---
title: "Measuring What Matters: Biomarkers, Imaging, and Statistical Rigor with Guest David Raunig"
description: "Tune into Fractals: Life Science Conversations with Hatch BioFund Managing Partner Dr. Lorenzo Pellegrini"
---

[Podcast ](https://www.thebrackengroup.com/podcast)

# [Measuring What Matters: Biomarkers, Imaging, and Statistical Rigor with Guest David Raunig](https://www.thebrackengroup.com/podcast/measuring-what-matters-biomarkers-imaging-and-statistical-rigor-with-guest-david-raunig)

 Written by [Fractals: Life Science Conversations](https://www.thebrackengroup.com/podcast/author/fractals-life-science-conversations) | May 27, 2025 6:05:59 PM

 

With more than two decades of experience at the intersection of biostatistics and biomedical imaging, Bracken Senior Partner [Dr. David Raunig](https://www.linkedin.com/in/david-raunig-ph-d-b6353a8/) 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 preferred podcast platform, and [contact Bracken](https://thebrackengroup.slack.com/archives/D054SNVE5HP/p1748368326564469) to learn more about how we can support you with biomarker and endpoint selection in your medical imaging projects.

<https://podcasts.apple.com/us/podcast/measuring-what-matters-biomarkers-imaging-and/id1707100631?i=1000710136810><https://open.spotify.com/episode/4LWIal8bh6v3VIqrfCwVm1?si=9d19e2dbe5b44755>

###### [Click here to read the transcript version of this episode.](https://www.thebrackengroup.com/measuring-what-matters-biomarkers-imaging-and-statistical-rigor-transcript?hs_preview=pbbgWyWx-190682435735)

 

 

[View full post](https://www.thebrackengroup.com/podcast/measuring-what-matters-biomarkers-imaging-and-statistical-rigor-with-guest-david-raunig)

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