Wilmington-based PPD is collaborating with a drug development services organization based in England to accelerate the development of pediatric drugs, according to an announcement Tuesday.
The partnership between Pharmaceutical Product Development LLC (PPD), a global contract research organization (CRO), and Nottingham, England-headquartered Quotient Sciences has benefits for both, a news release said.
The collaboration leverages PPD’s pediatric clinical trial experience, regulatory knowledge and site and pediatric patient networks, and Quotient’s expertise in pediatric formulation development, drug product manufacturing and global supplies, the release stated.
According to the release, the companies will jointly support pediatric drug development for clients from concept to market launch through an end-to-end service that will speed delivery of pediatric medicines.
The new service was established in response to increasing customer demand, the release stated, as well as the drive by regulatory agencies to promote the development of new medicines for children earlier in the product development lifecycle.
“Our collaboration with Quotient will enable us to jointly provide a one-of-a-kind offering that meets the needs of patients and regulators in the development of pediatric drug products,” said Karen Kaucic, senior vice president and global head of PPD’s Rare Disease and Pediatric Center of Excellence, in the release. “For our customers, this integrated, full-service approach will provide accelerated timelines through a simple contracting process, the rapid development and clinical testing of pediatric formulations, and comprehensive program design and regulatory support. We believe the combined global expertise that our two companies can offer in formulation, manufacture and clinical development of pediatric medicines is a unique offering that will accelerate the development of these important products.”
The release stated that the collaboration also "simplifies contracting and delivery by offering clients a single solution for an entire pediatric program, with only one contract and one PPD point of contact. As a result of that structure, the number of handoffs is significantly reduced and the process is much more streamlined, eliminating the delays that often occur when moving from early dosing to later phases."
PPD is a leader in pediatric clinical trials, having performed more than 300 studies in 95 countries with more than 100,000 patients over the past five years, according to the release. The collaboration with Quotient enhances the pediatric offerings and capabilities PPD uses to conduct those studies, the release said.
“Our commitment to pediatric medicines has been building for several years,” said Mark Egerton, CEO of Quotient, in the release. “Through our partnership with PPD, our customers can now access an end-to-end solution that can be tailored to their specific needs. PPD has built significant expertise and capabilities in delivering pediatric clinical trials, which we believe makes the partnership a natural fit for us.”
PPD has a pediatric investigator network that consists of 14 pediatric centers of excellence, according to the release.
"These centers are augmented by a newly added community-based U.S. network of more than 60 clinics and hospitals that focus on a wide variety of common pediatric indications, supporting PPD’s ability to deliver comprehensive pediatric site strategies across multiple therapy areas," the release stated.
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