QPS, a GLP/GCP-compliant contract research organization (CRO) supporting discovery, preclinical and clinical drug development, has announced the expansion of its U.S.-based Phase I clinical trial capabilities to support the growing needs of its pharmaceutical, biotechnology and CRO partners. To fill their drug pipelines, large pharmaceutical and biotechnology companies are buying promising drug compounds that have been developed by small biotech companies up to the point of candidate nomination. These promising compounds then become candidate drugs that the large companies put through rigorous testing and analysis before potentially being reviewed and assessed for approval by the FDA.
"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 First-in-Human trials to the point of candidate nomination," said CEO Benjamin Chien, QPS. "This strategic expansion complements our work with pharmaceutical and biotechnology companies, as well as our CRO partners, where 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," said Chien. "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 amount of First-in-Human studies are rapidly increasing and there are very few sites across the country that can conduct them," said Gutierrez. "QPS is well-known for its success in First-in-Human studies. We excel at complex and special population Phase I trials, and our enrollment and completion rates are among the best in the industry."
When it comes to complex, special population trials, QPS has experience in diabetes, NASH/NAFLD, elderly, CNS, pediatric, rheumatoid arthritis, asthma and COPD, allergies, women's health, and many more therapeutic areas. "Studying and ensuring the safety of a drug is of primary importance to our partners, and clinical pharmacology is front-and-center in leading that effort," Gutierrez said. This focus on safety is underscored by the QPS Miami site's full reaccreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), indicating QPS follows rigorous standards for ethics, quality and protections for human research.
With the expansion comes an increased focus on quality. "To ensure the quality of our clinical trials is maintained, QPS has hired two additional full-time principal investigators to ensure dedicated, physician-involvement at every stage of our trials," said Chien. "We now have five full-time principal investigators, and a network of more than 25 board-certified subspecialty physician investigators to support the increased volume of studies in our pipeline."
Sandra Pagnussat, MD, joined QPS as a primary investigator dedicated to Phase I trials. She brings to QPS expertise in internal medicine, pediatrics and rheumatology. Since the enactment of the FDA Safety and Innovation Act (FDASIA) in 2012, the number of pediatric clinical trials have increased. More than 436 separate studies that enrolled around 56,000 children have been performed, and the FDA has issued approximately 340 written requests for new pediatric studies.
"We expect this demand for pediatric studies to continue," said Pagnussat. "Pediatric trials are specialized and unique. And they are in high-demand, particularly for companies that want to extend their patents to include pediatric patients."
"Research shows that only about 25 percent of drugs used today have been labeled for pediatric patients. We support our partners 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 QPS 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.
The National Institutes of Health (NIH) estimates that approximately 23.5 million Americans live with an autoimmune disease and that its prevalence is on the rise. "We are well-versed in immunosuppressant drugs and immune-modulating therapies. We are comfortable with those medications, the potential side effects profile and how to monitor those patients," said Lipson. "As companies work to expand their indications, they partner with QPS in early- and late-stage trials because of our expertise in autoimmune disorders."
To meet growing client demand in all of these areas – small biotech companies progressing promising drug compounds to the point of candidate nomination, an increase in demand for First-in-Human studies, pediatrics, autoimmune disorders, and other complex, special population clinical trials – QPS has increased early-phase clinical capacity by more than 20 percent at its clinical site in Miami, FL. "By increasing the number of beds from 75 to 92, not only can QPS support our partners with larger studies, but we also can complete studies in less time," said Chien.
Additionally, QPS doubled its specialty lab space at the Miami site and co-located it with its Miami-based clinical site. "In the market, you'll find CROs that offer clinical services, and then you'll find specialized labs. At QPS, we now we have the unique combination of clinical services and a specialized lab combined under one roof," said Chien. "And, that's important because many of our studies require lab samples to be processed quickly, in less than eight hours. Having our clinical site and specialty lab co-located makes this possible."