With more than two decades of experience at the intersection of biostatistics and biomedical imaging, Bracken Senior Partner Dr. David Raunig has been a driving force in biomarker development, validation, and regulatory strategy. From leading FDA biomarker qualification review teams to co-inventing imaging advancements and setting industry-wide standards through QIBA, David has played a pivotal role in defining how we measure—and trust—biological data in clinical trials.

In this episode of Fractals: Life Science Conversations, David and host Colin Miller explore:

• What truly defines a biomarker—and how clinical outcome assessments differ from biological markers.
• Why the FDA’s "context of use" is key to biomarker qualification and how to demonstrate that a biomarker measures what it’s meant to.
• How the evolution of imaging—from WHO criteria to RECIST to AI-assisted reads—could transform how we assess tumor burden and therapeutic response.
• Statistical strategies for trial design and endpoint validation, and why QIBA’s standardized imaging protocols are essential tools for trial sponsors.

Tune in to Fractals on your favorite podcast platform, and connect with Bracken to learn how David and our experts can support your clinical trial strategy from biomarker planning to regulatory approval.