ool Vendors in Life Sciences, 2018
The company that’s on a mission to modernize the clinical research industry by empowering patients to share their data and participate anytime, anywhere. They are the first company to develop a proprietary “Smart Health Record”, consolidating patient data from Electronic Health Records (EHRs) and other sources, including mobile apps into a metadata rich record that informs study protocol design and provides pre-screening analytics capabilities for clinical trials. The monARC Smart Health RecordTM makes enrollment for a trial much easier and faster than before, solving one of the major challenges of clinical trial recruitment: identifying eligible patients. monARC also provides an end-to-end connected clinical trials platform that allows patients to participate in clinical trials from their home and/or within their community healthcare setting. By allowing patients to directly share 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.
San Francisco, CA (https://www.monarcbio.com)
Analysis by Jeff Smith
Why Cool: monARC provides precision-matched subjects for clinical trials using a mobile app and real world data from EHR systems as well as paper records. Recent statistics report that about 50% of clinical sites underperform (37% under-enroll and 11% fail to enroll a single patient), which results in actual enrollment timelines typically doubling planned timelines, a huge cost increase for the pharmaceutical companies running these trials and delays in access to new medicines for patients. Thus, the challenge of finding the right patients that can screen successfully and go on to complete a clinical trial is paramount.
monARC Bionetworks (“ARC” = “Accelerating Research through Collaboration”) is a healthcare technology company, that leverages digital tools to accelerate clinical research. It has developed a unique solution to the trial recruitment problem by pre-qualifying patients well beforehand, and precision matching them to the trials prior to a study’s start. They also leverage modern technologies like telemedicine and mobile apps to eliminate uncertainty of enrollment and broaden access for more patients to participate in clinical trials by eliminating the geography hurdle. In addition, using their disease specific mobile app (see PF Health in the app store), the company engages trial participants early and continuously, before, during and after the trial is complete. Part of the pre-qualification process includes building a proprietary monARC Smart Health Record for each patient by aggregating and consolidating all of their clinical and digital health data – from EHRs, imaging and lab data systems – into a comprehensive longitudinal patient record. monARC only notifies patients for trial participation if the company’s detects a precision match with a trial. Once enrolled in the trial, monARC’s mobile data collection platform with built in reminders and engagement tools fosters significant adherence rates during study conduct.
monARC builds their pre-qualified Patient Research Networks (PRNs) by partnering with patient advocacy groups and/or caregivers motivated to play a role in ongoing research for a particular medical condition or disease state. Then, they reach out to people who are motivated to participate in a trial, who can then download the mobile app and begin the accelerated pre-qualification process. In their first trial, monARC accelerated enrollment 20x faster then that industry standards in idiopathic pulmonary fibrosis where they also demonstrated 90% adherence from elderly patients using their digital data collection tools, like bluetooth connected spirometers, weight scales and activity watches. Inspired by the success, Pulmonary Fibrosis Foundation partnered with monARC to launch the PF Health App which encourages all of their members to track their symptoms in between clinic visits and share it with researchers to accelerate the search for a cure.
The monARC vision is one of patient centricity, which is the idea of putting the patient needs and desires first, and removing all obstacles to trial participation and adherence. As a part of this vision, they develop digital end to end connected clinical trials, using mobile devices, sensor, and wearable technology to allow the trial subjects to perform trial activities from home or within their community healthcare setting. Moving forward they plan to build more PRNs in general diseases and expand partnerships with more advocacy groups, and continue to refine their technology approach to build value for patients and sponsors.
monARC BioNetworks currently has 15 employees, planning to expand to 50 by the end of 2018 in order to fulfill the current customer demand and scale their PRNs into more general therapeutic areas. They have raised seed funding in 2016 and has already published an abstract with Genentech from their first trial. The company is engaging more biotech/pharma companies as well as establishing partnerships with health systems and advocacy groups.
Figure 3. monARC Bionetworks
Source: monARC Bionetworks
Challenges: monARC must overcome resistance to changing the approach towards running clinical trials from both sites and sponsors. monARC must help these organizations shift their mindset to embrace a patient-centric approach. In addition, although their business model works well on rare disease studies, where activate advocacy groups are already available, it remains unclear how successful this model will be in mass-market clinical trials, where collections of potential enrollees are not readily available. In addition, Life Sciences are already crowded with CROs looking for new approaches, so monARC must continue to leverage their technology strengths to build their patient networks and stay focused on areas that exploit the strength of their platform.
Who Should Care: Clinical Operations leaders interested in improving patient recruitment and adherence, particularly for rare disease studies. IT leaders involved with e-clinical strategy and the use of new technologies to improve operations, Patient Advocacy Groups, as well as Health Care Systems who would like to broaden trial access to their members.