CERSI News Story
2012-2013 Innovation Winners
The University of Maryland Center of Excellence in Regulatory Science and Innovation (UM-CERSI) has recently awarded two Innovation Awards, and two Innovations in Minority Health Awards.
The aim of M-CERSI Innovation Awards is to promote innovations in FDA training or research that, through well defined outcomes, will foster the development of regulatory science. M-CERSI Innovations in Minority Health Awards are similar to Innovation Awards and additionally aim to address racial and ethnic health disparities.
The four awardees for 2012-2013 are:
- Drs Jeffrey W. Herrmann and Monifa Vaughn-Cooke, Department of Mechanical Engineering
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 FDA’s regulatory processes and goals and the reliability assessment of state‐of‐the‐art medical devices and innovative emerging technologies.
- Dr Yihua Bruce Yu, Department of Pharmaceutical Sciences
Novel High-Thoughput Quality Control of Pharmaceutical Preparations
The goal is to study the NMR relaxation rates of the solvent molecule (i.e. water) in samples of biotherapeutics and suggest the model linear dependences of the NMR relaxivity on the degree of sample aggregation/degradation.
- Dr Olivia Carter-Pokras, Department of Epidemiology and Biostatistics
Improving Health Literacy and Cultural Competency of FDA Consumer Materials
The goal of this project is to provide evidence and recommendations to improve FDA communication on HIV/AIDS.
- Dr Julie M. Zito, Department of Pharmaceutical Health Services Research
Racial/Ethnic Differences in Pediatric Antipsychotic Use by FDA Labeled Status
The aim to study antipsychotic use in youth in relation to racial/ethnic differences, insurance type, and FDA labeled indication for use.
M-CERSI co-director James Polli indicates "These awards reflect the great depth and scope in research at the University of Maryland that have the potential to impact medical product regulation. Furthermore, the M-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" says M-CERSI co-director William Bentley.
December 5, 2012