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2012-2013 UM-CERSI Awards Announced

The University of Maryland Center of Excellence in Regulatory Science and Innovation (UM-CERSI) recently awarded two Innovation Awards and two Innovations in Minority Health Awards to recognize pioneering research initiatives in regulatory science.

By Malissa Carroll
December 7, 2012

UM-CERSI Innovation Awards are presented each year to promote innovations in Food and Drug Administration (FDA) training or research that, through well-defined outcomes, will foster the development of regulatory science. Similar to Innovation Awards, M-CERSI Innovations in Minority Health Awards additionally aim to address racial and ethnic health disparities.

“These awards reflect the great depth and scope in research at the University of Maryland that have the potential to impact medical product regulation,” says James Polli, PhD, professor of pharmaceutical sciences at the University of Maryland School of Pharmacy and co-director of UM-CERSI. “The UM-CERSI program facilitates even greater scientific interactions between university and FDA staff.”

“We are especially glad to be working with the FDA Office of Minority Health on some of these awards,” adds William Bentley, PhD, professor of engineering at the University of Maryland, College Park, and co-director of UM-CERSI.

The four awardees for 2012-2013 include:

Jeffrey W. Herrmann, PhD, associate professor of mechanical engineering, and Monifa Vaughn-Cooke, PhD, assistant professor of mechanical engineering, from the University of Maryland, College Park, for their project, “Analyzing Medical Device Recalls and Regulatory Decision Making to Advance Regulatory Science.” The proposed research will take a two?phase approach to identify possible discrepancies between the FDA’s regulatory processes and goals and the reliability assessment of state?of?the?art medical devices and innovative emerging technologies.

Yihua Bruce Yu, PhD, associate professor of pharmaceutical sciences at the University of Maryland School of Pharmacy, for his project “Novel High-Thoughput Quality Control of Pharmaceutical Preparations.” This project will study the nuclear magnetic resonance (NMR) relaxation rates of the solvent molecule (i.e., water) in samples of biotherapeutics and suggest the model linear dependences of NMR relaxivity on the degree of sample aggregation/degradation.

Olivia Carter-Pokras, PhD, associate professor of epidemiology and biostatistics at the University of Maryland School of Medicine, for her project “Improving Health Literacy and Cultural Competency of FDA Consumer Materials.” This project will provide evidence and recommendations to improve FDA communication on HIV/AIDS.

Julie M. Zito, PhD, professor of pharmaceutical health services research at the University of Maryland School of Pharmacy, for her project “Racial/Ethnic Differences in Pediatric Antipsychotic Use by FDA Labeled Status.” This project will study antipsychotic use in youth in relation to racial/ethnic differences, insurance type, and FDA labeled indication for use.

Established in 2011, UM-CERSI is an FDA-sponsored center at the College Park and Baltimore campuses of the University of Maryland. The Center aims to foster the development of regulatory science – the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. Its areas of emphasis include: improving pre-clinical assessments of safety and efficacy; ensuring readiness to evaluate innovative and emerging technologies; and harnessing diverse data through information sciences to improve health outcomes.

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