PALO ALTO, Calif., July 21, 2016 /PRNewswire/ -- Theranos, Inc., announced today the appointment of two new executives to lead the company's regulatory, quality and compliance efforts. Both are reporting to Theranos CEO Elizabeth Holmes.
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, who joined the Board of Directors in May, will chair the committee.
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.
He also will provide regulatory expertise to cross-functional teams for the development of new products.
"I am deeply gratified to have the opportunity to help advance Theranos' commitment to submit its laboratory developed tests to FDA and to contribute to its vision of increasing access to affordable, accurate and reliable health care information," Wurtz said.
"I look forward to leading the execution of the company's FDA submissions strategy to seek further clearance and approval of Theranos' proprietary technologies and support the implementation of rigorous procedures and practices across its operations," he said.
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 Miami-based Beckman Coulter Inc., a leading manufacturer of biomedical testing instrument systems.
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, 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 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.
Guggenheim earned a law degree from the University of California at Berkeley.
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 Inc., the world's largest independent biotechnology company, and at Baxter International Inc., a manufacturer of health care products.
"Theranos understands that regulatory compliance is an essential element of any successful and innovative health care company," Dr. Bonanni said. "This committee will be integral to fulfilling Theranos' commitment to bringing the highest integrity health information to every person."
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.
About Theranos Theranos, Inc. is a consumer health technology company founded in 2003 by Elizabeth Holmes. Theranos' mission is to make actionable information accessible to everyone at the time it matters most. By doing so, Theranos is working to facilitate the early detection and prevention of disease and to empower people everywhere to live their best lives. Theranos offers lab tests in convenient locations in its Wellness Centers in Arizona and California. Visit us at theranos.com.