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Expert Profile


Stuart Portnoy
Senior Consultant, Biologics Consulting Group,Inc.

MD is Senior Consultant, Medical Devices, Biologics Consulting Group, Inc., where he advises medical device manufacturers regarding regulatory strategy, clinical trial design issues, and technical considerations to gain FDA market-approval for their products. He previously worked as a consultant at PharmaNet for 5 years and before that, at FDA for 8 years including positions as Branch Chief of Interventional Cardiology Devices and Acting Deputy Director of the Division of Cardiovascular Devices in the Center for Devices and Radiological Health. While at FDA, Dr. Portnoy performed the clinical review of a wide range of cardiac devices and was an agency leader in developing the now well-established multicenter review practices for evaluating drug-eluting stents and other combination products. Dr. Portnoy is a graduate of George Washington University School of Medicine and also has an MS in Bioengineering from the University of Pennsylvania.

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