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. Students should consult the 2022 Advancing Regulatory Science Plan and the August 2011 Strategic Plan for Regulatory Science to guide their proposed solution. For 2023, the FDA has particularly expressed interest in proposed solutions that utilize data science techniques.
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- 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.
Examples of Proposed Solutions
Developing drugs, devices, and biologics is fraught with challenges. Likewise, there is continued need for new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products. Example proposed solutions include: an idea for a new toxicology test; a better biomarker; an approach to improve manufacturing; a way to detect counterfeit biologics; a test that evaluates a new medical technology; a new data signal that detects adverse reactions from a new drug; a way for FDA to better communicate risks of medications (e.g. friendlier product labels, use of social media or YouTube); use of crowdsourcing; a test for food contaminants; a way to respond to a nuclear agent/incident; and how to get patients to use a device safely.
All full-time and part-time students (e.g., undergraduate, professional, graduate) at the University of Rochester are eligible.
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.
While it is not required to have a faculty or FDA advisor for this project, it is strongly suggested that you at least 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 the email below ASAP. Keep in mind that material presented should be non-confidential.
Dates and Deadlines
Wednesday, November 8, 2023: Submit completed entry form by 5:00 p.m.
Wednesday, December 6, 2023: America’s Got Regulatory Science Talent Student Competition takes place 12-2 p.m. in Helen Wood Hall, Room 1W-509 (Craytor & McNerney Classroom).
Spring 2024: Winning team meets with the FDA.
University of Rochester Clinical & Translational Science Institute (UR CTSI), in collaboration with the University of Rochester Center for Medical Technology and Innovation (CMTI) and the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI)
The winning team will present their proposal to the FDA in spring of 2024.