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.
| Time | Activity |
|---|---|
| 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 |