William E. Bentley, Ph.D.

The Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System has received a grant from the Food and Drug Administration (FDA) to form the National Capital Consortium for Pediatric Device Innovation.  The grant is for $700,000 for FY2013, as part of an anticipated five year award…

…The NCC-PDI will be a collaboration of Children’s National Health System with the University of Maryland A. James Clark School of Engineering and its flagship institutes, the Maryland Technology Enterprise Institute (Mtech). The partnership will also involve the university’s Fischell Department of Bioengineering, chaired by Fischell Distinguished Professor and Co-PI William Bentley, and the Maryland Industrial Partnerships (MIPS).

Leaders of two academic centers tapped last year to pilot FDA’s Centers of Excellence in Regulatory Science and Innovation program said they are concerned about possible loss of funding due to sequestration or a constrained fiscal environment but are moving ahead while also remaining hopeful that some of the work would continue if federal funding is reduced. FDA — which planned to fund the collaborative centers at $1 million a year for three years — has already transferred money within the agency to bolster the programs and the agency’s science board was recently tasked with providing FDA input on the collaborations.

FDA officials have said regulatory science could take a hit if $319 million in cuts mandated by sequestration go into effect although the agency will look to leverage its resources through partnerships to continue its work.

William Bentley, co-director of the University of Maryland CERSI, said the constrained fiscal environment is a “big concern.” “If the FDA money were to disappear, it would be a major problem,” he said, adding that the scale of the program would have to be “dramatically” cut back.

Maryland is one of two new centers that will pilot ways universities can help improve how drugs and medical devices are evaluated.

The University of Maryland has created a new Center of Excellence in Regulatory Science and Innovation (CERSI), funded by an initial $1 million grant from the U.S. Food and Drug Administration. The center will focus on modernizing and improving the ways drugs and medical devices are reviewed and evaluated.

The new center will be a collaborative partnership between the University of Maryland, College Park and the University of Maryland, Baltimore. Researchers from both campuses will work with FDA scientists to develop new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products.

The FDA also awarded $1 million to Georgetown University for a sister regulatory science and innovation center. According to the FDA, the agency chose to pilot the two CERSIs in the Washington, D.C., area to allow for the greatest possible face-to-face collaboration and training with FDA staff.

“Maryland’s CERSI will draw from University of Maryland expertise on both the College Park and Baltimore campuses and create new mechanisms for scientific exchange, education and training, and regulatory science research,” said William Bentley, the Robert E. Fischell Distinguished Professor of Engineering and founding chair of the Fischell Department of Bioengineering at the University of Maryland, College Park. Bentley and James Polli, PhD, the Shangraw/Noxell Endowed Chair in Pharmaceutical Sciences at the University of Maryland School of Pharmacy are co-principal investigators on the CERSI initiative.

Joint Team to Develop Automated Machine Designed to Expedite the Diagnosis of Infectious Diseases

Canon U.S. Life Sciences, Inc., a subsidiary of Canon U.S.A., Inc., and the University of Maryland have launched a new research collaboration to develop a highly automated system providing rapid infectious disease diagnosis. Utilizing Canon U.S. Life Sciences’ proprietary genetic analysis system, the project aims to expedite the delivery of infectious disease test results while also simplifying the test process to allow a variety of clinical staff to perform automated disease diagnosis.

The research team is led by Hiroshi Inoue, senior fellow, Canon U.S. Life Sciences, and William Bentley, chair of the Fischell Department of Bioengineering in the university’s A. James Clark School of Engineering. Together with co-researchers Keith Herold and Ian White, both of Maryland’s Fischell Department of Bioengineering, they will pioneer the use of microfluidic chip technology in disposable testing cartridges containing human blood samples.