CeQur SA named a Johnson & Johnson (NYSE:JNJ) veteran to be its new executive vice president of regulatory affairs.
Robert O’Holla will oversee regulatory strategy for the Swiss firm, which has its U.S. headquarters in Marlborough, Mass. CeQur is developing an insulin delivery system for patients with Type II diabetes.
O’Holla spent 33 years at J&J, the last 18 as worldwide vice president for regulatory affairs, and had a hand in the approval of thee first drug-eluting stent, according to a press release. He’s a big gun in the regulatory world, having served as chairman of the Technology and Regulatory Advisory Committee at AdvaMed for 13 years. He was also a key figure in the construction of the Medical Device User Fee and Modernization Act of 2002, according to the release. Since leaving Johnson & Johnson in 2008, O’Holla worked as a senior regulatory consultant and vice president for regulatory affairs for Nfocus Neuromedical, which is developing products to embolize brain aneurysms.
He’s the second J&J bigwig to join CeQur, following former LifeScan Inc. president Eric Milledge, who is CeQur’s board chairman. In January, CeQur founder and CEO James Peterson told MassDevice that Milledge, who built J&J’s OneTouch brand, liked what he saw in CeQur.
"He saw CeQur as a very important opportunity to help patients and so he signed on as chairman of our board," Peterson told us.
In prepared remarks, he said O’Holla will be a "significant asset" as CeQur looks to win CE Mark approval in the European Union and 510(k) clearance from the Food & Drug Administration for its 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," Peterson said, according to the release.
For his part, Milledge fairly waxed rhapsodic about O’Holla.
"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," Milledge said in prepared remarks.
In January, CeQur closed a $30 million Series A round with a $10 million injection from a group of existing investors.