Regulatory Science Competition Winners Present Ideas to FDA

May. 6, 2014
FDA visit
Scott Steele (UR), David Brodell (UR), Stephen Ostroff (FDA), Chelsea Virgile (UMD), William Bentley (UMD), and Frank Weichold (FDA)

On April 28, University of Rochester student David Brodell and University of Maryland graduate student Chelsea Virgile traveled to the Food and Drug Administration (FDA) campus in Silver Spring, Maryland to present their winning "America's Got Regulatory Science Talent" competition proposals.

The UR Office of Government and Academic Research Alliances and the Clinical and Translational Science Institute hosted and sponsored an inaugural “America’s Got Regulatory Science Talent Competition” in January.  The event builds on a 2013 competition at the University of Maryland’s Center of Excellence in Regulatory Science and Innovation.  

The competition is a component of several Regulatory Science education initiatives led by Scott Steele, Ph.D., and Joan Adamo, Ph.D. designed 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. 

Brodell's "Team Cardioid" was selected for the entry, "Developing a High-Resolution 3D Heart Model for Drug Safety Assays."   His proposal looks to improve the process of determining whether an experimental drug will be toxic to the heart through the use of advanced computational simulations.

Advised by Jean-Phillippe Couderc, Ph.D., the project involves collaborations with researchers at IBM to better understand the mechanisms associated with drug-induced ion-channel dysfunction using a complex computer model of the human heart utilizing the university's Blue Gene/Q supercomputer. 

Virgile, who is also a graduate of the University of Rochester, was named the winner of this year's University of Maryland competition for her entry "Liquid Barcoding Pharmaceuticals for Counterfeit Pharmaceutical Drug Detection." Advised by William Bentley, Ph.D., her entry dovetails on technologies developed by Maryland start-up company Diagnostic anSERS, Inc., which incorporates inexpensive Surface Enhanced Raman Spectroscopy approaches for the detection of a variety of molecules.

Brodell and Virgile had the opportunity to present their proposals to FDA Chief Scientist Stephen Ostroff, M.D., as well as other FDA staff members and discuss how projects such as these could help shape future regulations and improve public health. 

The competition will be held again next year and a request for proposals will be announced in October 2014.  This is one of several events and initiatives to promote Regulatory Science awareness and opportunities at the University of Rochester.  A list of Regulatory Science news, events, and funding opportunities can be found here.