Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- CHAPTER 1 EXECUTIVE SUMMARY
- CHAPTER 2 BIOMARKER USE IN DRIVING EFFICIENCIES IN THE COMMERCIALIZATION
OF NOVEL ONCOLOGY PHARMACOTHERAPY
- Defining biomarkers in relation to the diagnosis and treatment of cancer
- Using biomarkers to mitigate productivity-constraining challenges in
oncology drug development
- Early changes in PSA may predict efficacy of novel developmental
agents targeting prostate cancer
- Cancer biomarkers have the potential to greatly enhance the screening,
diagnosis and treatment decision-making process
- Ideal biomarker requirements vary with their proposed clinical use
- Collaborative initiatives aim to facilitate biomarker discovery
- Defining prognostic and predictive biomarkers
- Prognostic biomarkers can be classified as 'biological progression
biomarkers' or 'risk biomarkers'
- Predictive biomarkers provide a measure of the impact of drug and
non-drug interventions
- FDA has designated 'Type 2' cancer biomarkers as valid surrogates of
clinical benefit
- Biomarker validation remains a major challenge for the scientific
community
- Lack of rigor and consistency in novel biomarker validation has
resticted their acceptance among the scientific and clinical community
- Current biomarkers and their clinical and commercial use
- Many cancer biomarkers in current clinical use are used to guide the
selection of novel targeted treatments
- Four biomarker assays dominate the marketplace and collectively
generated global sales of $860m in 2003
- CHAPTER 3 IMAGING BIOMARKERS ARE BEING ADOPTED WITH INCREASING FREQUENCY
- Functional imaging is generating the greatest interest as a tool to aid
drug development
- Focus on F-18-deoxyglucose Positron-Emission Tomography imaging to
facilitate early assessment of cancer drug efficacy
- Payer enthusiasm for PET scanning is shared by regulators
- Dynamic contrast-enhanced magnetic resonance imaging may provide an
valuable early assessment of the efficacy of angiogenesis inhibitors
- Developers show early signs of adopting DCE-MRI to assess the
antiangiogenic activity of novel developmental agents
- Developers will need to partner with functional imaging experts to
ensure quality assurance in functional imaging applications
- CHAPTER 4 NEXT GENERATION BIOMARKERS WILL FOCUS ON GENOMIC- AND
PROTEOMIC-BASED APPROACHES
- Protein function rather than protein quantification may be the more
salient approach
- Early demonstration of how protein expression profiles may help guide
pharmacotherapy decisions
- Genomic biomarkers herald the future
- Affymetrix-Roche's Amplichip represents the first FDA-approved
genomic-based prognostic tool
- Diagnostic biomarket market expected to reach $3 billion annually
- Single DNA-based biomarkers likely to be of little prognostic or
predictive value
- Epigenetic changes and mutations in oncogenes, tumor suppressor
genes and DNA mismatch repair genes are the focus of DNA-based biomarker
approaches
- Epigenetic biomarker have the potential to guide treatment decisions
for a number of marketed and developmental agents
- Viral biomarkers have clinical potential for predicting treatment
response and prognosis following the diagnosis of virally-mediated
tumors.
- Mitochondrial DNA analysis has huge potential
- Pattern-based RNA expression analysis has been demonstrated in a
number of tumor types
- Commercial potential of RNA-expression arrays demonstrated by
Genomic Health's Oncotype DX
- Predictive expression profiles also exist for diffuse large B-cell
non-Hodgkins lymphoma
- Advances in gene expression profiling need to be matched by
improvements in patient outcomes
- microRNA approaches offer a novel approach to molecular profiling
- But challenges still cloud the path to the commerciazation of novel
RNA-based biomarker approaches
- CHAPTER 5 REGULATORY ISSUES PROVIDE CHALLENGES TO CANCER BIOMARKER
DEVELOPMENT
- Regulatory procedures for cancer biomarkers can be onerous
- Anylate-specific reagent designation facilitates laboratory use of
novel biomarkers but prohibits payer reimbursement
- Case study of Affymetrix-Roche's AmpliChip illustrates impact of
regulatory hurdles
- Industry guidance on pharmacogenomics aims to build expertise and
foundation for developing scientifically sound regulatory policies
- Ambiguities and developer concerns persist despite guidance
- New drug test co-development guidance aims to change existing paradigms
- Scientific, business and regulatory challenges hinder drug-diagnostic
co-launches
- Drug-test co-development concept paper focuses on technical/analytical
issues rather than clinical aspects
- Drug-test co-development may ultimately be a mandatory rather than an
elective path for developers to follow
- CHAPTER 6 BENEFITS AND RISKS OF PURSUING INCREASED MARKET SEGMENTATION
- Risk of increased market segmentation in the era of 'personalized
medicine' countered by need for developers to demonstrate cost-effectiveness
of new high-cost treatments
- Case study of HER-2/neu testing illustrates potential commercial
rewards of biomarker testing
- Fragmentation of cancer staging sytems may limit their clinical utility
- Industry anxiety related to relabelling of existing drugs
- But could the availability of epidermal growth factor receptor
mutational analysis have mitigated the failure of AstraZeneca's Iressa?
- Pharmacoeconomic challenges to the implementation of biomarkers
- CHAPTER 7 APPENDIX
- Bibliography
- Research methodology
- About Datamonitor
- About Datamonitor Healthcare
- Datamonitor Healthcare's research and analysis methodologies
- Datamonitor Healthcare's therapy area capabilities
- About the Oncology analysis team
- Key therapy team members
- Nish Saini, Lead Oncology Analyst
- Disclaimer
- List of Tables
- Table 1: Prognostic and predictive biomarkers used in oncology
- Table 2: NIH-FDA classification of biomarkers
- Table 3: FDA-approved cancer biomarkers
- Table 4: Biomarkers to guide prognosis and treatment decisions
- Table 5: Selected FDA-approved biomarker assays, test systems and kits
for BTA, CEA, CA125 and CA27.19
- Table 6: Medical imaging techniques in oncology
- Table 7: DNA-based biomarkers
- Table 8: Viral biomarkers in oncology
- Table 9: Prognostic and predictive utility of RNA-expression analysis
- Table 10: Selected HER-2 tests available in the US
- Table 11: Crude incidence rates of female breast cancer (per 100,000)
in the seven major markets, 2006
- Table 12: Female breast cancer incidence forecast in the seven major
markets, 2002-16
- Table 13: Forecast sales of HER2/neu testing (FISH alone) in the 7
major pharmaceutical markets 2006-2016
- Table 14: Forecast sales of HER2/neu testing (IHC followed by FISH in
IHC positive patients) in the 7 major pharmaceutical markets, 2006-2016
- List of Figures
- Figure 1: Prognostic biomarkers
- Figure 2: Predictive biomarkers
- Figure 3: Development of biomarkers for clinical use
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