Pharmacodiagnostics: Technologies, Competition, and Market Models examines the reasons why the business environment of pharmaceuticals is changing in favor of pharmacodiagnostics, and describes market models that are likely to emerge as the pharmaceutical and diagnostic industries collaborate to bring personalized medicine to fruition.
Personalized medicine promises safe drugs that work. By using diagnostic tests to identify, in advance of drug treatment, patients who are likely to be good responders and/or who are unlikely to suffer an adverse drug reaction (ADR), it is possible to improve the efficacy and safety of existing and new medicines. The tests themselves are referred to as pharmacodiagnostics, and their application to enable personalized medicine is poised to have a dramatic impact on the pharmaceutical industry, the diagnostic industry, and the overall provision of healthcare.
Pharmacodiagnostics and personalized medicine promise to address the key problems faced by the pharmaceutical industry. In addition to the clinical problems caused by ADRs, there are also well-documented commercial problems for the pharmaceutical industry, which has experienced a number of recent high-profile drug withdrawals due to unacceptable safety profiles. With the number of recalls increasing, the need for a solution is becoming critical. Furthermore, with the era of blockbuster drugs in decline, pharmaceutical companies need to incorporate personalized medicine into their drug sales models to decrease drug development costs, reduce the drug development cycle, and possibly resuscitate failed drugs.
The potential to develop personalized medicine is much greater now than at any time in the history of the drug industry. The raw data are available, and there are few technical hurdles to be overcome to allow the discovery and development of pharmacodiagnostic tests. However, the success or failure of pharmacodiagnostics will depend largely on the pull from the consumer for personalized medicine, or the push from industry. Indeed, a variety of market forces?regulatory, payer, provider, and consumer?will influence the acceptance of pharmacodiagnostics. Pharmacodiagnostics: Technologies, Competition, and Market Models analyzes these factors in detail.
Ultimately, the rise of pharmacodiagnostics will necessitate collaborative relationships between pharmaceutical and diagnostic companies with shifting power balances and opportunities for economies of scale and scope. The report projects that four principal relationships?Turnaround, Make-to-Order, Use-to-Order, and Integrated?are likely to exist. Each model is presented in terms of its varying degrees of financial benefit in return for investment in the development of companion products, underpinned by high-quality relationship management.
Executive Summary
Chapter 1. Introduction and Background
- 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
Chapter 2. Technology Requirements for Pharmacodiagnostics
- 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
Chapter 3. Pharmacodiagnostic Products on the Market and in Development
- 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?
Chapter 4. The Business Environment for Pharmacodiagnostics
- 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
Chapter 5. Market Models for Pharmacodiagnostics
- 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
Chapter 6. Expert Interviews
- 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
Chapter 7. Outlook
- 7.1. In Discovery
- 7.2. In Development
- 7.3. In Diagnostics
