Most biotech leaders understand that launch preparation, building the plan, begins well before expected approval. That’s not the problem we see. The problem is what they’re not accounting for: how long it actually takes to build a functional team, how long culture takes to develop within that team, and how often poor governance quietly drains time (and energy) they don’t realize they’re losing. By the time those gaps surface, options are few, and the pressure is high as all the stakeholders, leadership, the Board, investors, and most of all, patients are waiting.
You Can Have a Plan and Not Have a Launch Team
We’ve worked with dozens of pre-commercial companies, and almost all of them have a launch plan in varying stages of completeness. Far fewer have an effective launch team. Humans who know how to work together and are aligned. The difference matters to the ultimate success of the launch.
A launch plan describes what needs to happen. A launch team is the cross-functional operating unit that makes it happen with shared accountability, shared decision-making authority, and a common understanding of where things stand at any given moment. Assembling representatives from each function and calling them a Launch Readiness Team is not sufficient. We’ve seen organizations with beautifully formatted Gantt charts and a PDUFA date on every wall that were, in practice, nowhere near ready.
Our recommendation is to establish a functioning launch team that is operational by 24 months pre-PDUFA. That window not only enables implementing those tasks with long timelines but, more importantly, it allows time for “building the team muscle.” As launch gets closer, you want a team that can surface problems, make decisions, and keep moving when the pressure rises. That capability doesn’t come from a kickoff meeting. It comes from months of working through challenges and opportunities together.
What Takes Longer Than Anyone Plans For
Three things consistently take longer than organizations expect, and underestimating any one of them compounds the others.
Aligning on the product story
Medical, Commercial, and Market Access often carry meaningfully different versions of the value narrative. Getting to a single, pressure-tested story requires real stakeholder input, real disagreement, consistent understanding of the data, and time to resolve it all. We’ve found that teams who skip this step produce messaging that might be technically accurate but can be strategically soft and undifferentiated.
Building an operating rhythm
A standing biweekly meeting does not represent an operating rhythm. A real rhythm means functional leads know exactly when they’re expected to update, in what format, and what happens when something is at risk. When those behaviors are so normalized that they occur without prompting — that’s when the real team cohesion happens. That kind of consistency takes months to build, especially as organizations are often building/hiring, so new people are joining with different experiences and expectations. Team-first behavior has to be habitual before it’s needed, because under launch pressure, people default to whatever is familiar, which is often their own comfort zone.
Establishing a culture where problems surface early
If the team doesn’t feel safe raising risks, they won’t. And the launch team will be the last to know. Culture is not created by a governance charter. It is created by leadership behavior, modeled consistently, over time. Open-ended questions, private feedback when coaching is needed, and a cheerleading approach to celebrate success are a few ways to create a high-performing shared team experience.
What Good Governance Actually Looks Like
Strong companies don’t just build governance infrastructure; they build the behaviors around it. In our experience, that distinction is everything.
We worked with a pre-commercial company (roughly 12–18 months from a PDUFA date) that did something we don’t see often enough: they commissioned an honest readiness assessment and surveyed their own team. Not to validate that things were going well. To dig deep into the reality.
What they found didn’t appear anywhere in the launch plan. Burnout was cited as a top operational risk by a significant majority of respondents. A top-down decision-making pattern was named as the most common behavioral obstacle to cross-functional alignment. There was genuine confusion across functions about the actual launch date.
They documented all of it. They brought it to leadership. And they did it early enough that something could still be done about it.
That willingness to look honestly at what the plan can’t show and put it in front of the people who need to see it is what governance maturity looks like before the structure fully exists. It is the humans that make it work (or not). It is also what separates the teams that celebrate at launch from the ones that scramble.
How Governance Challenges Silently Drain the Clock
The situation above doesn’t happen at every organization. Governance is often where most organizations lose time and energy. The governance infrastructure may exist on paper. The behaviors that make it work often don’t.
We worked with one client where the governance structure was genuinely well-designed. Decision logs, escalation paths, and a launch tracking tool with real status definitions were all in place. Also in place was an unwritten culture that penalized raising problems.
The result: risks that should have appeared at month 18 arrived at month 6. Decisions that were closed in discussion were relitigated under pressure because they had never been formally documented. The executive steering committee was receiving a curated, rosy picture of readiness instead of an accurate one. The governance structure existed. The conditions that make governance work did not.
We have found that the four most common governance failures include:
- Risks are not raised until options are limited
- Decision ownership is assumed rather than assigned, so decisions get made by whoever is most confident, rather than the stakeholders with the expertise
- Decisions that aren’t tracked (or trackers aren’t adhered to), therefore, decisions get made multiple times
- Escalation paths that exist on paper but aren’t actually used, because the cultural norm is to handle things at the functional level
Each failure is invisible until it isn’t. And by the time they become visible, the clock has already been running overtime.
Three Questions Worth Asking About Your Launch Team
- Who owns your three most consequential pre-launch decisions right now?Write them down, with a named owner and a resolution deadline?
- When did your launch team last surface a risk that changed what you did next? If you can’t recall a specific example, it’s time to dig deeper.
- Can you show a new steering committee member your decision log? This should include every decision in the last six months, who made it, what input was gathered, and whether it has been revisited.
If any of those questions don’t have a clear answer, governance is costing you time. It is time to start thinking about how to evolve your governance.
The companies that launch well aren’t the ones with the most sophisticated plans. They are the ones who built a team that could execute one — and who started building it early enough to get it right.
