How Theranos Is Trying to Right the Ship

The embattled blood testing company has hired industry veterans, and created a compliance and quality committee.

Nancy Crotti

Despite some grim setbacks, officials at once-vaunted blood testing company Theranos say they're laying the groundwork for a comeback.

The Palo Alto, CA-based company has appointed Dave Wurtz, formerly senior director for regulatory affairs, quality, and compliance at Thermo Fisher Scientific, to be vice president of regulatory affairs and quality. Attorney Daniel Guggenheim, former assistant general counsel for regulatory and compliance at healthcare giant McKesson in San Francisco, was named chief compliance officer.

Both will report to founder and CEO Elizabeth Holmes, whom the U.S. Centers for Medicare and Medicaid Services recently banned from the business for two years. Theranos noted that it has 60 days from the July 7 imposition of sanctions by CMS to appeal the agency's decisions. Those sanctions include fines and cancelling reimbursements for the Newark, CA, lab that was the center of CMS's investigation. Forbes once listed Holmes as being worth $4.5 billion during Theranos' better days. In June, it revised that estimate to zero.

Wurtz will lead the strategy and implementation of Theranos's pre- and post-market regulatory activities, including obtaining FDA clearances and approvals, marketing new products, and managing the company's regulatory affairs, medical device quality systems, and clinical affairs teams, according to a statement from Theranos.

Wurtz managed multiple FDA inspections and was responsible for all pre- and post-market regulatory activities worldwide for Thermo Fisher. At biomedical testing instrument company Beckman Coulter Inc. in Miami, Wurtz was quality group manager, overseeing compliance with FDA and other regulatory requirements.

Wurtz also worked at Osmetech and G.D. Searle, developing and managing the clinical trial program and monitoring compliance. He earned a bachelor of science degree from the University of Illinois at Chicago.

Guggenheim was McKesson's chief regulatory and compliance counsel and senior counsel for its pharmaceutical division, He worked on legal and regulatory matters for medical devices, drugs and healthcare IT.  He earned a law degree from the University of California at Berkeley and passed the California bar exam in 1991.

Theranos' board of directors also created a compliance and quality committee, to be chaired by Fabrizio Bonanni, a former quality and compliance executive at Amgen, Inc. and Baxter International, who joined the Theranos board in May.

"I want to have a quality program and a compliance program in place, I want to see FDA submissions going forward, I want to see the normal, serious work that needs to be done to effect the transformation of the company from an R&D startup to an operating company in the healthcare field," Bonanni told Bloomberg. "Being an operating company means you're subject to all the laws, and you're prepared to satisfy questions from every regulatory agency."

Nancy Crotti is a contributor to Qmed.

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