Evidence Threshold for Follow-On Indications
A small biopharma company was considering two clinically adjacent follow-on indications for a neurology asset. To determine whether the potential additional value justified the added development effort, the company needed to understand how neurologists manage these conditions, which patients might be candidates for the asset, and what evidence would make the product a credible option in each setting.
Because the decision depended on both the clinical realities of each condition and the plausibility of the asset’s evidence story, the work first established the patient and treatment context before assessing the evidence neurologists would need to consider the asset a viable option. This was done through a blended Habits & Practices and TPP-based concept test with neurologists.
Interviews mapped the patient journey for both conditions, from presentation and diagnosis through treatment, and explored where clinicians saw unmet need, sufficient current care, and diagnostic or management ambiguity. Respondents then reacted to a TPP concept for the asset in each indication, identifying what felt differentiated, where the profile risked being viewed as incremental, and what data would be needed to support use in relevant patient segments.
Outputs included comparative patient journey and treatment flow schematics, priority patient types, current treatment patterns and adverse event considerations, indicative patient volumes, and concise TPP feedback. Findings were synthesized into strategic considerations and next steps, including a structured view of remaining evidence questions.
The research shifted the discussion from abstract unmet need and market potential to the realities of clinical practice. It clarified where neurologists distinguished the conditions, where boundaries were blurred, and which patients they would realistically consider for a new option.
TPP feedback also made the evidence requirements more specific: which aspects of the profile were compelling, where it appeared incremental, and what level or type of evidence clinicians would need for confidence in use. This gave the team a clearer view of the likely development lift and the plausibility of building an evidence story that neurologists would act on.
The findings informed forecasting and broader portfolio discussions. Based on the balance of resource requirements and likely real-world use, the client chose not to pursue the two follow-on indications at that time.
The work supported a more grounded “no for now” decision, not by dismissing unmet need, but by clarifying what would need to be true for the indications to justify inclusion in the development strategy.
This is the kind of NPP work that reflects my approach: make assumptions explicit and bring structure to uncertainty so commercial recommendations are stronger without overreaching the evidence.