Episode 3

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Published on:

4th Sep 2025

Endpoints, Resistance, and the Architecture of Evidence in Immuno-Oncology

In this episode of Precision Signals, Dr. Sean Khozin speaks with Dr. James Gulley, Chief of the Medical Oncology Service and Co-Director of the Center for Immuno-Oncology at the National Cancer Institute.

Dr. Gulley is one of the world’s leading figures in immuno-oncology. He helped bring immune-based cancer therapies from an era of skepticism into a clinical mainstay, shaping both the science and the clinical frameworks that define the field today.

Their conversation explores the critical frontiers of immunotherapy: the limits of predictive biomarkers, the biological opacity of treatment resistance, and the shortcomings of current trial designs. They discuss adaptive clinical trials, new endpoints, and the integration of AI into clinical research. Emerging tools such as digital pathology, wearable monitoring, and continuous physiologic data capture are highlighted, including recent work detecting CAR-T toxicity before it becomes clinically evident.

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About the Podcast

Precision Signals
Decoding the Systems Behind Breakthroughs in Healthcare and Biomedicine
Precision Signals is a podcast from the CEO Roundtable on Cancer about decoding biomedical progress: what’s real, what matters, and what’s next. We talk with scientists, regulators, investors, and builders operating across the messy interface of research, healthcare, and policy. Some are moving the system from within; others are reshaping it from the outside. All of them bring signal in a world crowded with noise.

About your host

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Sean Khozin, MD, MPH

Sean Khozin, MD, MPH is a physician-executive and board-certified oncologist internationally recognized for his pioneering work on advancing the use of artificial intelligence and novel data science solutions in cancer research and drug development. As Chief Executive Officer of the CEO Roundtable on Cancer and its independent AI research organization, Project Data Sphere, he leads initiatives that bridge cutting-edge technology with clinically-meaningful applications to accelerate cancer research and care.

Dr. Khozin is founder of Phyusion Bio LLC, an advisory and venture creation firm specializing in precision therapies and AI-powered solutions. His entrepreneurial track record includes co-founding Hello Health (acquired by Myca Health) and serving as CEO of CancerLinQ, where he orchestrated its strategic acquisition by ConcertAI.

His regulatory and industry expertise spans leadership roles at Johnson & Johnson/Janssen R&D as Global Head of Data Strategy and at the US FDA, where he served as founding Executive Director of INFORMED—the agency's first data science incubator—while helping establish the Oncology Center of Excellence. Earlier in his career at the National Cancer Institute, he spearheaded clinical research on molecular profiling strategies for targeted therapy development.

Dr. Khozin maintains his academic connections as a Research Affiliate at MIT and serves on multiple boards advancing the intersection of cancer research and artificial intelligence in biomedicine.