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URMC / Clinical & Translational Science Institute / Stories / May 2017 / Regulatory Science Competition Winners Visit the FDA

Regulatory Science Competition Winners Visit the FDA

As part of their prize, the winners of the 2017 America’s Got Regulatory Science Talent Competition at the University of Rochester visited the Food and Drug Administration in April. The top two teams from this year’s local competition presented their winning ideas to key players at the FDA including Stephen Ostroff, M.D., who was the acting commissioner at the time, and discussed research related to their own projects with FDA scientists.   

UR Team with FDA Leadership

UR Teams With FDA Leaders: (from left) Carol Linden, Ph.D., Stephen Ostroff, M.D., Frank Weichold, M.D., Ph.D., Brittany Garrison, Kerry Donnelly, Scott Steele, Ph.D., Joan Adamo, Ph.D., and Bethany Lennox

The America’s Got Regulatory Science Talent competition at the University of Rochester is led by Scott Steele, Ph.D., director of Government and Academic Research Alliances and Joan Adamo, Ph.D., director for Regulatory Support Services as part of a broader initiative to increase awareness and interest in regulatory science for young scientists. Each year, winners of local competitions at the UR CTSI and the University of Maryland’s Center of Excellence in Regulatory Science Innovation present their ideas on how to address a set of regulatory challenges in front of FDA leaders and subject matter experts.  

The students also attend a set of meetings that are tailored to their interests, where they can discuss how to implement their ideas with scientists and leaders at the FDA. These meetings are also an excellent opportunity for the students to network and connect with pertinent members of FDA who can help them advance their regulatory science careers.

CTSI first place winner, Bethany Lennox, a graduate student in the Center for Medical Technology and Innovation at UR, presented her plan to make clinical trial results reported on ClinicalTrials.gov more accessible to the general public. Lennox later met with Patrick McNeilly, senior health policy analyst in the FDA’s Office of Good Clinical Practice, and Jarilyn Dupont, director of Regulatory Policy at the FDA, to further discuss ways to improve ClinicalTrials.gov and how it interfaces with the public.  

The CTSI’s second place team composed of Kerry Donnelly and Brittany Garrison, both graduate students in the Center for Medical Technology and Innovation at UR, proposed a streamlined process for ensuring the safety of personalized 3D printed implants. Donnelly and Garrison then continued the conversation about 3D printed medical devices with Lt. James Coburn, M.Sc., senior research engineer, and Matthew DiPrima, Ph.D., materials scientist in the FDA’s Additive Manufacturing of Medical Products research program.

The April 12th event was sponsored by the Office of Regulatory Science and Innovation in the Office of the Chief Scientist at the FDA. You can read more about the event in an FDA Voice blog article authored by former FDA Acting Commissioner Ostroff.

To read more about UR’s winning projects on the CTSI Stories Blog, click here.

To see the finalists’ presentations, visit FDA’s America’s Got Regulatory Science Talent web page.

Susanne Pritchard Pallo | 5/12/2017

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