Quintiles redux

RESEARCH TRIANGLE PARK, N.C.—Quintiles, a longtime major player in the world of contract research, and Population Genetics Technologies Ltd. (PGT), whose proprietary technology reduces costs and time for large-scale genomic testing and increases the probability of associating genomic variations with clinical outcomes, have announced a commercial collaboration to bring genomic testing into mainstream drug development in order to produce safer, more effective medicines.

Under the terms of the collaboration, Quintiles and PGT will jointly identify opportunities to apply the power of large-scale genomic analyses to test clinical hypotheses and correlate biomarkers of disease prognosis and drug responsiveness. The biopharma sponsor will identify a therapeutic area for investigation, postulate a hypothesis and fund or co-fund the study. PGT will help, if necessary, to determine likely candidate genomic regions, identify and access a suitable cohort of population samples with associated clinical data, perform its proprietary workflows, generate variant data by individual and perform phenotype or genotype correlations. Quintiles will make resources available for the clinical evaluation of sample sets, assist in the determination of most likely candidate regions and bring to bear its expertise in any subsequent clinical trial recruitment and completion.

The alliance is designed to leverage PGT's game-changing technology and Quintiles' clinical research expertise and global resources to bring the benefits of large-scale genomic testing within reach of virtually every biopharma company.

To date, such large-scale testing has been prohibitively expensive, as sample preparation, sequencing and analysis have to be undertaken separately for each sample. 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, the companies say.

"Both companies believe this alliance has the ability to dramatically accelerate use of PGx to improve drug development efficiency and effectiveness, and make the promise of personalized medicine a reality to improve human health and save lives," says Dr. Sandra Silberman, vice president of Quintiles' Innovation group. "It made perfect sense for PGT to partner with the world's largest CRO in order to bring the maximum benefit of its technologies to real-world stratified medicine, and similarly, Quintiles has the stated intention of using genomic advances to improve the efficiency and focus of its clinical trials for its biopharma partners. As in all successful alliances, people are the key component and both sides have developed a great mutual respect and working relationship."

The PGT collaboration is designed to enable the rapid identification of rare and common alleles that may collectively account for significant variation in treatment responses. Quintiles sees the collaboration as an important example of its commitment to personalized medicine. The traditional model of CROs as fee-for-service providers is "not sustainable," Silberman opines.

As part of the Innovation group created by Dr. M. King Jolly, senior vice president of Quintiles Innovation, Silberman and her colleagues will assert their intellectual capabilities to look at new models for doing the work, taking risks and making investments.

"We will see a return on our investment when we reach proof of concept," she says.

In addition to Quintiles' goal of speeding drug development through these types of collaborations, she notes it is also important to increase probabilities of success by using better-designed clinical trials and combination approaches as well as discontinuing development of ineffective or unsafe therapeutic candidates earlier—prior to Phase III—particularly in oncology.

"PGT's technology combined with Quintiles' global presence can bring the benefits of large-scale sequencing and analysis to virtually all biopharmaceutical companies," says Jolly. "The combination of Quintiles and PGT's capabilities can, we believe, increase the probability of success in clinical trials, reduce trial enrollment required to achieve statistical significance and diminish the costs and/or time required to bring a product to market—all while improving product differentiation."

PGT Chief Commercial Officer Dr. Frank Massam adds: "Our first project with Quintiles is a renal cancer clinical trial to identify genetic markers predictive of both adverse events and efficacy, but our workflows are appropriate to all therapeutic areas. We are currently running programs in breast cancer, leukemia and Alzheimer's disease. We are proud to be associated with the work that Quintiles is leading to deliver real patient benefits from cutting-edge genomic research."