FDA’s ELSA: The Future of AI Regulation? With: Rajeev Ronanki
Rajeev Ronanki, CEO of Lyric, unpacks the FDA’s bold step with ELSA, an agency-wide AI tool designed to harness the mountains of data it already holds. He explains that ELSA could transform the FDA from a reactive regulator into a proactive shaper of therapeutic pathways, accelerating drug development and safety monitoring. By simulating drug efficacy, side effects, and applicability across populations, ELSA could shorten approval timelines and improve innovation. Ronanki acknowledges early challenges and skepticism but stresses the need to let the system learn over time, much like autonomous driving technology. If implemented correctly, ELSA could reduce bureaucracy, minimize bias, and build public trust by grounding FDA processes in data-driven science.
Episode Contents:
About the Guest
Rajeev Ronanki is CEO of Lyric, where he leads efforts to develop ethical and responsible AI solutions for healthcare. He focuses on creating ecosystems that empower patients, improve equity, and reward data sharing to drive better outcomes.
Key Takeaways
- ELSA aims to turn the FDA into a proactive, data-driven regulator
- The tool could accelerate drug development by simulating efficacy and side effects
- Like autonomous driving, ELSA must learn over time to gain trust and effectiveness
Transcript Summary
What is FDA’s ELSA?
An AI tool to harness FDA’s vast datasets, simulate drug outcomes, and guide therapeutic pathways.
Why does it matter?
It could shorten approval timelines, reduce bureaucracy, and increase trust in science-based regulation.
What challenges lie ahead?
Early skepticism, potential failures, and the need to let the system learn and improve over time.
More Topics
- AI in the Healthcare Industry
- AI and Medical Innovation
- Healthcare Ethics and Policy
- AI in Patient Care
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About the Series
AI and Healthcare—with Mika Newton and Dr. Sanjay Juneja is an engaging interview series featuring world-renowned leaders shaping the intersection of artificial intelligence and medicine.
Dr. Sanjay Juneja, a hematologist and medical oncologist widely recognized as “TheOncDoc,” is a trailblazer in healthcare innovation and a rising authority on the transformative role of AI in medicine.
Mika Newton is an expert in healthcare data management, with a focus on data completeness and universality. Mika is on the editorial board of AI in Precision Oncology and is no stranger to bringing transformative technologies to market and fostering innovation.