UB biostatistics expert selected for FDA panel on medical product safety monitoring

BUFFALO, N.Y. — A University at Buffalo biostatistics researcher will be among the panelists at a public forum on the U.S. Food and Drug Administration’s electronic system for monitoring the safety of FDA-regulated medical products.

Marianthi Markatou, associate chair of research and healthcare informatics and professor of biostatistics in UB’s School of Public Health and Health Professions, was invited to speak at the 10th annual Sentinel Initiative Public Workshop on Feb. 7 in Bethesda, Maryland.

Panelists include scientists from Harvard, McGill and Duke universities, as well as FDA and industry representatives.

Sentinel is the FDA’s national electronic system that has transformed the way researchers monitor the safety of FDA-regulated medical products, such as drugs, vaccines and medical devices.

The FDA launched Sentinel at the urging of Congress in 2008, at a time when patients were demanding more information about the benefits and potential risks of medical products.

Sentinel enhances the FDA’s ability to proactively monitor the safety of medical products after they have reached the market. It uses a distributed data infrastructure approach, which allows the FDA to rapidly and securely access electronic health care data from more than 193 million patients from multiple data partners, while securing patient privacy.

Markatou’s expertise was sought for the panel session titled “A Look into the Future of the Sentinel System,” which will cover challenges and opportunities that need to be addressed to improve Sentinel and continue its modernization over the next decade.

The workshop is being convened through a cooperative agreement between the FDA and the Duke-Margolis Center for Health Policy. It will bring together researchers, FDA and industry representatives to discuss a range of topics related to medical product surveillance.

There will be approximately 200 people in attendance for the workshop, which will also be live-streamed on the Duke-Margolis Center’s website.