Gentris Corp.
This article was originally published in Start Up
Executive Summary
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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Pharmacogenomics' Reality Check
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.
The Pharmacogenomics Challenge
Individualized drug therapy represents such a potential watershed in the pharmaceutical industry that drug and biotech players have no option but to consider how and when they should participate in pharmacogenomics. But thanks to the evolving nature of the technologies and responses to the cultural and political issues pharmacogenomics raises, drug firms should think in particular about three areas of opportunity and risk: enhancing the commercial value of drugs; regulatory changes that could lead to micro-segmentation of markets; and new methodologies that streamline clinical development costs.
Pharmacogenetic Strategies
Stratifying patients in clinical trials based on their genes could help get new drugs approved faster, and revive failed compounds. Genomics companies have the infrastructure, technologies, and desire to make the science of pharmacogenetics their business. Start-ups are using people’s differing responses to drugs as platforms for new ‘personalized’ drug development strategies.