FDA panel: Project Facilitate speeds single-patient access to investigational cancer treatments

Project Facilitate, a program run by the Oncology Center of Excellence, helps clinicians and regulatory staff obtain single-patient investigational new drug (IND) access more quickly and consistently, panelists said during a Conversations on Cancer webinar.

“Hello, welcome to Project Facilitate,” Mitchell Chan, team lead for Project Facilitate, said while describing the program’s origins as a staffed call center that launched publicly at ASCO in 2019 and later expanded to make in-house decisions on requests. Chan and other panelists said centralizing reviews reduced handoffs across FDA divisions and shortened turnaround times for physicians and patients.

The panel laid out the three core components Project Facilitate typically needs to process a single-patient request: Form 3926, the treating physician’s qualifications or CV, and a Letter of Authorization (LOA) from the drug sponsor. “Kudos to you for making the FDA Form 3926, which is a very simple form compared to writing an IND,” Peter Anderson, a pediatric oncologist, said of the two-page form.

Panelists described how the LOA lets FDA and clinicians refer to the sponsor’s IND for chemistry and nonclinical information and, in many cases, serves as the sponsor’s assurance it will supply the drug. They also recommended that providers consult an Investigator’s Brochure from the company to understand monitoring and safety information.

Carrie Thomas, FDA regulatory compliance manager at Moffitt Cancer Center, described a practical difference Project Facilitate makes for institutions: consistent reviewer feedback so teams can “fail forward” — correct deficiencies and resubmit without encountering a new reviewer with different expectations. “It’s an open dialogue,” Thomas said. “It’s simpler than you might think.”

Panelists emphasized that Project Facilitate handles individual single-patient INDs; larger expanded-access programs (multiple or hundreds of patients) are handled by FDA review divisions and require attention to manufacturing and distribution concerns. The team described its current staffing as including three clinical analysts plus policy/regulatory leadership and said they consult review-division specialists for unusual pediatric or first-in-human cases.

The panel also addressed institutional barriers: some smaller hospitals lack Institutional Review Boards (IRBs) and may use external IRBs listed by the Reagan-Udall Foundation’s Expanded Access Navigator; the foundation’s site provides resources but not a call center. Panelists said Project Facilitate accepts submissions via that foundation or by email at projectfacilitate@FDA.hhs.gov to speed handling.

Panelists stressed that FDA decisions are individualized. Mitch Chan said staff check regulatory completeness, safety signals and consent; they noted the agency sometimes has safety information that is not public and that, while uncommon, the FDA may place a clinical hold for safety reasons. The group estimated the vast majority of single-patient IND requests are allowed — panelists referenced an approval rate in the high 90s percent range during discussion.

To illustrate impact, a panelist recounted a patient who, after multiple prior treatments failed, received an investigational drug through a single-patient IND and had what the panel described as a complete response. Panelists cautioned that such outcomes are exceptional and urged clinicians to prioritize clinical trials when available.

The panel closed by urging healthcare providers and regulatory staff to call or email Project Facilitate for help with applications and to remind patients to discuss options with their oncologist. For patient-facing questions, the panel recommended contacting the FDA’s Division of Drug Information.

The webinar did not include formal votes or policy changes; it focused on explaining Project Facilitate’s operations, submission requirements and outreach plans.