The deal brings together PPD’s experience in pediatric clinical trials with Quotient’s Translational Pharmaceutics platform, which integrates formulation development, real-time adaptive GMP manufacturing, and clinical research capabilities.
Through the new collaboration, the companies will offer a single solution for an entire pediatric program through a single contract and with one PPD point of contact.
“Significant strides have been made in advancing the testing and labelling of drugs specifically intended for use in children and adolescents, largely as a result of increased regulatory focus in the US and Europe,” explained Karen Kaucic, MD, senior vice president, global head of PPD’s Rare Disease and Pediatric Center of Excellence.
The regulations are aimed at generating data to support and authorize the use of age-appropriate formulations, Kaucic told us. However, there is a “well-recognized gap,” in the authorization and labeling of medicines for children and adolescents, she said.
“This partnership will allow us to provide comprehensive support for pediatric development programs,” explained Kaucic.
Services will include development and manufacture of pediatric formulations, design and execution of clinical trials to support marketing authorization, and regulatory and drug development consultation.
Kaucic also said the partnership will provide customers with enhanced program efficiency, including reduced active pharmaceutical ingredient (API) use, shorter timelines between manufacture and clinical testing, and the ability to rapidly assess multiple doses and formulations.
“Accelerating pediatric drug development is the key,” she added.
“We anticipate that the development and approval of age-appropriate medicinal formulations will be a continued focus of regulators, clinicians and parents, and we expect to see continued demand for rapid, high-quality and cost-effective pediatric development support.”