May 25, 2025
Commercial Transition
Navigating the Clinical-to-Commercial Supply Transition: What Biotechs Often Overlook
Transitioning from mid-stage clinical trials to Phase 3—and ultimately to commercial supply—isn’t just a scale-up. It’s a fundamental shift in how demand is defined, how supply is planned, and how risk is managed.
On the surface, the core mechanics of supply planning don’t change. But what feeds that planning does. The inputs on both sides of the equation—demand and supply—look completely different by the time you’re preparing for a product launch. If your planning team doesn’t anticipate that shift early, you may feel it later.
Clinical Demand: Unstable and Unforgiving
Clinical demand is inherently volatile. Patient enrollment ebbs and flows. Dosing adjustments happen based on adverse events or early efficacy signals. New sites and depots are added as studies expand or evolve. It’s a moving target, and the numbers rarely hold steady from one month to the next. On the supply side, there’s little flexibility to adjust. Manufacturing batches are often small—constrained by early-phase budgets and processes that haven’t yet been optimized. Lead times can stretch well beyond what most teams expect—especially when working with CDMOs, where 9–12 month timelines are common. Trying to match inconsistent clinical demand with rigid, slow-moving supply capacity is a core challenge. And it’s one that only gets harder if the transition plan isn’t mapped early.
Commercial Demand: Structured—but Still Volatile
Commercial demand brings more structure. Projections are based on market data, payer coverage assumptions, physician adoption curves. But variability doesn’t disappear—it just takes a new form. Post-approval uptake can spike unexpectedly. Competitive launches can change your volume assumptions. Access bottlenecks can delay demand entirely.
And the transition into this world must start before Phase 3 ends.
One of the most overlooked questions in this phase: Are your Phase 3 batches aligned with what your commercial supply chain needs to look like? If they’re not, you may face rework, misalignment, or even regulatory delays in your commercial prep.
Planning Ahead: It’s About Mitigating Risk
Transitioning well isn’t about perfect foresight. It’s about reducing avoidable risk.
The earlier supply teams can align on how things will change between phases, the more effectively they can build a stable, forward-looking plan. That includes validating commercial-scale batch sizes early, securing CDMO capacity that’s future-ready, and ensuring cross-functional awareness of what the transition actually requires.
Because while some technical details—like formulation or quality standards—might be out of a supply planner’s hands, what can be controlled is the clarity of the plan and the readiness to adapt.
Final Thought: Don’t Let the Shift Catch You Off Guard
If you’re leading clinical supply and you’re not already planning for commercial scale, you’re behind. Every assumption made in Phase 2 and Phase 3—about shelf life, depot reach, labeling, packaging configurations—needs to be stress-tested against commercial realities.
This transition is where seasoned supply leadership matters most. Not to predict everything perfectly—but to spot the cracks before they widen.
It’s not about getting it exactly right. It’s about not getting it wrong.