Agenda

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

Time	Activity
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)