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.

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.

America's Got Regulatory Science Talent: Competition Overview

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.

Competition Announcement

Students at the University of Maryland, Baltimore and the University of Maryland, College Park are invited to participate in the America’s Got Regulatory Science Talent competition, which 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.

Since 2022, FDA’s Office of the Chief Data Officer has been engaging with the University of Maryland regulatory science talent competition and is interested in applications with proposed solutions to opportunities or challenges in regulatory science which use data science techniques. FDA staff are available to mentor student teams whose proposed solutions use data science techniques and may be available for other student teams focusing on other topics as well.

The competition involves each team developing and presenting a proposed solution to a current opportunity or challenge in regulatory science. There are numerous needs in regulatory science.  Students should consult either the FDA Center/Office Regulatory Science Research Priority Areas for the CERSI Program or FDA Regulatory Science Framework. See the below examples of proposed solutions to opportunities or challenges in regulatory science.

The competition will be held in-person at the University of Maryland School of Pharmacy on Feb. 3, 2025, from 9 to 11 a.m. in Pharmacy Hall, Room N111. A team can include an individual or any number of students, although each team member must contribute to the proposed solution or the presentation. The presentation must be five 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 minutes of Q&A from the judges. By Jan. 15, 2025, please completed the Information Sheet.   

Questions? Email: RegSciTalent@rx.umaryland.edu

Examples of Proposed Solutions for Regulatory Science

  • Developing drugs, devices, and biologics is fraught with challenges. Likewise, there is a continuing need for new tools, standards and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products.
  • Examples of proposed solutions include:
    • Toxicological assays (in vivo and in vitro) to compare toxicity across different types of tobacco products within the same class, including electronic nicotine delivery systems (ENDS.)
    • Reducing health care-associated infection.
    • Methods to improve quality and safety of FDA-regulated products (e.g., methodologies for complex generic drugs, biosimilars, biological products, and medical devices; discovery and validation of minimally invasive biomarkers).
    • Methods and tools to improve and streamline clinical and postmarket evaluation of FDA-regulated products (e.g., approaches to incorporating patient input into regulatory decision-making; approaches to leveraging large data to inform regulatory decision-making, including use of “real world” data sources and mobile technologies; product safety and efficacy in special populations).
    • Some previous winning ideas involved improving how to report an adverse medication event to FDA, counterfeit drug detection, and a mobile application to communicate drug/device risks.

FDA Mentors on Regulatory Science Topics

Teams that wish to have a mentor from FDA must request one by emailing RegSciTalent@rx.umaryland.edu by Dec. 5, 2024, and provide a completed Information Sheet, which can be updated after meeting with the mentor. FDA will try to identify an FDA scientist to mentor the team in its area of interest (e.g., drug safety, device design, topic that uses data science techniques). It is important to express an area of interest. Drs. Bentley and Polli are glad to help you identify an initial area of interest. If a mentor is found, you will be contacted via email.

All full- and part-time students (e.g., undergraduate, professional, graduate) at the University of Maryland, Baltimore and the University of Maryland, College Park are eligible.

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 the 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, and Q&A responses.

About M-CERSI Center of Excellence in Regulatory Science and Innovation (CERSI)

M-CERSI is an FDA-sponsored center at the University of Maryland, Baltimore and the University of Maryland, College Park. Its mission is to foster the development of regulatory science – the science of developing new tools, standards and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products.

 

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:

  • 2023 FDA Article: 2023 Winners of the America's Got Regulatory Science Talent Competition Present at FDA
  • 2023 Feature Story: UMSOM student competition winners score the chance to work on regulatory science with FDA
  • 2023 Feature Story: Clinical Lab Scientists Win 11th “America’s Got Regulatory Science Talent” Competition
  • 2022 FDA Article: 2022 Winners of the America's Got Regulatory Science Talent Competition Present at FDA
  • 2022 Feature Story: M-CERSI Celebrates 10th Annual Regulatory Science Competition
  • 2021 FDA Article: 2021 Winners of the America's Got Regulatory Science Talent Competition Present at FDA
  • 2021 Feature Story: Ninth Annual M-CERSI Regulatory Science Competition Goes Virtual
  • 2021 Feature Story: Pharmacy Students Win Regulatory Science Contest
  • 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