Leveraging Rapid Clinical Assessments to Accelerate Pediatric Formulation Development

18 September 2023 10:20 - 10:50

There are many important considerations to keep in mind when developing a pediatric dosage form and the requirements can greatly differ from drug products designed for adult use. Development scientists must consider the route of administration, safety profile, overall taste and palatability, the child’s age, weight, physiologic condition and the treatment plan’s requirements. All these key factors must be balanced appropriately in order to successfully develop a pediatric product that garners clinical, regulatory and commercial success. Arguably the greatest industry challenge however remains a lack of knowledge and guidance on how these development objectives can be successfully met.  In this talk, Huw Jones, Executive Director of Patient Centric Medicines at Quotient Sciences, will share strategies and case studies illustrating how key challenges in pediatric product development can be overcome, allowing drug developers to get medicines to pediatric patients in need faster.

What you’ll learn:

  • How understanding taste issues early in development can help determine your taste masking strategy and target product profile (TPP)
  • How integrated clinical testing can be used to optimize pharmacokinetic (PK) performance of new pediatric drug products
  • How PBPK modelling and simulation can be utilized for dose extrapolation and to predict product performance
  • How adaptive clinical manufacturing and product supply strategies can get product to global pediatric trials faster

Huw Jones, Executive Director, Patient Centric Medicines, Pediatric Services Drug Development Consulting, Quotient Sciences