“The complexity and often rare nature of diseases of the central nervous system present a unique set of challenges in terms of developing new treatments,” said Robert Holloway, M.D., M.P.H., professor of Neurology at the Medical Center. “This new initiative by the NIH will create the economies of scale and coordination necessary to rapidly and efficiently move novel therapies closer to the point where they can ultimately benefit patients.”
The goal of the National Institute of Neurological Disorders and Stroke’s (NINDS) newly created Network for Excellence in Neuroscience Clinical Trials – or NeuroNEXT – is to conduct exploratory (Phase II) studies of treatments for neurological diseases through partnerships with academia, private foundations, and industry. The network is designed to expand the Institute’s capability to test the most promising new therapies, increase the efficiency of clinical trials before embarking on larger studies, and respond quickly as new opportunities arise to test promising treatments for people with neurological disorders.
This month, the NINDS made awards to 25 U.S. clinical sites – including URMC – and announced the program in a series of meetings with academic researchers, industry representatives, and patient groups.
“NeuroNEXT will expand the capacity to test the most promising new therapies for a wide range of neurological disorders affecting children and adults,” said Elizabeth McNeil, M.D., the NIH/NINDS director who will oversee the program. “Through 25 clinical sites across the U.S., as well as a clinical and a data coordinating center, the NIH will provide the expertise and infrastructure needed to rapidly assess treatments options as they become available from both academic and industry investigators.”
URMC will receive $2.9 million over the next seven years to serve as one of NeuroNEXT’s clinical sites and provide supply chain management and central laboratory services to the entire network. Holloway is the principal investigator of the Rochester site which will be called UR-NEXT.
In addition to serving as a location where clinical studies will be developed and evaluated in patients, the Medical Center’s Clinical Materials Service Unit (CMSU) will also be called upon to help manage the logistical drug supply operations of NeuroNEXT. CMSU, which is a part of the URMC Center for Human Experimental Therapeutics (CHET), consists of a dedicated, regulatory-compliant facility which provides investigational drug/device packaging, labeling, and distribution services for large, multi-center clinical trials. CMSU is currently involved in supporting the clinical supply needs of 18 clinical trials with funding from NIH, foundations, and several pharmaceutical and biotech companies. CMSU will coordinate the manufacture of clinical trial drug supplies through the University of Iowa Pharmaceuticals, a service division of the University of Iowa College of Pharmacy.
URMC LABS will provide central laboratory services for NeuroNEXT, playing a critical role in evaluating the safety and efficacy of new therapies that will be tested by the network. URMC Labs will oversee specimen collection, safety testing, and – if necessary – the development of new methods to evaluate the impact of experimental drugs on study participants. CMSU and URMC LABS will work in coordination with Massachusetts General Hospital and the University of Iowa and who are providing overall project management and data coordinating roles for NeuroNEXT.
“We are proud to play an essential role in this innovative, national approach to accelerating care,” said Cornelia Kamp, executive director of Strategic Initiatives for CMSU. “The University of Rochester has decades of experience in running large, complex, multi-center trials which we believe will help strengthen this effort and meet the network’s goals of rapidly and efficiently evaluating potential new therapies for neurological diseases.”
URMC brings to the network a unique set of attributes and decades of experience in experimental therapeutics. The Medical Center was one of the first 12 academic institutions chosen to be a part of the NIH’s Clinical and Translational Science Award program. To date, the Medical Center’s Clinical and Translation Science Institute has received more than $115 million to bring together the expertise and resources necessary to support clinical trials.
The URMC Department of Neurology is an internationally recognized leader in experimental therapeutics in neurological diseases with a breadth of expertise in clinical investigation in both common and rare adult and pediatric neurological disorders. In addition to 83 full-time faculty spanning every neurological specialty, the department also has 30 clinical research coordinators. Over the last 20 years, the department has sponsored 121 clinical trials. Additionally, the Clinical Trials Coordination Center – a research unit of CHET that specializes in the development, management, and operation of human clinical studies – has helped oversee more than 80 multi-center clinical trials in neurological diseases, many of which have been international in scope.
The Department of Neurology is also home to one of the nation’s longest serving post-doctoral training program specializing in clinical trial management. The Experimental Therapeutics in Neurological Disease, now entering its 21st year of NIH funding, has trained over 50 fellows since its inception, the majority of which have gone on to pursue careers in experimental neurotherapeutics.
“The University of Rochester has a longstanding track record in conducting and training physicians and other professionals in clinical trials of neurological conditions,” said URMC neurologist Robert Griggs, M.D. “Participating in this network will allow us to actively lead, contribute, and have access to the most efficient and innovative ways of developing novel therapeutics.”
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