The new Pediatric Site Network (PSN) is a series of pediatric research centers around the world, which according to PRA, will it to “improve pediatric clinical development and enhance access to novel medicines for the pediatric population.”
The contract research organization (CRO) has formalized relationships with centers in the EU, US, and Israel, and has plans to expand to Latin America and the Asia Pacific.
The “focal point and repository” for the company’s global pediatrics knowledge is its Center for Pediatric Clinical Development, it said.
PRA launched the center in May 2017, at which time the center’s VP Mark Sorrentino, MD, said the next step would be to form a global network.
“Operationalizing patient- and family-centered pediatric clinical trials is a complex process in that it requires careful consideration of study design and logistical challenges unique to this vulnerable population,” said Kirsten Sherman Cervati, senior director, Center for Pediatric Clinical Development, lead, Pediatric Site Network.
“Through our Pediatric Site Network we have opportunity to augment our existing pediatric expertise with insights from research minded thought leaders with the shared goal of advancing safe and effective treatment options within the pediatric space,” she told us.
More than 70% of medications are prescribed to children off label, though demand to conduct clinical trials to address this gap has increased significantly over the past 20 years, said Sherman Cervati.
Additionally, both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have published legislation requiring written plans for all medications under investigation to be assessed in children.
On the PRA’s recent Q3 earnings call, CEO Colin Shannon said the company has been looking at “a few things” over seas and contemplating adding to the business, though nothing is expected immediately.
“We see some market opportunities that we might want to take advantage of; and there could potentially be tuck-in acquisitions [that] would give us the capability to take advantage of some of our data solutions,” he said.
Shannon explained that PRA is looking to expand its capabilities in other markets, a lot of which can be done organically. “We're still building out some areas in Asia, and we're still [seeing] a lot of room to expand that significantly and we're working through that just now. I don't see that as being acquisitions, I do see that as more organic growth,” he added