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  • 7/11/2025
New drugs take too long to get to market because of clinical trial bottlenecks. Two cancer doctors built AI-enabled tech to speed up the process.

Read the full story on Forbes: https://www.forbes.com/sites/amyfeldman/2025/07/01/startup-pi-health-built-a-cancer-hospital-in-india-to-test-its-ai-software-clinical-trials/

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Transcript
00:00Today on Forbes, this startup built a hospital in India to test its AI software.
00:07As long-time cancer doctors with regulatory experience,
00:11Pi Health co-founders Jeff Kim and Bobby Reddy knew that completing clinical trials took far too long.
00:18There was the painfully slow process of signing up patients,
00:21and after that, a grueling slog through vast swamps of data to prepare voluminous regulatory filings,
00:26something that few hospitals and clinics can handle.
00:30The pair knew their startup's best chance of success meant doing an end-run around all that,
00:35so they did something audacious and unprecedented.
00:38They built their own cancer hospital in India.
00:42Clinical trials are an enormous bottleneck in drug development,
00:46and Kim and Reddy thought the AI-enabled software they'd been building at Pi Health
00:49could help do them faster and cheaper by expanding the pool of potentially eligible patients.
00:54But the majority of clinical trials today are done in top-notch academic medical centers,
01:00and first they needed to prove that their AI-enabled software could help overseas hospitals
01:05and smaller community cancer centers handle the documentation required to get through regulatory approval.
01:11So they found a site in Hyderabad, a major technology and pharmaceutical center in southern India,
01:17and built a 30-bed, state-of-the-art cancer hospital.
01:21Pi Health Cancer Hospital opened in September 2023 and began running clinical trials last year.
01:28It's participated in eight so far, including one that helped lead to a drug for head, neck, and lung cancer
01:34being approved in India just seven months after the first Indian patient was enrolled in the study.
01:40That's less than half the time such a process would typically take,
01:44and a major validation point for the software,
01:46one that Kim and Reddy believe will help them attract more customers.
01:49Kim, the company's CEO, told Forbes,
01:53We are trying to do everything in our power to make this a much more efficient process.
01:58There are all these new and exciting ways to attack cancer.
02:01If we can do the clinical trials faster and cheaper and get therapies out to patients,
02:06we want to do it now because there are people waiting right now.
02:10Only 8% of cancer patients in the U.S. participate in clinical studies,
02:15in part because of the voluminous paperwork required to run them.
02:18That limits understanding of the disease and the way that it affects diverse populations,
02:23and also means drug approvals take longer and cost more than they would
02:27if the limited pool of patients weren't a bottleneck.
02:30Pi Health's software aims to lower the burden.
02:33It combines all clinical trial data into one place,
02:36streamlining workflows and reducing errors,
02:39starting with the trial design and continuing through regulatory submission.
02:43It uses artificial intelligence to check for discrepancies and errors in data
02:47and to produce automated notes with clinical documentation from regulatory-grade data.
02:52To date, the Cambridge, Massachusetts-based startup has raised some $40 million
02:57at a valuation of nearly $100 million.
03:00It is generating revenue with signed contracts of more than $70 million.
03:04And it is working on nearly 20 clinical studies for five global pharmaceutical companies,
03:10including for B1 Medicines, formerly B-Gene,
03:13the $30 billion market cap cancer drug developer where Pi Health was incubated
03:18and which still owns a roughly 40% stake in the business.
03:22Kim, who is 48 years old, and Reddy, who is 40,
03:26launched Pi Health as an initiative at B-Gene,
03:29which they joined in 2019 after pitching the idea that became Pi Health to CEO John Euler.
03:36Kim, an oncologist, had previously worked for the Food and Drug Administration as a medical officer
03:40and director of oncology products for seven years.
03:44Reddy is an attending physician at Massachusetts General Hospital's
03:47Melanoma and Pigmented Lesion Center.
03:50They first met when Kim was a fellow at the National Cancer Institute,
03:53and Reddy was a research scholar at the Howard Hughes Medical Institute some 15 years ago.
03:59Kim subsequently recruited Reddy to work on his regulatory team at AstraZeneca in 2019,
04:04and they joined B-Gene later that year.
04:07Kim said, quote,
04:08I was really struck by how expensive these studies were.
04:12Everything that was said about the cost of clinical trials
04:14and why it was the bottleneck to clinical development was true.
04:19For full coverage, check out Amy Feldman's piece on Forbes.com.
04:24This is Kieran Meadows from Forbes.
04:27Thanks for tuning in.

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