Event

Apply for the America's Got Regulatory Science Talent Competition 2025

Thursday, December 5, 2024

University of Maryland, Baltimore
RegSciTalent@rx.umaryland.edu

Competition Announcement

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 2025!

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.

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 the 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 Baltimore campus on Monday, February 3 2025 from 9-11am in Pharmacy Hall Room N111.

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 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 2 minutes of Q&A.

By January 15, please email a completed Information Sheet to RegSciTalent@rx.umaryland.edu.

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 healthcare-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 a mentor by emailing RegSciTalent@rx.umaryland.edu by Dec 5, and provide a completed Information Sheet, which you can update later after meeting with the mentor. 

FDA will try to identify an FDA scientist who is willing to mentor your team in the area of your interest (e.g., drug safety, device design, topic that uses data science techniques). It is important to express an area of interest.

Dr. Bentley and Dr. Polli are glad to help you identify an initial area of interest. If a mentor is found, you will be contacted via email.

Criteria and Eligibility:

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

Presentation evaluation:

Each presentation will be evaluated by a panel of judges from Maryland and FDA in terms of 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.