A detailed agenda for "Pediatric Dose Selection" is provided below for the convenience of conference attendees.
Scheduled for Oct. 22-23, 2020, "Pediatric Dose Selection" is a one-day workshop hosted by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI).
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Thursday, Oct. 22, 2020
| Time | Activity |
|---|---|
| 10:00 – 10:05 a.m. | Welcome G. Burckart (FDA) |
| Introductory Talks Moderator: Jill Morgan (University of Maryland School of Pharmacy) | |
| 10:05 – 10:20 a.m. | What Information Does the Pediatric Clinician Need, and How is Dosage “Drift” Over Time Handled Clinically? J. Morgan (University of Maryland School of Pharmacy) |
| 10:20 – 10:35 a.m. | Review of the Adult Dose Selection EMA Workshop E. Manolis (EMA) |
| 10:35 – 10:50 a.m. | Review of the Methods Used for Dose Selection in U.S. Pediatric Drug Development Programs G. Burckart (FDA) |
| 10:50 – 11:05 a.m. | Drug Development Programs Where the Dose Was a Problem Y. Wang (FDA) |
| Review of Pediatric Dosing Approaches Moderator: Gil Burckart (FDA) | |
| 11:05 – 11:35 a.m. | Point-Counterpoint: Traditional Approaches Versus PBPK to Predict Pediatric Doses Two 15-minute Talks:
|
| 11:35 – 12:30 p.m. | Discussion and Questions Moderators: Jill Morgan (University of Maryland School of Pharmacy) and Gil Burckart (FDA) |
| 12:30 – 1:00 p.m. | Lunch Break |
| 1:00 – 1:15 p.m. | Exposure-Matching for Pediatric Patients with Efficacy Extrapolation H. Zhu (FDA) |
| 1:15 – 1:30 p.m. | Use of Exposure-Response in Pediatric Drug Development J. Wang (FDA) |
| 1:30 – 1:45 p.m. | Dose Determination in Neonates J. van den Anker (Children’s National) |
| 1:45 – 2:00 p.m. | Biologicals Dosing in Pediatrics B. Meibohm (University of Tennessee) |
| 2:00 – 3:00 p.m. | Discussion and Questions Moderators: Jill Morgan (University of Maryland School of Pharmacy) and Gil Burckart (FDA) |
Friday, Oct. 23, 2020
| Time | Activity |
|---|---|
| Filling the Gap Moderator: Jian Wang (FDA) | |
| 10:00 – 10:15 a.m. | Evaluation of Drug-Drug Interactions and Their Influence on Drug Dosing in the Pediatric Population D. Gonzalez (University of North Carolina) |
| 10:15 – 10:30 a.m. | Renal Impairment in Pediatric Patients: How Can We Promote Best Practices in Drug Dosing? M. Khurana (FDA) |
| 10:30 – 10:45 a.m. | Predictive Performance of PBPK Dose Estimates for Pediatric Trials A. Dallmann and I. Ince (Bayer) |
| 10:45 – 11:00 a.m. | How Can Pharmacogenomics and Cancer Genetics Be Incorporated in Pediatric Drug Development Studies? J. Yang (St. Jude Children’s Research Hospital) |
| Developing a Reasonable Approach for Pediatric Dose Selection Moderator: John van den Anker (Children’s National) | |
| 11:00 – 11:15 a.m. | Current and Future Pediatric Approaches J. Barrett (Critical Path Institute) |
| 11:15 – 11:30 a.m. | Current and Future Pediatric Dosing Considerations from a Regulatory Viewpoint L. Yao (FDA) |
| 11:30 – 12:30 p.m. | Discussion and Questions Moderators: John van den Anker (Children’s National) and Gil Burckart (FDA) Speakers: All Friday Speakers and Sander Vinks (University of Cincinnati), Dionna Green (FDA), Clinton Stewart (St. Jude Children’s Research Hospital) |
| 12:30 – 12:35 p.m. | Wrap-Up and Adjourn G. Burckart (FDA) |