What Expanded Access Really Means (On the Ground)

Let’s get clear: Expanded Access is not compassionate use in name only—it’s often the last option for patients who’ve exhausted all approved therapies. That means the stakes are high, the logistics are sensitive, and the visibility from regulators is sharp.

You’re often shipping one-off quantities, across borders, on short notice. And the expectations? No room for error, no operational delays, and ideally, no regulatory gaps.

The Supply Chain Can’t Be an Afterthought

In many cases, supply chain planning for Expanded Access lags behind. Teams treat it like a special case—until they realize the same rigor required for clinical trials is still expected. You’re not exempt from chain of custody, GMP storage, or customs clearance just because it’s a single-patient use.

Here’s where it gets tricky:

• Unstructured demand makes forecasting nearly impossible. You may not know when—or if—a request will come, but you still need inventory ready.

• Global requests often involve countries outside your primary trial footprint. That means new import licenses, regulatory filings, and distributor coordination.

• Urgency is standard. When a treating physician requests access, patients are often in late-stage disease. Every delay becomes a personal risk.

How Smart Sponsors Handle Expanded Access

The most effective sponsors approach Expanded Access with the same mindset they apply to trials—just adapted to real-world chaos.

Here’s what that looks like:

• They centralize supply oversight. Even if the EAP is managed through Medical Affairs or a third-party provider, the supply chain team owns the planning and release process.

• They pre-stage inventory strategically. Small GMP-labeled lots, stored centrally or regionally, allow for quicker deployment once requests are approved.

• They build a repeatable process. Even for a one-off, they use templated forms, QA-reviewed shipping documents, and predefined workflows to minimize surprises.

• They collaborate with local regulatory experts. If the EAP reaches countries outside your clinical trial footprint, lean on in-country resources early to avoid last-minute bottlenecks.

Expanded Access Is a Human Responsibility

Behind every EAP shipment is a patient waiting for a chance—sometimes their last one. That alone should elevate how we plan for these programs.

It’s not just about meeting compliance standards or checking a request off a list. It’s about designing a system that can respond with precision, care, and speed when it matters most.

Expanded Access may never be “predictable,” but with the right foundation, it can be repeatable—and reliable.

Key Takeaways

• Treat Expanded Access with the same operational rigor as your main trial.

• Plan inventory for unpredictability—small, ready-to-ship lots.

• Align cross-functional teams early, especially QA, Regulatory, and Supply Chain.

• Document the process, even for ad hoc requests.

• Lead with empathy: these shipments aren’t just data points—they’re decisions with real-life impact.

Expanded Access will never be as clean or predictable as a protocol-driven trial—and that’s exactly why your supply approach needs to be stronger, not looser. Patients and physicians are counting on fast, reliable access, not excuses. By operationalizing flexibility—through smart inventory planning, documented workflows, and tight cross-functional alignment—you’re not just supporting a program. You’re stepping up when it matters most.