Big Pharma Embraces Pharmacogenomics - But Are We There Yet?

Table of Contents

• Contents
• Executive Summary
• Strategic Considerations
• Stakeholder Implications
• Pharmacogenomics in Practice
• Leaders in the Implementation of PGx
• Celera Genomics
• Illumina
• Perlegen Sciences
• Well-Documented Patient Data Are Paramount
• DeCode Genetics-Icelandic Population
• Spectrum Expert Commentary: Difficulties in Using Founder Populations
• The Mayo Clinic-Olmsted County Epidemiology Data
• Genizon-Quebec French Canadian Founder Population
• Industry's Current Use of Pharmacogenomics
• Preclinical Drug Development
• DeCode Genetics-Identifying New Drug Targets
• Improving Safety and Efficacy of New Drugs
• Patient Segmentation
• Genentech/Roche/Chugai's Trastuzumab (Herceptin)
• Clinical Data/Genaissance's Vilazodone
• Perlegen's MCC-555
• Encode's Information-Rich Clinical Trials
• Drug Dosing and Metabolism
• NeoPharm's LE-SN38
• Warfarin (Bristol-Myers Squibb's Coumadin)
• Azathioprine and Mercaptopurines
• Adverse Drug Reactions
• GlaxoSmithKline's Abacavir (Ziagen)
• Eli Lilly's Atomoxetine (Strattera)
• Post-Marketing Efficacy Issues
• Epidermal Growth Factor Receptor-Based Drugs
• Clinical Data and Genaissance's STRENGTH and CARING Studies
• Major Challenges
• Regulatory Issues
• Reimbursement, Ethical, and Legal Issues
• Spectrum Expert Commentary: FDA Establishes New Processes:
• Pharmacogenomic Data Submissions and a Drug-Test Codevelopment Pathway
• Outlook

Tables

• 1. Financial Position of Key PGx Leaders, FY05
• 2. Select Celera Collaborations
• 3. Disease Correlations Identified by Celera
• 4. Select Perlegen Collaborations
• 5. Populations for Disease Correlation and PGx Studies
• 6. Effect of Genotype on Drug-Drug Interactions
  • A. Examples of Different Categories of Biomarkers
• 7. Select PGx Diagnostics

Figures

• 1. Potential of PGx in Practice
• 2. Founder Populations
• 3. Genomewide Scans and SNP Mapping
• 4. Genome-Based Drug Doses for Antidepressants
• 5. UGT1A1 Genotype Testing Before Irinotecan Rx
  • A. Drug-Test Codevelopment Process