Geoff Kim and Bobby Reddy, both experienced cancer doctors, recognized the slow pace of completing clinical trials in the drug development process. To address this bottleneck, they developed AI-enabled technology at their startup, Pi Health. In an unprecedented move, they built their own cancer hospital in India to streamline the clinical trial process. By expanding the pool of eligible patients and improving documentation handling, they were able to significantly reduce the time required for regulatory approval. This success has led to more efficient and faster drug development, ultimately benefiting patients in need of new therapies. The software developed by Pi Health aims to simplify the clinical trial process, reduce errors, and speed up drug approvals. The startup has already raised significant funding, signed contracts with pharmaceutical companies, and is actively working on multiple clinical studies. With their innovative approach, Kim and Reddy are determined to revolutionize oncology drug development and make a meaningful impact in healthcare. This implies that the clinical trial process is being prolonged significantly, or that a substantial amount of additional funds need to be invested in order to conduct a clinical trial.
Most clinical trials are typically carried out at large research hospitals such as Memorial Sloan Kettering in New York or Mass General in Boston. Consequently, patients with diseases in many parts of the U.S., as well as those in other countries, are often unable to participate in these trials—a situation that not only deprives these patients of potential treatment options but also hinders drug companies in their search for eligible participants among a smaller pool of individuals.
In order to recruit patients for clinical trials, drug developers utilize various channels including physicians, medical practices, patient organizations, and consumer advertising. The eligibility requirements usually involve factors such as the patient’s age, type and stage of cancer, as well as their previous treatments. While the establishment of a healthtech startup with its own hospital is uncommon, VC firm General Catalyst made a similar move with its acquisition of Ohio hospital system Summa Health as a means of testing new healthcare technology.
“There are numerous innovative approaches to combating cancer. If we can expedite and reduce the cost of [clinical trials] to provide therapies to patients sooner, we should pursue it immediately because there are individuals in urgent need right now.”
With the aim of simplifying the clinical trial process for both drug developers and cancer patients, Kim and Reddy developed AI-enabled technology. They approached the development of this technology by first identifying the desired end results, which Kim was familiar with from his experience at the FDA reviewing cancer drugs, and then working backwards to ensure that the software effectively addressed the issues they sought to resolve. “The clinical trial process can be very complex,” Kim noted. “It can be overwhelming with all the regulations and procedures involved. People may feel intimidated when participating in clinical trials. It can be a daunting experience.”
Having built the cloud-based technology while working at BeiGene, Kim and Reddy subsequently spun out the business with $30 million in venture funding led by AlleyCorp and Obvious Ventures in March 2024. By that time, they had already established the Hyderabad hospital at a cost of a few million dollars. Despite the challenges, including the Covid-19 pandemic, they managed to open the hospital and have it participate in multiple clinical trials.
Since its inception, Pi Health’s hospital in Hyderabad has engaged in several clinical trials, partnering with global pharmaceutical companies as well as local Indian firms. The rapid approval process for BeOne’s esophageal drug was particularly impressive, showcasing the significant impact on both time and finances for pharmaceutical companies. Clinical trials can be costly, with late-stage trials exceeding $100 million, but speed is also a crucial factor as it affects the duration before competitors can enter the market with similar products.
Looking ahead, Pi Health aims to expand its clinical trials software to other therapeutic areas beyond oncology, such as immunology and psychiatry. They have already launched the software at multiple centers worldwide and have begun collaborating with smaller community cancer clinics to facilitate their participation in trials. This expansion is a testament to their commitment to streamlining the clinical trial process and making it more accessible to a broader range of healthcare providers and patients alike. Arjun Iyengar, an oncologist and faculty member at NYU Grossman School of Medicine, co-manages the clinic with his father. Pi Health, led by Kim and Reddy, may not expand its cancer hospital network, but their bold actions have validated their innovative approach to healthcare delivery. Reddy emphasized the impact of their work in India in democratizing access to medicines and clinical trials. Their success speaks volumes about their commitment to making a difference in the healthcare industry.
