Major CRO PPD and U.K.-based drug development company Quotient have signed up to a new partnership aimed at shortening timelines, reducing costs and cutting down on paperwork when it comes to making new drugs for children.
The Wilmington, North Carolina-based CRO will combine its pediatric clinical trial experience, regulatory knowledge, and site and pediatric patient networks, alongside Quotient’s work 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 pair said in a statement.
They add that this new service, financial terms of which are not being disclosed, was born out of an “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.”
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“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., SVP and 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 collab is designed to streamline the processes involved in the entire pediatric program by having only one contract and one PPD point of contact. Simplicity in this regard should cut down on delays and red tape, the companies explain.