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Clinical & Translational Science Institute / Education and Career / America's Got Regulatory Science Talent

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

This competition is not currently accepting applicants. Notify When Available

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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 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 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

  1. 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.
  2. 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.
  3. Submit a completed entry form. 

Deadlines

Request a Faculty Advisor - Monday, September 28, 2026

Entry Form Due - 5:00 p.m. on Wednesday, November 4, 2026

Competition - Noon on Wednesday, December 2, 2026 at the Helen Wood Hall 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.

 

 

Current Competition

For 2023, the FDA has particularly expressed interest in proposed solutions that utilize data science techniques. Students should consult the 2022 Advancing Regulatory Science Plan and the August 2011 Strategic Plan for Regulatory Science to guide their proposed solution.

Schedule

Date & TimeSessionLocation

12/6/23
12-2 p.m.

America’s Got Regulatory Science Talent Student Competition

Helen Wood Hall, Room 1W-509

5/17/24Local winners present their proposed solutions to the FDA

FDA Headquarters in Silver Spring, MD

Presentation Evaluation

Each presentation (~5 minutes in length) will be evaluated by a panel of judges from the University of Rochester and local industry for the proposed solution and presentation quality. Elements of proposed solution include novelty and potential significance. Short-term feasibility is a plus, but not a requirement. Elements of presentation quality include verbal communication, visual communication, impact of any AV materials or demonstrations, as well as Q&A responses.

This competition is not currently accepting applicants.

Notify When Available

Resources

Resource 1

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Resource 2

Pellentesque eu tincidunt tortor aliquam nulla facilisi cras. Morbi tristique senectus et netus et malesuada fames ac turpis. Libero enim sed faucibus turpis in eu. Elementum nisi quis eleifend quam adipiscing vitae proin. Est pellentesque elit ullamcorper dignissim cras tincidunt lobortis feugiatPast Projects

Current Projects

First Place: Michaela Rymal and Bella Smith| Patent Pending : “Predicate Revalidation Equivalency Safety Scoring (PRESS)”

Second Place: Michelle Eldred, Farah Kabir, and Collins Owusu-Ansah | KIMpossible : Reducing FDA’s Reliance on Animal Studies: Kidney-on-a-Chip with Aptamer Biosensors

Third Place: Rhodalyn Essien | DELVE : Digital Ecosystem for Linking Data and Validating Adverse Events

Past Projects

First Place: John Alex, Archita Amudhan and Navya Soogoor | Re-RNA: Safeguards Against mRNA Integration

Second Place: Sadia Chowdhury and Liam Peterson | UV and Me: Sun Safety Sleuths

Third Place: Salome Ghvinephadze, Emily Reitz, Shivali Vashisht, and Sergio Garcia | Regul8tors: Streamlining Microfluidic Device Development Through an Open-Source Compendium

First place: John Miller; Stopping Runaway CAR-T Cells

Second place: Hossein Abolhassani and Chiao Yun Chen; 3D Organoid-On-A-Chip

Third place: Rana Alabdali and Ryan Owens; AI Detecting Infant Seizures

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.

First Place: Dan Farchione and Justin Jablonski; FoodWarn AI

Second Place: Reshul Narhari and Stella Nantale; Opi-Lock

Third Place: Melanie Singh; iDARE (Drug Availability Reporting and Expectations)

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. Learn more about the 2023 winners on the UR CTSI Stories blog. 

First Place: Warish Zaman Orko and Mark Truskinovsky; Smart Event Evaluation & Reporting

Second Place: Bahie Ezzat, Ejiroghene Davies-Okarevu, Katarina Lichak, and Nandita Bhowmik; COVIDeo App Uniters

Third Place: Yuthika Shekhar and Abhijeet Talaulikar; Identifying whole food allergens using Machine Learning

Both the 1st place and 2nd place teams presented their proposals to members of the FDA in March, 2022. Learn more about the winners on the UR CTSI Stories blog. You may also listen to the full recording of the 2022 Competition.

First Place: Alex McMullen, Aaron Craig, Megan Luzenski; A Proposed Regulatory Framework for 3D Printing Implants at Point-Of-Care Facilities

Second Place: Julia Schroth and Matt Izard, "Blood Contacting Device Testing Without the Bloodhound"

Third Place: 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. Learn more about the winners on the UR CTSI Stories blog.

First Place: Sydney Simpson; Data Science for Food Safety
Simpson presented her proposal as part of a virtual FDA event in April, 2020.

Second Place: John Lisi, Kale Friesen, Eric Cecco; FDA Award for Excellence in Innovative Quality Practices

Third 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. 

First Place: Sarah Hackley; My Real World Data

Second Place: Ashley Holum; Simulating Clinical Trials: Insilico Source

Third 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.

First Place: Xiaowen (Cindy) Wang; Dr. Data: An integrated Drug Repurposing Database for Identifying New Indications of FDA Approved Drugs  

Second Place: Eric Ravinal, Justin Schumacher, Vladimier Tokarchuk, Rebecca Amorese; Rochester Regulators: Ensuring FDA’s Readiness to Evaluate Additive Manufacturing

Third 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.

First Place: Bethany Lennox; Simple English Explanation Directive (SEED)

Second Place: Kerry Donnelly and Brittany Garrison; 3-Defining Patient Matched Implants

Third 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.

First Place: Angela Ryck; Emergency Situation Communication and Preparedness Evaluation (ESCAPE)

Second Place: Jesi To

Third Place: Mallory Scott

Learn more about the winners on the UR CTSI Stories blog and on the FDA website.

First Place: Corey Hoffman; GENE-ius: Genome Database in Clinical Trials to Innovate Personalized Medicine

Second Place: Deborah Cooper; Ripple

Third Place: Laura Hobbs, Courtney Kodweis, Megan Stockdill; Transparent Access

Learn more about the winners in the Q&A.

First Place: David Brodell; Team Cardioid: Developing a High-Resolution 3D Heart Model for Drug Safety Assays 

Second Place: Michael Moses and Allen Bennett; Team Bio-Logic

Third Place: Abeer Abu-Zeitone; Team Report-It

Learn more about the winners and their visit to the FDA on the Research@URMC blog.

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