Genae Appoints Two Core Lab Directors

Contract research organization (CRO) Genae has appointed Marco Costa, M.D., Ph.D., and Hiram Grando Bezerra, M.D., Ph.D., core lab directors.

“We are pleased and fortuned to be able to welcome Marco and Hiram, two pioneers in intravascular ultrasound, optical coherence tomography, computed tomography (CT) angiography, and cardiac magnetic resonance imaging (MRI) analysis for both heart and vascular clinical trials,” said Bart Segers, CEO of Genae. “We believe that their extensive clinical and research expertise in general and in medical image analysis in specific lifts the Genae core laboratories to an unsurpassed level of clinical insight and regulatory and safety compliance. The appointment further illustrates our ambition to become the number one CRO for medical devices.”

Genae’s core labs are ISO 9001 certified. They serve as centers for the interpretation of the results of pharmaceutical and mechanical intervention in coronary and peripheral artery disease. In their role, Costa and Bezerra will be responsible for the liaison with the study sponsors, presentations at investigator meetings, the design, and quality control and assurance of the image analysis processes.

Costa is director of the Interventional Cardiovascular Center and Director of the Research and Innovation Center, Harrington Heart & Vascular Institute, University Hospitals Case Medical Center in Cleveland, Ohio. He is a professor of medicine at Case Western Reserve University in the same city. He received his M.D. from Federal University of Minas Gerais in Brazil and his Ph.D. in interventional cardiology from Erasmus University, Rotterdam, the Netherlands. Costa completed fellowships in Basic Science, Vascular Medicine at the Cleveland Clinic Foundation, and Interventional Cardiology at Felício Rocho Hospital, Brazil, and Erasmus University, Rotterdam, the Netherlands. He was a staff cardiologist and director of interventional cardiology research at the Institute Dante Pazzanese de Cardiologia, São Paulo, Brazil, and was later named director of research, associate professor of medicine with tenure, and director of the Cardiovascular Imaging Core Laboratories at the University of Florida.

“Joining Genae represents a unique opportunity to leverage our multi-modality imaging expertise in the context of providing high quality services to the medical industries and optimize their resources for imaging selection and analysis planning,” said Costa.

Bezerra is a joint faculty member at the Department of Radiology and Cardiovascular Medicine as Assistant Professor of Medicine and Radiology at Case Western Reserve University. He is the medical director of the Cardiovascular Imaging Core Laboratories at University Hospitals Case Medical Center. Bezerra received his M.D. from the School of Medicine of the Santa Casa de Vitoria, in Vitoria, Brazil. He subsequently completed postgraduate fellowships in internal medicine, cardiovascular medicine and interventional cardiology at the University of Sao Paulo Heart Institute in Brazil. Bezerra completed his Ph.D. in cardiovascular imaging at the University of Sao Paulo. After having led an interventional program for five years at the Sao Camilo Hospital in Sao Paulo, he moved to Boston, Mass. for a fellowship in the emerging field of cardiac CT and MRI at the Massachusetts General Hospital, Harvard Medical School, one of the most active and recognized programs in advanced cardiac imaging.

“Today, the vast imaging portfolio provides unprecedented options, but also technical challenges on planning for device investigation research,” Said Bezerra. “[Genae offers] the most comprehensive imaging portfolio, with expertise in both the invasive and non-invasive field.”

As well as CRO and core labs, Genae also provides data management, statistical services, and training and education. The company is based in Cleveland, Ohio.