Pharmacogenetics : Opportunities and Challenges for Health Innovation.

Table of Contents......Page 7
Foreword......Page 5
Acronyms......Page 9
Executive Summary......Page 11
Introduction to the Policy issues......Page 17
Reducing risks, balancing benefits......Page 18
The pharmaceutical context......Page 21
The clinical context......Page 23
The regulatory and ethical contexts......Page 24
The framework for the OECD pharmacogenetics and health innovation project......Page 25
Structure of the report......Page 27
Notes......Page 28
The Supporting Infrastructures for Pharmacogenetics......Page 29
What are pharmacogenetics and pharmacogenomics?......Page 31
Technological developments......Page 32
Advancing pharmacogenetics through knowledge networks and open innovation......Page 34
Human genetic research databases: privacy and security issues......Page 35
Target identification and validation......Page 36
Conclusions......Page 41
Notes......Page 42
References......Page 43
Pharmacogenetics and Drug Development......Page 45
Trends in pharmaceutical innovation......Page 46
The pharmaceutical R&D pipeline problem......Page 48
Pharmaceutical industry R&D expenditure: the high cost of clinical trials......Page 52
Reducing the size of clinical trials......Page 54
Conclusions......Page 58
Notes......Page 60
References......Page 61
Business Models for Pharmacogenetics......Page 63
The blockbuster model and pharmacogenetics......Page 64
Challenges and opportunities for the pharmaceutical industry......Page 68
The device and diagnostics industry......Page 70
Challenges in co-development of drugs and tests......Page 72
Creating and capturing value from pharmacogenetics......Page 74
Conclusions......Page 75
Notes......Page 77
References......Page 78
Physician and Patient Demand for Pharmacogenetics......Page 79
The health-care context......Page 81
The role of pharmacogenetics in evidence-based medicine......Page 82
The role of physicians......Page 85
Physicians and the challenge of integrating information......Page 87
Patient demand......Page 89
The issue of access......Page 90
Health-care systems......Page 93
Education and workforce development......Page 94
Conclusions......Page 95
References......Page 96
Regulatory Authorities and Reimbursement Mechanisms......Page 99
The regulatory authorities......Page 100
Labelling of pharmacogenetic drugs......Page 106
Linking pharmacovigilance with pharmacogenetics......Page 107
The impact of reimbursement systems on pharmacogenetics......Page 108
Evidence-based coverage policies......Page 109
Challenges for capturing the value of pharmacogenetics......Page 115
Using economic evaluation techniques in assessing pharmacogenetics......Page 118
Conclusions......Page 119
Notes......Page 121
References......Page 122
Conclusions......Page 125