zeeshan khan
Geoff Kim and Bobby Reddy, cofounders of Pi Health, are seasoned cancer physicians with regulatory expertise who were aware that clinical study completion takes excessively lengthy. In addition to the excruciatingly long patient registration process, few hospitals and clinics are equipped to handle the laborious task of sorting through enormous data swamps in order to produce extensive regulatory files. The two realized that circumventing all of that would increase the likelihood that their startup would succeed. They therefore took a bold and unheard-of step by constructing their own cancer hospital in India.
Kim and Reddy believed that the AI-enabled software they had been developing at Pi Health may assist conduct clinical trials more quickly and affordably by increasing the number of potentially eligible patients. Clinical trials are a major bottleneck in drug development. However, since most clinical trials are now conducted in prestigious academic medical facilities, they had to demonstrate that their AI-enabled software could assist smaller community cancer clinics and hospitals abroad with the paperwork needed to obtain regulatory permission. Thus, they located a 30-bed, cutting-edge cancer hospital in Hyderabad, a significant pharmaceutical and technology hub in southern India.
Pi Health Cancer Hospital started conducting clinical trials last year after opening in September 2023. It has taken part in eight so far, including one that, just seven months after the first Indian patient was enrolled in the trial, contributed to the approval of a medication for head, neck, and lung cancer in India. This is a significant validation step for the software, which Kim and Reddy think will help them draw in additional clients, and it takes less than half the time that such a process would normally take.
The CEO of the company, told Forbes, “We are doing everything we can to make this a much more efficient process.” “Cancer may be attacked in a variety of innovative and interesting methods. There are people waiting right now, so if we can complete [the clinical trials] more quickly and affordably and bring treatments to patients, we want to do it now.
Due in part to the extensive paperwork needed to conduct clinical studies, just 8% of cancer patients in the United States take part in them. In addition to making treatment approvals take longer and cost more than they would if the small patient pool weren’t a barrier, this restricts knowledge of the illness and how it affects other demographics.
“The clinical study procedure is really perplexing. All it is is alphabet soup.”
The software from Pi Health seeks to lessen the load. Beginning with the trial design and continuing through regulatory filing, it centralizes all clinical trial data, optimizing workflows and lowering errors. It employs artificial intelligence to generate automatic notes with clinical documentation from regulatory-grade data and to look for inconsistencies and inaccuracies in the data.
At a valuation of about $100 million, the Cambridge, Massachusetts-based business has raised about $40 million so far. With more than $70 million in committed contracts, it is making money. Additionally, it is working on almost 20 clinical studies for five multinational pharmaceutical companies, including BeOne Medicines (previously BeiGene), a $30 billion (market cap) cancer medication developer that Pi Health was incubated at and still holds almost 40% of.
“We are committed to transforming the development of cancer drugs,” stated Reddy, the chief operational officer of the company. “There is too much of the same in the healthcare industry, and not enough people who are willing to take chances and try something new.”
There are only so many patients available, and an increasing number of trials and businesses are vying for a comparatively small and steady number of patients.
Daniel Chancellor, vice president of thought leadership at Norstella, a pharmaceutical intelligence company
After presenting the concept that would eventually become Pi Health to CEO John Oyler at BeiGene, which they joined in 2019, Kim, 48, and Reddy, 40, started the endeavor. Kim is an oncologist who spent seven years as a medical officer and director of oncology products at the Food and Drug Administration. Reddy works as an attending physician at the Melanoma and Pigmented Lesion Center at Massachusetts General Hospital. About 15 years ago, while Reddy was a research scholar at the Howard Hughes Medical Institute and Kim was a fellow at the National Cancer Institute, they first crossed paths. In 2019, Kim hired Reddy to join his regulatory team at AstraZeneca, and later that year, they joined BeiGene.
Citeline, which analyzes clinical trials, reports that the number of enrollees in clinical trials has only slightly increased, from 655,000 in 2010 to 764,000 in 2024. However, the number of businesses actively engaged in drug development has tripled, from 2,207 to 6,823 in 2024, and the number of medications in the pipeline, including pre-clinical ones, has increased from 9,737 in 2010 to 23,875 in 2024. Though it is impossible to push through the current infrastructure, that is fantastic for patients hoping for life-saving treatments.
Daniel Chancellor, vice president of thought leadership at pharmaceutical intelligence firm Norstella, Citeline’s parent company, stated, “We believe it to be the critical bottleneck.” There is a limited number of patients available, and an increasing number of studies and businesses are vying for a comparatively small and steady number of patients. This indicates that the clinical study is taking a lot longer to finish or that conducting one costs a lot more money.
Large research hospitals like Boston’s Mass General or New York’s Memorial Sloan Kettering conduct the majority of clinical studies. As a result, patients with illnesses in a large portion of the United States and other nations never have a chance to be enrolled. This is a clear problem for the patients, but it also makes it more difficult for pharmaceutical companies to find qualified patients from a much smaller pool.
Drug manufacturers use consumer advertising, patient organizations, and doctors and medical practices to find new patients. The patient’s age, the kind and stage of their cancer, and any prior medical treatments are usually included in the eligibility requirements. Although it is uncommon for a healthtech startup to construct its own hospital, venture capital firm General Catalyst did just that when it acquired the Ohio hospital system Summa Health, partly as a test site for new medical technologies.
Cancer may be attacked in a variety of innovative and interesting methods. There are people waiting right now, so if we can complete [the clinical trials] more quickly and affordably and bring treatments to patients, we want to do it now.
Dr. Geoff Kim, CEO and co-founder of Pi Health
Kim and Reddy reasoned that they could create AI-powered technologies that would relieve the strain of clinical trials on cancer patients and medicinal developers. In order to ensure that the software would truly solve the issues they were attempting to resolve, Pi Health’s engineers began by determining the end results they required, which Kim was well familiar with from his time at the FDA evaluating cancer medications. According to Kim, “the clinical trial process is so confusing.” Simply said, it’s alphabet soup. Individuals are being threatened with audits and other things. Clinical study participants experience intimidation. It is quite frightening.
While working at BeiGene, Kim and Reddy developed the cloud-based technology. In March 2024, they spun out the company with $30 million in venture capital headed by AlleyCorp and Obvious Ventures. At a cost of several million dollars, the Hyderabad hospital had been opened by that point. Reddy listed India’s infrastructure, data quality, and regulatory concerns as some of the reasons why the country, which is home to about 20% of the world’s population, hosts less than 2% of oncology trials worldwide. Rohan Ganesh, a partner at Obvious Ventures, stated, “There was a genuine desire to make this the hospital in Hyderabad where you can obtain experimental therapies.” “We thought the execution was excellent.It is difficult to run this business.
First first, during the Covid-19 pandemic, Pi Health constructed the India hospital. Even though it meant renting a crane to hoist the enormous medical device through a hole in the fourth story, Kim and Reddy refused to postpone building until a CT scanner arrived from Germany in order to meet their strict deadline. “We said, ‘We’ll build the hospital and figure out how to get the CT scanner in,’ because it was too big and you couldn’t take it up an elevator, and we couldn’t extend the timelines,” Reddy explained. “No one would have capitalized this if we had known [how difficult it would be].”
According to Vinayak Chintapally, general manager of the Pi Health facility in Hyderabad, the hospital has taken part in eight clinical trials since it opened, including with BeOne, two other major international pharmaceutical companies, and a few regional Indian businesses. These consist of Dr. Reddy’s Laboratory (unrelated to founders Bobby Reddy), Jazz Pharmaceuticals, and ImmunityBio.
Investor Ganesh described the accelerated approval path for BeOne’s Tevimbra, a medication for the head, neck, and lungs, as “just staggering.” The magnitude is measured in weeks or months rather than days. That has enormous financial ramifications for a pharmaceutical corporation. Late-stage trials can cost above $100 million, and clinical trials often cost over $10 million. However, the trial’s total cost is only one aspect of the financial impact; speed is perhaps more significant because drug developers usually file patents before clinical trials are finished, which starts the clock on their expiration. The sooner they get to market, the longer they have to contend with less expensive competitors.
“To get more drugs, trials should be quicker and less expensive for the whole industry,” he stated.
Global pharmaceutical companies have shown “a lot of interest,” according to Chintapally, the hospital’s manager in India, and the company anticipates taking on more trials for them. Pi Health has established a relationship with a hospital in rural Nizamabad, four hours away, down a gravel road where water buffalo congregate, now that the fully-owned Hyderabad facility is operational. According to Chintapally, “it’s all about the data and how to make sure the data quality, compliance, and risk mitigation are there.”
Pi Health is currently seeking to expand the use of its clinical trials software beyond oncology to include immunology, psychiatry, and other therapeutic fields. In the United States, India, Brazil, Australia, and China, it is introduced in 17 oncology sites. It has started collaborating with community cancer clinics in the United States that were previously unable to handle the compliance requirements of a clinical trial due to their modest size. For instance, the family-run Iyengar Hematology Oncology Center in Bayonne, New Jersey, is currently taking part in a BeOne therapy trial for recurrent follicular lymphoma.
Finding patients with such illness for a trial is especially challenging, and the clinic only has one participant, which would have needed excessive paperwork and documentation in the absence of the program. Dr. Arjun Iyengar, an oncologist and faculty member at NYU Grossman School of Medicine who co-runs the clinic with his father, stated, “The trial was proof of concept for us that we could run the clinical trials in the community.”
Although Pi Health does not intend to establish its own cancer hospitals, Kim and Reddy’s willingness to take a risk that initially appears somewhat absurd allowed them to demonstrate the rationality of their strategy rather than merely discussing the possibility. As stated by Reddy:
“Our actions in India demonstrate our ability to democratize access to clinical trials and medications.”
