2021 Winners of the America's Got Regulatory Science Talent Competition Present at FDA

Due to COVID-19 this event was online only.

Since 2013, the University of Maryland CERSI, an FDA grant recipient, and the University of Rochester CTSI have held their annual America’s Got Regulatory Science Talent Competition to foster student interest in the pioneering field of regulatory science – the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA‐regulated products. Each student team competing presented a proposed solution to a current challenge in regulatory science, aligned with the FDA Center/Office Regulatory Science Research Priority Areas for CERSI Program. The winning teams are listed below for both universities. A panel of judges evaluated each of the presentations for the quality, novelty, potential significance and feasibility of the students’ proposed solutions. Thank you to the FDA judges and mentors who volunteered to assist with the University of Maryland and University of Rochester Regulatory Science Competitions! Their names are listed in the below Talent Competition Abstracts and Bios documents for the University of Maryland and the University of Rochester.

Due to the COVID-19 pandemic, all the presentations were recorded virtually – you can view the recordings and see presenter slides. To learn more about the students on the winning teams and their proposed solution to a regulatory science challenge, see the University of Maryland and University of Rochester “Talent Competition Abstracts and Bios” documents found in the below links. Send questions for the winning teams to their email addresses found as hyperlinks associated with the winning team member names.

Recordings:

Note: After clicking on recording links, when a pop-up box appears with the label “Switch to Classic View,” click on the “Close” button.

Presentations:

Welcome Remarks – Dr. Tina Morrison, Director, FDA Office of Regulatory Science and Innovation
Recording: https://collaboration.fda.gov/ppdkq5nebxq7/

Overview of Competitions and Introduction of University of Maryland Talent Competition
– Dr. James Polli, University of Maryland
Recording: https://collaboration.fda.gov/pvdatnu6tevd/
Slides: Overview of Competitions and Introduction of University of Maryland Talent Competition 2021

University of Maryland CERSI’s “America’s Got Regulatory Science Talent” Competition Winners

University of Maryland Talent Competition Abstracts and Bios

First Place Team: “PrescripChain”
Team: Delaney McGuirt, Sona Ghorashi, Richard Lee, Amie Lette, Varsha Pradhan, and Amanda Summers
Brief description of proposed solution: The team presented its idea for “PrescripChain,” a user-friendly mobile application for adverse event reporting that utilizes blockchain technology to provide automatic, bench-to-bedside tracing of the entirety of a drug’s lifespan. It proposed this new app as an easy-to-use alternative to similar ones like MedWatch, noting that of 1,600,000 prescription-related adverse events reported in 2020, only 3.8% of those events were reported voluntarily using MedWatch. “PrescripChain” would use blockchain technology to securely track and display adverse event data clearly in real-time.
Recording: https://collaboration.fda.gov/pgi57ouzw9pv/
Slides: http://news.pharmacy.umaryland.edu/files/2021/01/prescripchain-final-presentation_FDAVersion.pdf

Second Place Team: “Braille-iant”
Team: Minseok Han, Lauren Correia, Nathan Feeley, Yididya Hambissa
Brief description of proposed solution: This innovative idea would improve visually impaired persons’ accessibility to prescription information. “Braille-iant” would provide auxiliary prescription labels with clear Braille overlay. This project idea was inspired by an American Foundation for the Blind survey. Team FFC aims to bring increased autonomy, accessibility, and medication safety for visually impaired people.
Recording: https://collaboration.fda.gov/pscowqahr34l/
Slides: http://news.pharmacy.umaryland.edu/files/2021/01/prescripchain-final-presentation_FDAVersion.pdf

Third Place Team: “ePROmetric”
Team: Vaani Shah and Yash Mehta
Brief description of proposed solution: The team presented its idea for “ePROmetric,” a wearable, tech-enabled patient health monitoring mobile application. The patient interface could easily relay data to providers, for example, efficient vitals and symptoms collection and predictive analytics for personalization.
Recording: https://collaboration.fda.gov/p2v5v4q5ytq9/
Slides: http://news.pharmacy.umaryland.edu/files/2021/01/eprometric-final-presentation_FDAVersion.pdf

University of Rochester Talent Competition and Introduction
– Drs. Scott Steele and Joan Adamo, University of Rochester
Recording: https://collaboration.fda.gov/pjv7rxhdgcu8/
Slides: https://www.urmc.rochester.edu/MediaLibraries/URMCMedia/ctsi/clinical-research/documents/URoch0_AGRST_2021_Intro_Steele_Adamo_5-27-21revised.pdf

University of Rochester’s “America’s Got Regulatory Science Talent” Competition Winners

University of Rochester Talent Competition Abstracts and Bios

First Place Team: “Preparing for POC: A Proposed Infrastructure for 3D Printing in Hospitals”
Team: Alex McMullen, Aaron Craig, Megan Luzenski
Brief description of proposed solution: Point-of-Care (POC) 3D printing of medical devices is now feasible as a result of advances in 3D printing technology. This team outlined a regulatory framework to help ensure these devices are safe and effective, using a combination of databases for reporting, training, and a system for validating the POC 3D printing equipment and the implants.
Recording: https://collaboration.fda.gov/p2aiswpdw00i/
Slides: https://www.urmc.rochester.edu/MediaLibraries/URMCMedia/ctsi/clinical-research/documents/Team-1-Proposed-Reg-Framework-for-3D-Printing-at-PoC_1.pdf

Second Place Team: “Blood Contacting Device Testing without the Bloodhound”
Team: Julia Schroth, Matt Izard
Brief description of proposed solution: In an effort to more closely model the use of a blood contacting medical devices and reduce animal use in research, this team proposed a new in vitro blood flow assay. The assay would use human blood and would more easily control and monitor a host of blood and vessel characteristics, while providing the same or better safety evaluation than currently accepted in vitro tests methods.
Recording: https://collaboration.fda.gov/p054p087k9i3/
Slides: https://www.urmc.rochester.edu/MediaLibraries/URMCMedia/ctsi/clinical-research/documents/Team-2-Blood-Contacting-Device-Testing-without-the-Bloodhound-Julia-Schroth-an-__1.pdf

For additional informationon America’s Got Regulatory Science Talent competitions see the University of Maryland and University of Rochester websites.

For questions:
Please contact Donna Blum-Kemelor at donna.blumkemelor@fda.hhs.gov

U.S. Food and Drug Administration

2021 Winners of the America's Got Regulatory Science Talent Competition Present at FDA

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