The Future of Cancer Treatment Is Now
Building Pi Health, a Global Clinical Trial System That Moves as Urgently as Patients Need Care
By Geoff Kim, Co-Founder & CEO, and Bobby Reddy, Co-Founder & COO
Right now, across the world, thousands of clinical researchers are making groundbreaking discoveries and working tirelessly to perfect and test therapeutics that could revolutionize cancer treatment.
Right now, across the world, millions of cancer patients are desperately seeking a cure but lack access to potentially life-saving experimental treatments.
Standing in between these researchers and patients is a Byzantine, splintered clinical trial system that prevents patients from accessing care that could improve or save their lives. In fact, only 2% to 8% of eligible cancer patients participate in clinical studies. And 80% of all clinical trials are delayed or closed due to enrollment issues. Never mind the fact that the patients who do enroll tend to be white and from middle/upper-class segments of the population in primarily wealthier countries.
At Pi Health, we think the clinical trial status quo is inexcusable. We are a team of Silicon Valley engineers, FDA regulators, Harvard physicians and researchers, and experienced drug developers, and we are on a mission. Personally and professionally, we’ve seen the mess of the clinical trial system up close. We are determined to tear down the bureaucracies, biases, and inefficiencies that stand between researchers and a representative, international patient base. In its place, we have built a comprehensive, single-solution software platform that significantly reduces friction and costs while rapidly increasing patient enrollment from around the globe. Our software is integrated into our growing international network of clinical trial sites that empower life sciences companies to develop medicines and reach diverse patient populations faster.
Cancer is one of the most democratic illnesses out there — it does not care who you are, what you look like, or where you’re from. But the clinical trial system is anything but democratic. We launched Pi Health in 2021 resolved to change this. Since then, thousands of patients and counting have validated our product, we have key clinical trial alliances on four continents, we are collaborating with some of the best life science companies around the world — and we’re just getting started.
Bobby Reddy, MD & Geoff Kim, MD
From Bond to Partnership: How We Joined Forces to Found Pi Health
We met in 2009, when Bobby was a medical student at the Howard Hughes Medical Institute Research Scholars Program at the NIH and Geoff was an oncology fellow at the NIH’s National Cancer Institute (NCI). We immediately bonded over an enthusiasm for exhilarating innovations in medical science and technology — as well as a concern for the roadblocks in their way and the pervasive disparities in treatment options for patients at a global scale.
When Bobby was 17, his mother died of breast cancer. Bobby saw first-hand the suffering and sense of powerlessness — for patients and their families — that comes with the disease. The experience fueled his desire to somehow reduce this kind of suffering for others. Bobby trained as a physician-scientist and became a dermatologist with a focus on melanoma. He eventually took a faculty position at Harvard Medical School and served as a clinician and researcher at Massachusetts General Hospital.
Bobby’s academic experience exposed him to a distressing paradox. We are entering the golden age of cancer treatment; he witnessed as several drugs came to market that turned once-fatal cancers into manageable diseases. Bobby was equal parts mesmerized by these novel and staggeringly effective treatments and discouraged to learn just how few patients across the world access them. As he dug into the reasons, he was struck with the cold reality: People across the globe suffer needlessly due to a fragmented, inefficient system.
Meanwhile, Geoff was growing all too familiar with serious workflow and data inefficiencies in healthcare. While in medical school and all the way up to his medical oncology fellowship at NCI, Geoff spent hours collecting, organizing, and curating clinical data — manually. His experience led him to two troubling conclusions: 1) Healthcare data is extraordinarily messy, often incomplete, and requires significant manual labor to be useful for research and analytical purposes. And 2) traditional healthcare technology and clinical workflows were not designed to capture the high quality of data needed to meet clinical research standards.
Geoff would move on to the U.S. Food and Drug Administration (FDA), eventually serving as the Division Director of Oncology Products 1, where he oversaw the evaluation and regulation of oncology drugs for breast, genitourinary, and gynecologic cancers. He subsequently became the Deputy Director for the inaugural Oncology Center of Excellence. While at the FDA, Geoff grasped the serious implications of his earlier realizations — poor and misfit data slowed down drug development. Not only did bad data protract the time it took for drugs to get approved, but it also extended the time researchers worked on drugs that the FDA would ultimately not approve. In the former, patients lost precious time waiting for life-saving therapies. In the latter, researchers wasted precious time on ineffective drugs. From this frustration, Geoff created a vision of the kind and quality of data every clinical trial needed to produce — what he called “finish-line data” — in order for bodies like the FDA to be able to swiftly assess a drug’s efficacy and safety.
After seven years with the FDA, Geoff accepted a role at AstraZeneca, where he held a strategic leadership position in the development and commercialization of oncology drugs and combinations. There, he gained insight into the hurdles drug developers face when trying to bring innovative medicines to patients. He became convinced that the challenges could be overcome if healthcare systems and life science companies had better technologies to collect the data needed for clinical research and automate manual, fractured processes.
Not a moment too soon, Geoff was tapped to found and build Applied Innovation, a technology incubation division under the Office of the CEO at BeiGene, a global biotech company specializing in cancer drug development. His first hire was Bobby.
Together, they set out to create a technology that would fix the cancer clinical trial system, beginning with an overhaul of the fragmented clinical trial infrastructure. Pi Health was born. Aware they couldn’t go it alone, they rounded out the team with experts in medicine, regulation, clinical trials, life sciences, and technology. After all, the problem they wanted to solve is massive. It can only be done with a team of people intimately attuned to the manifold challenges that weigh down the clinical trial system. And it can only be done with people intimately adept at building highly-sophisticated, highly-sensitive, and highly-complex technology that can work seamlessly in countries across the world. A unique problem demands a unique team, and they are honored by the industry leaders who believed in their vision enough to join it.
Problem Solving for Transformation
At Pi Health, our mission is to ensure that every cancer patient — regardless of country, income, or race — has equal and in-time access to the highest-quality care and clinical trials. To achieve this ambitious aim, we are attacking the problem on two levels: technological and global.
Technological
In addition to the many pain points around access, enrollment, and representation, the internal state of the clinical trial system is astonishingly fragmented and antiquated. Researchers and sponsors still rely on Excel sheets, binders, and manual data entry — which not only adds countless hours of work but also misses countless opportunities to harness and leverage existing technologies to capture, store, and transmit data to whatever destination that is required. While literally hundreds of SaaS solutions have entered the market, not one is comprehensive. As a result, the system’s infrastructure has devolved into a sea of point-solutions with unnecessary software silos and convoluted workflows. Furthermore, not one was built to seamlessly collect the type and quality of data the FDA requires its review process.
To this end, we built FICS (short for “Front-End Interoperable Capture Software”), a single-solution software that connects life science sponsors and trial sites. For FICS users, gone are the days of missing data or manually trying to square peg-round hole data. Instead, FICS automates manual processes for faster, higher-quality data collection and captures “finish-line data” from the start. By design, this unlocks unprecedented speed and cost savings in the drug development process, ultimately delivering life-saving medicines to patients sooner.
We were also aware that if our own tech was to get across the finish line and achieve scale, it had to make healthcare workers’ lives easier. One of our mantras is “more face time, less screen time.” What good is a technology, however sophisticated, if it pulls healthcare workers away from patients? Our technology and workflows enable physicians and nurses to spend less time interfacing with monitors and burdensome administrative tasks, and instead liberates them to spend more time doing what they love — taking care of patients.
With FICS, we went beyond FDA data compliance. We built a comprehensive software that streamlines all workflows on one platform. From the moment researchers and sponsors launch a trial to the moment they submit the drug for approval, and every single regulatory requirement and patient interaction in between, FICS has our life science sponsor and site users covered. FICS dramatically reduces administrative burden, automates multiple workflows, instantaneously captures and analyzes universalized data, and opens enrollment to a global audience. Instead of flipping through binders or trying to merge and reconcile data from a series of programs that don’t talk to each other, physicians are freed up to work with patients.
Global
We refused to build a solution that wouldn’t be relevant, resonant, and usable across the globe; anything less would continue to over-index for white patients of means and maintain an undemocratic status quo for a democratic disease. As we evolve and implement the architecture of our technology, meeting the diverse needs of a global audience guides all of our decisions.
Today, our health system partnerships include oncology centers across the US, Brazil, Australia, and India. We intentionally selected a critical mass of rural and community site partners, which enables patients in historically-underserved geographies to finally access trials. In September 2023, we opened the Pi Health Cancer Hospital in Hyderabad, India, with our entire tech stack fully integrated into the facility. Our hospital in Hyderabad is the physical manifestation of our ultimate vision with Pi Health, in that we don’t just want to bring clinical trials to long-underserved populations, but we also want to bring the most modern, efficient, cost-effective, and democratic clinical trials to all.
The More Who Join Us, The More Lives We Can Save Together
In 2018, Janet Woodcock, the former Director of the Center for Drug Evaluation at the FDA, declared the clinical trial system “broken.” Her words were a clarion call, and we commend her for them. It was disillusioning to see, year after year, just how broken this system was, with devastating effects on human lives.
But in four years, thanks to our growing number of partners and patients who have taken the leap with us, we are optimists. We know that we can continue to root out mass-scale inefficiency and replace it with the seeds of our new and blossoming infrastructure to fix decades of problems. We can see — both on the ground and in the data — that Pi is working. Trials are enrolling more patients, of more diverse backgrounds, and in record time.
Global transformation, however, is a matter of network effects. The more who join our cause, the more people we can continue to reach, and the more lives we can save together. We hope you’ll take the leap with us.
