America’s Got Regulatory Science Talent Competition Spurs Creative Solutions to FDA Focus Areas
Student-researchers from across the University addressed FDA focus areas of regulatory science with rapid-fire presentations at the America’s Got Regulatory Science Talent student competition.
Regulatory science develops new methods, tools, and standards to assess products up for FDA review, creating efficiencies in the approval process. Each team of students had only a few minutes to present their ideas to a panel of judges who asked questions, critiqued, and evaluated the presentations.
Taking first place was team Re-RNA, comprised of John Alex, Archita Amudhan, and Navya Soogoor. Re-RNA was interested in addressing the FDA’s guidance for vaccines that might undergo genomic integration, particularly in cancer patients and others who are immunocompromised. They proposed adding integration tests to FDA guidance on vaccine development, including nanopore DNA sequencing or paired-end DNA sequencing.
Over the course of preparing for the competition and presenting, the team gained a greater understanding of how scientific advancement and FDA regulations integrate, particularly in terms of how regulatory science can ensure vaccine development is safe and effective.
“As a student, I've always had a passion for learning about scientific advancements and the progress we have made throughout the decades,” said Amudhan, a senior pursuing a bachelor of science degree in cell and developmental biology. “Having the chance to take information from different classes, immerse myself in the current literature regarding mRNA vaccines, and put that into practical use by connecting them to current FDA regulations has been a fruitful process over the past few months.”Amudhan recognized that students can contribute and foster change to current, real-world regulations based on their own learning. Amudhan is participating in the Rochester Early Medical Scholars Program.
“This is our second time participating in this competition, and I think we learned a lot between the first and second presentation,” said Soogoor, a senior pursuing a degree in neuroscience and psychology. “We have learned about the intersection of science and regulation, and mainly about how the FDA plays a key role in bridging this gap. I have grown in my understanding of regulatory science throughout this process working with our FDA advisor, Dr. Peter Weina [associate director for Medical Countermeasures and Scientific Affairs, CBER, OVRR, FDA ] and with the event organizer Dr. Joan Adamo.” Soogoor plans to take a year to focus on her personal growth and enrichment before attending graduate school for psychology.
“We made a lot of revisions to our presentation, but it took the eyes of many people to finish,” said Alex, a senior pursuing a degree in microbiology with a minor in psychology. “I learned how important it is to ask for help when you are stuck on a problem from this experience, and that everyone has something valuable to add to the conversation.” Alex plans on pursuing a master’s degree in genetic counseling to research the intersection between genetics, culture, and mental health.
Taking second place was team UV & Me: Sun Safety Sleuths, comprised of Sadia Chowdhury and Liam Peterson. Third place went to team Regul8tors, featuring Salme Ghvinephadze, Emily Reitz, Shivali Vashisht, and Sergio Garcia.
Winning teams will receive prizes locally. The first-place team will interact with the FDA and with the winning team from the University of Maryland competition.
The competition was judged by David Borkholder, PhD, Bausch + Lomb Professor of microsystems engineering at the Rochester Institute of Technology; Kathleen M. Fear, PhD, director of data and analytics at UR Health Lab and assistant professor at the School of Nursing; and Deborah J. Ossip, PhD, professor of Public Health Sciences.
The top three presentations can be found here, via Box.
Jonathan Raab | 1/10/2025
