Announcing Winners of Seventh Annual Regulatory Science Talent Competition
Ten teams competed in the seventh annual America’s Got Regulatory Science Talent student competition on February 12, 2020, hosted as part of the UR CTSI’s Regulatory Science programs. Teams proposed a wide range of novel solutions to address nine scientific priority areas outlined in the Food and Drug Administration’s (FDA) Strategic Plan for Advancing Regulatory Science. The first place winner will present her proposal in person at the FDA in April.
Learn more about the top four winners (two teams tied for third):
Pathogen outbreaks in food – like E. coli in romaine lettuce – are fairly common, but current methods to trace contamination through the food supply chain are labor intensive, time consuming, imprecise and often end in the disposal of healthy produce. I propose using blockchain software, which is already commercially available and utilized for supply chains by some businesses, to record transactions involving nationally-distributed, high-risk produce (like romaine lettuce). Blockchain records each transaction, linking it to previous transactions and building a digital scaffold that can be easily traced – decreasing trace-back time from over a week to seconds. Under my proposal the FDA would either have access to these blockchain databases or would sync the information into one database, allowing for fast and efficient trace-backs of contaminated produce.
John Lisi, Kale Friesen, Eric Cecco
To facilitate innovations in product manufacturing and quality, we propose developing a national award to incentivize competition between medical device companies, similar to the JD Power Award. The FDA Award for Excellence in Innovative Quality Practices would be presented annually to the top 20 percent of medical device companies based on their innovation and maintenance of high quality standards. The award would boost the reputation of companies that go above and beyond current good manufacturing practices (cGMPs) to prioritize patient care through advances in quality management.
Third place (tie):
Mia Fiacchi, Catherine Krawiec, Anna Olsen
Understanding what’s in your food or nutritional supplements can be confusing. Ingredients can have long, complicated names that can confound or scare consumers. To clear up the confusion and help consumers make informed choices at the grocery store, we propose the Food Cam, a mobile app that translates food ingredients while users shop. The app pulls information from the FDA’s Food Additive Status List to present the user with the common name for the ingredient, its purpose and whether it is considered safe to consume. The app will also alert users when a product they have scanned is recalled. Armed with this information, the consumer can make a more-informed purchasing decisions.
According to data from 2013-2016 from the Centers for Disease Control and Prevention, nearly 50% of people in the U.S. had used at least one prescription drug – and 24% had used three or more – in the 30 days prior to polling. With all of that drug use, it could be easy to miss important drug interactions or changes in safety information. To keep patients better informed, I propose to develop a mobile app where users can log their daily prescriptions and get risk and benefit information about those drugs as well as real-time alerts from the FDA any time there is a change in their prescriptions’ safety information.
Thank you to this year’s judges: Michael Hasselberg, Ph.D., associate professor of Psychiatry and Clinical Nursing, and Valentina Kutyifa, M.D., Ph.D., associate professor of Cardiology Heart Research.
The America’s Got Regulatory Science Talent student competition is organized by Scott Steele, Ph.D., director of UR CTSI Regulatory Science Programs, and Joan Adamo, Ph.D., director of Regulatory Support Services at UR CTSI, and is supported by the University of Rochester CTSA award number UL1 TR002001 from the National Center for Advancing Translational Sciences of the National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Susanne Pritchard Pallo |