Paediatric Extrapolation in Drug Development: Has the Paradigm Shift started?
DRA symposium
The importance of evidence based medicine in children has received increasing attention after a history of neglecting children as part of drug development. Drug development present a complex dilemma where the need to gather evidence is balanced with the ethical considerations associated with the burden of conducting clinical trials in children. Pediatric extrapolation is an approach where clinical data in children is partially or fully generated by extrapolating data from relevant sources in adults. In many ways the technical framework for pediatric extrapolation is well established in the field of pharmacometrics and methods are generally encouraged by regulatory authorities. Thus, the use of pediatric extrapolation represents a paradigm shift from traditional drug development in children. But is pediatric extrapolation currently being used optimally? Has the pediatric extrapolation paradigm shift really started? And what is blocking the road for better drug development in children? These are questions we will discuss at this PopSim meeting.
Programme
| 13:00-13:15 | Welcome Rasmus Juul Kildemoes, PopSim, Novo Nordisk |
| 13:15-13:45 | Perspectives from the Danish Medicines Agency Anne-Mette Hoberg, Danish Medicines Agency |
| 13:45-14:30 | Paediatric Extrapolation: Has the Paradigm Shift started? Cécile Ollivier, Critical Path Institute |
| 14:30-15:00 | Break & Network |
| 15:00-15:30 | Paediatric drug development of GLP-1 agonists in treatment of type 2 diabetes Kristin Cecilie Carlsson Petri, Ascendis Pharma |
| 15:30-16:00 | Dose selection during paediatric development of Tapentadol – a novel opioid analgesic Estelle Watson, Lundbeck |
| 16:00-16:30 | Panel discussion: How can the regulations for paediatric drug development be further improved, for the benefit of paediatric patients? |
| 16:30-16:45 | Wrap-up and concluding remarks Rasmus Juul Kildemoes, PopSim, Novo Nordisk |
The symposium will be a semi-virtual meeting. Link to online participation: https://ucph-ku.zoom.us/j/63526172339?pwd=ZFY1N1JFOXNLQWxiSTNOTXBMSGhjZz09 , passcode 713551.
The symposium is organized on behalf of the graduate programme in pharmaceutical sciences, Drug Research Academy, by Trine Meldgaard Lund, Department of Pharmacy/Drug Design and Pharmacology, Faculty of Health and Medical Sciences, University of Copenhagen in collaboration with Rasmus Juul Kildemoes, PopSim, Section for Quantitative Pharmacology, The Danish Pharmaceutical Society.
The DRA symposium is free of charge and open for attendance by all interested parties.