The five decisions that make or break a U.S. launch
Most launches are decided long before launch day. These are the five calls that matter most, and when to make them.
Emilio Fernandez, Owner & CEO
· 4 min read
I have spent much of my career around launches: preparing them, leading them and learning from them. The lesson I keep coming back to is simple. A launch is not won on launch day. It is won, or lost, in a handful of decisions made months earlier, often when the team is still focused on approval.
The science gets a company to the starting line. These five decisions determine how fast it runs once the gun goes off.
1. Who, exactly, you are launching to
"Everyone with the condition" is not a launch strategy. The strongest launches start with a sharp answer to a narrower question: which patients, treated by which physicians, in which settings, will benefit first and most clearly? That answer drives everything downstream: the message, the evidence you lead with, where the field team goes on day one, and what success looks like in the first quarter.
Segmentation done well is not a slide in the brand plan. It is a set of choices the whole organization can repeat, including the choices about who you will not prioritize yet.
2. The value story, and how access will work
In the U.S., a great clinical profile does not automatically become a prescription that gets filled. Between the two sit payers, benefit designs, prior authorizations, specialty pharmacies and hub services. The value story you will tell payers, and the access strategy that supports it, need to be built early and built together with the clinical story, not bolted on after.
The question to answer well before launch: when the right patient meets the right physician, what has to happen, step by step, for that patient to start therapy and stay on it? If the honest answer has too many points of failure, fix them now.
3. The size, shape and timing of the field team
Field force decisions are among the most expensive and least reversible a launch team makes. Too small, and you cannot reach the accounts that matter. Too large, too early, and you burn cash and credibility before the market is ready. The shape matters as much as the size: the balance between sales, key account management, medical science liaisons, access and patient-support roles should follow the segmentation from decision one.
Timing is the hidden variable. Great people take time to recruit, and they need time to be trained before they are in front of customers. Work backward from the date you need them productive, not the date you need them hired.
4. The launch sequence
Launches rarely go everywhere at once, and they shouldn't. Which accounts, regions or channels go first? Which capabilities must be ready on day one, and which can follow in waves? A clear sequence, with readiness gates the team actually respects, protects the launch from the most common failure I have seen: trying to do everything at once and doing nothing exceptionally well.
5. What you will measure in the first 100 days, and what you will do about it
Sales lag. By the time revenue tells you something is wrong, months may have passed. Strong launch teams agree up front on a small set of leading indicators (account activation, time to first fill, access approvals, the quality of early customer feedback) and on the decisions each indicator will trigger.
The point is not the dashboard. It is the discipline of deciding in advance how you will course-correct, so that when the data arrives, the team acts instead of debating.
Make the decisions early, and make them together
Notice what these five have in common. None of them belongs to a single function. Segmentation shapes access, access shapes the field model, the field model shapes the sequence, and the sequence shapes what you measure. The launches I am proudest of were the ones where commercial, medical, access and finance made these calls together, early, and then held each other to them.
If you are a year or more from a U.S. approval, this is the moment. The decisions are still cheap to make and expensive to postpone.
Recommended for: Preparing a U.S. launch, Turnaround or growth acceleration
