EFGCP Better Medicines for Children Pre-Conference

The Fundamentals of Paediatric Extrapolation

Description

Event Workshop
Type Virtual Event
Language English
Date(s) 17 Oct. 2022
Day(s) 1 Day(s)
Duration 4 hours/ day

In Spring 2022, the International Council for Harmonization (ICH) published the E11A draft guideline establishing a framework for extrapolation from existing data to the pediatric population. The new guideline aims to promote international harmonization of methodologies and strategies to incorporate pediatric extrapolation into overall drug development plans, improving the speed of access to new drugs for pediatric patients while limiting the number of children required for enrolment in clinical trials. The extrapolation framework consists of a pediatric extrapolation concept, and the creation and execution of an extrapolation plan.

This workshop has been designed to provide pediatric researchers, trial sponsors, and regulatory reviewers an opportunity to actively engage with experts to learn the fundamentals of developing a pediatric extrapolation concept and plan.

Attendees will participate in interactive small group discussions learning how to assess the similarities and differences of disease between a reference and a target population. Experts will also guide attendees through the development of an extrapolation plan - determining the relevant studies to be performed, analyzing whether model-informed approaches are appropriate and evaluating potential study designs. Workshop attendees will learn about the use of bridging biomarkers, Bayesian strategies and single arm pharmacokinetic/pharmacodynamic (PK/PD) studies and their application in pediatric extrapolation.

NEWS! This event is complementary to the Better Medicines for Children Conference 2022. Benefit from reduced rates by registering to both event at the same time!
Registration to both events with reduced rate is available only from the Better Medicines for Children Conference 2022 page as breakout sessions is required for this conference, thank you for your understanding.

Programme

Monday 17 October 2022
13:00 Opening of Conference
13:00 Welcome and Introduction to the pre-Conference Workshop
Christina Bucci-Rechtweg, Novartis Pharmaceuticals Corporation
13:10 Lecture 1 - Why Extrapolation is Used in Paediatric Medicines Development
Dionna Green, Director, Office of Pediatric Therapeutics, Office of the Commissioner, FDA
13:25 Lecture 2 - What Extrapolation is Used in Paediatric Medicines Development
Andrew Thomson, Statistician, EMA
13:40 Lecture 3 - How Extrapolation is Used in Paediatric Medicines Development
Skip Nelson, Senior Director, Pediatric Drug Development (CHILD) & Pediatric Strategy Lead, Pediatric Development Team, Immunology, Janssen
13:55 Introduction of the Breakout Sessions
Moderator(s): Ashley Strougo, Sanofi
14:00 Breakout Session 1 - Case Study 1 "Developing an Extrapolation Concept and Plan & Handling Uncertainties"
14:50 Break-Out Session 1 Report Back
15:05 Summary of Case 1 Outcome
15:15 Break
15:25 Breakout Session 2 - Case Study 2 "Developing an Extrapolation Concept and Plan & Handling Uncertainties"
16:15 Break-Out Session 2 Report Back
16:30 Summary of Case 2 Outcome
16:40 Parting Comments & Key Take-aways
Lily Mulugeta, Clinical Reviewer, Division of Pediatric & Maternal Health, FDA
17:00 End of the Pre-Conference Workshop