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April 2006 

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The Impact of Genomics on Clinical Trials 
and Medical Practice
A CHI Insight Pharma MONITOR Series Report

Gwen Acton, Ph.D. 

New Page 1
Table 1.1. Stages of Clinical Trials

Table 2.1. Genomic Features with Clinical Applications

Table 2.2. Genetic Pathways That Could Alter Drug Efficacy and Safety: ADME

Table 2.3. Classes of Genetic Variation in Drug Metabolism

Table 2.4. Examples of Cytochrome P450 Gene Variation and Drug Interaction

Table 2.5. Examples of Genetic Variation in Drug Targets Affecting Drug Response

Table 2.6. Selected Toxicogenomics Databases

Table 2.7. Examples of Monogenic Diseases for Which Clinical Tests Are Available

Table 2.8. Examples of Genes Contributing to Complex Diseases

Table 2.9. Cancers with a Strong Genetic Component

Table 3.1. Types of DNA Variation

Table 3.2. Factors Influencing Genotyping Costs

Table 3.3. Criteria for Evaluating SNP Genotyping Accuracy

Table 3.4. Steps in Microarray Experiments

Table 3.5. Informatics Issues Associated with Microarrays

Table 3.6. Selected Companies Marketing Microarrays or Related Tools or Services

Table 4.1. Correlation of UGT1A1 Variants with Risk of Toxicity

Table 4.2. Selected Assays Used to Screen Newborns for Genetic Diseases

Table 4.3. Examples of Drugs Reported to Evoke Different Responses in Different Racial or Ethnic Groups

Table 4.4. Selected Drugs for Which the Target Population May Be Determined by Genetic Testing (U.S. prescribing information)

Table 4.5. Prescribing Information for Drug-Metabolizing Enzyme Genotypes

Table 5.1. Savings Resulting from Patient Stratification in a Breast Cancer Study

Table 5.2. Efforts to Standardize Gene Expression Data

Table 5.3. Factors Increasing or Decreasing Costs Associated With Genomic Technology

Table 5.4. Quick Reference on Pharmacogenomic Submissions

Table 5.5. Framework for Evaluating the Potential Cost-Effectiveness of Clinical Genomics Therapies

Figure 1.1. Preclinical Versus Clinical Applications of Genomics

Figure 1.2. Personalized Medicine

Figure 1.3. Taking Genomics to the Clinic

Figure 2.1. Estimated U.S. Cancer Deaths by Type, 2005

Figure 3.1. Single Nucleotide Polymorphisms

Figure 3.2. A Haplotype Block

Figure 3.3.
Functional Genomic Analysis of Gene Expression

Figure 3.4. Microarray Analysis

Figure 3.5. Diagram of Short Interfering RNAs

Figure 4.1. Distribution of Drug-Metabolizing Enzymes in the Population

Figure 4.2. Roche Diagnostics' AmpliChip CYP450

Figure 4.3. Effect of UGT1A1 on Irinotecan Metabolism

Figure 4.4. Distribution of TPMT Activity in Unrelated Adults

Figure 4.5. Estimated Growth of Genomics in U.S. Clinical Trials

Figure 4.6. Applications of Genomics in Drug Development

Figure 4.7. Application of Gene Expression Testing in Breast Cancer

Figure 5.1. How Patient Stratification Using Genomics Can Be Beneficial

Figure 5.2. Impact of Various Factors on Variation of Patient Response to Warfarin

Figure 5.3. Breakdown of Spending on Health Care in the United States, 2002

Figure 5.4. Codevelopment of Drugs and Diagnostics

Figure 5.5. Current and Possible Future Applications of Diagnostics

Figure 5.6. Limits to Genomic Predictions of Drug Efficacy

Figure 5.7. RNAi Market Forecast

 


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