Table of Contents
CHAPTER 1 THE BURNING PLATFORM: COSTS, COMPLICATIONS, COMPLIANCE
- 1.1. Drug Development Expenses Are Increasing at an Alarming Rate
- 1.2. Postlaunch Adverse Reactions Are Increasing
- 1.3. Strategies for Streamlining Drug Development and Use
- Individualized Drug Dosing
- Monitoring Patient Response to a Drug or Drug Candidate
CHAPTER 2 BIOMARKERS: AXIS OF INNOVATION FOR DIAGNOSTICS AND THERAPEUTICS
- 2.1. Limitations of Protein Biomarker Discovery in Blood
- 2.2. Examples of Drug/Diagnostic Combinations Currently in Use
- Genomic Health: Oncotype DX
- Clinical Data: Phase III Tandem of Vilazodone and Marker
- Roche: C-Reactive Protein as a Response Biomarker with Antibody Therapy
- Oncogene Science: HER2/neu Testing with Herceptin and Vascular
Endothelial Growth Factor and KDR Testing with Nexavar
- Sidebar: Monogram Biosciences' Trofile Assay: Co-developed for Use with
Pfizer' s Celsentri for HIV
- Celera Genomics: Cirrhosis in Chronic Hepatitis C Patients
- 2.3. Existing Biomarkers Used as Diagnostics
- Apolipoprotein E Genetic Variants and Alzheimer' s Disease
- Imatinib (Gleevec): A Genomically Targeted Therapy
- Thiopurine Methyltransferase
- Irinotecan (Camptosar)
- Warfarin
CHAPTER 3 DIAGNOSTIC TOOLS TO IMPROVE DRUG DISCOVERY AND THE PRESCRIPTION OF LICENSED DRUGS
- 3.1. Discovering New Drugs that Work Well in the Entire Population
- 3.2. Discovering New Targeted Drugs Aimed at Genomic Subpopulations
- 3.3. Approaches to Improve the Safety and Efficacy of Drug Development
- "Rescue" of Products in Late-Stage Trials Due to Adverse Drug Reactions
- Creation of New Drugs for Particular Subpopulations of "Good Responders"
- 3.4. Improving the Prescription of Licensed Drugs
- Preprescription Screening to Identify Patients at Risk for Adverse Drug
Reactions
- Postmarketing Surveillance of Approved Drugs
- Preprescription Screening to Identify Good Responders
- Use of Efficacy Data in Drug Marketing
CHAPTER 4 THE LABORATORY: CLINICAL DIAGNOSTICS DELIVERY MODEL
- 4.1. Quality Assurance and Validation Requirements of Pharmacogenomic
Testing
- 4.2. National Academy of Clinical Biochemistry Guidelines and
Recommendations
- 4.3. Metabolism Gene Variants as Markers for Therapeutic Response
- Cytochrome P450 System
- CYP2D6
- CYP2C9
- CYP2C19
CHAPTER 5 APPLYING DIAGNOSTICS TO HEALTH CARE AND THERAPEUTIC DEVELOPMENT
- 5.1. Open Databases as a Platform for Diagnostics/Therapeutics
Co-development
- 5.2. Test Validation Is Key
- 5.3. Opportunities for Future Pharmacogenetic/Drug Companion Tests: 3
Examples
- Abacavir (Ziagen)
- Amoxetine (Strattera)
- Proton Pump Inhibitors
CHAPTER 6 ASSESSING THE MARKET POTENTIAL FOR COMBINATION PRODUCTS: PATHWAYS TO SUCCESS
- 6.1. CHI Insight Pharma' s Proprietary Survey Results
- Characteristics that Recommend a Drug for Combination Rx/Dx Development
- Disease States Best Suited for Combination Rx/Dx Development
- 6.2. Market Dynamics
- The Molecular Diagnostics Segment Shows Robust Growth
- A Diagnostic Market Characterized by Consolidation
- The US Diagnostic Market: Historically Low Expectations
- 6.3. Trends in Drug/Diagnostic Development Point to Growth
- The Industry Sees Broad Opportunities for Combination Rx/Dx Development
- Projected Growth in the Rx/Dx Pipeline
- 6.4. Big Pharma' s Reluctance to Abandon the Blockbuster Model
- 6.5. Industry Views on Where and When Combination Strategies Will Be
Deployed
- Commentary from Industry Leaders, by Sector
- Players Poised to Succeed in the Brave New World of Targeted Therapies
and Companion Diagnostics
- 6.6. Pathways to Successful Development of Combination Drug/Diagnostic
Products
- Momentum Toward the Concept of Parallel Development of the Drug and the
Diagnostic
- Momentum Toward a Developmental Focus on Both the Disease and the Therapy
- 6.7. Reimbursement and Regulatory Incentives Will Drive Adoption
- Diagnostic Coding Requirements: An Outdated Hurdle to Adoption?
- A Case Study in Reimbursement for a Molecular Diagnostic: Genomic
Health' s Oncotype DX
- 6.8. Understanding Specific Disease-Related Diagnostic Opportunities in
the Cancer Space
- 6.9. Sectors and Strategies that Will Drive Combination Drug/Diagnostic
Development
- What Types of Companies Will Pursue a Combination Model?
- What Execution Strategy Will Most Companies Pursue?
CHAPTER 7 INTELLECTUAL PROPERTY PROTECTION
- 7.1. Where We' ve Been
- 7.2. Where We' re Going
- 7.3. Implications for Technological Protection and Remuneration
- 7.4. Strategies in Play
- Therapy-Centric
- Genetic/Proteomic Discovery
- Diagnostic-Centric
- 7.5. A Snapshot of Drug/Diagnostic Patent Applications Filed in the Second
Quarter of 2005
- Cancer
- Respiratory Diseases
- Neurodegenerative Diseases
- Viral Infections
CHAPTER 8 REGULATORY CONSIDERATIONS: RECENT FDA REGULATIONS AND GUIDANCES
- 8.1. The Regulation of Combination Products
- 8.2. FDA' s Office of Combination Products (OCP)
- 8.3. The OCP' s Charter: GMP Requirements and Adverse Event Reporting
- 8.4. FDA Endorses Retrospective Studies
- 8.5. Real-Time Review
- 8.6. Relevant and Recent Regulatory Actions Bearing on Combination
Drug/Diagnostics
- 510(k) or Full Premarket Approval (PMA)?
- Draft Guidance for Industry, Clinical Laboratories, and FDA Staff; In
Vitro Diagnostic Multivariate Index Assays (FDA; September 2006)
- Summary
- Draft Guidance for Industry and FDA Staff, Commercially Distributed
Analyte- Specific Reagents (ASRs): Frequently Asked Questions (FDA;
September 2006)
- Essential Regulatory Elements
- Definition of an ASR: The Key Delineation
- The Advanced Laboratory Diagnostics Act of 2006 (House of
Representatives; May 2006)
- Drug-Diagnostic Co-development Concept Paper (FDA; April 2005)
- Memorandum of Understanding between the FDA, NCI, and CMS (FDA, NCI,
CMS; January 2006)
CHAPTER 9 THE FUTURE IS NOW: CLINICAL TRIAL UPDATE
- 9.1. MINDACT
- 9.2. TAILORx
References
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