Quintiles: Patient selection, biomarkers key to cancer R&D

As the top cancer researchers gather in Chicago, the world's largest CRO is weighing in on how best to steer the future of oncology drug development, arguing that picking the right patients and biomarkers in early stages can mean the difference between a blockbuster and a late-phase failure.

In two reports authored by its in-house experts, Quintiles ($Q) singles out the most important decision points in drug studies, saying the biological complexity of cancer demands painstaking molecular profiling of patients early on in investigation, giving researchers as much information as possible before they decide whether to pursue a program.

"By identifying a well-defined group of patients with a particular molecular biological profile, we have the potential to make more efficient decisions on product candidates at the earliest possible stage," Quintiles' therapeutic strategy head Philip Breitfeld said in a statement. "As the cost of oncology drug development rises, the use of targeted therapies represents a path toward more precise treatment approaches that would drive down costs, timelines and failure rates."

And that's where biomarkers play a large part, Quintiles said, as diseases like multiple myeloma, lymphomas and leukemias can be charted by particular mutations, proteins and chromosomal abnormalities.

"While the use of biomarkers is widely supported and the hope of early detection is promising, few biomarkers have been identified or clinically validated for the early detection, progression or risk assessment for such malignancies," Quintiles oncology expert Harish Dave said in a statement. "Recent advances in understanding of these malignancies and the advent of high-throughput technologies have the potential to facilitate rigorous translational research toward the discovery, development and clinical validation of novel biomarkers."

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