Chairs: A Mahableshwarkar, MD; S Romano, MD; R Keefe, PhD; J Rasmussen, MD; S Comfort, MD, B Lavenstein, MD

A large number of clinical trials in children have been conducted since the introduction of pediatric exclusivity. There have been, though, relatively few new treatments for this important patient segment. Using epilepsy and depression as models, the joint session of the ISCTM-ASENT will evaluate challenges, pitfalls and opportunities in the development of new therapies. Specific issues related to both drug and device development will be discussed by experts, and global regulatory perspectives shared . The larger group will then break into the following four working groups: 1) Specific challenges, PK/PD, potential for longer term effects 2) Animal models for diseases, drugs and devices 3) Pediatric outcomes and scales 4) IRB and ethics. Each working group will identify specific challenges and develop preliminary plans to address these, which will then be presented to the larger audience. The session will conclude with a discussion of these proposed solutions and recommendations on implementation.