Written By: Jillian Aquino, Third-Year Student Pharmacist
Since 2013, the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) has hosted its “America’s Got Regulatory Science Talent” competition to help promote interest in the ever-expanding field of regulatory science. Students from all academic programs at the University of Maryland, Baltimore (UMB) and University of Maryland, College Park (UMCP) are invited to participate.
This year, our team –Maximizing Patient Reported Outcomes and Vigilance Efforts (M-PROVE) — became the first group of student pharmacists to take home first place in the competition. As part of our prize for winning the competition, I and my fellow third-year student pharmacist teammates Peter Nguyen, Justin Penzenstadler, David Tran, and Yoon Duk Hong were invited to visit the Food and Drug Administration (FDA) on May 6 to deliver our presentation addressing the challenges that currently face adverse effects reporting and shining a light on one potential innovation that could be implemented to improve the process. We were joined by second place team Max Elixirs, and the winning team from the University of Rochester.
M-PROVing the Competition
To compete in the “America’s Got Regulatory Science” competition, student teams must develop an innovative solution to a regulatory science challenge identified within one of the eight scientific priority areas in the FDA’s Strategic Plan for Advancing Regulatory Science. This year’s panel of judges evaluated each of the presentations for the quality, novelty, potential significance, and feasibility of the students’ proposed solutions.
Our team’s project, “Maximizing Patient Reported Outcomes and Vigilance Efforts,” proposed utilizing the modern patient to increase participation and signal detection in pharmacovigilance. Our idea focused on using Google to link patients to MedWatch. We know that many patients perform a Google search when experiencing adverse reactions or side effects from medications, so we recommended capitalizing on those Google searches by having the FDA partner with Google to include a side bar feature on the landing page of patients’ Google results to capture the information typically required for MedWatch. The patients would then be able to easily submit the necessary information to MedWatch.
Visiting the FDA
Having the opportunity to present our idea to the FDA was definitely a rush of different emotions. Many experts were present in the audience, and we felt nervous at first because we didn’t know what questions might be asked of us. We knew that our idea was innovative, but we also knew that some people might think our proposal to create a partnership between the FDA and Google was farfetched. However, feedback from different individuals at the FDA really helped us believe in our idea. The experience also encouraged us to continue to think “outside-the-box.” Creative and, sometimes, ambitious ideas are needed to tackle issues in health care.
Although it was a gray, rainy day outside, having the chance to spend time networking and talking about innovative ideas definitely made our experience at the FDA enjoyable and memorable. In the end, we learned that there are still several issues related to our idea that need to be resolved, but this experience showed us that anything is possible with the right approach. Apart from receiving the opportunity to present our idea, we also had an opportunity to network with a lot of experts at the FDA, including deputy directors and project managers from different divisions in the Center for Drug Evaluation and Research (CDER).