The bar for evidence has never been higher.
The EU’s Joint Clinical Assessment process went live in January 2025, introducing harmonised clinical evidence requirements across member states. Regulators are demanding greater transparency. Payers are scrutinising efficacy claims with increasing rigour.
And yet most biopharma teams are still playing catch-up. Rather than building evidence proactively, they’re:
- Commissioning studies after payer rejections
- Responding reactively to regulatory questions
- Filling gaps that should have been mapped years earlier
McKinsey puts the scale of this problem in sharp focus: claiming that only 20% of leading pharmaceutical companies possess an integrated evidence generation plan that spans the full product lifecycle.
This is the gap biopharma’s new evidence era is exposing. And within this, it’s holding a mirror up to sub-par commercialisation strategy development.
This is because evidence doesn’t fail because teams lack expertise or resource. It fails because the strategic foundations it’s built on are rarely examined with the same discipline as the evidence itself.
Building a commercialisation strategy fit for biopharma’s new evidence era requires three things:
- Identification of a clear winning aspiration
- Confidence in where to play and how to win there
- Prioritisation of the evidence needed to deliver for patients, providers, and payers
Here’s how to get started…
Define the commercial problem you’re solving for
This is where commercialisation strategy most often breaks down. Not at the point of study design but at the point where no one has agreed on what the evidence is for.
Without a shared goal, functions default to their own version of winning, such as:
- Clinical designs for regulatory approval
- HEOR builds models for a hypothetical payer
- Brand develops positioning around an unvalidated differentiator
Each workstream generates evidence. But the risk is none of it connects.
Beacon, part of Nmblr’s Explore toolkit, helps teams fix this. It’s built to support cross-functional teams to establish a clear, shared winning aspiration; a definition of the commercial problem that the whole organisation can align around and interrogate together.
This approach sets the guard rails for every strategic choice that follows, including which evidence to invest in, and why.
Regularly revisiting, and where necessary refining, your winning aspiration must also be a priority, as what you’re solving for at Phase II can look very different at launch and beyond.
Explore the different pathways to success
Knowing the problem and defining a clear winning aspiration is necessary. But it still doesn’t tell you where to focus for growth, or how you’re going to win there.
Most teams assume they’ve made these choices deliberately but in practice, they’re often made by default. They’re embedded in early commercial framing, long before anyone has looked carefully at where the real value lies.
The most consequential strategic decisions are frequently the ones teams didn’t realise they were making.
Explore’s Pathfinder module provides space to make investigating different pathways to success more collaborative and effective, helping cross-functional teams to:
- Surface the full range of strategic options, not just the familiar ones
- Map the behaviour change and belief shift each route requires
- Ask what would have to be true for this option to succeed? (a question that forces assumptions into the open and separates genuine contenders from noise)
Where to focus for growth must be considered early in the process, bringing together diverse points of view, to help shape what evidence is needed, when, and for which stakeholders.
Build an integrated evidence spine
The third foundation is building the evidence base deliberately, for every audience that will determine commercial success.
That means regulators, payers, clinicians, and patients. And it means starting from gaps and needs, not from functional habit.
Too often, teams prioritise regulatory approval and build outward from there. By the time payer or clinician evidence gaps become visible, the trials that could have closed them are already complete.
The alternative is an evidence base designed from the start to serve all stakeholders simultaneously, so the same data supports clinician, payer, and patient narratives without contradiction.