By Diagnostics World Staff
July 21, 2016 | Theranos continues to rearrange deck chairs in hopes of righting the ship. Today the company announced the appointment of two new executives to lead the company’s regulatory, quality and compliance efforts. Both are reporting to Theranos founder CEO Elizabeth Holmes, who earlier this month was banned from owning or operating a medical laboratory for two years.
Dave Wurtz, who has nearly two decades experience in U.S. and international regulated industries, including the life sciences industry, was named vice president, regulatory and quality, and Daniel Guggenheim, a lawyer with deep background and leadership in health care compliance and regulations, was named chief compliance officer.
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. Dr. Fabrizio Bonanni will chair the committee. Bonanni joined the Board of Directors in May when Theranos replaced the chief operating officer and expanded its board.
The executive-level appointments of Wurtz and Guggenheim are effective immediately.
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, the company said in a press release issued today. 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, where he managed multiple FDA inspections and was responsible for all pre- and post- market regulatory activities worldwide.
He has also overseen compliance with FDA and other regulatory requirements, at Beckman Coulter.
As chief compliance officer, Guggenheim 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.
Guggenheim has been assistant general counsel, regulatory law, at McKesson Corp., a health care distributor, business services and information technology provider in San Francisco and one of the largest health care companies in the world. 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.
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.
Dr. Bonanni, the committee chairman, has an extensive background in leading health care compliance, quality and operations, having served in senior executive roles at Amgen and Baxter International Inc.
It has been several painful months for Theranos, since an October 2015 Wall Street Journal article prompted multiple investigations into the company's claims. In her earliest responses, Holmes denied any wrongdoing, and later released a point-by-point rebuttal of the Journal article. But under increasing scrutiny, the company began making changes.
“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 press release stated.
But with the Holmes ban (which is set to go into effect 60 days from the July 7 letter), financial penalties, and revocation of the lab’s CLIA certification from the Centers for Medicare and Medicaid Services and several pending law suits, it may not be enough.