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Big Pharma Embraces Pharmacogenomics - But Are We There Yet?

Published by: Decision Resources

Published: Aug. 22, 2006 - 31 Pages

Price reduced due to age.

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

Abstract

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?

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?

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