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
Time | Activity |
---|---|
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
|
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
|
3:45-4:00 p.m. | Closing Remarks Issam Zineh, PharmD, MPH, FCP, FCCP Director, Office of Clinical Pharmacology Food and Drug Administration |