When questioned about discrepancies where a 24-week dose underperformed on the primary endpoint but was strong on secondary ones, the CEO avoided direct comparisons. Instead, he framed the results as a 'totality of evidence' supporting the drug's profile, a key communication tactic for presenting complex or imperfect data positively to investors and regulators.
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When a competitor (Beijing) presented similar positive data for its BTK degrader, the CEO of Neurix viewed it as a positive reinforcement for the entire drug class. In a novel field, parallel success from independent companies de-risks the underlying biological mechanism for investors, partners, and clinicians.
Instead of stating that customer retention improved from 80% to 95%, tell the story behind it. Explain the problem, the specific actions taken by a cross-functional team, and the resulting outcome. This narrative makes the numbers credible and memorable.
The FDA receives raw and cleaned datasets from sponsors, not just summary reports. Their internal teams conduct independent analyses, which can lead to findings or data presentations in the official drug label that differ from or expand upon what's in the published paper.
Progress in drug development often hides inside failures. A therapy that fails in one clinical trial can provide critical scientific learnings. One company leveraged insights from a failed study to redesign a subsequent trial, which was successful and led to the drug's approval.
The company reports 'overall MMR,' which includes patients maintaining a prior response—a less rigorous metric than 'MMR achievement' (new responses). The CEO notes that discerning investors are focused on the latter, more challenging endpoint, revealing a key area of due diligence for the company's impressive data.
Despite reporting positive Phase 2 asthma data that met the company's stated goals for 12-week dosing, Upstream Bio's stock dropped significantly. The CEO attributes this to the 24-week dosing data being less robust on the primary endpoint, highlighting the gap between achieving clinical goals and meeting nuanced market expectations for a best-case scenario.
Biotech leaders must stop viewing commercialization as a post-approval task. The critical window is Phase 2 clinical trials. By embedding patient journey and quality of life insights into secondary endpoints, companies can build a compelling value proposition for payers and physicians. Waiting until Phase 3 is too late.
Post-IPO, credibility is a biotech's most valuable asset. Leaders should "under-promise and over-perform" by avoiding specific quarterly guidance for clinical milestones. Instead, use broader windows like "first half of the year" to build in flexibility, as clinical trials rarely run on a perfect schedule.
Faced with a competitor's once-monthly dosing schedule versus their own weekly one, Vera's CEO strategically downplays frequency as a key differentiator. He emphasizes their drug's easy-to-use autoinjector, low volume, and high patient adherence, framing the weekly schedule as a minor detail within a superior overall patient experience.
When questioned about a seemingly suspicious cluster of non-responders in trial data, the CEO clarified the event was not statistically improbable. He stated the chance of it happening randomly was a significant 25-30%, demonstrating how to counter narrative-based skepticism with quantitative analysis.
