This symposium will highlight topics of relevance in the nonclinical and early phase arenas. The first presentation will discuss current perspectives on drug-transporter interactions in drug development and how results are applied to add value to clinical development. The second presentation will address efforts made to map and benchmark the process flow from nonclinical to early development. The third presentation will focus on the need for early consideration of pediatric investigation plans (PIPs) to support an indication in pediatric population, leading to an increased focus on the relevance of nonclinical studies in juvenile animals.

Learning Objectives:
Discuss the relevance of transporters to clinical development
Define benchmark duration metrics for the nonclinical phase
Discuss the use and need for juvenile animal studies in relation to pediatric development of medicines in EU environment.