FDA's Role in AI-Powered Drug Innovation With: Rajeev Ronanki
Rajeev Ronanki, CEO of Lyric, explores how the FDA’s evolving stance on artificial intelligence could reshape the future of drug development and healthcare delivery. In this compelling exchange, he unpacks the promise of Elsa—a tech-forward initiative by the FDA—and why it signals a paradigm shift from bureaucratic bottlenecks to data-driven decisions. Rajeev emphasizes how AI can accelerate therapeutic innovation, reduce inefficiencies, and make regulatory processes more transparent and predictive. His insights speak directly to healthcare executives, clinicians, and digital health innovators eager to understand federal AI adoption and its implications for clinical practice and pharma R&D.
Episode Contents:
About the Guest
Rajeev Ronanki is the CEO of Lyric and a leading voice in healthcare technology. He previously led digital transformation at Elevance Health and served as a partner at Deloitte Consulting, where he pioneered AI innovation in healthcare.
Key Takeaways
- The FDA’s initiative, Elsa, could transform how data is used to shape therapeutic pathways
- AI offers a chance to make drug development more predictive and simulation-based
- Rajeev compares the FDA’s AI journey to autonomous driving—starting imperfect but rapidly improving
- Human oversight should shift from manual control to intelligent monitoring
- Building trust in AI-driven regulation requires transparency, not bureaucracy
Transcript Summary
Q: What is Elsa, and why does it matter for healthcare?
A: I was surprised when the FDA announced it. Elsa shows that they’ve woken up to the real potential of AI. The agency sits on massive datasets from clinical trials and real-world monitoring. What they’re doing now is exploring how to use that data to help pharma innovate faster, simulate drug efficacy, and anticipate outcomes—all before drugs hit the market.
Q: How can AI reduce bureaucracy in regulatory processes?
A: Much like autonomous driving, AI at the FDA could make the process more efficient and less human-dependent. That’s not to devalue humans, but bureaucracy often slows down innovation. With AI, you shift humans into oversight roles—checking the math, ensuring the models work—while letting the system handle routine assessments.
Q: Can AI restore public trust in regulatory science?
A: Some view the FDA with suspicion. But AI, if grounded in science and benchmarked transparently, could eliminate emotional or self-serving bias. It offers a chance to create a truly evidence-based, reproducible framework for decision-making.
More Topics
- AI in Patient Care
- AI in the Healthcare Industry
- AI and Medical Innovation
- Healthcare Ethics and Policy
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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.