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.

“We are trying to do everything in our power to make this a much more efficient process,” Kim, the company’s CEO, told Forbes. “There are all these new and exciting ways to attack cancer. If we can do [the clinical trials] faster and cheaper and get therapies out to patients, we want to do it now because there are people waiting right now.”

Only 8% of cancer patients in the U.S. participate in clinical studies, in part because of the voluminous paperwork required to run them. That limits understanding of the disease and the way that it affects diverse populations, and also means drug approvals take longer and cost more than they would if the limited pool of patients weren’t a bottleneck.

“The clinical trial process is so confusing. It’s just alphabet soup.”

Pi Health’s software aims to lower the burden. It combines all clinical trial data into one place, streamlining workflows and reducing errors, starting with the trial design and continuing through regulatory submission. It uses artificial intelligence to check for discrepancies and errors in data and to produce automated notes with clinical documentation from regulatory-grade data.

To date, the Cambridge, Mass.-based startup has raised some $40 million at a valuation of nearly $100 million. It is generating revenue, with signed contracts of more than $70 million. And it is working on nearly 20 clinical studies for five global pharmaceutical companies, including for BeOne Medicines (formerly BeiGene), the $30 billion (market cap) cancer drug developer where Pi Health was incubated and which still owns a roughly 40% stake in the business.

“We are passionate about changing oncology drug development,” said Reddy, the company’s chief operating officer. “Being in healthcare, there’s too much of the same and not enough people that take bold risks and try to do something different.”

“There are only so many patients to go around, and there are more and more trials and companies competing for a relatively finite and stable number of patients.”

Kim, 48, and Reddy, 40, launched Pi Health as an initiative at BeiGene, which they joined in 2019 after pitching the idea that became Pi Health to CEO John Oyler. Kim, an oncologist, had previously worked for the Food and Drug Administration as a medical officer and director of oncology products for seven years. Reddy is an attending physician at Massachusetts General Hospital’s Melanoma and Pigmented Lesion Center. They first met when Kim was a fellow at the National Cancer Institute and Reddy was a research scholar at the Howard Hughes Medical Institute some 15 years ago. Kim subsequently recruited Reddy to work on his regulatory team at AstraZeneca in 2019 and they joined BeiGene later that year.

“I was really struck by how expensive these studies were,” Kim said. “Everything that was said about the cost of clinical trials and why it was the bottleneck to clinical development was true.”

The number of enrollees in clinical trials has increased only marginally, to 764,000 in 2024, from 655,000 in 2010, according to Citeline, which tracks clinical trials. Yet the number of drugs in the pipeline (including pre-clinical ones) has ballooned to 23,875 in 2024, from 9,737 in 2010, while the number of companies actively involved in drug development has tripled, to 6,823 from 2,207. That’s great for patients hoping for life-saving treatments, but impossible to push through the existing infrastructure.

“We think it is the critical bottleneck,” said Daniel Chancellor, VP of thought leadership at pharmaceutical intelligence firm Norstella, the parent company of Citeline. “There are only so many patients to go around, and there are more and more trials and companies competing for a relatively finite and stable number of patients. That means it’s taking much longer to complete the clinical trial or you have to spend a lot more money to run a clinical trial.”

Most clinical trials are done at big research hospitals like Memorial Sloan Kettering in New York or Mass General in Boston. The result is that patients with disease in much of the U.S., as well as those in other countries, never have a shot at being enrolled—something that’s an obvious issue for those patients but also slows the enrollment process for drug companies who must find eligible patients among a much smaller pool of people.

Drug developers recruit patients through physicians and medical practices, patient organizations and consumer advertising. Eligibility criteria typically include the patient’s age, their type and stage of cancer and the previous treatments they’ve received. While a healthtech startup building its own hospital is unusual, VC firm General Catalyst made a similar move with its acquisition of Ohio hospital system Summa Health, in part as a testing ground for new healthcare technology.

“There are all these new and exciting ways to attack cancer. If we can do [the clinical trials] faster and cheaper and get therapies out to patients, we want to do it now because there are people waiting right now.”

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.”

Kim and Reddy built the cloud-based technology while at BeiGene, then spun out the business with $30 million in venture funding led by AlleyCorp and Obvious Ventures in March 2024. By then, it had already opened the Hyderabad hospital at a cost of a few million. India represents nearly 20% of the global population, yet hosts less than 2% of global oncology trials, Reddy said, ticking off the reasons why that’s the case, including India’s infrastructure, as well as data quality and compliance issues. “There was real ambition to establish this as the hospital where you can get access to experimental therapies in Hyderabad,” said Obvious Ventures’ partner Rohan Ganesh. “We were really impressed with the execution…..This is not an easy company to run.”

For starters, Pi Health built the India hospital during the Covid-19 pandemic. To keep to its tight timeline, Kim and Reddy refused to delay construction for a CT scanner to arrive from Germany—even though that meant they had to lease a crane to lift the giant medical machine through a hole in the fourth floor. “It was too big and you couldn’t take it up an elevator, and we couldn’t extend the timelines, so we said, ‘We’ll build the hospital and figure out how to get the CT scanner in,’” Reddy said. “If we had realized [how hard it would be], nobody would have actually capitalized this.”

Since its opening, Pi Health’s hospital in Hyderabad has participated in eight clinical trials, including with BeOne, two other large global pharmaceutical companies and a few local Indian companies, said Vinayak Chintapally, general manager of the Pi Health hospital in Hyderabad. These include Jazz Pharmaceuticals, ImmunityBio and Dr. Reddy’s Laboratory (no relation to cofounder Bobby Reddy).

The compressed timeline for the approval of BeOne’s head, neck and lung drug, called Tevimbra, was “just staggering,” said investor Ganesh. “The magnitude is not days, it is weeks or months. Financially that has a humongous implication for a pharmaceutical company.” Clinical trials regularly cost more than $10 million, and late-stage trials can cost more than $100 million. But the overall cost of the trial is only one piece of the financial impact; a perhaps larger one is speed as drug developers typically file patents before clinical trials are complete, starting the clock ticking toward their expiration, so the faster they get to market the longer they have till they face cheaper competitors. “Trials should be faster and cheaper for the entire industry so that we get more drugs,” he said.

Chintapally, manager of the India hospital, said that there’s been “a lot of interest” from global pharmaceutical companies and that the company expects to take on more trials for them. Meanwhile, with the fully-owned Hyderabad hospital running, Pi Health has been able to set up a partnership with a hospital four hours away in rural Nizamabad off a dirt road where water buffalo gather. “It’s all about the data, and how do you make sure the data quality, compliance and risk mitigation is there,” Chintapally said.

Pi Health is now looking to roll out its clinical trials software more broadly, including beyond oncology in immunology, psychiatry and other therapeutics areas. It’s launched at 17 oncology centers in the U.S., India, Brazil, Australia and China. In the U.S., it has begun partnering with community cancer clinics that would previously have been too small to manage the compliance requirements of a clinical trial. Family-run Iyengar Hematology Oncology Center in Bayonne, N.J., for example is now participating in a trial for a BeOne treatment for a type of cancer called relapsed follicular lymphoma. It’s particularly difficult to find patients with that disease for a trial, and the clinic has just one person participating, something that would have required too much paperwork and documentation without the software. “The trial was proof of concept for us that we could run the clinical trials in the community,” said Dr. Arjun Iyengar, an oncologist and faculty member at NYU Grossman School of Medicine who runs the clinic with his father.

While Pi Health doesn’t plan to open additional cancer hospitals of its own, the willingness of Kim and Reddy to do something that on the face of it seems kind of crazy enabled them to prove their approach made sense rather than just talking about how it might. As Reddy said: “What we have done in India shows that we can democratize medicines and clinical trial access.”

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