Big Pharma Embraces Pharmacogenomics
But are we there yet
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By Dr CL Barton / Publication Date: 1st August 2006
Contents:
Executive Summary 3
Strategic Considerations 3
Stakeholder Implications . 3
Pharmacogenomics in Practice . 4
Leaders in the Implementation of PGx 5
Celera Genomics 5
Illumina . 6
Perlegen Sciences 7
Well-Documented Patient Data Are Paramount 8
DeCode Genetics–Icelandic Population 9
Spectrum Expert Commentary: Difficulties in Using Founder Populations 11
The Mayo Clinic–Olmsted County Epidemiology Data . 12
Genizon–Quebec French Canadian Founder Population .12
Industry’s Current Use of Pharmacogenomics . 12
Preclinical Drug Development . 13
DeCode Genetics—Identifying New Drug Targets 14
Improving Safety and Efficacy of New Drugs . 14
Patient Segmentation . 15
Genentech/Roche/Chugai’s Trastuzumab (Herceptin) . 15
Clinical Data/Genaissance’s Vilazodone .. 15
Perlegen’s MCC-555 .16
Encode’s Information-Rich Clinical Trials .16
Drug Dosing and Metabolism .16
NeoPharm’s LE-SN38 .16
Warfarin (Bristol-Myers Squibb’s Coumadin) 17
Azathioprine and Mercaptopurines .18
Adverse Drug Reactions 19
GlaxoSmithKline’s Abacavir (Ziagen) . 19
Eli Lilly’s Atomoxetine (Strattera) 19
Post-Marketing Efficacy Issues 20
Epidermal Growth Factor Receptor-Based Drugs . 20
Clinical Data and Genaissance’s STRENGTH and CARING Studies . 21
Major Challenges . 21
Regulatory Issues .22
Reimbursement, Ethical, and Legal Issues 23
Spectrum Expert Commentary: FDA Establishes New Processes:
Pharmacogenomic Data Submissions and a Drug-Test Codevelopment Pathway . 24
Outlook . 26
24
List of Tables:
1. Financial Position of Key PGx Leaders, FY05 6
2. Select Celera Collaborations 7
3. Disease Correlations Identified by Celera .8
4. Select Perlegen Collaborations . 9
5. Populations for Disease Correlation and PGx Studies . 10
6. Effect of Genotype on Drug-Drug Interactions .20
A. Examples of Different Categories of Biomarkers . 25
7. Select PGx Diagnostics 27
Figures
1. Potential of PGx in Practice . 4
2. Founder Populations . 10
3. Genomewide Scans and SNP Mapping 13
4. Genome-Based Drug Doses for Antidepressants 17
5. UGT1A1 Genotype Testing Before Irinotecan Rx 18
A. Drug-Test Codevelopment Process ..