Biostatistician named to FDA advisory panel

Marianthi Markatou, associate chair of research and healthcare informatics, and professor of biostatistics in the School of Public Health and Health Professions, has been appointed to an influential advisory committee for the U.S. Food and Drug Administration.

Markatou was appointed in September to the Scientific Advisory Committee of the Innovation in Medical Evidence Development and Surveillance-Methods (IMEDS-Methods) program. IMEDS-Methods is a program within the Reagan-Udall Foundation for the FDA, a not-for-profit organization created by Congress in 2007 to modernize product development, accelerate innovation and enhance product safety.

The IMEDS-Methods program aims to improve how the FDA conducts post-market safety surveillance of regulated products using automated health care data.

“Its impact is quite large. I am very happy, and humbled, by this appointment,” says Markatou, who holds a PhD in statistics from The Pennsylvania State University. “It is a vote of confidence in the scientific work I have done. I am looking forward to connecting with researchers from a variety of fields and who have diverse perspectives.”

The committee comprises experts from a range of scientific disciplines — statistics, bioinformatics and epidemiology, among others — and is charged with a number of responsibilities, including advising the IMEDS program director, ensuring the program follows scientifically sound practices and providing input on the scientific merit of IMEDS research proposals.

“Dr. Markatou is a recognized leader in biomedical informatics and has long consulted with the FDA on post-marketing surveillance methods,” says Alan Hutson, chair of the Department of Biostatistics.

“Her appointment to the IMEDS-Methods Scientific Advisory Committee is recognition of her long-standing leadership in providing the FDA important guidance on drug-safety monitoring methodologies,” Hutson adds.

This is the second prestigious appointment Markatou has received in the past year. Last September, she was named to the National Institutes of Health Biostatistics Methods and Research Design study section, a six-year appointment that runs through 2020.