What S&OP Actually Looks Like in a Lean Biotech
If you've spent any time around large pharmaceutical companies, you've heard the term S&OP, or Sales and Operations Planning. It usually comes with a heavy infrastructure: dedicated planning teams, enterprise software, monthly review cycles with executive sign-off, and slide decks that could fill a binder. It's a well-oiled machine built for organizations managing dozens of products across global markets.
If you're at a pre-commercial biotech with a lean team and one or two programs in late-stage development, that world can feel completely irrelevant. And I get it. When you're a 50-person company focused on getting through a BLA, the idea of standing up a formal S&OP process feels like something you'll worry about later. After approval. After launch. After you've grown into the kind of company that needs it.
But here's what I've learned from sitting inside these organizations at exactly this stage: by the time you think you need S&OP, you're already behind. And the irony is, you're probably already doing pieces of it, just not in a way that's connected, visible, or sustainable.
You're Already Doing It. You Just Don't Call It That.
S&OP, stripped to its essentials, is a process for making sure supply and demand are aligned, and that the people who need to make decisions together are actually talking to each other on a regular cadence. That's it. Everything else is sophistication layered on top.
At a pre-commercial biotech, those conversations are already happening. Someone is thinking about how many batches to manufacture and when. Someone else is tracking clinical demand or building early commercial forecasts. Finance is modeling cost of goods. Quality is managing CMO timelines. Regulatory is tracking submission dates that drive everything downstream.
The problem isn't that these conversations don't exist. It's that they're happening in parallel, in separate meetings, separate spreadsheets, separate hallways, without a single forum where the full picture comes together. That's the gap S&OP fills, and it doesn't require an enterprise system or a dedicated team to fill it.
What It Actually Looks Like at This Stage
When I’ve helped pre-commercial companies think about S&OP, we're not building a big pharma process in miniature. We're building something that fits the organization as it is right now, with the understanding that it'll evolve as the company grows.
In practice, that usually starts with a single monthly meeting, maybe 60 to 90 minutes, that brings together supply chain, CMC, quality, finance, and whoever owns the demand signal, whether that's clinical operations or an early commercial lead. The agenda is straightforward: here's what we expect to need, here's what we expect to have, here's where the gaps are, and here's what decisions need to be made.
The tools are simple. A shared spreadsheet that maps out the supply plan against projected demand over a rolling 12- to 18-month horizon. A summary of key risks and assumptions. An action log that carries forward from month to month. Nothing fancy, but documented, shared, and reviewed consistently.
What makes it work isn't the format. It's the discipline of doing it every month, regardless of how busy things get. Because the moment you skip a cycle is usually the moment something shifts. A CMO timeline moves, a regulatory milestone accelerates, a batch fails. Without that regular touchpoint, the ripple effects don't surface until they're already causing problems.
Why It Matters Before You Think It Does
The most common pushback I hear is some version of "we're too small for this" or "we only have one product, we can keep it all in our heads." And at a certain point, that's true. When you're in Phase I with a single CMO and a straightforward supply plan, you probably can manage it informally.
But programs have a way of getting complicated faster than organizations realize. A second indication enters development. A CMO change forces a tech transfer. The BLA timeline accelerates and suddenly commercial launch planning needs to happen in parallel with clinical supply. Each of these is manageable on its own. Together, without a structured way to see the whole picture, they start creating the kind of surprises that cost time and money.
I've seen companies arrive at the threshold of commercial launch and realize that different parts of the organization were working from fundamentally different assumptions about timing, inventory levels, and partner capacity. Not because anyone made a mistake, but because there was never a forum where those assumptions were compared and reconciled. That's the problem S&OP solves, and it's a much easier problem to solve at 50 people than at 200.
Start Simple. Start Now.
If you're at a pre-commercial biotech and you don't have anything resembling an S&OP process, you don't need to build one that would make Pfizer proud. You need a regular, cross-functional conversation about supply and demand that produces a shared view of reality. One meeting. One document. One set of assumptions that everyone is working from.
It will feel unnecessary the first few times you do it. That's fine. The value of S&OP isn't in the meetings where everything is on track. It's in the meeting where someone raises a flag that nobody else had visibility into. The CMO capacity issue that's about to collide with your commercial timeline, the shelf life constraint that changes your inventory strategy, the regulatory shift that moves your submission date and cascades through your entire supply plan.
Those moments are coming. The only question is whether you'll see them in a planning meeting or in a crisis.
Verant Consulting Group helps pre-commercial and emerging biotech companies build the planning processes and supply chain infrastructure they need to scale, without overbuilding for where they are today. Reach out if you want to talk about what S&OP could look like for your organization.