New Awards Support Research on Neonatal Ventilator Safety, Viral Diagnostics

• Shapiro

Clark School Fischell Department of Bioengineering professors Benjamin Shapiro (joint, Institute for System Research) and Ian White have received two of the University of Maryland Center of Excellence in Regulatory Science and Innovation's (UM-CERSI) four inaugural Innovation Awards. The one-year grants support collaborative research projects that foster the development of regulatory science in the areas of medications and/or medical devices.

Shapiro received his award for a proposal titled "FDA Safety and Performance Assessment of Emerging Autonomous Neonatal Ventilators by State-of-the-Art Robust Analysis Methods." The project aims to apply and develop use-control verification techniques, specifically robust analysis, to initiate best safety practices in the area of autonomous ventilators for preterm neonatal patients. Shapiro will conduct the study in collaboration with Bahram Parvinian, M.Sc., FDA Center for Devices and Radiological Health.

White received his award for a proposal titled "Collaborative Evaluation of Emerging Plasmonic Technologies for Point-of-Care Diagnostics in Low-resource Settings." The project focuses on the development of a paper-based, surface enhanced Raman scattering (SERS) assay for viral diagnostics. White will work in collaboration with Indira Hewlett, Ph.D., FDA Division of Emerging and Transfusion Transmitted Diseases.

"These Innovation Awards reflect the great depth and scope of research at the University of Maryland, which has the potential to impact drug and device regulation with the added benefit of facilitating even greater scientific interactions between university and FDA staff," says Natalie D. Eddington, professor and dean of the University of Maryland School of Pharmacy.

UM-CERSI, formed in 2011 and officially announced at the 2011 Fischell Festival, is an FDA-sponsored center run jointly by the College Park and Baltimore campuses of the University of Maryland. The Center's mission is 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.

"Combining the talented faculty researchers on our College Park and Baltimore campuses, the University of Maryland is uniquely positioned to assist the FDA in modernizing and improving the ways drugs and medical devices are reviewed and evaluated," says Vice President for Research at the University of Maryland, College Park, Patrick O'Shea. "Our new activities and joint efforts with colleagues at the FDA, as well as outreach to industry partners, will lead to groundbreaking advancements to help improve the lives of Americans."

"These partnerships represent a critical, necessary and creative investment-one that will benefit not just FDA and academia, but also American consumers and industry," adds FDA Chief Scientist Jesse L. Goodman. "The Centers of Excellence will create new scientific research, training and staff exchange opportunities for FDA and leading area institutions."

For More Information:

Visit the UM Center of Excellence in Regulatory Science and Innovation's (UM-CERSI) web site »

Story based on the original press releases by Lee Tune, UM Newsdesk and by Becky Ceraul, UM School of Pharmacy News Center.

Published April 5, 2012