Webcast | Virtual
Event Title
FDA Oncology Center of Excellence Presents Conversations on Cancer: Patient first = Project Facilitate June 10, 2026
June 10, 2026
- Date:
- June 10, 2026
- Time:
- 12:00 p.m. - 1:00 p.m. ET
- Organized By:
-
Organizer
Attend
X (formerly Twitter): #ConversationsonCancer
Sponsored by the U.S. Food & Drug Administration (FDA)
Background:
Join the FDA Oncology Center of Excellence for a compelling Conversation on Cancer focused on Project Facilitate, a dedicated resource designed to streamline access to investigational therapies for patients facing life-threatening cancers. When standard treatment options are exhausted and clinical trial enrollment isn't possible, FDA's Expanded Access Program offers a critical pathway for patients to access investigational drugs, biologics, or medical devices that have not yet received FDA approval. However, navigating the single-patient Investigational New Drug (IND) application process can be daunting, particularly for oncology healthcare providers without extensive regulatory experience. Project Facilitate serves as a single point of contact, offering expert guidance to help oncology professionals successfully submit expanded access requests and bring hope to their patients in urgent need.
In this session, the expert panel will explore the evolution of Project Facilitate from its inception to its current role as an essential resource for oncology providers nationwide, examining the concrete impact of Project Facilitate through data-driven insights. They will share cases that illustrate both common scenarios and unique challenges, providing practical guidance on how to submit a single-patient IND, highlighting common pitfalls to avoid and best practices for working with pharmaceutical companies, whose agreement is required before FDA review can proceed. Importantly, the panel will address how patient safety is maintained throughout the expanded access process, even when using investigational products whose safety and efficacy profiles are still being established.
Whether you're an oncologist considering your first expanded access request, a regulatory professional seeking to better understand the process, or simply interested in how FDA supports patient-centered innovation, this Conversation on Cancer will provide valuable insights into a program that puts patients first when time matters most.
Webcast Information:
A free-of-charge webcast of this program can be viewed on Wednesday, June 10, 2026, beginning at 12:00 PM EST on YouTube at: https://www.youtube.com/live/hkmnRdL4AGE
FDA also plans to post a webcast of this Conversations on Cancer program on YouTube for on-demand viewing at: https://www.youtube.com/@US_FDA/videos
Contact:
For any inquiries regarding this program, please send an email to: OCE-Engagement@fda.hhs.gov