Event
"America's Got Regulatory Science Talent" Competition
Friday, January 15, 2021
9:00 a.m.-11:00 a.m.
Virtual via WebEx
Ann Anonsen
aanonsen@umd.edu
Students at the Baltimore and College Park campuses of the University of Maryland are invited to participate in the "America's Got Regulatory Science Talent" competition on Friday, January 15, 2021.
The competition aims to promote student interest in regulatory science — the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products.
About the Competition:
The competition involves each team developing and presenting a proposed solution to a current opportunity in regulatory science. There are numerous needs in regulatory science. Students should consult the FDA Center/Office Regulatory Science Research Priority Areas for the CERSI Program.
The competition will be held via Webex on Friday, Jan. 15, 2021 from 9-11 a.m. A team can include either an individual or any number of students, although each team member has to contribute to the proposed solution or the presentation. The presentation must be five (5) minutes in duration or less. It may be as simple as a verbal description or may utilize AV materials. Creativity is encouraged. Proposed solutions should also aim to have high regulatory impact. Each presentation will be followed by two (2) minutes of Q&A.
If you are interested in participating in the upcoming competition, please email a completed Information Sheet (available below) to RegSciTalent@rx.umaryland.edu by Jan. 3, 2021.
Eligibility:
All full-time and part-time students, including undergraduate, professional, and graduate students, at the Baltimore and College Park campuses of the University of Maryland are eligible to participate.
Dates, Deadlines, and Parking:
Please submit your team's completed information sheet to RegSciTalent@rx.umaryland.edu by Sunday, Jan. 3, 2021. Teams that wish to have a mentor from the FDA must request a mentor by emailing RegSciTalent@rx.umaryland.edu by Sunday, Nov. 15.
The competition will be held via Webex on Friday, Jan. 15, 2021 from 9-11 a.m.
America's Got Regulatory Science Talent Competition Information Sheet (2021)
Evaluation:
Developing drugs, devices, and biologics is fraught with challenges. 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 might 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 the FDA to better communicate risks of medications (e.g., friendlier product labels, use of social media, use of crowdsourcing, etc.)
- A test for food contaminants
- A way to respond to a nuclear agent
- A way to get patients to use a device safely
Each presentation will be evaluated by a panel of judges from the University of Maryland and FDA for 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 A/V materials or demonstrations used, and responses provided during the Q&A session.
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