NINDS Network for Excellence in Neuroscience: Clinical Research Site at UC Davis

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This proposal contributes to the NINDS Network for Excellence in Neuroscience (NeuroNEXT) by renewing a clinical research site at the University of California Davis Health System located in Sacramento, CA, the capital of the most populous state in the country and one of the most diverse and integrated cities in the U.S. The UC Davis NeuroNEXT clinical research site will continue to contribute to the mission of NINDS by reducing the burden of neurologic diseases, and contribute an infrastructure which expands the NINDS capability to test promising new therapies, increase the efficiency of clinical trials, and respond quickly as new opportunities arise to test promising treatments for people with neurological disorders. Our experience as an existing NeuroNEXT site, neuroscience research excellence at UC Davis - the most comprehensive campus in the University of California system, a robust translational research infrastructure housed in a nationally recognized, experienced, and competitively renewed NIH CTSA (the UC Davis CTSC), neuroscience research and research training excellence, an innovative collaborative drug development pipeline from University of California Drug Discovery Consortium, a national center of excellence in telehealth strategically positioned to promote community outreach, innovative digital health informatics for case identification and electronic outreach, a well-established R25 offering strong innovative training in Neurotherapeutics Discovery and Development for Academic Scientists, new institutional commitment to protect up to 70% time for research training for NeuroNEXT Fellows and a R25 pipeline of diverse trainees, a competitively renewed and robust Alpha Clinic gene and cell therapy clinical trial infrastructure which will contribute to a new Gene Therapy Consortium and gene therapy trials, and access to diverse patients with neurological disorders managed in a highly ranked regional health system with active clinical affiliations, all work synergistically to position UC Davis to continue to be an outstanding and innovative Clinical Research Site for the NeuroNEXT network. UC Davis NeuroNEXT aims to: 1) Leverage existing resources and expertise to serve as a NeuroNEXT hub for efficiently implementing scientifically sound, possibly biomarker-informed exploratory multicenter neuroscience clinical trials evaluating promising therapies, and increase the efficiency and quality of trials conducted at UC Davis NeuroNEXT; 2) Provide local and regional community outreach to improve patient recruitment and retention and fully integrate community partners into the translational research enterprise; 3) Efficiently utilize, diversify, and leverage innovative digital health informatics resources for trials; 4) Provide collaborative and innovative clinical research training and a supportive environment for diverse early-career investigators to develop additional research skills and become independent clinical investigators; and 5) Partner with the NeuroNEXT Gene Therapy Consortium and UC Davis Alpha Clinic to efficiently conduct gene therapy trials. Our accomplishments to date – locally, regionally, and nationally – provide an outstanding foundation for future success.