KAVROS ADVISORS · CORNERSTONE
" 5 Things" Every Biotech CEO Should Get Right Long Before Launch
If you run a clinical-stage biotech, you are already making commercial decisions.
If you run a clinical-stage biotech, you are already making commercial decisions. You may not be calling them that. They look like clinical choices, portfolio choices, trial-design choices, hiring choices. But the decisions that will determine whether your therapy succeeds commercially are being made right now, years before you have a commercial team, and often by people who aren’t thinking about commercialization at all.
That’s an uncomfortable position for a CEO. You’re expected to have answers to questions you may never have faced, and to project confidence about them even when the honest truth is that you’re deciding under real uncertainty. I want to make that a little easier. Commercial success before launch isn’t about having a big team or a finished plan. It’s about getting a small number of high-consequence decisions right while they’re still cheap to change. Here are the five I’d focus on first.
1. Which indication you lead with.
Your lead indication is usually chosen on clinical logic: where the data looks cleanest, where the trial is fastest, where the biology is most convincing. All reasonable. But the indication you lead with is also the single most consequential commercial decision you will make, because it sets your first market, your first price reference, your first payer conversation, and the analog every investor will use to value you.
Two indications with identical trial odds can have completely different commercial futures: different competitive intensity, different treatment settings, different reimbursement dynamics, different room to expand. Choosing purely on speed-to-data can win you a fast approval into a small or crowded market, and then hand you a second, harder decision about how to grow from a beachhead you didn’t pick strategically.
The commercial question to ask alongside the clinical one is simple to state and hard to answer: if this trial succeeds, what business does it actually create, and is that the business we want to enter first? You don’t need certainty to ask it. You need to make sure the question is deliberately considered while the choice is still open, because once the pivotal trial is designed around an indication, the commercial die is largely cast.
Picture an asset with strong data in a narrow third-line setting and plausible data in a large first-line one. That is exactly the choice: the fast, defensible approval into a small market, or the bigger, harder market that takes longer to win. Neither answer is wrong. What’s wrong is defaulting to the faster trial because it’s faster, without anyone naming what it costs you commercially on the other side.
2. What your target product profile is really promising.
The target product profile reads like a scientific and regulatory document. It is also a commercial contract with your future self. Every claim you will eventually want to make to a physician, a payer, or a patient has to be earned by evidence you generate now.
If your differentiation depends on a quality-of-life benefit, a dosing advantage, or a subgroup effect, and the trial isn’t built to demonstrate it, that differentiation doesn’t exist commercially, no matter how real it is biologically. This is one of the most expensive gaps in biotech: a therapy that genuinely works, launched into a market that was never given a reason to prefer it.
The move is to work backward from the commercial case. Decide what will need to be true at launch for you to succeed, then pressure-test whether the development plan actually produces that evidence. Endpoints, comparators, and the populations you study are commercial decisions wearing clinical clothing. Getting them right years early costs a conversation. Getting them wrong costs a study you can’t re-run.
Here’s a test worth running now: write the launch press release and the first payer pitch as you’d want them to read, then check whether your current trial would actually substantiate them. Wherever it wouldn’t, you’ve found a claim you’re hoping for rather than building toward. Those gaps are cheapest to close while the protocol is still a draft.
3. How big the opportunity actually is.
Nearly every early plan sizes the market as the prevalence of the disease. The real number is smaller, and it is smaller in ways that matter for strategy. Between everyone with the condition and patients actually treated with your therapy sits a funnel: who gets diagnosed, who gets tested, who tests positive, who reaches a center that can treat them, who is eligible, who stays on therapy.
Each step is reasonable. Stacked together, they can turn a headline market into a fraction of itself. This matters long before launch, because the number drives everything upstream: which indication to lead with, how to design the trial, what you tell investors about the opportunity.
A plan built on prevalence sets expectations you can’t meet and hides the strategic choices, like diagnosis rates, testing infrastructure, and site of care, that actually determine whether an addressable market becomes a treated one. The discipline here isn’t pessimism about the number. It’s rigor about it: mapping the real path from prevalence to treated patient, and building strategy on what’s reachable rather than what’s theoretical.
In practice, this is the difference between a slide that says 40,000 patients and a plan that can identify the 6,000 who will realistically be diagnosed, tested, eligible, and treated in your first years. Investors know the difference, and the CEO who can walk that funnel earns more credibility than the one with the bigger top-line number.
4. When commercial starts informing development.
Most biotechs treat commercialization as a phase that begins near launch, owned by a team that doesn’t exist yet. So development, medical, regulatory, and portfolio decisions get made for years without a commercial perspective in the room. By the time commercial arrives, the decisions that shaped its job are already set.
The fix isn’t to build a commercial department early. It’s to give commercial thinking a seat at the decision table long before there is a department to fill it. That can be a fractional leader, an advisor, or simply a standing question the executive team commits to asking of every major decision: how does this affect the business we’re trying to build?
The companies that do this don’t just avoid mistakes. They compound small, correct choices over years into a launch that looks easy from the outside and was actually decided long before. Commercial isn’t only a downstream function. At this stage it’s a lens, and the earlier you apply it, the more it’s worth.
The lightest version of this costs almost nothing: a single recurring agenda item that builds a commercial view into portfolio, development, and investment discussions. The point isn’t to slow decisions down. It’s to make the commercial consequence visible before the decision is made, rather than discovered a year later.
5. When to build commercial capability, and who comes first.
Two mistakes cost biotechs the most here, and they are opposites. Build too early and you burn runway on an organization the asset can’t yet use, asking senior hires to wait for their own jobs to become real. Build too late and you hit a milestone (strong data, a partnering conversation, a launch decision) with the commercial thinking that should have informed it never done.
The answer to both is sequencing, not a headcount target: what capability does this specific asset need, at what moment, to inform the decision in front of you? Sometimes that’s a hire. Often, earlier on, it’s an answer, not an org.
And the first hire is a strategy decision disguised as a staffing one. The right first person for a company facing an indication-prioritization call is different from the right first person preparing a financing story, which is different again from one twelve months out from launch. Start from the decision, and the first hire, or the realization that you need an answer before you need an org, usually becomes obvious.
A practical way in: name the single most consequential commercial decision facing the company in the next twelve months, and staff to that, not to a generic org chart. If the decision is which indication to back, you need strategic commercial judgment, not a marketing team yet. Build the capability each decision demands, in the order the decisions actually arrive.
The Bottom Line.
None of these five require certainty, and none require a commercial department. They require making a handful of high-consequence decisions deliberately, while they’re still cheap to make, and being honest that you’re making them under uncertainty, because leading before the answers arrive is what the role requires.
The CEOs who do this well aren’t the ones who feel most sure. They’re the ones who asked the commercial question early, made the call, and moved. Your launch is being decided right now, in decisions that don’t look like launch decisions. The work is to treat them like the commercial choices they are, years before anyone else in the room does.
If you’re weighing any of these five right now, that’s the conversation I have with biotech CEOs at Kavros.
The decisions you make today determine commercial success years from now.
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