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Big Pharma Embraces Pharmacogenomics - But Are We There Yet?


Description: 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.

Get the Answers You Need to Shape Your Strategy
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?

Scope of this title:

- PGx leaders: review of companies that are leading the implementation of PGx.
- Patient populations: examples of well-documented patient samples used to determine disease correlations.
- PGx in practice: ways companies are currently using PGx in drug development, patient segmentation, drug dosing, and postmarketing.
- Remaining challenges: review of regulatory, ethical, reimbursement, and legal hurdles that companies must overcome.
- Spectrum Expert Commentaries: an official with the FDA and Decision Resources’ principal director for epidemiology share their insights.


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


Companies Mentioned - Abbott Laboratories - Affymetrix - Applera Genomics - Applied Biosystems - ARUP Laboratories - AstraZeneca - Bayer - BioGenex - Bristol-Myers Squibb - Celera Genomics - Cephalon - Chugai - Clinical Data - CuraGen - Dako - DeCode Genetics - Eli Lilly - Encode - Genaissance - Genentech - General Electric - Genizon BioSciences - Genomic Health - Genzyme Genetics - GlaxoSmithKline - Illumina - ImClone - Johnson & Johnson - Mayo Clinic - Medarex - Merck & Co. - Merck KGaA - MGI Pharma - Mitsubishi Pharma - NeoPharm - Novartis - Ortho McNeil - OSI Pharmaceutical - Perlegen Sciences - Pfi zer - PGx Health - Prometheus Laboratories - Riken - Roche - Seattle Genetics - Specialty Laboratories - Teva - Unilever - Ventana Medical Systems - Vysis - Wyeth


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