M-CERSI Now Accepting Regulatory Science Competition Applications

Students at the Baltimore and College Park campuses of the University of Maryland are invited to participate in the University of Maryland Center of Excellence in Regulatory Science and Innovation's (M-CERSI) "America's Got Regulatory Science Talent" Competition.

The competition will be held on the University of Maryland, Baltimore campus in Pharmacy Hall (20 Pine Street, Baltimore) on February 10, 2020 from 9 a.m. to 11 a.m.

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.

A participating 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 two minutes of Q&A. Lunch will be provided for all competing teams, and top contenders will receive prizes.

Each team must propose a proposed solution to an opportunity in regulatory science. FDA Center/Office regulatory science research priority area for the CERSI program can be found here.

To participate, please email a completed Information Sheet to RegSciTalent@rx.umaryland.edu by January 30, 2020.

Parking information for the competition is available online. Please note: the Saratoga garage and the Pearl garage are recommended for use during this event.

Examples of Proposed Solutions

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); and 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.

Teams that wish to have a mentor from FDA must request a mentor by emailing RegSciTalent@rx.umaryland.edu by December 15th. If possible, please indicate your preferred topic for the talent event (e.g., drug safety, device design) and FDA will try to identify an FDA scientist who is willing to mentor; if a mentor is found, you will be contacted via email.

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. Those from outside institutions should email RegSciTalent@rx.umaryland.edu with questions regarding this event.

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.

Published October 31, 2019