|
|
 |
|
Viewing report
|
|
|
|
How Overcoming the Challenge of Biomarker Validation Can Pay Off for Drug and Diagnostic Developers
Decision Resources, Inc., Feb 2008, Pages: 35
Introduction
Validating a biomarker is a resource-intensive undertaking. Is it worth it? We say, Yes. A biomarker that wins “known validated” status is best positioned for rewards: regulatory approval, optimal reimbursement, incorporation into personalized medicine approaches alongside companion therapeutics, partnership and promotion opportunities, and wider awareness and uptake. Companies that recently began fielding biomarker-based tests are reporting success in terms of a revenue upswing. And they have laid the groundwork for validation of tomorrow’s biomarker-based tools.
Get the Answers You Need to Shape Your Strategy
In December 2007, Panacea’s LC Detect for early lung cancer diagnosis was named one of Time Magazine’s Top 10 Medical Breakthroughs of 2007. What other biomarker-based tests are changing medical practice, and how?
- Validation is a key step in maximizing the clinical and commercial success of a biomarker. What is the validation process? What companies have successfully navigated it? What resources exist to facilitate the process?
- Validated biomarkers are the basis for several marketed companion diagnostics. Which products have received approval? How are these products faring? What tests are in development?
- For companies developing biomarker-based tests, a key strategy that taps the personalized medicine
paradigm is to partner with drug developers. Which biomarker companies lead the pack? Which
pharmaceutical companies have become involved in personalized medicine and drug/diagnostic codevelopment?
Scope
- About validated biomarkers: definitions, classifications, the value and process of validation.
- Types of biomarker-based tests: home-brew, de novo, in vitro diagnostic multivariate assay, therapeutic area focus (oncology is a leading area), technology focus (nucleic-acid testing, or NAT, is emerging as the key approach). Tables detail FDA-approved validated biomarkers and those in trials to achieve validation.
- Case studies: Genomic Health’s Oncotype DX and Agendia’s Mammaprint.
- Biomarker development environment: recent approvals, reimbursement challenges, supporting consortia.
- Where is the pay-off?: company profiles, revenue trends, industry outlook.
Key Terms
- Biomarkers
- CLIA
- Clinical Laboratory Improvement Act Amendments
- Clinical trials
- Clinical utility
- Clinical validity
- Co-development of drugs and diagnostics
- Collaboration
- Companion diagnostics
- De novo tests
- Direct-to-consumer advertising
- Drug development
- DTC
- Exporatory biomarkers
- FDA
- Gene profiling
- “Home brew”
- In vitro diagnostic multivariate assays
- Known valid biomarkers
- Microarray
- NAT
- Oncology
- Partnering
- Patient selection
- Personalized medicine
- Pharmacodiagnostics
- PMA
- Probable valid biomarkers
- Reimbursement
- Reverse transcriptase polymerase chain reaction
- Theranostics
- Validation
Customers who bought this item also bought
Biomarker Technology Platforms for Cancer Diagnoses and Therapies
It's All About the Biomarkers: How 2008's Biomarker-Based Partnering Is Driving Personalized Medicine
Trends in the Commercialization of Biomarkers: Tests and Companies
Blood Biomarkers and Beyond: Biomarker and Diagnostic Opportunities in Cardiovascular Disease
Biomarker and Diagnostic Opportunities in Clinical Research for Neurological Diseases
Companion Biomarkers in Drug Development
Clinical Proteomics: Rethinking Approaches to Protein Biomarker Discovery
Licensing Strategies for Accessing Biomarker Technologies
Companion Diagnostics in Personalized Medicine and Cancer Therapy
Harnessing Biomarker Research in Academic Institutions for Use in Industry
Enabling Oncology Diagnostics: Predictive Biomarkers Based on Genes, Proteins, and Pathways
Biomarkers - Technologies, Markets and Companies
|
|
|
|
