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Pharmacogenomics' Reality Check

This article was originally published in Start Up

Executive Summary

Pharmacogenomics is making its way into the infrastructure of clinical medicine. Large companies are discussing pharmacogenomics at the board level, and issuing top-down pronouncements about it. It is also entering the vocabulary of drug testing teams; pharmacogenomics is, for instance, being applied to traditional pharmacogenetic drug metabolism tests. The technology will almost certainly impact drug discovery. Knowing the genetic variability of a target can help a drug developer choose the best candidate from among three or four leads early in the game. But cost-effective enabling technologies do not yet exist. Most sorely missed are cost-effective, high-throughput genotyping methods. For now, companies are banking samples of patients' DNA and developing genetic tests to accompany drugs in clinical trials and on the market. Even as tool providers work to overcome technology hurdles, drug companies unquestionably remain worried about the possibility that pharmacogenomics information could limit the market potential of their products. Nevertheless, the buy-in may well come--surprisingly--from marketing people.

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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.

Why Don't Big Pharmas Buy Pharmacogenomics?

Pharmacogenomics has disappointed advocates who saw the opportunity to apply a discovery tool to the near-term goal of increasing approval chances and marketability for late-stage and marketed compounds. In return, they hoped to take a percentage of the highest-cost segment of the pharmaceutical budget. But Big Pharma is by and large not using pharmacogenomics for late-stage and marketed compounds: senior executives don't believe there's enough evidence it works and are afraid of limiting the marketability of the products by segmenting broad target populations into niches. Some also worry about uncovering potential side-effects that non-pharmacogenomic trials wouldn't reveal. Nonetheless, pharmacogenomics has made it to Big Pharma: most companies, for example, are banking samples from clinical trials to be pharmacogenomically tested retrospectively, thereby informing future trials. Not that this means the pharmacogenomics specialists will be able to sign high-value deals with the commercial side of drug companies, who believe that pharmacogenomic analysis is available from a number of sources, including internal ones, and feel they own the key assets for creating meaningful programs: compounds and patient samples. Instead, pharmacogenomics will find its place first as a discovery technology, integrated with other methods for finding, validating and prioritizing targets. That means that to succeed selling pharmacogenomics, biotechs will have to combine their pharmacogenomic assets with other discovery technologies, perhaps through mergers. An alternative: use their technologies to find drug products that they can themselves develop, perhaps later out-licensing them.

Gentris Corp.

Gentris Corp. is developing and commercializing proprietary clinical pharmacogenomic markers, initially for pharmaceutical customers but ultimately to offer as clinical diagnostics. Pharmacogenomics, it believes, can improve trial design, and increase predictability, shorten the drug development cycle, improve new drug approval rates, and enable companies to retest drug candidates that fail to meet clinical trial or FDA approval standards.

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