Conversations on Cancer: Patient First = Project Facilitate

Why It Matters

Accelerating expanded‑access approvals saves lives and demonstrates a scalable model for streamlined FDA collaboration with clinicians and patients.

Key Takeaways

• Project Facilitate streamlines single-patient IND and expanded access processes
• In‑house decision making cuts FDA response time dramatically
• Outreach targets small clinics and military facilities to reduce access gaps
• Consistent feedback loop improves application quality and reduces rejections
• Program now includes research, policy, and personalized support for patients

Summary

The Oncology Center of Excellence’s Project Facilitate, launched at ASCO in 2019, provides a centralized, patient‑first service that helps physicians navigate single‑patient INDs and expanded‑access pathways for investigational oncology therapies.

Panelists explained how the program evolved from a simple call‑center into an in‑house decision‑making hub that directly manages applications, eliminating the previous “telephone game” of triaging requests through multiple FDA divisions. This redesign has slashed turnaround times, delivering faster FDA approvals for critically ill patients.

Key participants highlighted concrete benefits: Carrie Thomas noted the dramatic reduction in waiting periods; Mitch Chan described the shift to a one‑stop shop; Alison Bateman‑House emphasized the need for a single point of contact; and the team cited outreach to smaller clinics and VA facilities that uncovered systemic barriers. Data collection now informs targeted research and policy adjustments.

The program’s consistent feedback loop, combined with dedicated clinical analysts, creates a predictable, collaborative environment that improves application quality and reduces rejections. By accelerating access to investigational drugs, Project Facilitate sets a precedent for more efficient FDA‑industry‑provider partnerships, potentially reshaping how life‑saving therapies reach patients nationwide.

Original Description

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.