Medical Center selected for major roles in neuroscience network

By Mark Michaud

The University of Rochester Medical Center has been tapped by the National Institutes of Health (NIH) to play a critical role in a new national initiative to accelerate the process of turning promising discoveries into new ways to treat neurological diseases.

“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. (R ’93, MPH ’96, FLW ’96), 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 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.

The Medical Center is one of 25 clinical sites selected by NINDS in October.

“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.”

The Medical Center 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) also will help manage the logistical drug supply operations of NeuroNEXT. CMSU, which is a part of the 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, operated under the Department of Pathology and Laboratory Medicine, 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, which are providing overall project management and data coordinating roles for NeuroNEXT.