An agenda for "Pediatric Ontogeny: Ready for Incorporation into Modeling in Pediatric Drug Development?" is provided below for the convenience of workshop attendees.

This one-day conference is scheduled for Thursday, May 16, 2019. It will be held in the Kirschstein Auditorium in the Natcher Conference Center at the National Institutes of Health, located at 9000 Rockville Pike in Bethesda, Md.

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Moderators:

  • Gilbert J. Burckart, PharmD
    Associate Director for Pediatrics
    Office of Clinical Pharmacology
    Food and Drug Administration
  • Jian Wang, PhD
    Associate Director for Regulatory Science
    Office of Drug Evaluation IV
    Office of New Drugs
    Center for Drug Evaluation and Research
    Food and Drug Administration
  • Jill Morgan, PharmD, BCPS, BCPPS
    Professor and Chair
    Department of Pharmacy Practice and Science
    University of Maryland School of Pharmacy

Download a printer-friendly agenda here.

TimeActivity
Introduction
8:00-8:35 a.m. Welcome/Pediatric Drug Development
Gilbert J. Burckart, PharmD
Associate Director for Pediatrics
Office of Clinical Pharmacology
Food and Drug Administration
8:35-8:55 a.m. Developmental Pharmacokinetics
John van den Anker, MD, PhD
Pediatric Clinical Pharmacology
Children’s National Medical Center
8:55-9:15 a.m. Developmental Pharmacodynamics
Greg Kearns, PharmD, PhD
President
Arkansas Children’s Research Institute
9:15-9:35 a.m. Modeling and Simulation Applications for Predicting Pediatric Ontogeny
Stefan Willmann, PhD
Clinical Pharmacometrics
Research & Development
Bayer
Drug Metabolism and Transporter Function
9:35-10:00 a.m. Ontogeny and Phase II Metabolism of Drugs
Stephan Schmidt, PhD
Associate Professor
Center for Pharmacometrics and Systems Pharmacology
University of Florida
10:00-10:20 a.m. Break
10:20-10:45 a.m. Ontogeny of Phase I Metabolism of Drugs
Steve Leeder, PharmD, PhD
Marion Merrell Dow Endowed Chair in Pediatric Precision Therapeutics
Mercy Children's Hospital
10:45-11:10 a.m. Ontogeny of Drug Transporter Function
Shiew Mei Huang, PhD
Deputy Directory, Office of Clinical Pharmacology
Center for Drug Evaluation and Research
Food and Drug Administration
11:10 a.m. - Noon Moderated Panel Discussion
Moderators: Drs. Burckart and Morgan

Panelists: Drs. van den Anker, Kearns, Huang, Leeder, Willmann, Edress Darsey (Pfizer), and Sander Vinks (University of Cincinnati)
Noon – 1 p.m. Lunch
Renal Function, Pharmacogenomics Ontogeny
1:00-1:25 p.m. Ontogeny of Renal Function and Renal Drug Elimination
Jian Wang, PhD
Associate Director, Regulatory Science
Office of Drug Evaluation IV
Office of New Drugs
Food and Drug Administration
1:25-1:50 p.m. Ontogeny and Application of Pharmacogenomics to Pediatrics
Dionna Green, MD
Deputy Director, Office of Pediatric Therapeutics
Commissioner’s Office
Food and Drug Administration
Applications to Pediatric Drug Development
1:50-2:20 p.m. Application of Ontogeny within MIDD for Pediatrics
Hao Zhu, PhD
Deputy Director, Division of Pharmacometrics
Office of Clinical Pharmacology
Center for Drug Evaluation
Food and Drug Administration
2:20-2:40 p.m. Break
2:40-3:10 p.m. Industry Perspective on Utilizing MIDD for Pediatric Studies Requiring Integration of Ontogeny
Solange Corriol Rohou, MD, PhD
Chair, ICHE11 M&S Subcommittee
Senior Director, Global Regulatory Affairs & Policy, Europe
AstraZeneca Global Medicines Development
3:10-4:00 p.m. Moderated Panel Discussion
Moderators: Drs. Burckart and Jian Wang

Panelists: George Giacoia (NIH); Issam Zineh (FDA); Hao Zhu (FDA); Solange Corriol Rohou (AstraZeneca); Stephan Schmidt; Linh Van (Novartis); Dionna Green (FDA)
4:00-4:15 p.m.

Pediatric Ontogeny and Modeling and Simulation: Remaining Questions
Gilbert J. Burckart, PharmD
Associate Director for Pediatrics
Office of Clinical Pharmacology
Food and Drug Administration

Thanks to Program Committee Members:

Gil Burckart (FDA), Jian Wang (FDA), Jill Morgan (University of Maryland), John van den Anker (Children’s National, Washington D.C.), Andre Dallmann (Bayer), Dionna Green (FDA), Sander Vinks (University of Cincinnati), and George Giacoia (NIH)