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.
Discuss Individual Patient Expanded Access Applications and FORM FDA 3926, including the regulatory requirements and responsibilities associated with these kinds of treatment protocols, and the difference from intermediate access and treatment INDs
Share practical tools for implementing an S-IND facilitation program, including strategies for collaborating with key stakeholders (e.g., IRB, pharmacy, etc.) and managing limited resources
Disclose implications and limitations of requesting an alternative IRB review procedure for individual patient expanded access and provide strategies for managing amendments and continuing review