Clinical Pharmacology Corner: Public Meeting on Extrapolation of Efficacy in Pediatrics

The Food and Drug Administration (FDA) in Collaboration with The University of Maryland Center of Excellence in Regulatory Science and Innovation (CERSI) To Host Public Meeting on Quantitative Assessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics

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 entitled 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. This public workshop will 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; and 
• Presentation and discussion of examples in partial onset seizures, inflammatory bowel diseases, and polyarticular juvenile idiopathic arthritis.

The symposium will be held on Wednesday, June 1, 2016 in Building 31, Room 1503 (the Great Room) at the FDA’s White Oak Campus, located at 10903 New Hampshire Avenue in Silver Spring, MD, from 8:00 a.m. to 5:00 p.m.

This collaborative workshop is open to the public, and interested individuals can attend the meeting in person or via webcast. Seating will be limited, so early registration is recommended.

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For additional information this public workshop, including registration information and a detailed agenda please visit: http://www.pharmacy.umaryland.edu/centers/cersievents/pedsextrapolation/

For further information contact: Lily Mulugeta, M.D. (email: yeruk.mulugeta@fda.hhs.gov)

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This burst was prepared by the Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

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FDA/Center for Drug Evaluation and Research (CDER)
Office of Translational Sciences
Office of Clinical Pharmacology
Email: ocp@fda.hhs.gov