Komathi Stem, CEO & Founder
One of the biggest trends impacting the healthcare industry today is the move toward accessible care. The growth of digital health tools has made it simpler for patients to track and measure critical health information from the convenience of their homes. It has also empowered patients to take charge of their data, controlling its access and usage by healthcare stakeholders. While these advancements in digital health and patient engagement solutions have appreciably revolutionized the traditional healthcare practice, the domain of clinical research management, on the other hand, did not make any significant technological leap. This is where Komathi Stem, a veteran in the pharmaceutical and biotech industry, steps in. Passionate about transforming the drug discovery and development arena, she wanted to utilize people’s enhanced participation in healthcare to reimagine the way clinical trial processes are designed and executed. Wielding this vision into reality, Stem founded monARC Bionetworks in 2016.
Stem—monARC’s founder and CEO—and her multidisciplinary team has created a digital end-to-end clinical trial platform that makes it possible for patients to get trial ready and to participate in clinical research from anywhere, anytime by leveraging telemedicine and mobile technologies. By allowing patients to directly donate their data, monARC is creating a new data-sharing economy that will transform the highly sequential and siloed drug development model into an integrated and a collaborative model with patients.
The way this is possible is by activating disease specific Patient Research Networks (PRNs) powered with a transformative data collection and analytics platform that converges data from clinical care and digital devices (smartphones and sensors) into monARC’s Smart Health Record™—a holistic, longitudinal medical record that generates deep insights to inform trial designs and stratify patients.
Through monARC’s Smart Health Record™ and via the use of study specific monARC’s apps, patients track their disease, report clinical outcomes, stay connected to their patient community and participate in clinical studies from their home or by leveraging their community’s physicians. In exchange for their participation in the PRN, patients receive their consolidated medical record—a full collection of the patient’s past medical history—gathered from disparate providers.
Our mission is to help customers streamline the clinical trial operations process to save time and
resources, allowing our customers to focus on the science and take care of the patients
“With the help of the patient’s medical history and real-time app data, monARC’s Smart Health Record™
provides a longitudinal view of the patient’s health, giving patients a powerful tool to actively engage in the management of their health,” says Stem. When pharma and device manufacturers need to recruit patients for their trials, monARC seamlessly applies inclusion and exclusion criteria to their PRN to qualify patients for the trial. At the end of the trial, patients can keep using the application to monitor their health and stay engaged and supported by the network. That said, Stem also notes that their responsibilities toward patients do not end with the trials. “Our mission is to help our networks to continue contributing their data beyond the trial to accelerate the search for new treatments” Stem adds.
Meanwhile, monARC’s integrated research platform also places equivalent attention to the principles of evidence-based medicine to deduce the inference of a clinical trial. By converging clinical practice with clinical care, monARC creates a new pathway for adaptive and pragmatic trials that are necessary to realize the full promise of precision medicine—capable of personalizing healthcare and improving outcomes.
When it comes to the company’s recent milestones, Stem highlights monARC’s newly published study on a spirometer device, in association with Genentech. Enrollment was completed in three weeks—instead of the nine months forecasted by industry standards. it took four months from final protocol to publication—a ‘lightning-fast’ timeline when it comes to clinical research. For the research, monARC engaged their Idiopathic Pulmonary Fibrosis PRN and the selected patients could participate in the trials from the comfort of their homes. Each patient was instructed to use the spirometer and watches—sent to them through mail—and monARC would monitor the activity and flag discrepancies in real-time. monARC’s patient-centric research model was so successful that by the end of the study, the trial achieved over 90 percent adherence.
“Our patient-centric, full-service research approach has always been our unique differentiator,” mentions Stem. Having earned astounding recognition in the pharmaceutical industry, monARC plans on expanding their partnership with healthcare systems as well. The partnership would allow monARC to gain access to bigger patient populations and run expansive trials. Simultaneously, “We are also planning to build new disease state networks and grow our pipeline of new customers,” concludes Stem.