This article has been updated to include comments from a Quintiles spokesperson.
By Turna Ray
Quintiles is ramping up its genomics data-analysis capabilities to drug firms developing personalized medicines thanks in part to a recently announced collaboration with UK startup Population Genetics Technologies.
The non-exclusive deal, announced earlier this month, gives Quintiles access to PGT’s genomic data-analysis technology, which the contract research organization claims can cheaply and efficiently "process many hundreds of genomes simultaneously" while "retaining the ability to identify each individual genome during post-sequencing data analysis."
The arrangement with PGT is in line with Quintiles' ongoing efforts to expand its pharmacogenomics research capabilities. Last November, Quintiles announced a collaboration with PGx firm London Genetics to provide personalized medicine services to drug developers (PGx Reporter 11/30/2010).
Earlier that same month, Quintiles said it would work with Dako to advance personalized medicine products. The first project under that deal will involve an oncology drug in AstraZeneca's pipeline (PGx Reporter 11/03/10).
According to a Quintiles spokesperson, the most prominent barriers for biopharmaceutical companies looking to invest in the development of personalized medicine products are experimental costs, data management and analysis, as well as the ability to correlate DNA SNPs to clinical outcomes. "Correlating such biomarkers to clinical outcomes may enable better patient selection for trials, which has potential to improve efficacy rates, reduce adverse event rates and improve product differentiation," the spokesperson told PGx Reporter. "Quintiles and PGT can lift these barriers through identification and correlation of these biomarkers in a more cost-effective manner, while finding correlations that previously were not observed or thought to be artifacts of the analysis."
Quintiles' work with PGT will focus on identifying rare and common alleles that are associated with variability in how people respond to treatments. According to PGT's website, its proprietary genomic technology could save researchers money and time by "shortcutting" next-generation sequencing techniques and focusing on analyzing regions of the genome that display variation compared to the rest of the population.
As described by PGx Reporter sister publication In Sequence, PGT has developed a tagging method that allows it to sequence pools of samples and distinguish between true variants and errors introduced during the PCR-enabled amplification process (IS 05/10/2011).
"Large-scale testing has been prohibitively expensive, as sample preparation, sequencing, and analysis have to be undertaken separately for each sample," Quintiles said in a statement. "PGT’s innovative technology can process many hundreds of genomes simultaneously, in a single sequencing assay, while still retaining the ability to identify each individual genome during post-sequencing data analysis."
Using this technology, Quintiles and PGT plan to help drug developers analyze samples from hundreds or thousands of individuals, and streamline genomic analysis in their clinical trials. "We believe this technology, especially for large clinical trials, offers significant benefits -- reduced trial enrollment required to achieve statistical significance, which saves time and/or costs; fewer adverse events and greater efficacy by identifying genetic markers indicative of both; and improved product differentiation," a company spokesperson said.
Quintiles believes that after moving away from blockbuster drugs, biopharma’s future is in so-called "multi-buster" drugs targeted at genomically defined subpopulations of patients. "Biopharma recognizes this -- 70 percent of all phase I-III trials include biomarkers in their protocols," the Quintiles spokesperson said. "In the near future, as DNA sequencing becomes standard in trials and clinical labs, we believe this technology will become a part of mainstream drug development."
According to PGT Chief Commercial Officer Frank Massam, PGT's first project with Quintiles will focus on identifying efficacy and adverse events biomarkers for an unnamed renal cancer drug. Quintiles and PGT couldn't identify the specific drug involved in the project due to confidentiality agreements with their partner. PGT is also conducting genomic research on breast cancer, leukemia, and Alzheimer’s disease.
Last October, PGT announced it had received a $1.2 million Translation Award from the Wellcome Trust to conduct a two-year study of genetic predisposition to Alzheimer’s disease in collaboration with Cardiff University in Wales.
Commenting on the non-exclusivity of the agreement, the partners said in a statement that they will both "seek other opportunities to demonstrate to biopharma companies, payers, academic researchers and patient groups the value of this approach to improving human health."
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