NIH presents new research 'roadmap'

Broad strategy aims to change the way institutes orchestrate medical research | By EuGENE Russo

The National Institutes of Health (NIH) will adopt a radically new strategy for pursuing basic and clinical research, NIH Director Elias Zerhouni and a panel of NIH institute directors announced yesterday (September 30) at a press briefing in Washington, D.C. Zerhouni told the audience that medical research was at a "critical point in its history" and that despite the many recent advances in science and medicine, the field of biology has also grown exceedingly complex.

The so-called "NIH Roadmap," which is primarily geared toward extramural academic centers, represents a major revamping of the way NIH funds research, Zerhouni said. The new approach aims to take on, as a group of institutes, projects that no one institute could tackle on its own for lack of resources, expertise, or infrastructure.

"These initiatives are integrated to accelerate our knowledge, to translate that knowledge into effective prevention and treatment strategies, and in many ways transform the way we conduct research and the way we accelerate the translation of that research to the bedside and eventually to clinical practICE," Zerhouni told the audience.

He added that the research initiatives are intended to encourage the sort of cutting-edge, risk-taking research that hasn't been typical of the NIH. "If this were easy, it would have been done already," said Zerhouni.

First conceived of a year ago, the roadmap received input from 300 leaders in academia, industry, government, and the public. It includes 28 initiatives organized under three major umbrella themes: "New Pathways to Discovery," "Research Teams of the Future," and "Re-engineering the Clinical Research Enterprise."

The broad range of initiatives will cost a projected $130 million in fiscal year 2004 and an estimated $2.1 billion over the next 5 years. The roadmap will be paid for, according to Zerhouni, not by new money, but by siphoning off roughly half a percent from the budgets of each of the NIH's 27 institutes and centers.

Zerhouni told the scientist that all of the roadmap initiatives were well within reach, even given likely modest NIH budget increases in the next several years. "We had many more good initiatives," he said. "But we didn't want to make promises we couldn't deliver on." Zerhouni said that the roadmap represented the "minimum set of compelling initiatives that we could not, not do."

The "New Pathways to Discovery" initiatives will produce tools to target diseases and hasten improvements in human health, National Human Genome Research Institute Director Francis Collins said. The initiatives will focus on molecular libraries and molecular imaging, BioInformatics and computational biology, nanomedicine, and structural biology building blocks and pathways.

Collins laid out a few of the major goals: Through a network of screening centers and a shared public database, universities and hospitals will gain better access to small molecules technology—typically the purview of biotechnology and pharmaceutical companies. (Though Collins noted that the NIH is not looking to take over the complex and expensive task of drug development that is typically the purview of big pharma.)

Also, new national technology centers for networks and pathways will help to prioritize which new pathways to target. "We've identified many of the parts list entries for human cells—gene transcripts, proteins, metabolites, organelles, cellular compartments," he said. "But we don't' know enough about how they work in concert, how the systems are wired together."

The roadmap also proposes national centers for biomedical computing to explore massive datasets coming from things like the human genome, protein structures, and environmental exposure data.

The "Research Teams of the Future" initiatives will focus on high-risk research, interdisciplinary research, and public-private partnerships. Speaking at the press briefing, Stephen Straus, director of the National Center for Complementary and Alternative Medicine, emphasized a move away from typical multidisciplinary research. The intent, he told The Scientist, will not be to have individuals from different fields write grants together, as is now commonplace, but to "take people from diverse fields and put them in the same room" in hopes of tackling complex biological problems and spawning "unexpected insights or whole new scientific fields."

To encourage greater team collaboration between industry and NIH-funded investigators, the roadmap will establish a central NIH point of contact called the Director's Liaison for Public–Private Partnerships, an office that will assist members of industry in finding partnership opportunities. The NIH will also establish new interdisciplinary research centers, the planning grants for which will be offered immediately.

To encourage "out of the box" thinkers, said Straus, a new set of NIH Director's Innovator Awards will be established. The awards, $500,000 per year for 5 years, are aimed at high-risk research. Ten awards will be offered in the first year. "We recognize many will fail initially," Straus told reporters.

As part of "Re-engineering the Clinical Research Enterprise," the roadmap seeks, in part, to harmonize clinical research regulatory requirements, integrate clinical research networks, develop technologies to improve the assessment of clinical outcomes, and offer better training for clinicians.

Stephen I. Katz, director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, described plans for new initiatives for early career development of clinical researchers and new "translational core centers" to facilitate translational research with tools like novel reagents and toxicity testing. A new "national electronic clinical trials and research network" will facilitate sharing of data and resources. The NIH will also attempt to harmonize and simplify confusing regulatory requirements that currently impede the conduct of clinical research and discourage making careers in it, said Katz.

The first four roadmap Requests for Applications were posted yesterday, for Metabolomics Technology Development, Exploratory Centers for Interdisciplinary Research, National Technology Centers for Networks and Pathways, and National Centers for Biomedical Computing.

Links for this article
National Institutes of Health Roadmap
http://www.nihroadmap.nih.gov/

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