America's Got Regulatory Science Talent
The annual America’s Got Regulatory Science Talent Student Competition provides an opportunity for students from across the University of Rochester to compete for a chance to present their regulatory science ideas at the Food and Drug Administration (FDA). Teams of students develop and present a proposed solution to a current area of need related to regulatory science, the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products.
This competition is now accepting applicants. Apply
Goals
The America's Got Regulatory Science Talent competition is part of a broader initiative to increase awareness and interest in regulatory science among young scientists. Each year, the UR CTSI hosts the competition in collaboration with the University of Rochester Center for Medical Technology and Innovation and the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI). Students in the local competitions at UR CTSI and M-CERSI vie for the chance to present their ideas on how to overcome a set of regulatory science challenges or address one of the FDA’s priority regulatory science areas to key personnel at the FDA.
Contact
Joan Adamo, Ph.D., Director of the Office of Regulatory Support, Function Leader for Regulatory Knowledge and Support, and Co-leader of the Digital Health and Regulatory Science Core
joan_adamo@urmc.rochester.edu
(585) 275-0742
How to Apply
- Request an FDA advisor: While it is not required to have a faculty or FDA advisor for this project, it is strongly suggested that you consult with faculty familiar with the scientific and regulatory issues in the field of your proposal. If you would like assistance in being paired with a faculty or FDA advisor, contact us at researchhelp@urmc.rochester.edu. Keep in mind that material presented should be non-confidential.
- Select FDA focus areas: Review the FDA Focus Areas of Regulatory Science Report and select up to three focus areas that apply to your proposed solution.
- Submit a completed entry form.
Deadlines
Monday, September 30, 2024 - Last call for requesting an FDA Advisor
Wednesday, November 6, 2024 - Completed Entry Form is due by 5:00 pm
Wednesday, December 4, 2024 - America's Got Regulatory Science Talent student competition will take place at 12:00 pm, School of Nursing Auditorium, 1W-304.
Eligibility
All full-time and part-time students (e.g., undergraduate, professional, graduate) at the University of Rochester are eligible.
- A team can consist of one to four students.
- Each team member must contribute to the proposed solution or the presentation.
- The presentation must be five minutes in duration or less and may utilize AV materials. Creativity is strongly encouraged!
- Each presentation will be followed by two minutes of Q&A.
- Presentations should aim to have high regulatory impact.
Cost
There is no cost to participate in this competition. Winners’ travel costs to visit the FDA are covered by the UR CTSI.
Past Projects
- First place: John Miller; Stopping Runaway CAR-T Cells (slides)
- Second place: Hossein Abolhassani and Chiao Yun Chen; 3D Organoid-On-A-Chip (slides)
- Third place: Rana Alabdali and Ryan Owens; AI Detecting Infant Seizures (slides)
The first and second place teams traveled to the FDA in May 2024 and presented their Regulatory Science proposals to the FDA. Learn more and watch their presentations.
- 1st place: Dan Farchione and Justin Jablonski; FoodWarn AI (slides)
- 2nd place: Reshul Narhari and Stella Nantale; Opi-Lock (slides)
- 3rd place: Melanie Singh; iDARE (Drug Availability Reporting and Expectations) (slides)
Our first place team traveled to the FDA at White Oak Maryland in April and presented their winning entry along with the winning teams from the University of Maryland. You may view their slides above and an overview of the competition. Learn more about the 2023 winners on the UR CTSI Stories blog.
- 1st place: Warish Zaman Orko and Mark Truskinovsky; Smart Event Evaluation & Reporting (slides)
- 2nd place: Bahie Ezzat, Ejiroghene Davies-Okarevu, Katarina Lichak, and Nandita Bhowmik; COVIDeo App Uniters (slides)
- 3rd place: Yuthika Shekhar and Abhijeet Talaulikar; Identifying whole food allergens using Machine Learning (slides)
Both the 1st place and 2nd place teams presented their proposals to members of the FDA in March, 2022. You may view their slides above and an overview of the competitionLearn more about the winners on the UR CTSI Stories blog. You may also listen to the full recording of the 2022 Competition.
- 1st place: Alex McMullen, Aaron Craig, Megan Luzenski; A Proposed Regulatory Framework for 3D Printing Implants at Point-Of-Care Facilities
- 2nd place: Julia Schroth and Matt Izard; Blood Contacting Device without the Bloodhound
- 3rd place (tie):
- Yunpeng Pang; Team Organoid
- Aliza Panjwani; My Health
Both the 1st place and 2nd place teams presented their proposals as part of a virtual FDA event in May, 2021. You may view their slides below and an overview of the competition. Learn more about the winners on the UR CTSI Stories blog.
- 1st place: Sydney Simpson; Data Science for Food Safety
Simpson presented her proposal as part of a virtual FDA event in April, 2020. View her slides and an overview of the competition. - 2nd place: John Lisi, Kale Friesen, Eric Cecco; FDA Award for Excellence in Innovative Quality Practices
- 3rd place (tie):
- Mia Fiacchi, Catherine Krawiec, Anna Olsen; Food Cam
- Shannon Keenan; Inform Empower Labeling
Learn more about the winners on the UR CTSI Stories blog and on the FDA website.
- 1st Place: Sarah Hackley; My Real World Data
- 2nd Place: Ashley Holub; Simulating Clinical Trials: Insilico Source
- 3rd Place: Simeon Abiola; Patient-Centered Medical Devices for Patients with Multimorbidity
Learn more about the winners on the UR CTSI Stories blog and on the FDA website.
- 1st Place: Xiaowen (Cindy) Wang; Dr. Data: An integrated Drug Repurposing Database for Identifying New Indications of FDA Approved Drugs
- 2nd Place: Eric Ravinal, Justin Schumacher, Vladimier Tokarchuk, Rebecca Amorese; Rochester Regulators: Ensuring FDA’s Readiness to Evaluate Additive Manufacturing
- 3rd Place: Amanda Smith, Meghann Meyer, Emily Newman, Evan Sosnow; FDA Alert: Approved Listings & Explanations of Regulated Technology
Learn more about the winners on the UR CTSI Stories blog and on the FDA website.
- 1st place: Bethany Lennox; Simple English Explanation Directive (SEED)
- 2nd place: Kerry Donnelly and Brittany Garrison; 3-Defining Patient Matched Implants
- 3rd place: Simeon Abiola; Regulatory Innovation Science Expert (RISE) Initiative
Learn more about the winners on the UR CTSI Stories blog, on the FDA website and on the FDA Voice blog.
- 1st place: Angela Ryck; Emergency Situation Communication and Preparedness Evaluation (ESCAPE)
- 2nd Place: Jesi To
- 3rd Place: Mallory Scott
Learn more about the winners on the UR CTSI Stories blog and on the FDA website.
- 1st place: Corey Hoffman; GENE-ius: Genome Database in Clinical Trials to Innovate Personalized Medicine
- 2nd Place: Deborah Cooper; Ripple
- 3rd Place: Laura Hobbs, Courtney Kodweis, Megan Stockdill; Transparent Access
Learn more about the winners in the UR CTSI Stories blog post and Q&A.
- 1st place: David Brodell; Team Cardioid: Developing a High-Resolution 3D Heart Model for Drug Safety Assays
- 2nd Place: Michael Moses and Allen Bennett; Team Bio-Logic
- 3rd Place: Abeer Abu-Zeitone; Team Report-It
Learn more about the winners and their visit to the FDA on the Research@URMC blog.