NIH Chooses Rochester to Lead National Initiative

$40 million award is largest NIH grant ever to the University of Rochester

October 03, 2006

The National Institutes of Health has selected the University of Rochester School of Medicine and Dentistry as one of 12 institutions to lead the emerging field of clinical and translational research by producing innovative technology and methods that more efficiently and more quickly advance treatments to patients.

The School of Medicine will receive $40 million from NIH over five years and establish a Clinical and Translational Science Institute. The award is the largest grant ever from NIH to the University.

“We have been piecing together the building blocks for clinical and translational science at the School of Medicine over my entire time as dean,” said David Guzick, M.D., Ph.D., dean of the School of Medicine since 2002 and principal investigator for the NIH project. “We share a common vision with NIH that there should be an academic home for such research. Our Institute is the next logical step in this area of investigation.” (Guzick left URMC in 2009 to serve as senior vice president of Health Affairs at the University of Florida.)

“The University of Rochester and the School of Medicine increasingly will be known as one of the places for conducting translational research and for training successful academic researchers,” said Guzick, who will be director of the new Institute.

The School of Medicine’s plan establishes the Institute as a new structure that will organize, streamline and expand translational research. The goals of the new Institute include: increased funds for pilot projects and faculty training; enhanced services for data management, computer simulation, biostatistics, epidemiology, research ethics and community involvement; new master’s and doctoral degree programs in clinical and translational science; and formation of a network of hospitals and biomedical research institutions in upstate New York whose members will collaborate on projects and share resources.

“This award places the University and the School of Medicine in the vanguard of the emerging field of translational science,” said University President Joel Seligman. “The NIH reviewers called the School’s plan innovative, detailed and well formulated. They said it will have a deep impact on the overall quality of research and expand collaborations through upstate New York. This investment will pay enormous dividends to the University and to the Rochester community and beyond.”

Bradford C. Berk, M.D., Ph.D., chief executive officer of the Medical Center, emphasized the regional impact.

“The NIH award and our Institute also have great importance for the people of the Rochester area and upstate New York. They will have early access to many more clinical trials and actual clinical applications – the cutting-edge treatments – will more readily be incorporated in patient care,” Berk said.

As one of the first institutions chosen by NIH, the School of Medicine will influence the national approach to clinical and translational science, actively contributing to the development of research methods and infrastructure, Guzick said. The establishment of the Institute – and the prominence given to institutions receiving the initial NIH awards -- will make Rochester a better competitor for future research projects and for new clinical trials sponsored by government and industry, he said.

“We will be training and attracting more researchers who will bring in more grants. There will be a multiplier effect that impacts basic research, clinical practice and community outreach,” Guzick said. “We will receive more awards and more contracts.”

Training and Collaboration

A significant part of the NIH award will be designated for the education and training of physicians and researchers. The money will support the development of a national model for training the next generation of researchers with the knowledge and skills to take a scientific discovery and develop drugs, devices, and diagnostic tests that are clinically useful, said Thomas Pearson, M.D., M.P.H., Ph.D., an Institute program co-director and senior associate dean for clinical research and chair of the Department of Community and Preventive Medicine.

“We expect the University of Rochester to be one of the very best places in the United States at which to receive this type of training,” Pearson said.

Under Pearson’s leadership, the School of Medicine also will organize a consortium known as the Upstate New York Translational Research Network. In addition to the School of Medicine, the proposed members are: State University of New York (SUNY) at Buffalo, SUNY Upstate Medical University in Syracuse, SUNY Binghamton, Cornell University Division of Nutritional Sciences, Ordway Research Institute, Albany Medical College, Albany School of Pharmacy, Bassett Healthcare System in Cooperstown, and Guthrie Healthcare System in Sayre, Pa. The proposed members already have indicated their support for the network.

“This network will serve as a national model for regional collaboration and enable the area to better compete against cities and regions known for their concentration of biomedical research, such as the Research Triangle in North Carolina. This will create a regional dynamo for biomedical research and training,” Pearson said. “We hope this award will assist our regional partners in developing their own translational research programs and together that we can be very competitive against the most prestigious institutions in the country.”

Medicine at a Crossroads

NIH defines clinical research as studies and trials that involve human subjects. Translational research includes the process of applying discoveries made in the laboratory, testing them in animals, and developing trials and studies for humans and research that enhances the adoption of best treatment practices in the medical community. The major grants to the School of Medicine and other institutions in what NIH calls a “national consortium” are being awarded to spur the transformation of clinical and translational research, said NIH Director Elias A. Zerhouni, M.D.

“The development of this consortium represents the first systematic change in our approach to clinical research in 50 years,” said Zerhouni. “Working together, these sites will serve as discovery engines that will improve medical care by applying new scientific advances to real world practice. We expect to see new approaches reach underserved populations, local community organizations, and health care providers to ensure that medical advances are reaching the people who need them.”

In addition to Rochester’s School of Medicine and Dentistry, the initial award recipients in NIH’s translational science initiative are: Columbia University Health Sciences, Duke University, Mayo Clinic College of Medicine, Oregon Health and Science University, Rockefeller University, University of California at Davis, University of California at San Francisco, University of Pennsylvania, University of Pittsburgh, University of Texas Health Science Center at Houston and Yale University.

The NIH award and the establishment of the Institute will affect almost everyone doing research at the Medical Center, Guzick said.

Howard Federoff, M.D., Ph.D., senior associate dean for basic research and an Institute program co-director, call the NIH award “a great enabler.”

“The NIH award and the new institute will make basic scientists more interested in learning how to approach the issues of translation at an earlier stage,” said Federoff. “The award is a great enabler. Through the time span of the grant, we will develop more resources for this kind of research, more high technology, more capability, more expertise and more discoveries.”

Building Blocks

For almost a decade, University and Medical Center leaders have explored ways to build on its strong foundation in clinical and translational science as a complement its investments in basic research.

In 2002, as the new dean of the School of Medicine and Dentistry, Guzick began a series of steps to utilize the School’s collaborative, cross-disciplinary spirit as the basis for a more integrated and robust clinical and translational research enterprise. He created two positions, naming Federoff and Pearson as senior associate deans to lead basic and clinical research respectively. Another important early step was the creation of a Research Resource Inventory that tracked clinical and basic research at the Medical Center. The inventory archives and updates clinical research outcome data and provides an online directory of shared services and opportunities for collaboration.

The School of Medicine also has expanded training and educational opportunities for faculty members and for those in pre-doctoral or post-doctoral programs. For example, the School established the Rochester Clinical Research Curriculum (RCRC), initially funded by an NIH award in 1999 and renewed recently for funding through 2010. The RCRC provides a core of training in the principles and methods of clinical research, as well as a series of skill-building workshops and visits to clinical research facilities and support services at the Medical Center. Participants take part in a mentored clinical research project. Those who complete the program earn a master’s degree in public health with a concentration in clinical investigation. More than 130 trainees have been enrolled. Of the first 52 RCRC scholars completing the program, 29 are Principal Investigators on their own research grants. RCRC scholars, including those still in the program, account for 148 externally-funded grants.

Technology and skills in biostatistics are essential for clinical and translational research. In 2002, Andrei Yakovlev, PhD, was appointed chair of the Department of Biostatistics and Computational Biology. Since then, the department has grown from 7 to 20 faculty members, and increased its sponsored research from $800,000 annually to more than $5 million a year. The School also has a committee already at work to improve review and administration of research projects by enhancing communication and efficiency. Other steps include a planned expansion of the General Clinical Research Center.

“These steps took us to our outstanding NIH award,” Guzick said.

The CTSA initiative grew out of the NIH commitment to re-engineer the clinical research enterprise, one of the key objectives of the NIH Roadmap for Medical Research. The consortium will be led by the National Center for Research Resources, a part of the NIH.  Funding for the initiative comes from redirecting existing clinical and translational programs, including Roadmap funds. When fully implemented in 2012, the initiative is expected to provide a total of $500 million annually to 60 academic health centers.

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