Report: Pharmacodiagnostics: Technologies, Competition, & Market Models TOC

1.1. What Is Personalized Medicine?
1.2. Historical Perspective: Archibald Garrod and Inborn Errors of Metabolism
1.3. Differential Drug Response is Both a Clinical and a Commercial Problem: Drug Safety as a Clinical Problem; Drug Safety as a Commercial Problem; Drug Efficacy as a Clinical Problem; Drug Efficacy as a Commercial Problem
1.4. Why People Vary in Their Responses to Drugs
1.5. Personalized Medicine for Safe and Effective Therapies
1.6. Personalized Medicine - Why Now?
1.7. Impact of the Genome Sequence and Other Data on the Pharmaceutical and Diagnostic Industries - More Targets: Drug Targets - The Druggable Genome; Diagnostic Targets-The Assayable Genome
1.8. Pharmacogenetics and Other Pharmacodiagnostic Markers
1.9. Sources of Clinical Information: The Challenge of Validating Pharmacodiagnostics in Clinical Trials; Possible Scenarios for Validating Pharmacodiagnostics
1.10. What Are the Drivers of Personalized Medicine?
Pharmaceutical Industry Perspective: -Regulatory Pressure; -Competitive Pressure; -Intellectual Property; -Clinical Practice; -Consumer Demand; -Litigation; Diagnostic Industry Perspective
Consumer Perspective: -Providers; -Patients; -Physicians

2.1. Technologies for Discovery, Development, and Delivery: Discovery; Pharmacodiagnostic and Drug Discovery and Development Timelines; Clinical Development; Diagnostic Delivery
2.2. Discovery Technologies
DNA - Review of Types of Genetic Variation: -SNPs; -Haplotypes - The HapMap; -Chromosomal Changes
DNA Discovery: Candidate Gene Analysis: -Hybridization; -Incorporation; -Extension; -Ligation; -Conformation; -Single-SNP Versus Multiplex Assays
Discovery Technology - Gene Scanning: -Automation-Based Methods; -Multiplex-Based Methods; -Single-Molecule Analysis; Discovery Technology - RNA; Discovery Technology - Proteins; Discovery Technology - Metabolomics; Bioinformatics
2.3. Technologies for Development: Introduction: Development Technology - DNA; Development Technology - RNA; Development Technologies - Proteins; Development Technologies - Metabolites
2.4. Technologies for Diagnostics: Introduction: Diagnostic Products and Diagnostic Services
DNA -Based Diagnostics: -Roche s AmpliChip P450 Assay; RNA-Based Diagnostics; Protein and Metabolite Diagnostics

3.1. Introduction
3.2. Companion Products on the Market by Disease Area: Cardiovascular Disease; Infectious Disease
Oncology: -Gleevec; -Herceptin
3.3. Marketed Products Whose Strategy "By-Passed" Companion Tests: Iressa; Lovenox
3.4. Companion Products in Development
Cardiovascular Disease: -LpPLA2
Infectious Disease: -Bacterial Sepsis; -Antibiotic-Resistant Infections; -Influenza
Inflammatory Disease: -Rheumatoid Arthritis
Multiplexing: -Oncology; -Liver Disease; -Alzheimer s Disease
3.5. What About Real Partnerships?

4.1. Introduction
4.2. Stakeholder Issues: Pharmaceutical Industry; Diagnostics Industry
Regulators: -The United States; -Europe; -Japan; Providers; Insurers/Payers
4.3. Drivers and Barriers
External Drivers: -Regulators; -Payers; -Government; -Healthcare Providers; -Patients
Internal Drivers: -Pipelines and Processes; -Compound Attrition; -Blockbusters; -Resources, Capabilities, and Competencies; -Competition, Patents, and Generics
4.4. The Value-Adding Role of Diagnostics in Pharmaceutical Research, Development, and Marketing
4.5. The Impact on Drug Development: Reducing Cycle Times; Reducing Study Sizes; Facilitating Earlier and Better Decisions; Facilitating Regulatory Approval
4.6. The Impact on Market Uptake: Increasing Prescribing (by PCPs); Increased Market Share; Faster Penetration of Market; Market Enlargement; Exclusivity and Defense Against Generics
4.7. Conclusions: Product Revenue Scenarios With and Without a Companion Diagnostic

5.1. Introduction: The Role of Intellectual Property; -Diagnostic Rights; -Pharmacodiagnostic Rights; -Therapeutic Targets from Biomarker Discovery
5.2. The Importance of Relationship Management: Co-Opetition; The Intermediate Organization
5.3. Target Test Profiles and Target Product Profiles: The Target Profile: Price, Position, Promotion, Place
5.4. Market Models: Methodology and Assumptions; Model 1: Turnaround; -Diagnostic Partner Power; -Revenue Mechanism; Model 2: Use to Order; -Diagnostic Partner Power; -Revenue Mechanism; Model 3: Make to Order; -Diagnostic Partner Power; -Revenue Mechanism; Model 4: Integrated Model; -The Timing Issue: Three Approaches; -Diagnostic Partner Power; -Revenue Mechanism
5.5. The Integrated Company
5.6. Conclusions

David Atkins, Ph.D., Veridex LLC

Dr. Walter P. Carney, Oncogene Science (part of Bayer HealthCare)

Richard Frank, GE Healthcare

Dr. Steven I. Gutman, United States Department of Health & Human Services, FDA

Dr. Jorge Leon, Leomics Associates, Inc.

Allen D. Roses, M.D., GlaxoSmithKline

Pharmacodiagnostics: Technologies, Competition, & Market Models