By Deborah Borfitz 

January 23, 2025 | A spinoff of global biotech company BeiGene is looking to transform the clinical development of oncology medicines with a software platform integrating all the features study sponsors and sites need to conduct trials and communicate with each other in a compliant way. The capabilities of its Front-end Interoperable Capture System (FICS), which notably includes the generation of regulatory-grade data at the point of care, are enabled by generative artificial intelligence (AI) and a growing list of partnerships with hospitals, health systems, oncology health networks, and community oncology practices the world over, says cofounder and Chief Operations Officer Bobby Reddy, M.D. 

Boston-based Pi Health incubated as a wholly owned subsidiary company of BeiGene for four years before taking flight as an independently operated, venture-backed company. It announced over $30 million in Series A funding, led by Obvious Ventures and AlleyCorp, on Pi Day in March 2024. To date, the company has raised nearly $40 million in funding. 

It is now poised to make a new and much-anticipated addition to its toolbox of interconnected automation products—FICS Genesis, an AI-enabled site onboarding platform for optimizing site selection “from feasibility through greenlight.” The launch will happen at the Summit for Clinical Ops Executives (SCOPE) this February in Orlando, highlighting the overview Reddy will be presenting on the health technology and clinical research organization. 

FICS Genesis is designed to help sites and sponsors start clinical trials faster, track critical milestones and documents, and improve site-sponsor dialogue and collaboration on shared trial-related tasks. “This product is going to make a very big difference for both health systems and sponsors globally,” enthuses Reddy, who is also a practicing dermatologist at Massachusetts General Hospital. 

Pi Health estimates substantial reductions in costs associated with startup delays, study startup time, time spent on document collection and review, and email volume related to startup activities. “Our technology is vertically integrated with global sites across four continents to enable out-of-the-box GCP compliance and breakthrough clinical trial efficiencies,” he says. 

Major Moves 

Pi Health certainly has plenty of regulatory experience, with nearly one-quarter of the U.S. team formerly employed by the Food and Drug Administration (FDA). Among these is cofounder and Chief Executive Officer Geoff Kim, M.D., former director of the division of oncology products at the FDA and deputy director of the FDA’s Oncology Center of Excellence; Todd Palmby, vice president and head of precision health, who has nearly a decade's worth of experience at the FDA as a pharmacology and toxicology reviewer; and several others serving in data science and regulatory roles at the company. 

One of the major achievements of Pi Health over the past year was the December 2023 opening of the Pi Health Cancer Hospital in Hyderabad, where its FICS forms the entire technology infrastructure, facilitating regulatory-grade data capture of real-world patients and clinical trial patients, automated clinical documentation, and prescreening and recruitment. It has thereby been empowered to be research-focused, providing patients who have historically been left behind access to trial opportunities—and offering evidence to sites elsewhere that the model is viable and valuable, says Reddy.    

Since inception, Pi Health Cancer Hospital has run seven industry sponsored trials, he reports. It is worth pointing out that India has a population of close to 1.5 billion people and accounts for 8% of the worldwide cancer burden. 

Pi Health is not in the hospital-building business, Reddy makes clear. Moving forward, its operational strategy is focused primarily on striking up partnerships with health systems across the world to deploy its software platform and provide any needed operational support to introduce new and better ways of conducting clinical trials in oncology. 

Its current global network of sites includes 16 rapidly growing health centers in New Jersey, North Carolina, and Maryland, as well as Brazil, Australia, and India. These partnerships include hospitals, government research sites, non-academic research clinics, and community networks. Pi Health Cancer Center, being a subsidiary company of Pi Health, operates independent of the other partnerships. 

‘Not Just a Technology Vendor’ 

The uniqueness of the Pi Health platform is its ability to comprehensively aid clinical development from the site to the sponsor level, says Reddy. A variety of disconnected technologies are currently being utilized to help with different parts of the study process, such as data collection and document management. 

FICS Harmony comprises several components, including the clinical interface for capturing regulatory-grade data for evaluating drug efficacy and safety that electronic health record (EHR) systems were not designed for, he continues. Since repurposing EHR data for trials requires a lot of manual labor and effort, “we try to get finish-line data from the very beginning” using generative AI to automate clinical documentation. The platform also integrates investigative site files and clinical trial management systems for sites.   

Pi Health now has several use cases where it has stepped in with technology and operational support to give trial-naïve community oncology centers the wherewithal to run global phase 3 studies. Community-based oncology centers where most cancer patients get their care often have inadequate access to global clinical trials, due both to where studies are placed and the willingness of local physicians to refer patients to a large city hospital, says Reddy. 

These local sites often have a long history in the community, an excellent reputation and rapport with patients, but limited experience complying with study protocols, regulations, and guidelines. Even if practicing physicians wish to conduct clinical trials themselves, they're stymied by logistical challenges and perceived administrative burdens. Pi Health is helping to address this unmet need, which Reddy says is ripe for further expansion. 

“We’re not just a technology vendor,” he stresses. “We are a full-service clinical development company... able to run clinical trials for sponsors utilizing our technology and existing [and expanding] site network.” The global scale of the network means drugmakers can draw from a diverse genetic pool.  

Merging Perspectives 

The leadership team at Pi Health has some longstanding ties. Reddy was a Howard Hughes Medical Institute research scholar at the National Cancer Institute (NCI) about 15 years ago when he first met Kim, then an NCI oncology fellow. While Reddy went on to academics at Harvard after medical school residency, Kim pursued his illustrious career at the FDA. 

The two reconnected after Kim came to AstraZeneca, where he served as vice president of oncology and head of oncology strategic combinations, and recruited Reddy to head up oncology regulatory science and innovation. What they witnessed as practicing physicians, and on the clinical development side from the regulatory and industry perspectives, is what inspired them to start Pi Health, Reddy says.  

“We thought the [clinical development] process could be done much better and in a way that benefits all stakeholders... most importantly, the patients,” says Reddy. “A cancer diagnosis is often the most important thing in their life, and how it’s treated and what [trials] they can access means everything.”