More than 25 years of research has given us valuable information for developing new pediatric drugs but there is a need to explore novel alternative methods (NAMs) moving forward.
Workshop Objectives
- To understand the current programs in federal agencies related to novel alternative methods and pediatric developmental biology;
- To discuss the identification and utilization of secondary targets in a pediatric developmental safety assessment;
- To review the use of juvenile animal studies and in vitro tools to assess pediatric developmental safety assessment; and
- To explore the use of model-informed drug development techniques such as quantitative systems pharmacology and the use of artificial intelligence and machine learning in pediatric developmental safety assessment.
Meeting Materials
Final Agenda
Speaker, Panelist and Moderator Biographies
Planning Committee Roster
Watch Recording
Speaker Slides:
Topic Introduction and Overview (Dr. Gilbert Burckart, Associate Director for Pediatrics, Office of Clinical Pharmacology, Center for Drug Evaluation Research, U.S. FDA)
FDA Experience with Secondary Targets for New Drugs (Dr. Rebecca Racz, Senior Pharmacokineticist, Office of Clinical Pharmacology, Center for Drug Evaluation Research, U.S. FDA)
Industry Experience with Juvenile Animal Studies (Dr. Susan Laffan, Senior Director, Translational Safety and Risk Sciences, Amgen)
Microphysiological Systems to Predict Pediatric Developmental Efficacy and Safety Outcomes (Dr. James Hickman, Chief Scientist, Hesperos Inc.)
Building a QSP Tool for Pediatric Safety Analysis: DILIsym (Dr. Paul Watkins, Distinguished Professor, Eshelman School of Pharmacy, University of North Carolina Chapel Hill and Co-Director, Triangle Center of Excellence in Regulatory Science and Innovation)
Adapting a Secondary Pharmacology-Based Tool to Flag-up Off-Target Interactions of Particular Concern in Pediatric Patients (Dr. Will Redfern, Vice President, Quantitative Systems Toxicology and Safety, Certara)
Resources Available for Analysis of Prior Information for Pediatric Developmental Safety (Dr. Lang Li, Professor and Chair, Maternal and Pediatric Precision In Therapeutics (MPRINT) Data and Model Knowledge and Research Coordination Center, Department of Biomedical Informatics, College of Pharmacy, Ohio State University
How Can We Answer the Pediatric Developmental Safety Questions in ICH E11A Using These Techniques? (Dr. Gilbert Burckart, Associate Director for Pediatrics, Office of Clinical Pharmacology, Center for Drug Evaluation Research, U.S. FDA)
Registration Information
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