SPI Infoamtion

Table of Contents

Executive Summary

Overview
Breast cancer
Colorectal cancer
Lung cancer
Other diseases
Future outlook

Chapter 1 Overview

Summary
Introduction
The rise of personalized medicine

Population and disease-based biobanks
Healthcare costs and R&D productivity

Applications

Predictive tests
Prognostic tests
Pharmacogenetic tests

Regulation

US
EU
Regulators response to emerging genomics-based diagnostics

Chapter 2 Breast cancer

Summary
Introduction
Prognostic tests

MammaPrint
Oncotype DX
Uptake of tests
Other prognostic tests

Predictive tests

Hormonal therapies
Taxanes/anthracyclines
Biologicals
Triple negative breast cancer
Other novel biomarkers

Chapter 3 Colorectal cancer

Summary
Introduction
Prognostic tests
Predictive tests

Cetuximab
Panitumumab
Other predictive tests

Chapter 4 Lung cancer

Summary
Introduction
Predictive tests

Gefitinib
Erlotinib
Other predictive tests

Novel therapies

Chapter 5 Other diseases

Summary
Prostate cancer
Ovarian cancer
Malignant melanoma
Non-cancer indications

Cardiovascular diseases
CNS diseases

Chapter 6 Future outlook

Summary
Introduction
Drug development

Clinical trial enrichment
Retrospective study of biomarkers
The importance of tissue collection
Coverage and reimbursement

Conclusion

Appendix

Methodology
Glossary

List of Figures
Figure 1.1: Cancer cases versus five-year survival, US
Figure 1.2: Projected health expenditure, 2009-2018, US
Figure 1.3: New drug approvals and R&D spending, 1996-2008, US
Figure 1.4: Applications of personalized medicine
Figure 2.5: Oncotype DX sales ($m), 2004-2008, US
Figure 2.6: Comparison of Oncotype DX and MammaPrint
Figure 2.7: Simplified schematic of treatment selection in breast cancer
Figure 3.8: Development of KRAS as a predictive marker of cetuximab efficacy
Figure 6.9: Targeted versus non-targeted drug approvals, 1998-2008, US
Figure 6.10: Clinical trials using predictive biomarkers, 2005-2009
Figure 6.11: Drivers and resistors to personalized medicine

List of Tables
Table 1.1: Estimated US cancer cases, by site, 2009
Table 1.2: Drugs with target specific indications
Table 1.3: US drug labels with pharmacogenomic information
Table 2.4: Prognostic breast cancer assays
Table 2.5: Predictive breast cancer assays
Table 2.6: Selected ongoing breast cancer trials
Table 3.7: Selected ongoing colorectal cancer clinical trials
Table 4.8: Selected ongoing lung cancer clinical trials
Table 5.9: Selected ongoing miscellaneous clinical trials