A schedule of events for Pediatric Drug Development: Use of Exposure Matching and Exposure-Response for Extrapolation of Efficacy in Pediatric Product Development is provided below for your convenience.

This one-day conference scheduled for Thursday, January 22, 2015, 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.

TimeActivity
8:30–8:40 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
8:40–9:10 a.m. Pediatric Extrapolation: Using Exposure As A Surrogate for Efficacy
Robert "Skip" Nelson, MD, PhD
Senior Pediatric Ethicist and Lead Medical Officer
Office of Pediatric Therapeutics
Office of the Commissioner
Food and Drug Administration
9:10–9:30 a.m. FDA Perspective: Exposure-Response Assessments and Applications to Drug Development in the FDA
Kevin Krudys, PhD
Pharmacometrics Reviewer
Office of Clinical Pharmacology
Food and Drug Administration
9:30—9:45 a.m. What Constitutes A Meaningful Endpoint for Establishing Exposure-Response Similarity Between Adults and Pediatric Patients?
Lynne Yao, MD
Associate Director
Division of Pediatric and Maternal Health
Food and Drug Administration
9:45-10:00 a.m. Case Examples: Exposure-response to Support Extrapolation of Efficacy of IBD for Children
Kerry Jo Lee, MD
Pediatric Gastroenterologist, Gastroenterology and Inborn Errors Products
Office of New Drugs
Food and Drug Administration
10:00–10:20 a.m. Assessing Quality and Quantity of Data to Establish Exposure-Response Similarity Between Adults and Pediatric Patients: PEACE Initiative
Angela Men, MD, PhD
Neurology Team Leader
Food and Drug Administration
10:20—10:45 a.m. Break
10:45-11:00 a.m. Case Examples: Extrapolation of Efficacy for JIA in Children
Satjit Brar, PharmD, PhD
Team Leader, Clinical Pharmacology
Food and Drug Administration
11:00-11:15 a.m. Dealing with Uncertainty of Extrapolation Assumptions
Tarek Leil, PhD
Head, Quantitative Clinical Pharmacology Group
Bristol-Myers Squibb
11:15 a.m. - 12:30 p.m. Panel Discussion/Public Q&A
Moderators: Vikram Sinha and Gilbert Burckart

Panel Members: Darrell Abernethy, Robert Temple, Dianne Murphy, Marc Gastonguay, Tarek Leil, John Pellock, Ron Portman, and Lynne Yao
12:30-1:30 p.m. Lunch
1:30–1:45 p.m. Experience in FDA Submissions with Matching Pediatric Drug Exposure to Adult Drug Exposure
Lily Mulugeta, PharmD
Pediatric Clinical Pharmacologist
Office of Clinical Pharmacology
Food and Drug Administration
1:45-2:00 p.m. Case Examples: Extrapolation of Efficacy of GERD in Children
Insook Kim, PhD
Clinical Pharmacology Reviewer
Food and Drug Administration
2:00-2:15 p.m. The Pediatric Trials Network: Experience with Matching Drug Exposure in Infants and Neonates to Adult Drug Exposure
Daniel Gonzalez, PharmD, PhD
Assistant Professor
Department of Pharmacotherapy and Experimental Therapeutics
University of North Carolina Eshelman School of Pharmacy
2:15-2:40 p.m. Methods for Determining Similarity of Exposures Between Adult and Pediatric Patients and Trial: Design Considerations
Marc R. Gastonguay, PhD
President & Chief Executive Officer
Metrum Research Institute
2:40-3:00 p.m. When Does Exposure Matching Require Additional Consideration?
Jeff Barrett, PhD
Vice President, Interdisciplinary Pharmacometrics Program
Sanofi
3:00—3:15 p.m. Break
3:15—4:00 p.m. Panel Discussion/Public Q&A
Moderators: Lily Mulugeta and Jeff Barrett

Panel Members: Shirley Seo, Skip Nelson, Andrew Mulberg, Kimberly Bergman, Daniel Gonzalez, Catherine Sherwin, and Marc Gastonguay
4:00–4:15 p.m. Closing Remarks and Next Steps
Gil Burckart, PharmD
Associate Director for Pediatrics
Office of Clinical Pharmacology
Food and Drug Administration