Microsoft Research Podcast AI Testing and Evaluation: Learnings from pharmaceuticals and medical devices
Jul 7, 2025
In this intriguing discussion, Daniel Carpenter, a Harvard government expert on FDA regulations, Timo Minssen, a Copenhagen law professor specializing in biomedical innovation, and Chad Atalla from Microsoft Research explore the complexities of AI in pharmaceuticals and medical devices. They delve into the evolving FDA landscape, the critical balance between innovation and safety in drug approvals, and the innovative strategies needed for efficient clinical trials. The group highlights the importance of aligning AI technologies with societal values and overcoming bias in AI systems.
AI Snips
Chapters
Transcript
Episode notes
Daniel's FDA Origin Story
- Daniel Carpenter's interest in the FDA sparked during his graduate school when studying decisions on AIDS drugs.
- A summer internship and news on AIDS drug regulation led him to focus on pharmaceutical regulators.
FDA's Dual Testing Role
- The FDA uniquely requires proof of both safety and efficacy before a drug hits the market.
- It acts as a gatekeeper, controlling which drugs reach consumers through rigorous, expensive human trials.
Evolution of Pharma Regulation
- Historically, the US FDA was the most stringent regulator, with other countries relying on their approvals.
- Recently, the FDA has started to partially deregulate for innovative therapies and deadly diseases to speed market access.