A schedule of events for Innovative Approaches to Pediatric Drug Development and Pediatric Medical Countermeasures: A Role for Physiologically-Based PK? is provided below for your convenience.

This one-day conference scheduled for Monday, May 5, 2014, will be held at the Food and Drug Administration's (FDA) White Oak Campus. It is open to the public. For a printable agenda, please download the conference brochure‌.

Moderators: Thomas Dowling and Jian Wang

TimeActivity
8:30-8:45 a.m. Opening Remarks: Opportunities and Challenges in Pediatric Drug Development and Regulatory Science
Gil Burckart, PharmD
Associate Director for Pediatrics
Office of Clinical Pharmacology
Food and Drug Administration
8:45-9:15 a.m. Modeling and Simulation in Pediatric Patients: Top-Down, Bottom-Up, and What It All Means Clinically
Sander Vinks, PharmD, PhD
Director, Division of Clinical Pharmacology
Professor of Pediatrics
University of Cincinnati
9:15-9:45 a.m. PBPK in Pediatric Drug Development: Prior FDA Experience
Vikram Sinha, PhD
Director, Division of Pharmacometrics
Food and Drug Administration
9:45-10:15 a.m. EMA experience of pediatric PBPK
Ine Skottheim Rusten, PhD
Scientific Officer
European Medicines Agency
10:15-10:30 a.m. Break
10:30-11:00 a.m. A Workflow Example of PBPK Modeling to Support Pediatric Research and Development
Jeff Barrett, PhD
Vice President, Interdisciplinary Pharmacometrics Program
Sanofi
11:00-11:30 a.m. Use of PBPK in Drug Development and Application to the Pediatric Setting
Jörg Lippert, PhD
Global Head, Clinical Pharmacometrics
Bayer
11:30-12:00 p.m. Practical Application of PBPK in Neonates and Infants, Including Case Studies
Neil Parrott, PhD
M&S Scientist
Roche Pharmaceuticals
12:00-1:00 p.m. Lunch
1:00-1:30 p.m. Managing Pediatric Poisons: How Important Are Accurate Dose Recommendations?
Kevin Watt, MD
Assistant Professor of Pediatrics
Duke University School of Medicine
1:30-2:30 p.m. Panel Discussion #1: Special Considerations and Utility of PBPK for Pediatric MCM
Moderator: Dionna Green
  • Dionna Green -- Introduction (15 minutes)
  • Jiang Liu -- Case Presentation (10 minutes)
  • Panel Discussion (35 minutes) with Panelists:
    • Suzie McCune, MD (Deputy Director, OTS)
    • Ping Zhao, PhD, (PBPK Lead, OCP)
    • Kim Bergman, PhD (Antiviral Team Leader, OCP)
    • Jiang Liu, PhD (Pharmacometrics Reviewer, OCP)
    • Karen Davis-Bruno, PhD (Nonclinical Team Leader, OND)
    • Jorg Lippert, PhD, Bayer Pharmaceuticals
    • Jeffrey Fisher, PhD, Research Toxicologist, NCTR, FDA
2:30-2:45 p.m. Break
2:45 – 3:45 p.m. Panel Discussion #2: Modeling and Simulation in Neonates and Infants
Moderators: Sander Vinks and Tom Dowling
  • Jian Wang -- FDA Experience with Neonatal Trials (10 minutes)
  • Panel Discussion (50 minutes) with Panelists:
    • Suzie McCune, MD (Deputy Director, OTS)
    • Jian Wang, PhD, Senior Reviewer, Pediatric Clin Pharm Staff
    • Yaning Wang, PhD, Deputy Director, Division of Pharmacometrics
    • Kevin Watt, MD, Duke University School of Medicine
    • Neil Parrott, PhD, Roche Pharmaceuticals
    • Jeff Barrett, PhD, Sanofi
    • Ine Skottheim Rusten, PhD, Norwegian Medicines Agency
3:45-4:00 p.m. Closing Remarks
Issam Zineh, PharmD, MPH, FCP, FCCP
Director, Office of Clinical Pharmacology
Food and Drug Administration