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URMC / Clinical & Translational Science Institute / Stories / March 2019 / Announcing the Winners of the America's Got Regulatory Science Talent Student Competition

Announcing the Winners of the America's Got Regulatory Science Talent Student Competition

Twelve teams competed this year in the sixth annual America’s Got Regulatory Science Talent student competition, hosted as part of the Regulatory Science programs at the University of Rochester Clinical and Translational Science Institute (UR CTSI). Teams proposed a wide range of novel solutions to address the nine scientific priority areas outlined in the Food and Drug Administration’s (FDA) Strategic Plan for Advancing Regulatory Science. From a farm-to-table produce tracking app to a public alert system for product recalls and disease outbreaks, this year’s competition was full of innovation.

The top three proposals are summarized below. The first place winner will present her proposal in person at the FDA next month. Congratulations to all!  

First place: My Real-World Data (RWD)

Sarah Hackley, undergraduate student of Bioethics at the University of Rochester School of Arts & Sciences

Wearable and data-sharing medical devices are on the rise. While the FDA encourages transparency and patient access to data from these devices, it is not required. My RWD is a regulatory science measure that provides an efficient and validated process for consented participants to access and share mobile health data with third parties for research purposes, while also increasing autonomy by allowing individuals a mechanism to change their level of participation or opt-out entirely.

Second place: Trial Simulation

Ashley Holub, epidemiology graduate student in the Department of Public Health Sciences at URMC

Using computational models to simulate clinical trials could help hone in on the most promising therapies while sparing much of the cost of traditional preclinical and clinical studies. Clinical trial simulation might also result in new improved models and methods that could replace current models. Despite this, data on existing simulations can be hard to locate, slowing progress in scientific advancements. A central database of all simulation trials could help further the science and promote the use of simulations in clinical trials.

Third place: ARG

Simeon Abiola, graduate student in the UR CTSI’s Translational Biomedical Science PhD Program at URMC

More than 100 million Americans have multiple chronic health issues (referred to as multi-morbidity), and many of them manage their care with multiple technologies tailored to individual diseases. Our group analyzed pre-market notifications, required documents that describe the intended use(s) of a medical device, to uncover opportunities to monitor multi-morbidity using existing devices. For example, a scale might be used to screen not only for risk factors of cardiovascular disease (e.g. excessive body weight), but also for any unexplained weight loss which may portend certain forms of cancer. Our proprietary database could help expedite the clearance of new medical devices and, in conjunction with nationally representative public health datasets, advance the development of novel databases to support the manufacture of patient centered medical devices.


The America’s Got Regulatory Science Talent 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.

Michael Hazard | 3/28/2019

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