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Student's Winning Plan Can Simplify Adverse Drug Reporting to FDA

14 March 2013 No Comment
From left: Raafat Fahmy, PhD, Food and Drug Administration science advisor and America’s Got Regulatory Science Talent student competition judge, with winner Curtis Gallagher (Photo by Steve Berberich).

From left: Raafat Fahmy, PhD, Food and Drug Administration science advisor and America’s Got Regulatory Science Talent student competition judge, with winner Curtis Gallagher (Photo by Steve Berberich).


Curtis Gallagher, a PhD graduate student in molecular medicine at the School of Medicine, says it once took him nearly 20 minutes to figure out how to report a bad medication reaction to the Food and Drug Administration (FDA).

But now, Gallagher will have a chance to tell a top FDA administrator about that frustrating experience and suggest a way to improve the agency’s reporting system.

Gallagher recently won the University’s first America’s Got Regulatory Science Talent student competition at the School of Pharmacy. He convinced the judges—two pharmacy faculty members and an FDA official—that his Interactive Medication Guides could improve the process of reporting an adverse medication event to the regulatory agency. His first-place winnings are an iPod and a chance to meet Jesse Goodman, MD, MPH, chief scientist at the FDA.

“I had that [adverse reaction] experience, and I thought there must be a more efficient way to report side effects,” Gallagher says. “This FDA medication guidance also will increase the number of consumer reports.” He points out that the 427,000 reports in 2010, the last complete data available, represent “a minuscule” percentage of the 150 million Americans who take at least one prescription drug.

The student competition was presented by the University’s Center of Excellence in Regulatory Science and Innovation (M-CERSI), a collaboration with the University of Maryland, College Park. In late 2011, the FDA awarded $2 million to launch CERSI programs at the University of Maryland and Georgetown University.

M-CERSI is intended to modernize the FDA’s regulatory processes through a more robust science culture, according to Goodman, who is working closely with faculty at both the School of Pharmacy and College Park on the center’s initiatives. 

James Polli, PhD, co-director of M-CERSI, and the Ralph F. Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics at the School of Pharmacy, says the competition was “designed to promote student interest in regulatory science—the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products.”

The judges awarded second place in the competition to a team of five doctoral students in the School of Pharmacy for developing an electronic system to promote better medication safety and adherence by facilitating more collaboration between physicians and pharmacists. Team members were Mehmet Burcu, Sarah Dutcher, Patience Moyo, Xinyi Ng, and Dinci Pennap.

The third-place team of Jane Kalinina and Neha Patel outlined how to add medication indications to pharmacy labels in order to increase patient compliance and better outcomes. Both students are earning simultaneous pharmacy and law degrees at the University of Maryland, Baltimore. 

“Several graduate students and postdoctoral fellows already work on M-CERSI research projects with the FDA,” says Polli. “In addition, this competition allowed even more students from various degree programs and disciplines to be involved and learn about regulatory science. The quality of ideas and presentations was excellent. The student teams put a lot of effort into their proposed solutions. It was a lot of fun, and we’ll do it again next year.”

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