Nationwide Children's Hospital

She manages a wide ranging portfolio of regulatory filings for drugs and devices being developed for off-label or expanded access use at Nationwide Children’s Hospital and The Ohio State University.

Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or large B-cell lymphoma patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release

Efficacy of cannabidiol in convulsive and nonconvulsive seizure types associated with treatment-resistant epilepsies in the Expanded Access Program.

It is recognized that there may be circumstances in which “off label” use of a HUD may be necessary to save the life or protect the well-being of a given patient. Under either of these situations, the investigator must follow the emergency use procedures outlined in the NCH IRB SOP HRP-023.