UMSOM Graduate Students Win Top Prize at the 11th Annual “America’s Got Regulatory Talent” Competition

Students Suggest 'Innovative Solutions' to Address Key Issues in Regulatory Science

A group of four clinical laboratory science graduate students within the Department of Medical and Research Technology (DMRT) at the University of Maryland School of Medicine (UMSOM) took the top prize at the 11th annual America’s Got Regulatory Science Talent competition, which was held on February 6, 2023, at the University of Maryland School of Pharmacy (UMSOP).

“The exposure of our department, students and profession through this competition was very important because we are facing a critical shortage of medical laboratory professionals and clinical laboratory scientists. Although always behind the scenes, the role of these clinical laboratory scientists and professionals are critical and indispensable for almost every medical decision,” said Ivana Vucenik, PhD, Professor of Medical Research & Technology and Pathology, Graduate Program Director of DMRT. “As DMRT students have a vast knowledge of laboratory regulations and by winning this prize, the profession of Clinical Laboratory Science is brought to the forefront where it can be acknowledged and recognized as a vital part of the health care team.”

The competition, hosted by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), promotes 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 United States Food and Drug Administration (FDA).

Open to students at the University of Maryland, Baltimore (UMB) and the University of Maryland, College Park (UMCP), the competition provides an opportunity for students to learn from and have meaningful interactions with staff from the FDA, located in nearby Silver Spring, MD. Eight participating teams presented topics that ranged from drugs, devices, apps, tobacco products, and artificial intelligence and how these products and approaches can be used to improve public health. For this year’s contest, five FDA staff scientists served as judges.

“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.”

The winning team, Clinical Lab Scientists, comprised of graduate students Diran Dasi, MS Candidate; Marilyn Bekima, MS Candidate; Rebecca Collins, MD Candidate; and Peyton Liebhardt, MS Candidate, proposed strengthening the regulatory oversight of laboratory developed tests (LDTs), a classification of medical devices lightly regulated by the FDA.

“It came as a pleasant surprise to win,” said Ms. Bekima. “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 taken seriously.”

The team’s inspiration for their idea came after learning of Theranos, a health technology company that falsely marketed advanced blood tests as LDTs.

“We are 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 Mr. Dasi, the team captain.

Second place was awarded to MagiKRx, a team of PhD and MS students in the School of Pharmacy’s Pharmaceutical Health Services Research graduate program. 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.

NociRx, an app intended for older adults that checks for drug-drug interactions between current prescriptions and over-the-counter analgesics, placed third in the competition. NociRx’s team included four Doctor of Pharmacy (PharmD) students.

The FDA Office of Regulatory Science and Innovation (ORSI) has invited the top three teams to an in-person visit to their offices in April.

About the University of Maryland School of Medicine

Now in its third century, the University of Maryland School of Medicine was chartered in 1807 as the first public medical school in the United States. It continues today as one of the fastest growing, top-tier biomedical research enterprises in the world -- with 46 academic departments, centers, institutes, and programs, and a faculty of more than 3,000 physicians, scientists, and allied health professionals, including members of the National Academy of Medicine and the National Academy of Sciences, and a distinguished two-time winner of the Albert E. Lasker Award in Medical Research. With an operating budget of more than $1.3 billion, the School of Medicine works closely in partnership with the University of Maryland Medical Center and Medical System to provide research-intensive, academic, and clinically based care for nearly 2 million patients each year. The School of Medicine has nearly $600 million in extramural funding, with most of its academic departments highly ranked among all medical schools in the nation in research funding. As one of the seven professional schools that make up the University of Maryland, Baltimore campus, the School of Medicine has a total population of nearly 9,000 faculty and staff, including 2,500 students, trainees, residents, and fellows. The combined School of Medicine and Medical System (“University of Maryland Medicine”) has an annual budget of over $6 billion and an economic impact of nearly $20 billion on the state and local community. The School of Medicine, which ranks as the 8th highest among public medical schools in research productivity (according to the Association of American Medical Colleges profile) is an innovator in translational medicine, with 606 active patents and 52 start-up companies. In the latest U.S. News & World Report ranking of the Best Medical Schools, published in 2021, the UM School of Medicine is ranked #9 among the 92 public medical schools in the U.S., and in the top 15 percent (#27) of all 192 public and private U.S. medical schools. The School of Medicine works locally, nationally, and globally, with research and treatment facilities in 36 countries around the world. Visit medschool.umaryland.edu