UM-CERSI Awards Inaugural Innovation Grants to UMD, UMB and FDA Collaborators

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

The four Innovation Awards support research for one year on:

A novel anesthesia registry

Use of imaging to predict drug interactions

Techniques to initiate best safety practices in the area of autonomous ventilators for preterm neonatal patients

A new assay for viral diagnostics

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.

2012 Awardees

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
in conjunction 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.