PHARMACEUTICAL PROJECT MANAGEMENT

By EMILY MARTIN

CONTENTS PART ONE THE LIFE SCIENCE INDUSTRY CONTEXT FOR PORTFOLIO, PROGRAM, AND PROJECT MANAGEMENT 1 A REVIEW OF PROJECT MANAGEMENT IN LIFE SCIENCE INDUSTRY SECTORS 2 THE IMPACT OF ORGANIZATIONAL SIZE ON DRUG PROJECT MANAGEMENT 3 DRUG DEVELOPMENT IN BIOTECHNOLOGY AND HOW WE CAN DO IT BETTER 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 5 PORTFOLIO MANAGEMENT IN THE PHARMACEUTICAL INDUSTRY: BALANCING CORPORATE NEED WITH THE REALITY OF DELIVERING PRODUCTS TO THE MARKET 6 PROGRAM MANAGEMENT IN DRUG DEVELOPMENT 7 PROJECT CONTROL 8 MANAGING UNCERTAINTY IN DRUG PROJECTS 9 MANAGING DRUG SAFETY RISK 10 DEVELOPING PROGRAM STRATEGY 11 DEVELOPING PRODUCTS WITH “ADDED VALUE” PART THREE INTEGRATING THE PROCESSES 12 INTEGRATED BUSINESS PROCESSES TO SUPPORT CROSS-FUNCTIONAL DRUG DEVELOPMENT 13 INTEGRATED DRUG DEVELOPMENT: FROM CRADLE TO GRAVE AND FROM LAB TO MARKET 14 THE DEVELOPMENT OF P3M CAPABILITY IN DRUG DEVELOPMENT ORGANIZATIONS 15 IMPLEMENTING PORTFOLIO, PROGRAM, AND PROJECT MANAGEMENT BEST PRACTICES IN DRUG DEVELOPMENT ORGANIZATIONS BIBLIOGRAPHY SINCE CONTEXT IS VITAL TO UNDERSTANDING THE APPLICATION OF PORTFOLIO, PROGRAM, AND PROJECT MANAGEMENT (P 3 M ) – IN ANY SECTOR – THE ? RST 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 EXPERIMENTS HIGH RATES OF ATTRITION, PARTICULARLY IN THE EARLY STAGES OF THE LIFE CYCLE FOR DRUGS FLUIDITY OF THE REGULATORY ENVIRONMENT HIGH COSTS OF DEVELOPMENT THROUGH THE LIFE CYCLE TO LAUNCH LONG TIME FRAMES FROM NEW CHEMICAL ENTITIES (NCES) COMING OUT OF DISCOVERY TO NEW DRUG APPLICATION (NDA) SUBMISSION GREAT VARIATION IN SIZE OF ? RMS IN THE SECTOR, FROM “ BIG PHARMACEUTICAL” COMPANIES WITH TENS OF THOUSANDS OF EMPLOYEES, TO START - UPS AND VIRTUAL BIOTECHNOLOGIES WITH LESS THAN PART ONE THE LIFE SCIENCE INDUSTRY CONTEXT FOR PORTFOLIO, PROGRAM, AND PROJECT MANAGEMENT