Qualcomm-Novartis Deal Portends Wave of Clinical Trial Innovation

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support innovations in digital health and related health technologies.

With each company committing $50 million to the fund, Valencia says the joint fund grew out of discussions he’s had over the past three years with David Epstein, the pharmaceuticals division head at Novartis. “We started having discussions around types of startups and innovations we would like to see,” Valencia says.

So what’s the significance of the Novartis-Qualcomm Life collaboration in clinical trials?

In conventional clinical trials, much of the data used to support new drug applications are collected from the patients themselves. They log their own data in patient journals. Instead of basing new drug applications on such “self-reported data,” Novartis is now moving to wireless technology that automatically collects patient data remotely, using health sensors that measure pertinent vital signs.

The difference is huge, according to Patrick and others, because studies have shown that patients tend to fudge, so that “self-reported data” can be notoriously inaccurate. In clinical trials, the key to winning regulatory approval lies in generating enough data to prove the safety and efficacy of new drug candidates to health regulators. So the quality of the data is imperative.

Patrick contends that automated data collection will amass a bigger and more comprehensive database, which can be analyzed more thoroughly for signs of side effects and other long-term problems. Experts say costs also can be substantially reduced over time.

As Patrick puts it, “It can’t be overstated, how big the bump is in comparing continuously collected data with self-reported data.”

Qualcomm Life has spent years building out its wireless reference design and technology licensing business for medical-grade data collection. The number of FDA-approved sensors for remotely monitoring patient health also has been proliferating—as part of an explosion in wearable health and fitness trackers that was a major theme at last week’s CES show.

The market for clinical trials data already has proved to be a bonanza for Entra Health Systems (EHS), a San Diego-based startup that won

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.