February 2023

Regulatory Science Event Breeds 'Innovative Solutions'

February 15, 2023    |  

A group of clinical laboratory science graduate students at the University of Maryland School of Medicine (UMSOM) took the top prize at the 11th annual America’s Got Regulatory Science Talent competition held on Feb. 6 at the University of Maryland School of Pharmacy (UMSOP).

The competition, hosted by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), is open to all students at the University of Maryland, Baltimore and the University of Maryland, College Park. It aims to promote student interest in the field of regulatory science — the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of products regulated by the Food and Drug Administration (FDA).

“This event is one of my favorite activities with students,” said James Polli, PhD, the Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics in the Department of Pharmaceutical Sciences at the School of Pharmacy and co-director of M-CERSI. “Students from a variety of disciplines take time to become more familiar with regulatory science, an area that will probably play a very important role in their future careers.”

The annual event is also an opportunity for students to learn from and interact with staff from the FDA, located in nearby Silver Spring, Md. Five FDA staff scientists served as judges for this year’s contest. As is customary, the FDA Office of Regulatory Science and Innovation (ORSI) is planning to host an in-person visit for the top three teams to the FDA offices.

“The America’s Got Regulatory Science Talent competition serves to inspire and challenge students to tap into their imaginative potential in order to offer innovative solutions to challenging issues in regulatory science,” said Tracy Chen, PhD, DABT, toxicology advisor at the FDA’s Office of the Chief Scientist. “The competition enables collaboration and mentorship by FDA scientists, aligns with the FDA’s public health mission, and provides students with a platform to consider and pursue future career opportunities in regulatory science.”

Lessons from Theranos

The winning group, Clinical Lab Scientists, emerged from eight teams, whose presentation topics ranged from drugs, devices, apps, tobacco products, and tools like artificial intelligence and how these products and approaches can be better used to improve public health.

Clinical Lab Scientists proposed strengthening the regulatory oversight of laboratory developed tests (LDTs), a classification of medical devices lightly regulated by the FDA. The team drew inspiration for their idea from Theranos, a health technology company that falsely marketed advanced blood tests as LDTs.

“We’re trying to see how the FDA can become more involved, gain more regulatory oversight, and prevent issues like Theranos and noncompliance in the laboratory area,” said Diran Dasi, the team captain.

Clinical Lab Scientists is comprised of four graduate students in UMSOM’s Department of Medical and Research Technology: Dasi, Marilyn Bekima, Rebecca Collins, and Peyton Liebhardt.

“It came as a pleasant surprise to win,” Bekima said. “It just shows the importance of laboratory science. There are more tech companies trying to get into the quick diagnosis of laboratory tests. We want to make sure laboratory developed test regulation is really taken seriously.”

Second place went to MagiKRx, a team of PhD and MS students in the School of Pharmacy’s Pharmaceutical Health Services Research graduate program including John Rizk, Godwin Okoye, Udim Damachi, and Bernard Bright K. Davies-Teye. MagiKRx presented the idea of a web-based app to improve diversity and real-world evidence generation for a newly approved Alzheimer’s disease drug.

Third place went to NociRx, an app intended for older adults that checks for drug-drug interactions between current prescriptions and over-the-counter analgesics. NociRx’s team included four Doctor of Pharmacy (PharmD) students: Mehak Muneer, Urooba Ali, Nan Esi Bray, and Naiha Muneer.