowledge-intensive operations that now form the core of many organizations [8].

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