How can a brilliant oncologist, computer scientist, and former top FDA official fix the slow, broken, and expensive system of clinical trials? In this episode, we sit down with Dr. Amy Abernethy, a true physician innovator, to uncover the critical need for streamlining clinical research with real-world data. Dr. Abernethy has spent her career tackling one of healthcare’s biggest challenges: how to get effective treatments to the patients who need them, faster. From pioneering research at Duke to scaling a startup to a multi-billion dollar acquisition and modernizing the FDA’s entire data infrastructure, she reveals the playbook for building a true learning health system.
In this deep-dive conversation, Dr. Amy Abernethy shares her incredible physician innovator career path, which took her from the clinic at Duke University to executive roles at Flatiron Health, the FDA, Verily, and now as the co-founder of Highlander Health. She begins by detailing her early academic work building a "Center for Learning Healthcare," where she focused on using patient-reported outcomes and electronic data to understand what treatments truly work. However, she hit a ceiling in academia, realizing that the grant-based model couldn't scale. This led to her pivot to industry and Flatiron Health, where she shares invaluable lessons on scaling health tech companies. Dr. Abernethy discusses the importance of creating a common language ("lingua franca") between clinicians, engineers, and product teams, and establishing a North Star through shared corporate values.
This experience was crucial for her next chapter at the U.S. Food and Drug Administration, where she served as Principal Deputy Commissioner. Dr. Abernethy provides a rare insider's look at the immense challenges and surprising speed of government work, particularly her focus on FDA data modernization. She explains how the looming wave of cell and gene therapies and the EVALI vaping crisis created an urgent need for a cloud-forward, scalable agency capable of using real-world data for regulatory decisions. This work in advancing real-world evidence in regulatory science set the stage for her current mission. Now in "founder mode" at Highlander Health, she is building the infrastructure for the future of evidence generation by both funding non-profit research and investing in key companies like Target RWE, continuing her lifelong mission of streamlining clinical research with real-world data. This episode is a masterclass for anyone interested in health tech, public policy, and the future of medicine.
ABOUT OUR GUEST:
Dr. Amy Abernethy is a physician, researcher, and health tech leader who is currently the co-founder of Highlander Health. Her distinguished career includes roles as a medical oncologist and researcher at Duke University, Chief Medical Officer and Chief Scientific Officer at Flatiron Health, Principal Deputy Commissioner of the U.S. Food and Drug Administration (FDA), and a leader in product development at Verily. She is a world-renowned expert in real-world data, evidence generation, and building learning health systems.
TIMESTAMPS:
(00:00) Introduction to Dr. Amy Abernethy's Trailblazing Career
(02:19) The Origin Story: From NASA Programmer to Clinical Oncologist
(05:35) Building a "Learning Health System" at Duke University
(07:57) The Pivot from Academia to Industry: Why Scale Matters
(10:10) Lessons in Scaling a Mission-Driven Health Tech Company
(15:54) Shaping the Narrative for Real-World Evidence (RWE)
(18:43) From Industry to Government: A New Chapter at the FDA
(22:27) Modernizing FDA Data Systems for Future Health Crises
(27:39) Founder Mode: The Launch of Highlander Health
(35:41) Advice for Aspiring Physician Innovators
LEARN MORE FROM OUR GUEST / EPISODE RESOURCES: