8:00 a.m.

Welcome and Introductory Remarks

Jeffrey Botkin, MD,
Chair of Pediatric Ethics Subcommittee
Professor of Pediatrics
Adjunct Professor of Medicine
University of Utah

Walter Ellenberg, PhD
Executive Secretary, Pediatric Advisory Committee
Office of Pediatric Therapeutics, OC, FDA

8:05 a.m.

Agenda Overview

Robert 'Skip' Nelson, MD, PhD
Senior Pediatric Ethicist/Lead Medical Officer
Office of Pediatric Therapeutics, OC, FDA

8:15 a.m.

Phenotyping Studies in Children:
Why, How and Issues to be Addressed

J. Steven Leeder, MD
Division Chief Clinical Pharmacology
Children’s Mercy Hospitals and Clinics

Opportunity for questions

9:00 a.m.

Evaluating Exploratory IND Studies According to the Ethical Framework of 21 CFR 50 subpart D

Robert 'Skip' Nelson, MD, PhD
Senior Pediatric Ethicist/Lead Medical Officer
Office of Pediatric Therapeutics, OC, FDA

Opportunity for questions

9:45 a.m.

Break

10:00 a.m.

Presentation of Questions

Michelle Roth-Cline, MD. PhD
Pediatric Ethicist/Health Scientist
Office of Pediatric Therapeutics, OC, FDA

Committee Discussion

11:00 a.m.

Open Public Hearing

12:00 p.m.

Lunch

1:00 p.m.

Discussion and Recommendations

3:00 p.m.

Adjourn

Jeffrey Botkin, MD, Chair
Professor of Pediatrics
University of Utah