M-CERSI Accepting Regulatory Science Innovation Submissions

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. 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.

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.

Last year's first- place competition winner Team Brain Alliance (Adaeze Amaefule, Breanna Owoo, Hannah Kim, and Sydney Yuen) proposed a user-friendly tool which would synthesize multiple tools provided by the FDA, including recalls, premarket approvals, and registering a device. 

Additional information about competition paticipation is available online.