|
|
Successful Pharmacogenomics Business ModelsPublished by: CHI Insight Pharma Reports Published: Nov. 1, 2003 - 126 Pages Table of ContentsCHAPTER 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 Ethics CHAPTER 2. Introduction 2.1. Genetic Variation and Implications for Medicine 2.2. Pharmacogenomic Applications in Research, Development, and Medicine 2.3. Ris ks & 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 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 Pharmacogenomics 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 -Maintaining Independence for Operations 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 Prpperty Background 8.2. What Is and Is Not Patentable 8.3. Pharmacogenomics and Intellectual Property 8.4. Strategic Considerations & Implications of Patenting 8.5. Ethical Issues -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 AbstractSuccessful Pharmacogenomics Business Models provides a theoretical framework to evaluate pharmacogenomics initiatives wit hin 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.
Please Note: The cost of PDF Email Delivery for this report includes a single license or a country license. A country license means that any of an organization's branches within the same country can access the data without an additional fee.
|
|
|||
|
About MarketResearch.com
|
||||