CeQur SA names Robert O’Holla EVP for Regulatory Affairs
Former Worldwide VP for Regulatory Affairs at Johnson & Johnson Brings Vast Experience in Medical Device Submissions, Approvals and GMP Compliance.
MONTREUX, Switzerland, April 13, 2010 – CeQur SA, a company focused on the development and commercialization of insulin delivery systems to improve the management of type 2 diabetes, announced the appointment of Robert O’Holla as executive vice president for regulatory affairs, effective May 1.
O’Holla previously spent 33 years at Johnson and Johnson, where, for the last 18 years, he served as worldwide vice president for regulatory affairs. While at J&J, he oversaw numerous regulatory submissions and approvals for medical devices, creating strategies that led to the successful approval of novel devices and combination products, including the first drug-eluting stent. Since leaving his post at J&J in 2008, O’Holla has served as a senior regulatory consultant and as vice president for regulatory affairs for Nfocus Neuromedical, a medical device company developing products to treat brain aneurysms.
Throughout his career, O’Holla has led efforts to improve FDA regulatory policy, industry R&D efforts and medical device quality. He served as chair of the Technology and Regulatory Advisory Committee at AdvaMed for 13 years, and was a key figure in the construction of the Medical Device User Fee and Modernization Act of 2002.
“Bob O’Holla brings an unmatched wealth of experience in designing and executing successful regulatory submission strategies for a range of medical devices,” said James Peterson, founder and CEO of CeQur. “His experience will be a significant asset as we move forward with our plans for obtaining a CE mark and submitting a 510K for our CeQur™ Insulin Infuser. We’re excited that we will have this ‘best in class’ regulatory expert to lead the way to approval of what we think will be a ‘best in class’ insulin infusion device.”
CeQur is developing the CeQur™ Insulin Infuser, a discreet, wearable device that provides three days of consistent, basal insulin delivery, along with on-demand bolus insulin at the push of a button. The small device comprises a disposable infuser reservoir attached to a reusable electronic monitor.
O’Holla’s appointment provides additional depth to CeQur’s management and executive team, which comprises some of the most experienced and recognized experts in the development and commercialization of diabetes treatments and medical devices.
“After working with Bob for 33 years at J&J, I can say without question that he is among the best in the business at building and implementing regulatory submission and GMP compliance strategies,” said Eric Milledge, chairman of CeQur. Milledge joined CeQur in October 2009 after 34 years at Johnson & Johnson, where he led the diabetes diagnostics and device units. “I am very happy to be working with Bob again to make the CeQur Insulin Infuser available to type 2 diabetes patients who need help managing their disease.”
“The simplicity, convenience and discreteness of the CeQur Insulin Infuser will be important to a range of type 2 diabetes patients who are frustrated by the challenges associated with multiple daily insulin injections and the limitations of current insulin injection devices,” O’Holla said. “I am eager to play my part in bringing this important advancement in insulin therapy to the many patients looking for ways to achieve better glucose control.”
About CeQur SA
CeQur SA is dedicated to developing and commercializing advanced insulin delivery systems that make it easier for people living with type 2 diabetes to comply with therapy and stay in control of their disease. The company is headquartered in Montreux, Switzerland, with
operations in Nordborg, Denmark and Marlborough, Massachusetts.
CeQur was established in January 2008 as a spin out from Danfoss A/S, a large, global Danish industrial products group. The company’s lead product candidate is the CeQur™ Insulin Infuser, a novel, wearable insulin delivery device that provides freedom from multiple daily injections by offering up to three days of consistent, basal insulin delivery along with bolus insulin at the push of a button. More information can be found at www.cequrcorp.com.