Daniel -
…Patients’ genetic ancestry can sometimes significantly determine how well or how poorly they respond to a drug. Having a large repository of clinical samples defined with such data might help researchers at pharma and diagnostics companies run more efficient clinical trials, ….
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“We have presumably an underlying ethnic consideration with the biology of these patients that predisposes them to either respond or not respond to drugs,” BioServe CEO Kevin Krenitsky told Pharmacogenomics Reporter this week. “So, if you’re going to go and spend $600 million to $700 million developing a drug, it behooves you, if you’re using human biological samples for target identification, target validation, or even diagnostics, that you utilize the appropriate genetic panels using genetic ancestry tagging.”
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According to Krenitsky, the “goal … is not necessarily to come up with a drug or a target that may be suited for a particular ethnic group, but to come up with a target that works independently of the ethnic groups, so you can find a true marker that is indicative of the population as a whole without regard to the ethnic group.
“The goal would be to find tests and drugs that would work in everyone,” he said.
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Still, given the soaring cost of drug development and the high rate of attrition in late-stage clinical trails, genetic differentiation of ancestry is growing in prominence among drug and diagnostic developers looking to run safer clinical trials and learn more about investigational products earlier in the development process.
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“The legislation and the push for pharmacogenomic testing now is so great that pharma companies don’t really have a choice. It’s a situation now where, as we get into more niche drugs, the pharmaceutical companies are being forced to respond to this issue upfront,” Krenitsky said.
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“If you look at the pipelines at the pharma companies and how they have been stretched thin over the last few years, and there is a move to outsourcing to innovating biotech companies, they can’t afford to spend several hundred million dollars before they find out that drug A or B failed because it has minimal response in a certain segment of the population. So they’re being forced to really embrace pharmacogenomics.”
DNAPrint Genomics offers computational biology and pharmacogenomics services to biopharmaceutical companies, a service that may benefit with a more detailed biological sample repository. BioServe’s global repository also facilitates its collaborations with pharma, biotech, and diagnostic firms to identify and validate disease-causing biomarkers, and to correlate clinical and molecular data to develop diagnostic tests.
Good luck to all longs...!
sam
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