Length 184 pages

Date published June 2009

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Pharmacogenomics: Delivering on the Promise Tables and Figures


Author: Leslie A. Pray, PhD

Fifty-five Diseases and Traits With Published Genome-Wide Association Studies
A List of Genetic Biomarkers Included In FDA-Approved Drug Labels
The Four FDA-Required Pharmacogenomic Tests
An Optimistic View of How Pharmacogenomics Can Be Used to Accelerate Drug Development
A Select List of Pharmacogenetic Tests Used (Or Not Used) in Psychiatry

Pharmacogenomics in Clinical Practice
The Growing Cost of US Healthcare and Growing Cost of Prescription Drug Expenditures in the United States: Driving Pharmacogenomics
The Widening Gap Between New Drug R&D Spending and New Drug Approvals: Driving Pharmacogenomics
Differential Drug Responses: Driving Pharmacogenomics
How the Past Ten Years Culminated in 2007 Being a “Spectacular” Year for Human Disease Genetics
Warfarin’s Narrow Therapeutic Window
Preliminary Results of an Association Between CXCL5 Genotype and Statin Response

Question 1: Please classify your organization.
Question 2: What disease area does your company, or lab, focus on?
Question 3: When did your company or lab become involved with pharmacogenomics? (Or, if the sole focus of your organization is pharmacogenomics, when was your organization founded)?
Question 4: About what percentage of your company or lab’s research and/or development efforts revolve around pharmacogenomics?
Question 5: Will your company or lab be expanding its pharmacogenomics-based research or development efforts in the near future?
Question 6: What is your or your organization’s chief application of pharmacogenomics?
Question 7: If you (or your organization) are involved with discovering or analyzing gene-drug response associations, which theoretical approach do you take?
Question 8: If your company, organization, or laboratory is involved with the development, manufacturing, or marketing of a pharmacogenomics-based product or service, which of the following business models best describes your company?
Question 9: Have you been involved in any way and at any stage, from basic research through marketing, with a pharmacogenomics-based product (either drug or test) that is currently on the market?
Question 10: If your company or organization is involved with drug development, how often does your company or organization collect pharmacogenomic information during clinical development?
Question 11: Is genotyping done because preclinical or other evidence suggests that it should be done, or is it done for a broad range of genes and not necessarily for any particular reason?
Question 12: Is genotyping done in-house, or is it outsourced?
Question 13: Is the genotyping required for FDA review?
Question 14: Which of the following genotypes have been used?
Question 15: At what stage of development is pharmacogenomic information collected?
Question 16: How is pharmacogenomic information used?
Question 17: If your answer to question 16 was “To evaluate whether pharmacogenomic information should be included on the product label,” who is usually responsible for developing the companion diagnostic?”
Question 18: Which of the following do you think will most likely emerge as the most common application of pharmacogenomics?
Question 19: What do you think is (or will be) the greatest challenge to moving pharmacogenomics forward?
Question 20: Do you think that pharmacogenomics is industry’s only feasible option for dealing with the growing problem of drug safety? 
Question 21: If you answered “no” to question 20, what other options should (or must) industry consider?