When you're a launch leader, you are expected to make things happen and make critical decisions at a time when you might have constrained resources.
For many organizations, launch is treated as a project that kicks off in Phase III, with a situation assessment and a range of strategic plays focused heavily on activation.
The pitfalls of this approach are all too common and industry benchmarks reveal a sobering reality: a significant percentage of recent pharmaceutical launches fail to meet their year-one expectations. When you wait until Phase III to start planning, it is already too late to influence trial design, label claims, or the value story in any meaningful way. The result is familiar and frustrating: last‑minute scrambling with misaligned expectations across functions and geographies.
The ultimate outcome is even worse. A delayed start leads to significant access and reimbursement challenges, limited differentiation, and suboptimal customer engagement. Sadly, this diminishes the lifetime value of the brand and limits our opportunity to improve patient outcomes.
Top-tier launches move away from the traditional, sequential handoff where R&D simply throws the asset over the wall to Commercial in Phase III. As such, launch shouldn’t be treated as an event, but instead as a continuum. It truly begins in late Phase II, with the right cross functional input. This is the exact moment when the Target Product Profile (TPP), trial design decisions, endpoints, and the differentiating value proposition can still be influenced.
This is also the time when co‑creating with customers matters most. Working together early to identify unmet needs ensures that you are building value hypotheses that will actually stand up to payer and clinician scrutiny.
The hesitation to start this early usually stems from a lack of perfect clinical data. But if you are not yet at the point where you can make a definitive strategic decision, your immediate action should be to map out exactly what you don't know.
This is where early scenario planning becomes critical. Rather than planning for a single clinical outcome, you must map multiple futures. Understanding how your strategy pivots based on different clinical, regulatory, or competitive scenarios ensures that when the data finally does arrive, your team is executing a pre-aligned strategy rather than starting from scratch.
Once you move into Phase III, the foundational strategy should be set. Launch activation now becomes evidence‑led and scenario‑driven, coupled with agile execution. The focus shifts to the few things that make the biggest difference: closing evidence gaps (for example, through RWE or IIS) and addressing capability gaps, such as field skills and local access know‑how.
While launch thinking should start in Phase II, we all operate with finite budgets and people. The continuum is really about starting the understanding, thinking, and decision-making early, and evolving it over time.
It also recognizes that not all launches are equal. A novel asset in a new disease area, a new asset in a known disease, and an in-market asset in a new indication require different breadth and depth of focus and therefore all warrant very different levels of resourcing. The most effective approach is a core cross-functional launch team that can "pulse in" the right functions and expertise—both above and in-market—at exactly the right time to create the optimal conditions for launch activation.
Building a modern, successful launch capability is a continuous journey. This article is the first in a five-part series exploring the realities of pharma commercialization today. In the coming weeks, we will explore: