QPS Expands US-Based Phase I Clinical Trial Capabilities

QPS, a contract research organization (CRO) is expanding its United States-based Phase I clinical trial capabilities in response to an increase in promising drug candidates in the pharmaceutical pipeline. Currently, company managers say, large pharmaceutical and biotechnology companies are filling their drug pipelines by buying drug candidates in development by small biotech companies up to the point of candidate nomination.

“We’ve seen this trend evolve and have expanded our Phase I clinical trial capabilities to better serve the hundreds of smaller companies developing potential new drugs. We have completed more than 150 Phase I trials, and this expansion will enable us to support exponentially more sponsors as they progress compounds through proof of concept and [f]irst-in-[h]uman trials to the point of candidate nomination,” said QPS CEO Benjamin Chien, in a company press release. “This strategic expansion complements our work with large pharmaceutical and biotechnology companies, [for whom ] we have successfully conducted more than 1,300 Phase I–IV clinical trials for drug candidates.”

“Engaging smaller biotechnology companies is key in expanding QPS Phase I capabilities, and these companies don’t have large research or clinical pharmacology departments,” Chien added. “We appointed Marcelo Gutierrez, PhD, to serve as our director of clinical pharmacology so sponsors can tap into his vast experience working for three well-known pharmaceutical companies. His guidance with respect to the safe translation of drugs into humans, protocol design, and interpretation of preclinical data and results, will be invaluable to sponsors seeking nomination for promising drug compounds.”

“Our pipeline is filled with sponsors that need this level of support. The [number]of [f]irst-in-[h]uman studies is rapidly increasing and there are very few sites across the country that can conduct them,” said Gutierrez in the press release. “QPS is well-known for its success in [f]irst-in-[h]uman studies. We excel at complex and special population Phase I trials, and our enrollment and completion rates are among the best in the industry.”

QPS has experience developing therapies that target allergies and diabetes, as well as diseases that affect women, children, and the elderly; central nervous system disorders; rheumatoid arthritis, asthma; and chronic obstructive pulmonary. “Studying and ensuring the safety of a drug is of primary importance to the sponsor, and clinical pharmacology is front-and-center in leading that effort,” Gutierrez added.

New expert appointments

The company has hired two additional full-time principal, so that its staff now includes five full-time principal investigators and a network of more than 25 board-certified subspecialty physician investigators to support anticipated growth.

Sandra Pagnussat, MD, joined QPS as a primary investigator dedicated to Phase I trials. She has expertise in internal medicine, pediatrics, and rheumatology. Since the enactment of the FDA Safety and Innovation Act (FDASIA) in 2012, Chien notes, the number of pediatric clinical trials has increased. More than 436 separate studies involving around 56,000 children have been performed, and FDA has issued approximately 340 written requests for new pediatric studies.

“We expect this demand for pediatric studies to continue,” said Pagnussat in the company press release. “Research shows that only about 25 percent of drugs used today have been labeled for pediatric patients. We support sponsors in conducting pediatric clinical trials to test how drugs work in children,” she continued.

QPS also appointed Aliza Lipson, MD, an adult rheumatologist, to the role of primary investigator dedicated to late-phase clinical trials. “This hire enables QPS to extend the Phase I rheumatology and autoimmune disorder work [the company] is already doing under the direction of Martha Hernandez-Illas, MD, medical director of the QPS Phase I Unit, to late-phase clinical trials,” said Chien.

To meet growing client demand for all these areas-small biotech companies progressing promising drug compounds to the point of candidate nomination; an increase in demand for first-in-human studies; and pediatrics, autoimmune disorders, and other complex, special population clinical trials-QPS has increased early phase clinical capacity by more than 20% at its clinical site in Miami, FL. “By increasing the number of beds from 75 to 92, not only can QPS support sponsors with larger studies, but we also can complete studies in less time,” said Chien.

Additionally, QPS has doubled specialty lab space at its Miami site and co-located it with its clinical site. “We now we have clinical services and a specialized lab combined under one roof,” Chien commented. “And, that’s important because many of our studies require lab samples to be processed less than eight hours. Having our clinical site and specialty lab co-located [should make] this possible.”

Source: QPS