Pharmaceutical Product Development, LLC (PPD), a leading global contract research organization (CRO), and Quotient Sciences (Quotient), a drug development services organization, announced a new collaboration to accelerate pediatric drug development.
The partnership 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 companies will jointly support pediatric drug development for clients from concept to market launch through a unique end-to-end service that will speed delivery of pediatric medicines. The new service was established in response to increasing customer demand and the drive by key regulatory agencies to promote the development of new medicines for children earlier in the product development life cycle.
“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, M.D., senior vice president, global head of PPD’s Rare Disease and Pediatric Center of Excellence. “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 collaboration 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.
“Our commitment to pediatric medicines has been building for several years,” said Mark Egerton, CEO of Quotient. “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 is a leader in pediatric clinical trials, having performed more than 300 studies in 95 countries with more than 100,000 patients over the last five years. The collaboration with Quotient enhances the pediatric offerings and capabilities PPD utilizes to conduct those studies.
PPD also leverages a pediatric investigator network, consisting of 14 pediatric centers of excellence, to further enhance its pediatric clinical development capabilities by providing clients with faster trial startup, more predictable patient enrollment and higher-quality data. 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.
Quotient has innovated a new approach to drug development called Translational Pharmaceutics® that integrates formulation development, real-time adaptive GMP manufacturing and clinical research capabilities, to reduce drug development costs and shorten timelines. Quotient’s comprehensive knowledge of pediatric patient needs, as well its expertise and capabilities in preformulation, formulation, analytical characterization, product stability, process development, clinical trial supplies, regulatory needs and commercial production, enable customers to access customized pharmaceutical development programs to meet the complex technical challenges of pediatric products.