Attrition in the Pharmaceutical Industry: Reasons, Implications, and Pathways Forward [Hardcover]

With a focus on case studies of R&D programs in a variety of disease areas, the book highlights fundamental productivity issues the pharmaceutical industry has been facing and explores potential ways of improving research effectiveness and efficiency.

• Takes a comprehensive and holistic approach to the problems and potential solutions to drug compound attrition
• Tackles a problem that adds billions of dollars to drug development programs and health care costs
• Guides discovery and development scientists through R&D stages, teaching requirements and reasons why drugs can fail
• Discusses potential ways forward utilizing new approaches and opportunities to reduce attrition

Contributors xiii

Introduction 1
Alexander Alex C. John Harris and Dennis A. Smith

References 4

1 Attrition in Drug Discovery and Development 5
Scott Boyer Clive Brealey and Andrew M. Davis

1.1 The Graph 5

1.2 The Sources of Attrition 7

1.3 Phase II Attrition 9

1.3.1 Target Engagement 11

1.3.2 Clinical Trial Design 11

1.4 Phase III Attrition 12

1.4.1 Safety Attrition in Phase III 14

1.5 Regulation and Attrition 17

1.6 Attrition in Phase IV 19

1.7 First in Class Best in Class and the Role of the Payer 32

1.8 Portfolio Attrition 34

1.9 Avoiding Attrition 36

1.9.1 Drug Combinations and New Formulations 36

1.9.2 Biologics versus Small Molecules 37

1.9.3 Small?-Molecule Compound Qual#