In Effort to Reform, Struggling Theranos Hires New Chiefs to Help Pull It Out of Its Ditch

In Effort to Reform, Struggling Theranos Hires New Chiefs to Help Pull It Out of Its Ditch July 21, 2016
By Alex Keown, BioSpace.com Breaking News Staff

PALO ALTO, Calif. – In an effort to correct its course, beleaguered blood-testing company Theranos has hired two executives to manage compliance and regulatory matters.

Theranos tapped Dave Wurtz, senior director of regulatory, quality and compliance at Thermo Fisher Scientific , as its new vice president of regulatory and quality affairs.

Theranos named Daniel Guggenheim, an attorney specializing in regulatory law formerly with McKesson Corp. , as its new chief compliance officer.

Wurtz will be leading the strategy and implementation of Theranos' pre- and post-market regulatory activities, including obtaining Food and Drug Administration clearances and approvals. He will also be responsible for the marketing of new products and managing the regulatory affairs, medical device quality systems and clinical affairs teams, Theranos said. Wurtz has a big challenge ahead of him as Theranos has faced intense scrutiny over its testing procedures and products—scrutiny that resulted in the company’s founder and chief executive, Elizabeth Holmes, being banned earlier this month from owning or operating a blood testing laboratory for two years.

In a statement, Wurtz said he was excited about the opportunity to help Theranos submit its testing to the FDA and “contribute to its vision of increasing access to affordable, accurate and reliable health care information.”

As chief compliance officer, Guggenheim will lead implementation and oversight of the company's compliance program. Theranos said he will place and emphasis on “maintaining and enhancing policies, procedures, training and monitoring mechanisms to promote compliance with all applicable state and federal regulations,”—something the company has had issues with, which caused the U.S. Center for Medicare and Medicaid Services to initiate the ban on Holmes since Theranos announced it was voiding two years’ worth of blood-testing data that invalidated test results for an estimated tens of thousands of patients.

In addition to the ban on Holmes operating a blood-testing facility, the CMMS ban also shut down one of the company’s laboratories in Newark, Calif., which has been at the center of federal concerns due to poor operational procedures and standards. The ban does not go into effect until September and Theranos said it is working with regulators to “resolve and remediate outstanding issues in the Newark lab.”

In addition to the staffing moves, Theranos’ board of directors also created a compliance and quality committee to oversee and advise the company's executive leadership on regulatory compliance and quality systems obligations.

The committee will be helmed by Fabrizio Bonanni, who joined the Theranos board of directors in May.

Although Theranos is making some changes to its executive team, the company is still facing some legal challenges due to the voiding of two years’ worth of data, as well as a Congressional inquiry over the matter. Theranos is also the subject of a criminal investigation by the U.S. Department of Justice with investigations centering on whether or not Theranos and its executives misled investors as to the efficacy of its blood-testing products.

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