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UM-CERSI Awards Inaugural Innovation Awards

Funded projects are collaborations between faculty in Baltimore, College Park, and staff at the FDA

By Becky Ceraul
March 21, 2012

The University of Maryland Center of Excellence in Regulatory Science and Innovation (UM-CERSI) has recently awarded four Innovation Awards to research projects that foster the development of regulatory science in the areas of medications and/or medical devices. The Innovation Awards support research activities for one year.

The four awardees for 2012 are:
*Thomas E. Grissom, MD, Department of Anesthesiology, University of Maryland School of Medicine
“Potential Application of a Novel National Perioperative Outcomes Registry in Support of Active Post-Marketing Surveillance”
This project aims to assess the advantages of using a large, novel anesthesia registry in support of FDA-mandated, post-marketing surveillance programs for anesthetic drugs and medical devices.

*Jean-Pierre Raufman, MD, Division of Gastroenterology and Hepatology, University of Maryland School of Medicine, and James Polli, PhD, Department of Pharmaceutical Sciences, University of Maryland School of Pharmacy, in collaboration with Lei Zhang, PhD, FDA Office of Clinical Pharmacology
“Development of Imaging as a Tool for in vivo Drug?interaction Assessments”
This project aims to use imaging to predict transporter-mediated drug-to-drug interactions.

*Benjamin Shapiro, PhD, Fischell Department of Bioengineering, University of Maryland, College Park, in collaboration with Bahram Parvinian, M.Sc., FDA Center for Devices and Radiological Health
“FDA Safety and Performance Assessment of Emerging Autonomous Neonatal Ventilators by State-of-the-Art Robust Analysis Methods”
This projects 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.

*Ian M. White, PhD, Fischell Department of Bioengineering, University of Maryland, College Park, in collaboration with Indira Hewlett, PhD, FDA Division of Emerging and Transfusion Transmitted Diseases
“Collaborative Evaluation of Emerging Plasmonic Technologies for Point-of-Care Diagnostics in Low-resource Settings”
This project aims to develop a paper-based, surface enhanced Raman scattering (SERS) assay for viral diagnostics.

“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, PhD, FAAPS, FCP, professor and dean of the School of Pharmacy.

The UM-CERSI, formed in 2011, 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. ” said Vice President for Research at the University of Maryland, College Park, Dr. 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,” said FDA Chief Scientist Jesse L. Goodman, MD, MPH.“The Centers of Excellence will create new scientific research, training and staff exchange opportunities for FDA and leading area institutions.”

UM-CERSI areas of emphasis are 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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