Quantitative Assessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics

Flyer: pedsextrapolation-flyer June 1 2016 workshop.pdf (136.0 KB)

Agenda: systemspharmawpsorger2011.pdf (1.3 MB)

The Food and Drug Administration (FDA), in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (CERSI), is holding a public workshop on June 1st, 2016 titled Quantitative Assessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics.

The objective of the workshop is to discuss quantitative and qualitative approaches for verifying assumptions pertaining to disease and therapeutic response similarity between adults and children. The workshop will also provide a forum for discussion on the use of modeling and simulation for systematic assessment of extrapolation assumptions. The purpose of this public workshop is to provide an opportunity for relevant stakeholders, including clinicians, academia, industry and FDA to discuss systematic assessment of data needed to support extrapolation of efficacy in pediatric product development. Specifically, the workshop will include:

• Presentations on approaches for assessing disease and therapeutic response similarity between adults and pediatrics
• Discussion of alternative approaches to the assessment of extrapolation assumptions in pediatric product development, including the use of clinical trial simulation and Bayesian approaches.
• Examples in partial onset seizures, inflammatory bowel diseases, and polyarticular juvenile idiopathic arthritis will be presented and discussed.

Date: Wednesday, June 1st, 2016, 8:00 a.m. - 5:00 p.m.

Location: FDA White Oak Campus, Building 31, the Great Room (Rm. 1503A)

Interested individuals can attend the meeting in person or via Web cast. Seating will be limited, so early registration is recommended. Registration is free and will be on a first-come, first-served basis.

For more information, please visit: http://www.pharmacy.umaryland.edu/centers/cersievents/pedsextrapolation/
For further information contact: Lily Mulugeta (email: yeruk.mulugeta@fda.hhs.gov)