For better or worse, A.I. in the pharmaceutical industry has reached a fever pitch—a point of no return. Ever cautious, the Food and Drug Administration (FDA) has stepped in to regulate the burgeoning use of A.I. in drug discovery and development, vowing to “promote innovation and protect patient safety.” But while the agency ponders policy, companies like Immunai have already charged ahead. The biotech company recently inked an $18 million deal with AstraZeneca, which aims to harness Immunai’s A.I.-powered immune system model to optimize clinical trials. Startups like Insilico Medicine and Recursion Pharmaceuticals tout A.I. as their secret weapon in the hunt for new drugs, though skeptics whisper that their claims smack of A.I. washing.

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“There is a spectrum of opinions on whether A.I. is going to solve problems on its own in drug development, versus whether it’s not going to be relevant and feasible at all. I think I sit somewhere in the middle,” Raviv Pryluk, co-founder and CEO of PhaseV, tells Observer. Pryluk, who previously served as SVP of operations and analytics at Immunai, struck out on his own in 2023 to launch a company focused on using A.I. and machine learning to streamline clinical trials. “It can bring a tremendous amount of value, but only when done carefully,” he cautions.

The FDA claims that since 1995, it has received over 300 submissions for drugs and biological products containing A.I.........

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