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Earlier this year, the FDA released draft guidance endorsing Bayesian methods and simulation-based evidence in clinical trials in a significant shift in how regulators think about predictive medicine.
In a new pharmaphorum podcast, Dr Irina Babina, CEO of oncology R&D platform Concr, discusses how current regulatory frameworks were built for static, one-test-one-answer diagnostics, as well as the potential of digital twins, and how, if regulators keep approving AI medical tools the way they approve blood tests, the most promising predictive technologies will never reach patients.
You can listen to episode 276 of the pharmaphorum podcast in the player below, download the episode to your computer, or find it – and subscribe to the rest of the series – on Apple Podcasts, Spotify, Overcast, Pocket Casts, Podbean, and pretty much wherever else you download your other podcasts from.
