W2A3 - Implementing a Streamlined Process to Facilitate Physicians' Requests for Individual Patient Expanded Access Applications at an Academic Medical Center

The University of Colorado Denver, Anschutz Medical Campus has developed a unique and efficient strategy for processing Individual Patient Expanded Access Applications (i.e., Single Patient Investigational New Drugs (S-INDs)) that leverages the strengths and capabilities of the various stakeholders involved by streamlining data collection to eliminate redundancies, address bottlenecks and responsibility gaps, and decrease each stakeholder's regulatory and administrative burdens. In this advanced session, speakers will describe the steps and requirements for treating patients under a S-IND, identify practical strategies for harmonizing stakeholder goals and institutional procedures to efficiently and effectively process the S-IND, and address the maintenance of S-INDs. Attendees should be familiar with the FDA drug and device regulations regarding expanded access before attending this session.