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Perlegen: Will Numbers Enable Pharmacogenomics

This article was originally published in Start Up

Executive Summary

Until now, Perlegen contends, pharmacogenomics has failed to deliver because no one has had the statistical power to show connections. With its whole genome scanning technology, Perlegen aims to prove that it can come up with usable and predictive markers of drug response by inexpensively screening for millions of SNPs and analyzing subsequent patterns--even without any significant biological understanding. The start-up aims to use its technology to help compounds win regulatory approval and more market share than they otherwise could. Perlegen also plans to support in-licensed drug candidates and seek disease genes. It wants a share of drug sales its studies enable, and to leverage all the IP it can capture. Absent its own drug discovery and development program, Perlegen needs partners to provide the compounds and clinical samples with which it can create pharmacogenomic data and secure an FDA imprimatur. Competitors argue that smaller sets of data, informed by a clearer biological understanding, will provide equally effective pharmacogenomic data, cheaper.

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Pharmacogenomics: Promises and Problems

So far, pharmacogenomics, the study of the effects of an individual's genetic makeup on their response to drugs, has not produced the hoped-for revolution in the pharmaceutical industry, due primarily to lagging approvals and the high cost of molecular testing. Nevertheless, the promise of personalized medicine is very real, and several exciting products have received FDA approval.

The Outlook for Pharmacogenomics Testing in Primary Care

The FDA sees pharmacogenomics as a key tool for optimizing both the development and clinical utility of drugs. But most of the visible examples to date of pharmacogenomics have been in specialty areas like oncology and virology. The Vioxx situation raises an inevitable question as Pharma looks to improve R&D efficiency and clinical utility. What is the role of pharmacogenomics in assessing the safety and efficacy of primary care drugs?

The Outlook for Pharmacogenomics Testing in Primary Care

The FDA sees pharmacogenomics as a key tool for optimizing both the development and clinical utility of drugs. But most of the visible examples to date of pharmacogenomics have been in specialty areas like oncology and virology. The Vioxx situation raises an inevitable question as Pharma looks to improve R&D efficiency and clinical utility. What is the role of pharmacogenomics in assessing the safety and efficacy of primary care drugs?

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