Treating phase 2 study design as a scientific decision is compromising launch performance, warns expert
August 17, 2026 |
17th August 2026 – Treating Phase 2 study design solely as a set of scientific decisions, without commercial input, is compromising launch performance, according to Janice MacLennan, founder of Nmblr, the commercialisation and strategy platform for biopharma.
According to MacLennan, this common sequencing failure is deciding, often years in advance, what assets will be allowed to mean. She comments: “Positioning work typically begins once Phase 2 data exists but by then the evidence base is fixed. Teams generate positioning ideas, then discard the most compelling ones because nothing in the dataset supports them. What survives isn’t the position that would most change behaviour, it’s the one the study data happens to support.
“Teams aren’t short of ideas about how to position their asset,” adds MacLennan. “They’re short of permission to use them. The positioning idea that would actually shift behaviour gets killed because the data is not being generated to support it. This often shows up in underperformance at launch yet nobody registers it as a strategy failure because the decision that caused the problem was made three years earlier and filed under science.”
MacLennan’s warning comes on the back of data that highlights half of the 2023 US pharmaceutical launch class underperformed pre-launch first-year forecasts[i] and separate research found that clinical differentiation alone lifts a launch’s overperformance rate from only 44% to 49%[ii]. MacLennan advocates that the gap isn’t between good science and bad science, it’s between the evidence designed to satisfy a regulator and evidence capable of compelling a behaviour.
Her argument is that positioning and the value proposition belong in front of the Phase 2 protocol, not behind it. Start with the disease state and the people living in it: what motivates them to engage with the healthcare system, to start a therapy, to stay on it for as long as it delivers benefit.
Define the unmet need precisely, the gap between what motivates people and how far current therapies close it. From there, build a positioning idea: how the asset needs to be perceived by patients, prescribers and payers to compel the behaviours commercial success depends on. The value proposition follows. The claims that would have to be substantiated, to support it, follow from that. And those claims tell you what the study has to measure, in which population, against which comparator, and which indications to prioritise.
“This isn’t about deciding the position before the molecule has shown what it can do. You can’t know at Phase 2 where you’ll land,” MacLennan says. “But you can know which positions are worth being able to occupy, and design the phase 2 programme so they stay open. This way the science can be designed to support a positioning that’s grounded in real human motivation, not developed to work with the data that’s available.”
This approach underpins Define, Nmblr’s new toolkit for building positioning, value proposition, and success factors early and from the patient’s perspective, and the people who serve them, outward, so the case for a medicine is grounded in real motivation before critical endpoints are chosen.
Visit the Nmblr website to learn more about the Define toolkit.
This content was provided by Nmblr
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