Working Together to Improve Patient Access to Investigational Therapies

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To further our common commitment to improving patient access to investigational therapies, the Foundation is pleased to join FDA for Project Facilitate: Enhancing the Single Patient IND Process for Oncology Health Care Providers. This public workshop brings all stakeholders together to discuss FDA’s Project Facilitate and the Expanded Access Navigator. Project Facilitate, a pilot program developed under the Oncology Center of Excellence (OCE), is planned as a call center to facilitate the Single Patient IND request process for oncologists treating patients with cancer. This pilot may create a model to ultimately extend across disease states.

Workshop Objectives

• Obtain input from multiple stakeholders on gaps in patient and healthcare provider knowledge of the current system for Single Patient IND requests, challenges with the current system for requesting Single Patient INDs, and suggestions for improving the current system.
• Discuss updates to Reagan-Udall Foundation’s Expanded Access Navigator.
• Obtain feedback on Project Facilitate, a planned pilot call center to facilitate the Single Patient IND request process for oncologists treating patients with cancer