|
시장보고서
What Is the Future Role of Predictive Safety Biomarkers in Drug Development?
|
Abstract
Introduction
Predictive safety biomarkers are categorized by their target action -
predicting drug toxicity, selecting patients for treatment, or predicting
treatment effi cacy. Increasingly, diagnostics developers and pharmaceutical
companies are collaborating on biomarker identifi cation and validation. The
role of predictive safety biomarkers in the drug development paradigm is
essential in today' s cautious and budget-sensitive environment because
pharmacogenomic biomarkers are paramount to informing decisions of patient
eligibility for drug treatment, potential toxicities, and drug dosages.
Get the Answers You Need to Shape Your Strategy
- Many, but not all, available biomarker-based tests that predict safety
have been approved by the FDA. Do physicians use non-FDA-approved tests?
What challenges do the marketers of approved diagnostic tests still face?
- Approximately 50% of NMEs are estimated to have a biomarker element also
in development. What does this mean for biomarkers that inform decisions
regarding patient eligibility for drug treatment, potential toxicities, and
drug dosages?
- Demonstrating the clinical utility of predictive safety biomarkers could
be advantageous. How does clinical utility evidence infl uence
reimbursement for a biomarker-based test?
- Monitoring mutations in the KRAS gene - a key predictive safety biomarker
- determines response to certain therapies for select cancers. What is the
future impact of this safety biomarker and other key markers on drugs and
diagnostics in development market?
Scope
- Predictive biomarkers and diagnostic tests: drug development
process, key reimbursement issues, and marketability.
- Case study on the utility of predictive safety biomarkers in the
postmarketing setting: warfarin metabolism testing environment, lessons
learned, and future impact.
- Codevelopment strategies to explore: drug-diagnostic codevelopment
in HIV and oncology.
- Current applications: CLIA-laboratories and select companies in the
fi eld, using predictive safety biomarkers to select patients for
non-small-cell lung cancer and colorectal cancer therapies.
- Future role of predictive biomarkers: impact of KRAS gene, use of
FDA guidance, and generating interest and support through consortia.
Mentioned in This Spectrum Report
Companies and Organizations
- Affymetrix
- Amgen
- AstraZeneca
- AutoGenomics
- Bristol-Myers Squibb
- Cepheid
- Chugai
- Clarient Diagnostic Services
- Clinical Data
- Dako
- Dana Farber Cancer Institute
- Defi niens
- Delphic Diagnostics
- DxS Diagnostics Innovations
- Genelex
- Genentech
- Genomic Health
- Genzyme Genetics
- GlaxoSmithKline
- ImClone
- Innate Pharma
- Kimball Genetics
- Luminex Molecular Diagnostics (formerly Tm Biosciences)
- Merck KGaA
- Moffi tt Cancer Center
- Monogram Biosciences
- Nanosphere
- NeoGenomics
- Novartis
- Oasis Diagnostics
- OSI
- Osmetech Molecular Diagnostics
- Paragon Dx
- Pfi zer
- Prediction Sciences
- Response Genetics
- Rules-Based Medicine
- Third Wave Technologies
- Verigene
- ViennaLab Diagnostics
Table of Contents
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Introduction
- Utility of Predictive Safety Biomarkers
- Predictive Safety Biomarker Types
- Positioning Biomarkers in the Drug Development Timeline
- Predictive Safety Biomarkers for Patient Stratifi cation
- Role of EGFR in Selecting Patients for Treatment
- Role of KRAS in Selecting Patients for Treatment
- Regulating Predictive Safety Biomarkers and Tests
- FDA Biomarker Qualifi cation
- Predictive Safety Biomarkers Approved by the FDA
- Maximizing Adoption Rates of Predictive Safety Biomarkers
- Predictive Safety Biomarkers as Companion Diagnostics Case Study -
Selzentry and Trofi le
- Prospective Clinical Evidence
- Reimbursement Considerations
- Competitive Intelligence
- Seizing the Opportunity
- Biomarkers in a Postmarketing Setting Case Study - Warfarin Metabolism
Testing
- Nanosphere' s Verigene Warfarin Metabolism Nucleic Acid Test
- AutoGenomics' Infi niti Warfarin XP Assay
- ParagonDx' s Rapid Genotyping Assay
- Osmetech Molecular Diagnostics' eSensor Warfarin Sensitivity Test
- CLIA-Approved Warfarin Tests
- Lessons Learned
- Evaluating the Reimbursement Environment
- Predictive Safety Biomarkers
- Predictive Safety Biomarker-Based Diagnostic Tests
- Warfarin Sensitivity Tests
- Seeking Advancements in Safety Biomarker Development Through Key
Partnerships
- Predictive Safety Testing Consortium
- Other Clinical Research Consortia
- Select Companies Developing and Marketing Emerging Biomarkers
- Affymetrix
- Clarient Diagnostic Services
- Clinical Data
- Dako
- DxS Diagnostics Innovations
- Genomic Health
- Genzyme Genetics
- Monogram Biosciences
- Response Genetics
- ViennaLab Diagnostics
- Future Dynamics and the Role of Predictive Safety Biomarkers
- FDA Guidance and Communication
- Collaboration Opportunities
Sidebars
- Establishing Clinical Superiority: Monitoring Mutations in KRAS
- Clinical Studies Evaluating Genetic Warfarin Sensitivity Tests
Tables
- 1. Select Predictive Safety Biomarkers, Related Diagnostic Tests,
and Prices
- 2. Comparison of Key Predictive Biomarkers for Selecting Patients
for NSCLC and CRC Treatment
- 3. FDA-Approved Predictive Safety Biomarkers and Select Diagnostic
Products
- 4. Genetic Warfarin Sensitivity Tests: A Competitive Market for
Safety Biomarkers
- 5. Select Emerging Predictive Safety Biomarker Products
Figures
- 1. Likely Intervention Points for Safety Biomarkers in Drug
Development
- 2. Key Elements in Developing and Marketing a Predictive Safety
Biomarker
|
