This book reviews how the emergence of pharmacogenetics will impact the efficiency of pharmaceutical R&D and improve healthcare decision making and clinical care. It discusses what policies need to change in order for the public to reap the benefits from advances in diagnostic genetic testing.

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Pharmacogenetics: Opportunities and Challenges for Health
Innovation
Published on November 2009
Report Summary
This book reviews how the emergence of pharmacogenetics will impact the efficiency of pharmaceutical R&D and improve healthcare
decision making and clinical care. It discusses what policies need to change in order for the public to reap the benefits from advances
in diagnostic genetic testing.
Table of Content
Acronyms
Executive Summary
Chapter 1. Introduction to the Policy Issues
-Introduction
-Reducing risks, balancing benefits
-The pharmaceutical context
-The clinical context
-The regulatory and ethical contexts
-The framework for the OECD pharmacogenetics and health innovation project
-Structure of the report
Chapter 2. The Supporting Infrastructures for Pharmacogenetics
-What are pharmacogenetics and pharmacogenomics'
-Technological developments
-Advancing pharmacogenetics through knowledge networks and open innovation
-Human genetic research databases: privacy and security issues
-Target identification and validation
-Conclusions
-References
Chapter 3. Pharmacogenetics and Drug Development
-Trends in pharmaceutical innovation
-The pharmaceutical R&D pipeline problem
-Pharmaceutical industry R&D expenditure: the high cost of clinical trials
-Reducing the size of clinical trials
-Conclusions
-References
Chapter 4. Business Models for Pharmacogenetics
-The blockbuster model and pharmacogenetics
-Challenges and opportunities for the pharmaceutical industry
-SMEs and the biotechnology sector
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-The device and diagnostics industry
-Challenges in co-development of drugs and tests
-Creating and capturing value from pharmacogenetics
-Conclusions
-References
Chapter 5. Physician and Patient Demand for Pharmacogenetics
-The health-care context
-The role of pharmacogenetics in evidence-based medicine
-The role of physicians
-Physicians and the challenge of integrating information
-Patient demand
-The issue of access
-Health-care systems
-Education and workforce development
-Conclusions
-References
Chapter 6. Regulatory Authorities and Reimbursement Mechanisms
-The regulatory authorities
-Labelling of pharmacogenetic drugs
-Linking pharmacovigilance with pharmacogenetics
-The impact of reimbursement systems on pharmacogenetics
-Evidence-based coverage policies
-Challenges for capturing the value of pharmacogenetics
-Using economic evaluation techniques in assessing pharmacogenetics
-Conclusions
-References
Chapter 7. Conclusions
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