This is the third in a three-part series drawn from PrincetonOne’s video conversation with Scotty Kinn and Dave Malenfant on life sciences supply chain.
Catch up on What Good Outsourcing Looks Like and What Goes Wrong and Drug Pricing Pressure Doesn’t Have to Mean Layoffs
or watch the full video series.
The Hand-Off Between Clinical and Commercial Supply Chains
“One of the issues we have in life sciences,” says Dave Malenfant, Founder and CEO of MDM Consulting, “is the commercial supply chain not talking to the clinical supply chain.” The clinical team’s job, as he describes it, ends at approval: “All they’re concerned about is getting it through clinicals and not worrying about commercialization. Just throw it over the fence, and the commercial supply chain worries about it.”
This division of labor causes real problems fast. “Now we’ve got some drugs that can’t be commercialized,” Dave says, because nobody on the clinical side asked whether the commercial infrastructure could support what they were building. A drug that requires -20°C storage all the way to patient dispensing runs into the same problem: “We don’t have the infrastructure on the pharma side to do that effectively. So now we’ve got to come up with some complex packaging to deliver it to the patient,” built after the fact, under pressure, instead of by design.
The fix must happen earlier than launch
Dave’s prescription is specific: bring the commercial supply chain into the process during supplier negotiations. “A lot of the suppliers in the clinical supply chain will choose not to have the scalability to meet manufacturing needs,” he explains.
“But if you bring commercial early into the R&D, when you negotiate with the supplier, whether it’s a CDMO or CMO, and make sure they’ve got the scalability, then you’re protecting the entire commercial supply chain.”
The key moment is supplier negotiation. The specific person who needs to be in that room is someone from the commercial supply chain, someone who can ask the scalability questions. That person is harder to find than a standard commercial supply chain hire. The seat needs someone who has run manufacturing and external supply at commercial scale, who can also sit credibly across the table from R&D and clinical teams during Phase 3, often two to three years before the product is even submitted for approval.
Most candidates are strong on one side of that line and thin on the other, which is exactly why the seat tends to stay empty until the gap becomes a crisis.
Niche talent scarcity in life sciences is well known among TA leaders who own this problem, and a hybrid profile this specific narrows an already shallow pool even further.
This Is a Hiring Calendar Problem
Most organizations won’t fund a commercial supply chain hire until Phase 3 data or approval proves the drug is real. But the supplier negotiation that hire needs to be part of happens years earlier. Add a realistic time-to-fill on top, and the hire needs to happen two to three quarters before anyone thinks to make it.
The −20°C packaging scramble is what that gap looks like in practice: a problem caught after the supplier is locked in, not asked during the negotiation. Miss that moment, and no amount of post-launch coordination fixes it.
Why this keeps happening anyway
If the fix is this identifiable, why doesn’t it happen by default?
Because clinical and commercial supply chain functions are usually staffed, measured, and managed as separate tracks with separate priorities: clinical optimizes for speed to approval, commercial optimizes for scale and cost once a product is real.
Nobody owns the hand-off itself. It’s not one team’s job to make sure the other team’s supplier can manufacture at commercial volume; it falls into the gap between two teams that each did their own job well.
There are three realistic ways to close this gap. A company can create a role whose only job is bridging clinical and commercial supply chain. It can give an existing commercial supply chain leader formal authority over supplier scalability during clinical-stage negotiations. Or it can bring in a contractor with the right background just for the negotiation window. Each fits a different situation, but all three do the one thing that matters: name an owner before the negotiation happens, not after it fails.
The stakes only grow from here. Dave points to the industry’s shift toward home delivery and cold-chain-at-the-doorstep models, and each depends on manufacturing partners vetted for scale from the start.
It’s the same test that decided whether the first outsourcing model in this series worked or broke down: does the partner understand the function well enough to know who fits before anyone gets placed? A commercial supply chain candidate and a clinical one can look nearly identical on paper. Knowing how to tell them apart, years before the org chart admits it needs the role, is the whole difference.
