Yale-Mayo CERSI and Biofourmis to Study mHealth App for Drug Development

Through a new research partnership between digital therapeutics company Biofourmis and the Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI), researchers will leverage a mobile health (mHealth) app to measure biomarkers in patients with heart failure and potentially improve outcomes.

The Yale-Mayo CERSI is an effort between Yale University, Mayo Clinic and the U.S. Food and Drug Administration (FDA) to advance regulatory science through innovative research, training and scientific exchanges.

Biofourmis’ Biovitals app will help researchers monitor functional capacity and quality of life to see if these measures should be a greater focus in the drug approval process.

“This joint project has the potential to advance the science of clinical trial design,” said Kuldeep Singh Rajput, Ph.D., CEO of Biofourmis. “Ultimately, this study could open the door for regulatory agencies to consider including patient-centric endpoints in the drug approval process — which could potentially speed the regulatory approval process.”

Starting in August, the partners will conduct a multicenter study of recently discharged patients with heart failure. Patients will be screened and monitored at home for 60 days.

The goal of the study is to measure the correlation between physiology and noninvasive monitoring biomarkers with clinical endpoints. Data can also help researchers assess medication adherence, dose changes and the percentage of patients on target dosages of Guideline Directed Heart Failure Therapies.

Patients will be monitored using Biovitals, a sensor-agnostic mHealth platform compatible with FDA-cleared and medical CE-marked wearable sensors. The app captures raw biosensor data and uses machine learning to derive physiology biomarkers. Biovitals also detects heart failure decompensation using multivariate physiology analytics.

Biovitals will capture biomarkers and physical activity continuously in real-world settings using two wearable biosensors: Everion, a medical-grade device, and Apple Watch Series 4, a consumer wearable.

The app will sync data from the wearables and capture electronic patient-reported outcomes, including medication adherence, symptoms, responses to the Kansas City Cardiomyopathy Questionnaire and the guided mobile-based two-minute step test.

“We have entered into a new era in clinical trial design that encourages patient engagement and values quality of life,” Rajput said. “By leveraging our user experience, powerful data-analytic capabilities and vendor-agnostic sensor compatibility, we are excited about the prospect that Biofourmis will play a part in establishing new patient-centric endpoints for clinical trials, starting with heart failure.”

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