The contract research organization (CRO) has expanded its Miami, FL-based Phase I clinical trial capabilities by more than 20%, increasing its bed count from 75 to 92.
Dr. Martha Hernandez-Illas, medical director of Phase I studies at the site, said the expansion “is really going to help support exponentially more sponsors.”
“It allows us to accommodate larger trials and it also helps us complete trials in less time,” she told Outsourcing-Pharma.com in an exclusive interview.
Additionally, the CRO has doubled its specialty lab space at the site to provide same-day results – and further time savings. Specifically, Hernandez-Illas explained that having a lab on-site enables QPS to confirm a patient’s eligibility the day of testing, and to “pick up” on safety trends quickly.
In parallel, QPS has grown in terms of personnel with the recent onboarding of Marcelo Gutierrez, PhD, as the company’s new director of clinical pharmacology, a role in which he will help guide sponsors, Hernandez-Illas said.
Two additional principal investigators (PIs) also have been hired, including Sandra Pagnussat, MD, who specializes in internal medicine, pediatrics, and rheumatology, as well as Aliza Lipson, MD, an adult rheumatologist who will be dedicated to late-phase clinical trials.
With the new hires, QPS now employs five full-time PIs supported by a network of more than 25 board-certified subspecialty physician investigators.
Shifting demand
Hernandez-Illas said the addition of Pagnussat is “really going to expand” the company’s ability to conduct more pediatric clinical trials, demand for which has been increasing since the US Food and Drug Administration (FDA) passed the Safety and Innovation Act (FDASIA) in 2012.
The FDA has issued approximately 340 written requests for new pediatric studies, said Hernandez-Illas.
“There’s definitely been a shift in terms of trials that are in high demand,” she said of pediatric trials, adding that as “more and more” people are living with autoimmune disease it is another area QPS has seen an increase in demand.
According to the National Institutes of Health (NIH) approximately 23.5m Americans live with an autoimmune disease.
Large pharma to small biotech
Mirroring this shift in demand is the company’s evolving customer base:
“There is going to be a shift in our business of years ago being mostly large pharma … I think things are going to shift where there is going to be a much bigger portion of our early phase work coming from these smaller companies that don’t have that same support,” Hernandez-Illas said.
“Large pharma companies are more and more often buying their molecules from smaller biotech companies that maybe just have one or two drugs that they are focused on,” she explained, adding that these small biotech companies do not have the resources of the larger pharmaceutical companies.
Hernandez-Illas said, “That is really where we can come in and support and supplement what they are missing.”
Phase III trials
For later phase trials, QPS last year expanded its headquarters in Delaware Technology Park. According to the CRO, the expansion enables it to process high sample volumes for Phase III clinical trials.
The investment increased its laboratory staff of 57 to 88. The number of analysis teams also increased from seven to 11.
Additionally, QPS created a working group to handle the demand for neutralizing antibody assays. In line with the additions, the company has also expanded its dedicated immunobioanalysis and cell culture space, as well as the protein mass spectrometry area.
