Codeveloping Targeted Therapies and Diagnostics: What's in It for Me?

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