Table of Contents
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- RxDx Products: Balancing Public Benefit and Company Profit
- Key Codevelopment Concepts
- The FDA Concept Paper
- Draft Paper Addresses RxDx Codevelopment Timelines/Steps
- Clarifications Requested by Industry
- It' s All About the Biomarker
- Who Has the Biomarkers?
- When Is RxDx Development Necessary and When Is It Not?
- What' s in It for Me?
- Incentives to Codevelop an RxDx
- Decreasing Costs of RxDx Codevelopment
- Increasing Pricing/Reimbursement for RxDx Products
- Robbing Rx to Pay Dx
- Increasing Market and Patent Exclusivities
- Case Study: Herceptin, HER-2 Tests, and the Value of RxDx
- Cost-Effectiveness of Herceptin
- Cost-Effectiveness of HER-2 Tests
- Executive Perspective: Value of RxDx
- Detailed Analysis: Cost-Effectiveness of Herceptin
- Outlook
- RxDx Partnering Challenges
- Parallel and Nonparallel RxDx Partnerships
- "We Choose to Go to the Moon"
- Companies to Watch
- It Will Be Done in This Decade
Tables
- 1. Ranking of Monoclonal Antibodies by Indication and Worldwide Sales
- 2. Select Companion Diagnostic Tests
Figures
- 1. Biomarkers and Drug Development
- 2. RxDx Codevelopment Process
- 3. Chromosome 5: Distribution of Single Nucleotide Polymorphisms
- 4. Average Response Rates to "One-Size-Fits-All" Drugs
- 5. When to Develop Companion RxDx Products
- 6. Perception of Benefit by Different Stakeholders
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