Quintiles is looking into a new way of using biomarkers to speed the process of selecting patients for trials and new treatments, Quintiles Chief Medical and Scientific Officer Dr. Jeff Spaeder told us.
In participation with US Oncology Research, Quintiles is working on a feasibility study that explores the benefits of genomic profiling of patients’ metastatic colorectal cancer tumors. The study is investigating the impact of pre-profiling and genomic sequencing data on physician treatment decisions and selecting appropriate clinical trials for patients.
“Early indications from this study suggest that we can provide physicians and patients with early visibility on potentially clinically actionable biomarkers within a rapid two-week timeframe,” Dr. Spaeder said.
He said biomarkers were previously used in sequential tests but “now we have a number of biomarkers that are available” and can be looked at “in parallel.”
“In the past health providers haven’t really thought about the spectrum of biomarkers, so they may have looked at a couple up front and ordered some additional ones,” Dr. Spaeder added.
As far as how many CROs like Quintiles might be able to conduct such biomarker testing, Dr. Spaeder did not compare Quintiles with their competitors but he noted that “this is not a trivial undertaking. This requires a lot of scientific and technical capability and coordination,” especially in terms of extracting DNA, processing the genetic material and then analysing the genomic sequences.
Examples of CROs taking advantage of biomarkers include Indian CRO GVKBIO, which has a biomarker database that sponsors and CROs tap for early clinical research. The US FDA was granted further access to the database earlier this year .
AstraZeneca also recently sought the help of the Sarah Cannon Research Institute to develop oncology compounds through biomarker screening.
But biomarkers haven’t always offered rosy success stories. In fact, in May Dr. Spaeder told us , “We’ve been a little disappointed that some biomarkers have not had the correlation with the outcomes we would’ve liked, but we needed them for earlier assessments of efficacy and safety and to make go and no go decisions.”
The increasing use of biomarkers also pushes Quintiles further into the field of personalized medicine, which is increasingly becoming the path companies are looking to for developing more targeted therapies.