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, Jan. 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.
In this five-minute video, Dr. James Polli discusses how the "America's Got Regulatory Science Talent" competition is organized each year. All full-time and part-time students at the University of Maryland, Baltimore and University of Maryland, College Park are eligible to participate. Download the presentation shown in the video.
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.
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.
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.
About the Sponsor:
|The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) focuses on modernizing and improving the ways in which drugs and medical devices are developed and evaluated. It is a collaborative partnership between the Food and Drug Administration (FDA) and the Baltimore and College Park campuses of the University of Maryland.|
For More Information:
For questions or additional information about the "America's Got Regulatory Science Talent" Competition, please email RegSciTalent@rx.umaryland.edu.
For information about previous "America's Got Regulatory Science Talent" Competitions, please explore the following resources:
- 2021 Feature Story: Ninth Annual M-CERSI Regulatory Science Competition Goes Virtual
- 2020 Blog Post: Regulatory Science Competition Winners Take Presentations Online
- 2020 Feature Story: SOP Hosts Eighth Annual “America’s Got Regulatory Science Talent” Competition
- 2019 Feature Story: Student Competition Spotlights Innovation in Regulatory Science
- 2018 Feature Story: Annual Competition Spotlights Student Innovation in Regulatory Science
- 2017 FDA Article: America's Got Regulatory Science Talent Winners Presentations at FDA 2017
- 2017 Feature Story: Talent Competition Highlights Student Innovation in Regulatory Science
- 2016 Feature Story: SOP Talent Competition Brings Student Innovation to the Forefront
- 2015 Feature Story: Talent Competition Highlights Student Innovation in Regulatory Science
- 2014 Feature Story: SOP Talent Competition Highlights Student Innovation in Regulatory Science
- 2013 Feature Story: Student Talent Competition Focuses on Improvements in Regulatory Science
- 2013 FDA Voice Blog Post: Students Bring Energy and Good Ideas to the Table