Abstract
Introduction
Pharmacogenomics will revolutionize the drug industry by linking the right drug to the right patient. Several companies and regulatory agencies are leading the charge to implement this approach of developing targeted medicines. PGx's integration is inevitable; pharma companies must get on board now or risk being left behind.
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Big pharma companies have become increasingly interested in PGx. These companies realize that PGx offers a way to develop better and safer drugs. Which companies are leading the charge to integrate PGx into drug discovery and development? Appropriate genetic markers and well-documented patient samples are critical to determining disease correlations. How are companies obtaining this information, and how are they using it to create personalized medicines? Although PGx is being integrated into many aspects of drug discovery and development, many regulatory and ethical challenges persist. What are the major issues remaining, and what are companies and regulatory agencies doing to overcome these challenges?
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
