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Gopal Abbineni, MS, PhD

Director
Bayer, United States

Dr. Gopal Abbineni is a Director of Global Regulatory Affairs for Radiology with Bayer. He has over 15 years of experience in original research and regulatory affairs from the pharmaceutical and medical device industry. Gopal has strong regulatory working experience in radiation therapy, nuclear medicine, radiology, cardiology, neurology, in-vitro diagnostics, and digital devices. He obtained his PhD in Biochemistry from The University of Oklahoma where his thesis was focused on developing novel nanoconjugates for breast cancer imaging. In 2011, he joined the National Cancer Institute (NCI) Radiation Oncology Branch as a post-doctoral fellow where he investigated the use of approved chemotherapeutic drugs as potential radiation sensitizers in animal models. In 2014, he joined the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) as an Interagency Oncology Task Force (IOTF) fellow and continued as a lead reviewer. Gopal served as a team lead in different offices (namely radiation therapy team (OHT8), neuro-interventional team (OHT5), and cardiac occluders and hemostasis devices (OHT2)) within CDRH. At the FDA, he served as a lead reviewer and subject matter expert for biocompatibility, sterility, reprocessing and usability focus areas. After nearly eight years of experience at FDA, he moved to Bayer as a director of regulatory affairs. In his current role, he provides global regulatory strategy for medical devices and software as medical device (SaMD) clinical applications for launching new products.

Disclosure information not submitted.

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