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Workshop: Pediatric Modified Release -What’s the Problem and What are Some Solutions?

Monday, July 8, 2024
1:00 PM – 5:00 PM CET
Location: Sala Italia

Sponsored By 
The workshop is centered on obtaining expert input into the challenges associated with modified release formulations (especially parenterals) in pediatric patients, and some technologies old and new emerging as solutions to these challenges. For both aspects there will be a speakers with regulatory, industry and academic backgrounds, and separate panel sessions with Q&A on challenges and solutions. Industrial formulation and regulatory scientists presented with these challenges, academics looking to enter this research field and students active in the pediatric formulation field will gain the most from this workshop.


Agenda


1:00 pm to 1:10 pm                                   Welcome & Introductions
                                                                    Daniel Schaufelberger, PhD, Johns Hopkins University
                                                                    Ben Boyd, PhD, University of Copenhagen and Monash                                                                                                                    University

1:10 pm to 1:30 pm                                   Challenges in Pediatric Drug Development
                                                                    Daniel Schaufelberger, PhD, Johns Hopkins University


1:30 pm to 2:00 pm                                   Global Partnerships to Accelerate Innovation for Better Paediatric                                                                                              Formulations 
                                                                    Martina Penazzato, MD, MSc, PhD, World Health Organization


2:00 pm to 2:30 pm                                   Pediatric Drug Development, Scientific & Regulatory Considerations
                                                                    Karl-Heinz Huemer, PhD, MD, khh consult


2:30 pm to 3:00 pm                                  Coffee Break


3:00 pm to 3:30 pm                                  Nanosuspension Stability and Pediatric Utility
                                                                   Rene Holm, PhD, DSc, University of Southern Denmark


3:30 pm to 4:00 pm                                  Subcut Models
                                                                   Tyler Novak, PhD, Gilead Sciences


4:00 pm to 4:30 pm                                  Long-Acting Injectables; Including Examples for Treatment and                                                                                                  Prevention of HIV
                                                                   Terry Ernest, PhD, Almac Group


4:30 pm to 5:00 pm                                  Panel Discussion - Refining the Problem Statement and Potential                                                                                              Solutions
                                                                   All Speakers