Clinical OMICS

MAR-APR 2019

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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www.clinicalomics.com March/April 2019 Clinical OMICs 13 the hospital, the lower the possibility of readmission," said Rosenbaum-Chou. Saving Drug Discovery Millions Most people would agree that getting more value for health- care dollars in the U.S. includes reducing the cost of bring- ing individual prescription drugs to market, which was estimated at $2.7 billion in 2017 by the Tufts Center for the Study of Drug Development. Pharmaceutical companies are keen to reduce the money spent on drugs that don't gain FDA approval. Chris Benko, CEO of Koneksa Health, spoke at a Keystone Symposium on Digital Health in January 2019 in which he made the case that digital biomarkers are the key to making drug trials more efficient, weeding out costly underperformers more quickly, and potentially saving the industry millions—or even billions—of dollars. Koneksa's platform allows its client researchers to remotely capture real-world data—including physical activity, blood pressure, ECG, spirometry, and other digi- tal measures—from patients in real time from remote bio- metric trackers, mobile devices, and health apps. Koneksa also works to develop devices and validate the measures to be used in a study, delivering to clients a device kit for each study participant, then collecting and analyzing the data. This individualized approach is necessary, Benko said, because all digital biomarkers are not created equal. The intended use of the data defines the rigor of bio- marker validation needed—the commercial fitness tracker data intended for personal use are different than the data intended for a drug approval, which needs to meet the FDA requirements for human experimentation. "In almost every case, we invest in studies that collect the human data to characterize a particular biomarker and determine if such a biomarker is fit-for-purpose," Benko noted. The fit-for-purpose principle means that biomarker development and validation experiments are tailored to answer specific questions asked by drug development stud- ies. The study participants take experimental medicines while digital biomarker data is being collected to see if, for example, there is a response to treatment or there is a safety signal. Later, the data needs to be presented to the regulators. Eventually, Benko predicted, traditional assess- ments presented to the FDA will be replaced by digital ones because they are collected in a real-life setting and more accurately reflect how patients feel 24/7. The importance of validation depends on how data will be used, said André Henriksen, a research fellow in med- ical informatics at UiT The Arctic University of Norway, Tromsø. In some research, the wearables are not replac- ing research-grade instruments, but being used as addi- tional sources of data. "With the built-in sensors, we can track activity, heart rate, sleep, location, and more, and future devices are bound to include even more sensors with added capabilities," Henriksen said in an e-mail. The pace of technology is one thing researchers like Henrik- sen must confront. Although several validation studies on consumer-based fitness trackers are published each year, very often these studies do not include recent models. But, he said, "without these objectively conducted validation studies, we cannot truly know how accurate the devices are." For researchers like Henriksen, the possible utility of digital biomarkers outweighs the challenges. "There is a large potential here, and I think we will see a huge increase in wearable usage in research going forward." Fitbit

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