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Strategic Consulting

Strategic Biomarker Development: Enhancing Diagnostic Platforms for Cardiovascular Health

Challenge:

A pre-clinical diagnostics company specializing in novel biomarkers and diagnostic platforms needed support in selecting circulating biomarkers for inclusion in their platform. The goal was to identify multiple biomarkers that could monitor cardiovascular health in individuals with type 2 diabetes, providing an accurate and early prediction of disease progression.

Solution:

To address this challenge, we conducted a thorough assessment of biomarkers identified through high-throughput screening of plasma samples from diabetic mouse models at various stages of disease progression. Partnerships were established with pre-clinical investigators to develop a lab-on-a-chip diagnostic platform capable of isolating and identifying a panel of microRNAs that monitor the onset of heart failure prior to clinical symptoms. Additionally, we facilitated connections between scientific investigators and regulatory bodies to ensure a smooth transition to early-phase trials.

Outcomes

  1. Understanding the Unmet Need: Developed a clear understanding of the unmet need within the therapeutic area, aligning research priorities with clinical objectives.

  2. Comprehensive Biomarker Evaluation: Conducted an in-depth literature review to highlight the potential of candidate biomarkers as reliable diagnostic tools.

  3. Expert Collaboration: Established connections with key opinion leaders (KOLs) to refine and select the most appropriate biomarkers for inclusion in the diagnostic platform.

  4. Pre-Clinical Research Plan: Designed a robust pre-clinical research plan to further explore the role of these biomarkers in predicting cellular function and disease progression.

Key Takeaway

Through strategic evaluation and expert collaboration, this diagnostics company advanced the development of a cutting-edge platform to monitor cardiovascular health in type 2 diabetes patients, addressing a critical unmet need and positioning their solution for future clinical success.