1;Preface for 2nd Edition;5 2;Preface for 1st Edition;9 3;Contents;13 4;I. Innovation: Key to Success in the Pharmaceutical Industry;16 4.1;The Productivity Paradox;16 4.2;The Blockbuster Imperative;19 4.3;High Risks in Drug Development;25 4.4;Strategies for Growth;27 4.5;Differentiation via Clinical Profiles;30 4.6;Entering the Market Quickly;31 4.7;Conclusions;32 5;II. The Industry Challenge: Do You Really Want to Be in This Business?;34 5.1;High Complexity of the Industry;34 5.2;How Attractive is the Pharmaceutical Industry?;37 5.3;Force 1: Bargaining Power of Suppliers;39 5.4;Force 2: Bargaining Power of Buyers;40 5.5;Force 3: Risk of Entry from Potential Competitors;41 5.6;Force 4: Threat of Substitute Products;42 5.7;Force 5: Rivalry among Established Companies;43 5.8;Force 6: The Regulators;43 5.9;Conclusions;45 6;III. The Science and Technology Challenge: How to Find New Drugs;48 6.1;Rise of the Biotechnology Industry: Boosting Innovation;48 6.2;High-Throughput Screening: Fail Earlier, Succeed Sooner;53 6.3;Combinatorial Chemistry: Cut Experimental Cycle Times;54 6.4;Bioinformatics: More than 100 Gigabytes of Data per Day;55 6.5;Proteomics: Profiting from the Human Genome Project;57 6.6;Genomics: Towards Individualization and Mass Customization;58 6.7;Pharmacogenomics: Create Tailor-made Drugs;60 6.8;Molecular Design: From Experimenting to Analytic Design;62 6.9;Conclusions;63 7;IV. The Pipeline Management Challenge: How to Organize Innovation;66 7.1;The Relevance of Pipeline Management;66 7.2;Complexity and Phases of the R&D Process;71 7.3;The Importance of Project and Portfolio Management;80 7.4;The Disaggregation of the Pharmaceutical Value Chain;83 7.5;Impact of Outsourcing on Pharmaceutical R&D;86 7.6;Rising Importance of R&D Collaborations;90 7.7;Research Alliances: Accessing Early-stage Innovation;93 7.8;In-licensing: Enhancing the Innovation Pipeline;96 7.9;Co-development: Mutually Benefiting from Joint Resources;98 7.10;Out-licensing: Commercializing Internal Research Results;101 7.11;How to Commercialize a Breakthrough Technology;110 7.12;Conclusions;115 8;V. The Internationalization Challenge: Where to Get Access to Innovation;118 8.1;Trends and Drivers of R&D Internationalization;118 8.2;Primary Locations of Pharmaceutical R&D around the World;123 8.3;New Opportunities for Drug Development in China;126 8.4;Three Principal Problems of Dispersed R&D;132 8.5;Conclusions;136 9;VI. Management Answers to Pharmaceutical R& D Challenges;138 9.1;Managing R&D Organization at Roche;138 9.2;Managing R&D Strategy at Schering;140 9.3;Managing the Research-to-Development Handover at Roche;142 9.4;Managing Outsourcing Activities at Solvias;145 9.5;Managing Intellectual Property Rights at Bayer;148 9.6;Managing Out-licensing at Novartis;152 9.7;Managing Uncertainty at Roche;159 9.8;Managing Global R&D at Major Swiss Pharma Companies;160 9.9;Managing a Niche-Market Strategy at Intarcia;166 9.10;Managing Virtual Project Management Pools at Roche;168 9.11;Conclusions;171 10;VII. Future Directions and Trends;174 11;Bibliography;180 12;Index;188 13;Glossary;194 14;Authors;200