SITUATION
A global biopharma company was advancing a novel CNS therapy targeting early-stage neurodegenerative disease. The therapy, based on a new mechanism of action, was designed to intervene before significant cognitive decline but early identification of eligible patients remained a major barrier.
In parallel, the company had also invested in a blood-based biomarker diagnostic that could signal disease presence earlier and more efficiently than imaging or spinal fluid tests. While both assets showed promise, the development teams were operating independently, and leadership recognized an opportunity to integrate the diagnostic and therapeutic programs more strategically.
CHALLENGE
The company needed to determine how best to combine the diagnostic and therapeutic programs to support trial design, stakeholder engagement, and commercial success, while avoiding internal misalignment or regulatory complications.
Key challenges included:
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Lack of precedent on co-developing diagnostics and therapies in neurodegenerative conditions
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Difficulty estimating real-world diagnostic adoption and its impact on trial recruitment
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No unified narrative around how the diagnostic and therapy could together improve outcomes
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Concerns about payer acceptance of combined value if both components were priced separately
The company needed a clear framework to align strategy across medical, regulatory, and commercial teams.
APPROACH
ConsaInsights was brought in to map out a strategy for combining diagnostic and therapeutic planning. The goal was to accelerate trial execution and improve stakeholder alignment while maximizing the impact of both assets.
Our structured approach involved four key workstreams:
Diagnostic Adoption & Use Case Modeling
We assessed real-world blood-based diagnostic adoption across 7 therapeutic areas with similar challenges. This included uptake timelines, reimbursement trends, and infrastructure requirements. Findings helped set realistic expectations for diagnostic availability during pivotal trials.
Trial Design Integration Support
We reviewed 15 recent co-development programs across oncology and rare disease to identify best practices for embedding diagnostics into trial design. Based on this, we recommended diagnostic screening flows, site enablement plans, and patient identification strategies.
Unified Value Proposition Development
We created a cross-functional messaging framework highlighting how early diagnosis + early intervention could shift clinical outcomes. This value story was structured to resonate with regulators, payers, and advocacy groups.