Notes from presentations delivered at Innovative Approaches to Pediatric Drug Development and Pediatric Medical Countermeasures: A Role for Physiologically-Based PK? are provided below for the convenience of conference participants.

Opening Remarks: Opportunities and Challenges in Pediatric Drug Development and Regulatory Science‌
Panel Discussion #1: Special Considerations and Utility of PBPK for Pediatric MCM‌
Panel Discussion #2: Modeling and Simulation in Neonates and Infants‌
Gil Burckart, PharmD
Associate Director for Pediatrics
Office of Clinical Pharmacology
Food and Drug Administration

PBPK in Pediatric Drug Development: Prior FDA Experience‌
Vikram Sinha, PhD
Director, Division of Pharmacometrics
Food and Drug Administration

EMA experience of pediatric PBPK‌
Ine Skottheim Rusten, PhD
Scientific Officer
European Medicines Agency

A Workflow Example of PBPK Modeling to Support Pediatric Research and Development‌
Jeff Barrett, PhD
Vice President, Interdisciplinary Pharmacometrics Program
Sanofi

Use of PBPK in Drug Development and Application to the Pediatric Setting‌
Jörg Lippert, PhD
Global Head, Clinical Pharmacometrics
Bayer

Practical Application of PBPK in Neonates and Infants, Including Case Studies‌
Neil Parrott, PhD
M&S Scientist
Roche Pharmaceuticals

Managing Pediatric Poisons: How Important Are Accurate Dose Recommendations?‌
Kevin Watt, MD
Assistant Professor of Pediatrics
Duke University School of Medicine

Special Considerations and Utility of Modeling and Simulation for Pediatric Medical Countermeasures:Introduction‌
Dionna Green, MD
Medical Officer
Office of Clinical Pharmacology
Office of Translational Sciences
Center for Drug Evaluation and Research
Food and Drug Administration

MCM Pediatric Dose Selection: Case Presentation‌
Jiang Liu, PhD
Pharmacometrician
Division of Pharmacometrics
Office of Clinical Pharmacology
Food and Drug Administration

Pediatric PBPK Panel Discussion: Clinical Pharmacology Studies in Neonates‌
Jian Wang, PhD
Senior Staff Fellow
Pediatric Clinical Pharmacology Staff
Food and Drug Administration