Qualcomm-Novartis Deal Portends Wave of Clinical Trial Innovation

stock image from Depositphotos_credit-Maksym-Mzhavanadze

FDA clearance in 2009 for its Bluetooth-enabled device for tracking blood glucose levels. But the startup encountered stiff resistance from entrenched competitors, and Entra Health CEO Rick Strobridge says the company “really survived and grew” by shifting its focus to clinical trials.

Entra Health is now providing its wireless blood glucose tracking technology in clinical trials with five big pharma companies, including Eli Lilly, Strobridge says. (Under its contracts, Entra Health is prohibited from disclosing its other big pharma customers.)

“Our sweet spot has been with big pharmas that are involved in diabetes care,” says Strobridge. Government regulators in 50 countries (China gave its approval at the end of 2014) have approved Entra Health’s wireless blood glucose device, and marketing chief Bruce Ahern says Entra Health is selling its devices to contract research organizations that conduct clinical trials in Eastern Europe and elsewhere.

“We started with glucose monitoring, but half of all diabetics also have high blood pressure,” Strobridge says. So Entra Health has been adding wireless sensor capabilities to remotely monitor blood pressure, weight, and heart data.

Entra Health also was one of the first healthtech startups to integrate Qualcomm’s 2net technology. Strobridge says the company’s big pharma customers especially like the architecture of MyhealthPoint, the mobile app and back-end system that Entra Health developed for collecting data from multiple sensors, and for managing and mining the database.

Novartis already is using Qualcomm Life’s 2net technology to collect biometric data in patients’ homes as part of an existing clinical trial with chronic lung disease patients, according to Qualcomm Life’s Valencia. “What they are looking to us for is that connection with the patient, which is really the data, the biometric data,” he says.

Rick Valencia of Qualcomm Life (photo courtesy of Qualcomm)
Rick Valencia of Qualcomm Life (photo courtesy of Qualcomm)

While the pharmaceutical industry was initially resistant to the adoption of new wireless health technologies, Valencia says big pharmas are now looking to support their case for “improved outcomes and lower health costs,” which is rapidly becoming the new mantra in their regulatory approval process.

“Big pharma has bought into the idea and fully believes that healthcare as it is today is [economically] unsustainable, and that we’re moving away from ‘fee for service’ to an outcomes-based model,” Valencia says. “And in order to promote outcomes, they need data.”

At the Center for Wireless and Population Health Systems, Patrick predicts there will be an increasing emphasis on wireless data collection, especially as healthcare regulators realize the differences in data quality. “If you can measure it objectively rather than subjectively,” Patrick says, “you will be asked by reviewers, ‘Why didn’t you do that?”

Author: Bruce V. Bigelow

In Memoriam: Our dear friend Bruce V. Bigelow passed away on June 29, 2018. He was the editor of Xconomy San Diego from 2008 to 2018. Read more about his life and work here. Bruce Bigelow joined Xconomy from the business desk of the San Diego Union-Tribune. He was a member of the team of reporters who were awarded the 2006 Pulitzer Prize in National Reporting for uncovering bribes paid to San Diego Republican Rep. Randy “Duke” Cunningham in exchange for special legislation earmarks. He also shared a 2006 award for enterprise reporting from the Society of Business Editors and Writers for “In Harm’s Way,” an article about the extraordinary casualty rate among employees working in Iraq for San Diego’s Titan Corp. He has written extensively about the 2002 corporate accounting scandal at software goliath Peregrine Systems. He also was a Gerald Loeb Award finalist and National Headline Award winner for “The Toymaker,” a 14-part chronicle of a San Diego start-up company. He takes special satisfaction, though, that the series was included in the library for nonfiction narrative journalism at the Nieman Foundation for Journalism at Harvard University. Bigelow graduated from U.C. Berkeley in 1977 with a degree in English Literature and from the Columbia University Graduate School of Journalism in 1979. Before joining the Union-Tribune in 1990, he worked for the Associated Press in Los Angeles and The Kansas City Times.