QPS, a CRO supporting discovery, preclinical and clinical drug development, is expanding its U.S.-based Translational Medicine division, which supports nucleic acid therapeutics. The expansion at its Newark, DE site allows QPS to support additional partners for next-generation drug therapies.

“Gene therapy will become important in treating, and possibly curing, the neediest of more than 1.5 billon people who have mutations linked to genetic diseases,” said John L. Kolman, Ph.D., vice president and Global Head of Translational Medicine, QPS. “Many pharmaceutical and biotech companies are diverting resources to develop gene therapy candidates, and they choose QPS because we’ve been in the gene therapy bioanalytical space from the beginning. Our team of scientists has extensive experience helping sponsors measure nucleic acid drug pharmacokinetics (PK), biodistribution and clearance. Additionally, by measuring secondary targets and biomarkers, QPS enables partners to demonstrate that their therapeutics are delivering the corrective effects expected.” 

QPS has tripled the footprint of its Translational Medicine site in Delaware. “Our partners require this level of scientific support as they work to find cures for these difficult and previously incurable diseases. In fact, one of our partners recently began a First in Human clinical trial of a lead candidate drug to replace a key protein, the absence of which is the underlying cause of the disease indication,” Susan Zondlo, Ph.D., Director of Bioanalysis, QPS Translational Medicine, said. “This partner started working with QPS in the early preclinical phase. Our high-quality, on-time delivery led the partner to choose QPS, again, for the clinical trial.” 

“We provide multiple assay platforms including qPCR, chromatography and mass spectroscopy, making it possible for us to measure nucleic acid therapeutics of different modalities,” Zondlo said. “So, whether it’s a viral vector used for traditional gene therapy, an mRNA encoding a replacement protein, an siRNA to downregulate gene expression, or the downstream targets of any of these strategies, we have the solutions that our partners need.”

QPS is currently working with a partner on small molecule biomarkers that measure the efficacy of a new nucleic acid drug to treat a rare disorder. “Our ability to deliver critical data on short notice is one of the many reasons this particular partner chose QPS,” Zondlo said. 

QPS is working with several partners to perform PK analysis and clearance of “armed” oncolytic viruses to combat solid tumors. “Our team is measuring the expression of viral transgenes in tumor and normal cells to demonstrate targeted action of the drugs. A number of partners have promising nucleic acid lead candidates for treatment of cancer patients,” Zondlo said.