We propose a University of Maryland Center of Excellence in Regulatory Science and Innovation (UM-CERSI) through a consortia of two leading sister campuses within the University System of Maryland, and theFDA. This proposal leverages the engineering, device, and technologies strengths at UMCP with thebiomedical and health outcomes strengths at UMB. These strengths at UMCP and UMB, in concert with FDA,will allow for innovations in regulatory science in three areas:Project 1. Improving pre-clinical assessments of safety and efficacyProject 2. Ensuring readiness to evaluate innovative and emerging technologiesProject 3. Harnessing diverse data through information sciences to improve health outcomes'Improving pre-clinical assessments of safety and efficacy' will focus on membrane transporters in drugdevelopment, hepatotoxicity biomarkers, and personalized medicine. 'Ensuring readiness to evaluateinnovative and emerging technologies' will focus on performance of optical imaging and therapeutic systems,biocompatibility of stents and vascular grafts, and engineered cartilage constructs. 'Harnessing diverse datathrough information sciences to improve health outcomes' will focus on evaluation of risk evaluation andmitigation strategies, as well as infrastructure support and methods development to support decision sciencewithin pharmaceutical safety and effectiveness studies.
Three Specific Aims are: 1. Establish and BuildMechanisms for Scientific Exchange and Training; 2. Create New Opportunities for Collaborative RegulatoryScience Research; and 3. Establish Core Program Support and Management Plan to Ensure Success.Scientific exchange and training will entail formalized Center-wide programs including a CERSI Day,formalized programs in three proposed areas (e.g. quarterly lectures, workshops, semester courses, VisitingScientist program, resource centers), casual discussions, as well as collaborative graduate student research.The sum of these activities will be a vibrant, cutting edge Center that stimulates innovative thought,disseminates understanding of regulatory sciences and practices, and generates new knowledge in support ofthe FDA's fundamental mission - to promote and protect the public health. These regulatory sciencesadvances will also promote the Critical Path Initiative toward more effective and efficient product developmentand evaluation.
We propose a University of Maryland Center of Excellence in Regulatory Science (UM-CERSI) that involves the University of Maryland in Baltimore (UMB), the University of Maryland College Park (UMCP), and the FDA, with scientific exchange, research, academic, and outreach components. The mission of the Center will be 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.
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