Former McKesson legal chief named chief compliance officer at Theranos

PALO ALTO, Calif. — A former McKesson legal chief on Thursday was one of two executives to join Theranos, the lab-testing company that earlier this month was sanctioned by  the Centers for Medicare & Medicaid Services, the company announced.



The two new executives will lead the company’s regulatory, quality and compliance efforts and will report to Theranos CEO Elizabeth Holmes.



Daniel Guggenheim, a lawyer with deep background and leadership in health care compliance and regulations, was named chief compliance officer. And Dave Wurtz, who has nearly two decades experience in U.S. and international regulated industries, including the life sciences industry, was named VP regulatory and quality.



Meanwhile, the Theranos board of directors has created a Compliance and Quality Committee. It will oversee and advise the board and the company’s executive leadership on regulatory compliance and quality systems obligations.



Fabrizio Bonanni, who joined the board of directors in May, will chair the committee.



The Compliance and Quality Committee will oversee the company’s government compliance and regulatory obligations, including working directly with Wurtz and Guggenheim and further implementing and monitoring its compliance program.



The executive-level appointments of Wurtz and Guggenheim are effective immediately.



Guggenheim, as chief compliance officer, will lead day-to-day implementation and oversight of the company's compliance program, with an emphasis on maintaining and enhancing policies, procedures, training and monitoring mechanisms to promote compliance with all applicable state and federal regulations.



“Theranos is committed to meeting the highest standards in its compliance practices. I am eager to start to build on the foundation that Theranos is making to be a best-in-class health care company,” Guggenheim said.



Guggenheim has been assistant general counsel, regulatory law, at McKesson. He was the company’s chief regulatory and compliance counsel and senior counsel for its pharmaceutical division, addressing legal and regulatory matters on the sale of medical devices, the marketing and sale of drugs and health care information technology.



Guggenheim earned a law degree from the University of California at Berkeley.



Wurtz will be leading the strategy and implementation of Theranos’ pre- and post-market regulatory activities, including obtaining FDA clearances and approvals and marketing of new products and managing the regulatory affairs, medical device quality systems and clinical affairs teams.



He also will provide regulatory expertise to cross-functional teams for the development of new products.

 

Wurtz previously served as senior director of regulatory, quality and compliance at ThermoFisher Scientific. He managed multiple FDA inspections and was responsible for all pre- and post- market regulatory activities worldwide.

 

He earned a bachelor of science degree from the University of Illinois at Chicago.



The new executive appointments and the creation of the committee are the latest in a series of significant actions Theranos has taken to ensure that it meets the highest standards in its laboratories, medical products and operations, the company stated.