Innovative Approaches to Pediatric-Drug Development
Monday, May 5, 2014
8:30 a.m.-5:00 p.m.
FDA WO Campus, Building 31 Great Room-Section A
Innovative Approaches to Pediatric-Drug Development and Pediatric-Medical Counter Measures: A role for Physiologically-Based PK?
Understanding drug disposition and elimination in pediatric populations, especially neonates and infants, is a challenging problem requiring a clear understanding of the dynamic interplay between pediatric growth and development, maturation of processes involved in drug metabolism and elimination, disease effects, and intrinsic properties of the drug. The challenge is even greater when the drug and dosing regimen may not be able to be tested clinically in pediatric patients, such as for drugs developed for anti-terrorism Medical Counter Measures (MCM). Physiologically-Based Pharmacokinetic (PBPK) modeling provides a platform that could explicitly account for these processes to predict pharmacokinetic properties for devising pediatric development strategies.
The proposed workshop will address three major objectives: (1) to review current practices and applications of pediatric PBPK modeling from industry, academia, and FDA; (2) to define demonstrated and potential contributions of PBPK in pediatric drug development and regulatory science; and (3) to assess current PBPK methodologies and review specialized software for PBPK modeling with the identification of their limitations and outstanding issues in pediatric drug development. The workshop will provide an opportunity for experts from industry, academia, and regulatory agencies to share their experience and reach a consensus at certain levels regarding the best practice of PBPK in pediatric drug development and pediatric MCM.