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Clinical trials are an enormous bottleneck in drug development, and Kim and Reddy thought the AI-enabled software they’d been building at Pi Health could help do them faster and cheaper by expanding the pool of potentially eligible patients. But the majority of clinical trials today are done in top-notch academic medical centers, and first they needed to prove that their AI-enabled software could help overseas hospitals and smaller community cancer centers handle the documentation required to get through regulatory approval. So they found a site in Hyderabad, a major technology and pharmaceutical center in southern India, and built a 30-bed, state-of-the-art cancer hospital.
Pi Health Cancer Hospital opened in September 2023, and began running clinical trials last year. It’s participated in eight so far, including one that helped lead to a drug for head, neck and lung cancer being approved in India just seven months after the first Indian patient was enrolled in the study. That’s less than half the time such a process would typically take and a major validation point for the software, one that Kim and Reddy believe will help them attract more customers.
Kim and Reddy figured they could develop AI-enabled technology that would ease the burden of clinical trials for drug developers and cancer patients. To build it, Pi Health’s developers started with the end results they needed—which Kim knew so well from his years at the FDA reviewing cancer drugs—and essentially worked backwards to be sure that the software would actually address the problems they were trying to solve. “The clinical trial process is so confusing,” Kim said. “It’s just alphabet soup. There’s audits and threatening people with audits and all sorts of things. People get intimidated participating in clinical trials. It is really intimidating.”
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