Successful Pharmacogenomics Business Models

1. Executive Summary

2. Introduction

• 2.1. Genetic Variation and Implications for Medicine
• 2.2. Pharmacogenomic Applications in Research, Development and Medicine
• 2.3. Risks & Industry Issues Facing Pharmacogenomics Adoption
• 2.4. Factors Enabling Pharmacogenomics

3. Market Opportunities Arising from Pharmacogenomics

• 3.1. Overview
  • 3.1.1. Pervasiveness of Pharmacogenomics
  • 3.1.2. Applications of Use for Pharmacogenomics
  • 3.1.3. Use of Diagnostics to Enable Drug Sales
  • 3.1.4. Recent Pharmacogenomics Examples
• 3.2. Pharmacogenomics Applications in Practice
  • 3.2.1. Three Pharmacogenomics-Enabled Drug Sales Models
  • 3.2.2. Price Premium for Diagnostic-Influenced Drug Sales
• 3.3. P450 Pharmacology and Drug Applications
  • 3.3.1. Targeted Therapies Leveraging Genetic Variation
• 3.4. Market Entry Theory and Implications for the Pharmaceutical Industry
  • 3.4.1. Economic Viability of Using Diagnostics in the Drug Sales Model
  • 3.4.2. Breakeven Analysis of the Diagnostic-Enabled Drug Model
• 3.5. Implications for Industry

4. Cost Opportunities Arising from Pharmacogenomics

• 4.1. Overview
  • 4.1.1. Current and Required Costs for SNP Genotyping
  • 4.1.2. Importance of Cost Versus Quality and Accuracy
  • 4.1.3. Impact of Adverse Drug Reaction Costs
• 4.2. Elements of Cost in Drug Research & Development
  • 4.2.1. Phased Drug Development Costs and Milestones
  • 4.2.2. Opportunities and Cost Quantification for Clinical Productivity
  • 4.2.3. Areas of Impact from Pharmacogenomics-Driven Clinical Productivity
• 4.3. Elements of Cost in Healthcare
  • 4.3.1. Composition of Adverse Drug Reaction Costs
  • 4.3.2. Drivers of Adverse Drug Reaction Costs
  • 4.3.3. Variance Analysis of Increased Adverse Drug Reaction Costs
  • 4.3.4. Avoidable Adverse Drug Reaction Costs Due to Pharmacogenomics
• 4.4. Cost Effectiveness of Pharmacogenomics
  • 4.4.1. Effective Measurements for Pharmacogenomics Applications
  • 4.4.2. Cost and Throughput Comparison of Competing Genotyping Technologies
  • 4.4.3. Benefits and Hurdles with Linkage Disequilibrium and Haplotyping Techniques
• 4.5. Results of Pharmacogenomics
  • 4.5.1. Impact of Pharmacogenomic Cost Advances

5. Industry Overview & Outlook

• 5.1. Key Elements of the Pharmaceutical Value-Chain
  • 5.1.1. Why Molecular Diagnostics is Critical
  • 5.1.2. Pharmaceutical and Biotechnology Companies
    • 5.1.2.1. NCE Introduction Drives Discovery Actions
    • 5.1.2.2. Marketing Strategy and Execution
    • 5.1.2.3. Clinical Trial Management
  • 5.1.3. Molecular Diagnostics and Testing
    • 5.1.3.1. Integrated Diagnostics Capability in Practice
    • 5.1.3.2. Diagnostics Versus Therapeutic Value Proposition
  • 5.1.4. Payer / Provider
    • 5.1.4.1. Impact on Industry Adoption
    • 5.1.4.2. Cost Efficiency Driven by Diagnostics
  • 5.1.5. Physician and Healthcare Delivery
    • 5.1.5.1. Concentration of Prescribing Physicians
    • 5.1.5.2. Adverse Events, Negligence and Impact on Industry
    • 5.1.5.3. Pharmacogenomics Adoption Drivers for Physicians
  • 5.1.6. Negligence, Litigation and Impact on Industry
    • 5.1.6.1. Negligence Criteria
    • 5.1.6.2. Therapeutic Surveillance and Impact on Companies
  • 5.1.7. Relative Cost of Adverse Reactions
    • 5.1.7.1. Cost of Adverse Reactions Within Industry
    • 5.1.7.2. Quantification of Adverse Events

6. Creating and Optimizing the Pharmacogenomics Business Model

• 6.1. Existing Pharmacogenomics Business Models
• 6.2. Biotechnology Companies Stand-Alone Pharmacogenomics Business Models
  • 6.2.1. Microarray Chip
  • 6.2.2. Services and Diagnostic Kits
  • 6.2.3. Platform Technologies
  • 6.2.4. Bundled Drug and Test
• 6.3. Assessing Pharmacogenomic Business Models and Disruptive Technologies
  • 6.3.1. Exploring the Rationale Behind New Business Models
  • 6.3.2. Determining Characteristics of the Innovation
  • 6.3.3. Assessing the Consequences of the Advancement Via Experiment
  • 6.3.4. Finding a Viable Initial Market for Disruptive Technology
  • 6.3.5. Carving-Out Responsibility for Implementation
  • 6.3.6. Maintaining Independence for Operations
• 6.4. Large Pharma Pharmacogenomics-Enabled Business Models
  • 6.4.1. Targeted Therapies
  • 6.4.2. Ultra-Blockbuster
  • 6.4.3. Development Rescue
• 6.5. Implications for Industry

7. Regulatory Overview

• 7.1. Current Regulatory Process for Drug Development
  • 7.1.1. Influence of Current Federal Code on Pharmacogenomics
  • 7.1.2. FDA Budget and Organizational Changes
• 7.2. FDA Pharmacogenomics Regulation Proposal
  • 7.2.1. Procedure for Creating Regulatory Proposal
  • 7.2.2. FDA Pharmacogenomics Regulatory Proposal
  • 7.2.3. Key Issues Facing Industry
  • 7.2.4. Issues Facing the FDA
• 7.3. Testing Kit Regulations and FDA Approval Process
  • 7.3.1. Background and Changing Regulatory Dynamics
  • 7.3.2. Testing Kit Regulations
  • 7.3.3. Testing Kit FDA Approval Process
• 7.4. Impact to Industry from Pharmacogenomics Regulation
• 7.5. Pharmacogenomic Data Submitted to Regulatory Agencies
• 7.6. Implications for Industry
• 7.7. Conclusion

8. Intellectual Property and Ethical Issues

• 8.1. Overview
  • 8.1.1. Intellectual Property Basics
  • 8.1.2. Types of Patents
  • 8.1.3. Duration of Patent and Patent Classifications
  • 8.1.4. Criteria and Qualitative Benchmark for Meeting Criteria
• 8.2. What Is and Is Not Patentable
• 8.3. Pharmacogenomics and Intellectual Property
• 8.4. Strategic Considerations & Implications of Patenting
  • 8.4.1. Scope, Value of Claims and Business Model Linkage
• 8.5. Ethical Issues
  • 8.5.1. Respect for Persons
  • 8.5.2. Beneficence
  • 8.5.3. Justice
• 8.6. Pharmacogenomic Applications of Ethical Considerations
  • 8.6.1. Race & Genotype
  • 8.6.2. Negligence
  • 8.6.3. Informed Consent
  • 8.6.4. Privacy
  • 8.6.5. Market Segmentation
  • 8.6.6. Media and Opinion Leader Edification
  • 8.6.7. Regulatory Implications