Amid a heap of regulatory trouble, start-up life sciences company Theranos recently announced the appointment of two new executives to lead the company’s regulatory, quality and compliance efforts.
Dave Wurtz, who has nearly two decades experience in U.S. and international regulated industries, including the life sciences industry, was named vice president of regulatory and quality. Daniel Guggenheim, a lawyer with deep background and leadership in health care compliance and regulations, was named chief compliance officer.
The executive-level appointments of Wurtz and Guggenheim are effective immediately. Both report to Theranos CEO Elizabeth Holmes.
Wurtz will lead 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, a global life sciences company. He managed multiple FDA inspections and was responsible for all pre- and post- market regulatory activities worldwide. He formerly served as quality group manager, overseeing compliance with FDA and other regulatory requirements at MBeckman Coulter, a manufacturer of biomedical testing instrument systems.
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 healthcare company McKesson. While there, 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.
New compliance and quality committee
The Theranos board of directors also has created a compliance and quality committee, which will oversee and advise the board and the company’s executive leadership on regulatory compliance and quality systems obligations. This 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.
Fabrizio Bonanni, who joined the board in May, will chair the committee. Bonanni has an extensive background in leading health care compliance, quality and operations, having served in senior executive roles at Amgen, an independent biotechnology company, and at Baxter International, a manufacturer of healthcare products.
The new executive appointments and the creation of the committee are the latest in a series of significant actions Theranos has taken in the same month that the Centers for Medicare & Medicaid Services imposed numerous sanctions on the firm following a review last year of its laboratory operations, which uncovered numerous compliance violations. As Compliance Week previously reported, the Securities and Exchange Commission, the Department of Justice, and federal health regulators launched civil and criminal investigations following allegations that the company is not using its proprietary technology for most of the tests it offers.