When the wait outlasts the window: prior authorization, PDUFA VIII, and the road to patient access

“The field is evolving rapidly and there is a lot of change, but pipelines have remained strong.”

Abigail Pinchbeck, Commissioning Editor, Cell & Gene Therapy Insights , speaks with Margarita Valdez Martínez, Chief Advocacy Officer, American Society of Gene and Cell Therapy, following the ASGCT’s 2026 Policy Summit, about regulatory and legislative priorities for cell and gene therapies, point-of-care manufacturing, the Cell and Gene Therapy Access Model and prior authorization, barriers to patient access, and US FDA engagement and capacity.

Please enter your email to access content Read now