Click the title to purchase "Successful Pharmacogenomics Business Models"

Overview
The tools for pharmacogenomics carry the promise of achieving improved drug safety, earlier attrition rates, decreased drug development costs, a reduced drug development cycle, and resuscitation of failed drugs. Delivering on these promises will lead the way toward longer patent life and greater profits for new drugs. The challenge—and opportunity—for pharmaceutical companies is to figure out how to deploy the appropriate pharmacogenomics strategy into the drug sales model to facilitate maximum return.

Successful Pharmacogenomics Business Models is a new Cambridge Healthtech report that provides a theoretical framework to evaluate pharmacogenomics initiatives within pharmaceutical companies. The objective of the framework is to 1) determine the situation where pharmacogenomics is viable within the current and future large pharmaceutical drug development model; 2) determine requirements for success for each viable pharmacogenomics strategy; and 3) understand the implications for the pharmaceutical and diagnostics industries.

A key perceived risk in adopting pharmacogenomics is a decrease in market share due to smaller patient populations. Successful Pharmacogenomics Business Models examines how an appropriate pharmacogenomics strategy can actually open up additional revenue streams and contribute significantly to the bottom line by extending the patent protection period for a drug by reducing the time to market, saving costly Phase III trials through early attrition, and diminishing overall healthcare costs by improving safety profiles and Phase IV surveillance.

The report evaluates numerous factors driving the pharmacogenomics market, and addresses key issues shaping the adoption of pharmacogenomics testing including the following:
• The rapidly decreasing cost of SNP genotyping as a catalyst for pharmacogenomics adoption.
• A detailed analysis of the measurements used by pharmaceutical companies—cost-minimization, cost-benefit, cost-effectiveness and cost-utility—to evaluate pharmacogenomic testing.
• An evaluation of the factors impacting the strategic, commercial and operational aspect of delivering pharmacogenomics to the marketplace.
• The factors influencing the integration of pharmacogenomics into clinical trials, including an FDA proposal to address the following issues: the implications of existing regulations as they pertain to required or requested pharmacokinetic and pharmacogenetic/genomic data from the FDA; clarification on governance of pharmacogenomics tests in laboratories; whether a test is defined as clinical (drug specific) or non-clinical (research only); and future directions the FDA will take to drive the implementation of applied pharmacogenomics.
• An evaluation of successful pharmacogenomic business models.
• A scenario forecasting for the adoption of pharmacogenomics in industry based on two key variables—time to adoption and available capital to address hurdles in the industry.
• A discussion of the issues of payer/provider support and physician adoption.

Table of Contents

CHAPTER 1. EXECUTIVE SUMMARY
Market Opportunities
Key Pharmacogenomics Players
Cost Opportunities
Industry Overview and Outlook
Pharma/Biotech
Molecular Diagnostics
Payer-Providers
Physicians/Healthcare Providers
Pharmacogenomics Business Model Creation
Large Pharma
Biotechnology
Assessing Pharmacogenomic Business Models and Disruptive Technologies
Regulatory Overview
Intellectual Property and Ethics

CHAPTER 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

CHAPTER 3. MARKET OPPORTUNITIES ARISING FROM PHARMACOGENOMICS
3.1. Overview
3.2. Pharmacogenomics Applications in Practice
Targeted Therapies
Product Extensions
Ultra-Blockbuster
3.3. Market Entry Theory and Implications for the Pharmaceutical Industry
Economic Viability of Using Diagnostic in the Drug Sales Model
Breakeven Analysis of Diagnostic-Enabled Drug Model
Implications for Industry

CHAPTER 4. COST OPPORTUNITIES ARISING FROM PHARMACOGENOMICS
4.1. Overview
4.2. Elements of Cost in Drug Research & Development
4.3. Elements of Cost in Healthcare
4.4. Cost Effectiveness of Pharmacogenomics
4.5. Results of Pharmacogenomics

CHAPTER 5. INDUSTRY OVERVIEW & OUTLOOK
5.1. Key Elements of the Pharmaceutical Value Chain
Pharmaceutical and Biotech Companies
Molecular Diagnostics and Testing
Payer-Provider
Physicians and Healthcare Delivery
5.2. Industry Outlook
Demonstrated Validation of SNPs as Valid Biomarkers
Cost per SNP and High-Quality Test on the Market
Pharmacogenomics Integrated into Clinical Trials
Payer-Provider Support of Genomic Testing
Physician Adoption of Routine Pharmacogenomics Testing
5.3. Industry Scenario Forecasting
Guiding Assumptions

CHAPTER 6. CREATING AND OPTIMIZING THE PHARMACOGENOMICS BUSINESS MODEL
6.1. Existing Pharmacogenomics Business Models
Summary of Existing Business Models—Large Pharmaceuticals
Summary of Biotechnology Business Models Employed
6.2. Assessing Pharmacogenomic Business Models and Disruptive Technologies
Determining Characteristics of the Innovation
Assessing the Consequences of the Advancement via Experiment
Finding a Viable Initial Market for the Disruptive Technology
Carving Out Responsibility for Implementation
6.3. Large Pharma Pharmacogenomics-Enabled Business Models
6.4. Implications for Industry

CHAPTER 7. REGULATORY OVERVIEW
7.1. Current Regulatory Process for Drug Development
7.2. FDA Pharmacogenomics Regulation Proposal
Procedure for Creating Regulatory Proposal
FDA Pharmacogenomics Regulatory Proposal
Key Issues Facing Industry
Issues Facing the FDA
7.3. Testing Kit Regulations and FDA Approval Process
Background and Changing Regulatory Dynamics
Testing Kit Regulations
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

CHAPTER 8. INTELLECTUAL PROPERTY AND ETHICAL ISSUES
8.1. Intellectual Property Background
8.2. What Is and Is Not Patentable 1
8.3. Pharmacogenomics and Intellectual Property
8.4. Strategic Considerations & Implications of Patenting
8.5. Ethical Issues 4
Respect for Persons
Beneficence
Justice
8.6. Pharmacogenomic Applications of Ethical Considerations
Race & Genotype
Negligence
Informed Consent
Privacy
Market Segmentation
Professional, Media, and Opinion Leader Edification
Regulatory Implications

Appendix. Pharmacogenomics Business Models: Consumer Survey

Glossary

Company Index

Tables and Figures

Table 1: Criteria for Use of Pharmacogenetics to Reduce Adverse Drug Reactions
Table 2: Diagnostics Versus Therapeutic Value Proposition
Table 3: Molecular and Pharmacogenomics Diagnostics Players
Table 4: Assumptions for Pharmacogenomics Scenario Forecast
Table 5: Pharmacogenomics Providers
Figure 1: Drug Applications of Pharmacogenomics
Figure 2: Price Premium for Tailored Drug
Figure 3: Decision Tree and Economics In and Out of a Pharmacogenomics Environment
Figure 4: Price, Cost, Adoption Percent for Pharmacogenomics Environment
Figure 5: Breakeven Level for Adoption of Pharmacogenomics
Figure 6: Cumulative Cost of Clinical Drug Development with Preclinical Expense not Included
Figure 7: Avoidable Cost of $177.4B of Drug-Related Morbidity and Mortality
Figure 8: Variance Analysis of Increased Cost Originating from Drug-Related Morbidity and Mortality
Figure 9: Pharmaceutical Industry Value Chain
Figure 10: New Chemical Entities (NCEs) Approved by Calendar Year (PhRMA)
Figure 11: Clinical and FDA Lead Times for NDA Approval in Months (PhRMA)
Figure 12: 2003 U.S. Prescription Coverage by Provider Type
Figure 13: 2003 Estimated Large Pharma Cost-to-Serve and 2000 Drug-Related Morbidity and Mortality Cost (billions of dollars)
Figure 14: Pharmacogenomics Risk Factors Preventing Widespread Market Adoption
Figure 15: Scenario Forecasting the Pharmacogenomics Industry
Figure 16: Pharmacogenomics Business Models and Applications
Figure 17: Failed Drug Recovery Proforma; Stand-Alone Business, in $ Millions
Figure 18: FDA Drug Development Process
Figure 19: FDA Guidance Actions, Timing, and Status for Pharmacogenomics Submissions as Part of the Regulatory Process
Figure 20: Diagram for Data Submission Proposed by the FDA
Figure 21: Proposed Regulatory Process for Pharmacogenomics Data Submission
Figure 22: Increasing Number of Pharmacogenomic Data Submissions to the FDA
Figure 23: Breakdown of Genotyping and Phenotyping in FDA Survey
Figure 24: Pharmacogenomics Patents Issued in United States
 

Click the title to purchase "Successful Pharmacogenomics Business Models"

See also:

How Will the Diagnostic Company Business Model Evolve to Incorporate Pharmacogenomics

New Study Addresses Key Issues and Requirements Shaping the Adoption of Pharmacogenomics Testing