Children Are Not Small Adults – Importance of Biopharmaceutics and Dose Design in Pediatric Drug Development
Sponsored by: Catalent Pharma Solutions
- Pediatric Drug Development
Date: 27 April
Time: 4PM London/ 11AM New York
Over the years, tremendous efforts have been made by regulators to incentivize pharmaceutical companies to develop medicines specifically for the pediatric population. However, developing drug products for pediatric populations is a challenging undertaking due to the physiological differences between children and adults. This complexity is further compounded with the requirement of age appropriate dosage forms.
Join this webcast to hear a distinguished speaker discuss the current challenges in pediatric drug development programs including predicting oral absorption, and in vitro and in silico methods that can be applied to predict behavior in pediatric populations. During this session, a Catalent expert will highlight formulation and dosage form development strategies based on target product profiles that can help bring patient centric treatments to market faster.
Professor Hannah Batchelor,
Strathclyde Institute of Pharmacy and Biomedical Sciences, Glasgow
Professor Hannah Batchelor is a pharmaceutical scientist who has worked in academia, the NHS and within pharmaceutical industry. She is currently based at the Strathclyde Institute of Pharmacy and Biomedical Science, University of Strathclyde in Glasgow.
She works on the design and manipulation of medicines to create age appropriate drug formulations to maximise clinical efficacy in paediatric patients. Her research interests lie in the optimisation of drug formulations to maximise their biopharmaceutical performance and acceptability to children. Her research is informed by the views of children, young people and parents to ensure that the patients are at the centre of new developments. Hannah is recognised as an expert in biopharmaceutics and leads the Academy of Pharmaceutical Scientists Focus group on biopharmaceutics in the UK as well as the European Paediatric Formulation Initiative’s biopharmaceutics workstream. She is also an active member of the Understanding Paediatric Gastrointestinal Processes (UNGAP) consortium. She has ongoing research projects that explore paediatric biopharmaceutics in conjunction with Janssen; Certara; the FDA and GlaxoSmithKline.
Dr. Andrew Parker,
Director Open Innovation, Small Molecules, Oral and Speciality Drug Delivery, Catalent Pharma Solutions
Andrew’s technical background is in colloid and surface science. After completing his undergraduate studies in Chemistry at the University of Bristol in 1996, Andrew performed research for his doctorate at the Bristol Colloid Centre (BCC) in biocompatible coatings. Andrew has spent the last 20 years in the CDMO industry, in a variety roles and has supported and managed a number of paediatric drug product development projects. Andrew is now a Director of Open Innovation at Catalent with a strong interest in the evolution of paediatric formulation and testing approaches.
Key Learning Objectives
- Learn about current challenges in predicting oral absorption in pediatric populations
- Explore biorelevant age appropriate in vitro and in silico methods for pediatric drug development
- Discover formulation development strategies and dose form presentation based on target product profiles for pediatric patients
- Understand how dose form manufacturing capabilities are scaled to meet pediatric clinical trial and market requirements
- Senior/Director New Product Strategy & Development
- Senior/Director Product Development
- Senior/Director R&D
- Formulation Scientists
- Project Leaders/Project Management
- Head/Senior/Director - CMC
- Senior/Director - Strategic Sourcing and Consultants