ELIAS A. ZERHOUNI TO END TENURE AS DIRECTOR OF THE NATIONAL INSTITUTES OF HEALTH

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U.S. Department of Health and Human Services
NATIONAL INSTITUTES OF HEALTH NIH News
NIH Office of the Director (OD) <http://www.nih.gov/icd/od/>
For Immediate Release: Wednesday, September 24, 2008

CONTACT: NIH News Media Branch, NIH OCPL, 301-496-5787, <e-mail: nihnmb@xxxxxxxxxxxx>

NIH NEWS ADVISORY

ELIAS A. ZERHOUNI TO END TENURE AS DIRECTOR OF THE NATIONAL INSTITUTES OF HEALTH

Bethesda, Md, September 24, 2008 -- Elias A. Zerhouni, M.D., the director of the National Institutes of Health, today announced his plans to step down at the end of October 2008 to pursue writing projects and explore other professional opportunities.

Dr. Zerhouni, a physician scientist and world-renowned leader in radiology research, has served as NIH director since May 2002. He led the agency through a challenging period that required innovative solutions to transform basic and clinical research into tangible benefits for patients and their families. One of the hallmarks of his tenure is the NIH Roadmap for Medical Research, launched in 2003, after extensive consultations with the scientific community. The NIH Roadmap brought together all of the NIH 27 Institutes and Centers to fund compelling research initiatives that could have a major impact on science, but that no single institute could tackle alone. Additional information about the NIH Roadmap can be found at <www.nihroadmap.nih.gov>.

Dr. Zerhouni also launched new programs to encourage high-risk innovative research, such as the Director's Pioneer Awards and New Innovator Awards, and focused especially on the need to support new investigators and foster their independence. During his tenure, Zerhouni worked to lower barriers between disciplines of science and encourage trans-NIH collaborations. For example, he inspired significant interdisciplinary efforts such as the NIH Strategic Plan for Obesity Research and the Neuroscience Blueprint.

Zerhouni also led a major reform of the translational and clinical research system in the United States. He also worked to improve public access to scientific information. These efforts, along with his continual advocacy for the public's investment in the NIH, greatly contributed to Congress passing the NIH Reform Act of 2006, which was a sign of renewed confidence in the NIH. (For more detailed information, see a listing of key accomplishments attached to this release.)

"I have had the privilege of leading one of the greatest institutions in the world for six and a half years," Dr. Zerhouni said. "NIH's strength comes from the extraordinary commitment and excellence of its people in serving a noble mission. It also comes from the nation's scientific community, whose discoveries alleviate the suffering of patients throughout the world. Over the past six years, we experienced a revolution in the biomedical sciences and I feel fortunate to have been part of it. I will miss the NIH and all my colleagues, not only for their friendship and support through 'thick and thin,' but also for their essential role in the progress we made in advancing innovative research, fostering scientific collaboration, supporting young scientists, and enhancing basic, translational, and clinical research, despite great challenges."


"Elias has been a powerful voice for the medical research community as head of the NIH. His tenure has been marked by the spirit of collaboration, good management and transformation. The Roadmap for Medical Research that he developed and implemented will benefit the health of this nation for many years to come," said Secretary of Health and Human Services Michael O. Leavitt. "His many achievements include promotion of genetic research, support for advances of biodefense research and helping raise awareness of women's heart disease. I want to thank Elias for his leadership and wish him the best of luck as he begins this new chapter."

NIH is part of the U.S. Department of Health and Human Services (HHS), and is the nation's premiere biomedical research agency. The agency has more than 18,000 employees and a fiscal year 2008 budget of $29.5 billion. It supports more than 325,000 researcher personnel at more than 3,100 institutions throughout the United States, and around the world.

The Office of the Director, the central office at NIH, is responsible for setting policy for NIH, which includes 27 Institutes and Centers. This involves planning, managing, and coordinating the programs and activities of all NIH components. The Office of the Director also includes program offices which are responsible for stimulating specific areas of research throughout NIH. Additional information is available at <http://www.nih.gov/icd/od/>.

The National Institutes of Health (NIH) -- The Nation's Medical Research Agency -- includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit <www.nih.gov>.

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KEY ACCOMPLISHMENTS OF ELIAS A. ZERHOUNI, M.D.

As NIH Director, Dr. Zerhouni significantly advanced the NIH mission: (1) to pursue fundamental knowledge about the nature and behavior of living systems, and (2) to apply that knowledge to the extension of healthy life and the reduction of the burdens of illness and disability. Zerhouni forged new connections between basic and clinical research, integrating the component parts of NIH's mission to unprecedented degrees. He also led the agency to be better prepared to meet the public health and science needs, challenges, and opportunities of the 21st century.



THE NIH ROADMAP
As NIH director, Dr. Zerhouni launched a number of far-reaching initiatives to address the explosion of new knowledge in the biomedical sciences and the growing challenges in public health. In September 2003, he with the Institute and Center leadership initiated the NIH Roadmap for Medical Research, a vision that helped chart the course for the future of NIH. The NIH Roadmap focused on a short list of compelling initiatives for the NIH to pursue that would make a profound, measurable difference in biomedical research. The NIH Roadmap efforts stimulated new pathways to discovery, building research teams for the future, and re-engineering the clinical research enterprise. The NIH Roadmap is a continuing programmatic priority at NIH and is managed by a newly-established Office of Portfolio Analysis and Strategic Initiatives (OPASI). The ongoing goal of the NIH Roadmap is to ensure that NIH is nimble, dynamic, and responsive to emerging scientific opportunities and public health needs.



TRANS-NIH COLLABORATIONS
Drawing from a "common fund" of money, NIH's 27 Institutes and Centers collaborate on initiatives that are essential to the advancement of biomedicine, initiatives that no single Institute or Center are able to undertake alone. The NIH Office of Portfolio Analysis and Strategic Initiatives is organized around three themes: "New Pathways to Discovery": "Re-engineering the Clinical Research Enterprise," and "Research Teams of the Future." Today, initiatives within each of these themes are making significant contributions to the science and practice of medicine. In 2006, Congress passed the NIH Reform Act. Only the third omnibus reauthorization in NIH's history, the Reform Act gives the NIH Roadmap, and the Common Fund, legislative weight and continued support.


TRANS-NIH INITIATIVES TO ADDRESS MAJOR PUBLIC HEALTH NEEDS
Dr. Zerhouni also established NIH-wide research initiatives to address major public health problems, including obesity research and neuroscience research. Shortly after Dr. Zerhouni's arrival in 2002, he established the NIH Obesity Research Task Force to address one the nation's most costly and debilitating health challenges. The task force drew representatives from 7 NIH Institutes, Centers, and Offices and developed a strategic plan that combined new research opportunities with the coordination of resources across the NIH. The plan called for interdisciplinary research teams to bridge the study of environmental and behavioral causes with the study of genetic and biologic causes.

Dr. Zerhouni also spearheaded the NIH Neuroscience Blueprint to (1) leverage the resources of 17 NIH Institutes and Centers, (2) tackle common scientific problems and (3) train the future generation of neuroscientists, all in an effort to address mental illness, neurological disorders, and a range of behavioral disorders that together affect millions of individuals at a yearly cost to the U.S. of more than $500 billion.


CLINICAL AND TRANSLATIONAL SCIENCE AWARDS
In October 2006, Dr. Zerhouni launched a national consortium designed to transform clinical and translational research. Called the Clinical and Translational Science Awards (CTSAs), the program represented the first systematic change in the agency's approach to clinical research in 50 years. The consortium got underway in with 12 sites; more were added each year with the plan of supporting 60 such institutions by 2012. NIH began to see the transformative effects of the program as changes occurred and new partnerships at institutions were forged. 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.



MOLECULAR LIBRARIES
The NIH Roadmap identified one key "new pathway": the need for molecular libraries. The Molecular Libraries initiative resulted in development of a nationwide consortium of 10 small molecule screening centers; including NIH; a database, PubChem; and new tools and technologies to better serve investigative needs. PubChem provides free access to discoveries about the chemical structures and biological activities of small molecules. The program was designed to provide investigators with a comprehensive set of small molecule modulators of a majority of the genes and functions of humans and other organisms. The Molecular Libraries initiative is also aimed at producing innovative chemical tools for use in biological research and drug development. The Molecular Small Molecule Repository currently contains over 300,000 small molecules, and the network of centers has entered the second phase of its research agenda, focusing on small molecule probes.

SUPPORT FOR HIGH RISK/HIGH IMPACT RESEARCH
During his tenure, Dr. Zerhouni also addressed the agency's continued support of high risk/high impact research, innovation in research, and funding for early-career investigators.


NIH DIRECTOR'S PIONEER AWARDS
Dr. Zerhouni launched the NIH Director's Pioneer Award Program in 2004 as a high-risk research initiative. The awards are designed to support individual scientists of exceptional creativity who propose pioneering-and possibly transforming approaches-to major challenges in biomedical and behavioral research. "Pioneering" refers to highly innovative approaches with the potential of producing an unusually high impact on a broad area of biomedical or behavioral research. Awards may include grants for conducting research as opposed to recognizing past achievement.

PATHWAY TO INDEPENDENCE AWARDS
In January 2006, Dr. Zerhouni announced the NIH Pathway to Independence Award program, which targeted promising postdoctoral scientists for receipt of mentored and independent research support, both from the same award. The program is among several initiated by Dr. Zerhouni to support scientists at the early part of their careers while maintaining the agency's "pipeline" of future-generation researchers.

With the program's debut, Dr. Zerhouni said, "Encouraging independent inquiry by promising new investigators is a major goal for NIH. We must invest in the future of our new scientists today if we expect to meet the nation's health challenges of tomorrow. New investigators who successfully cross the bridge from research dependence to research independence bring fresh ideas and innovative perspectives to the research enterprise."

NIH NEW INNOVATOR AWARDS
In March 2007, Dr. Zerhouni announced the New Innovator Awards Program, designed to cultivate new investigators, support innovative ideas, and encourage and reward creativity. Under the program, New Innovator Awardees propose bold and highly innovative research approaches that have the potential to produce solutions for broad, important problems in biomedical and behavioral research. The program complements other NIH efforts to fund new investigators through R01 grants, the original and historically oldest grant mechanism used by NIH, and the one that continues to be the major source of NIH support for new investigators. In 2007, thirty new investigators were provided New Innovator Awards under the NIH Roadmap to initiate their own new five-year research programs. The awards provide brilliant emerging scientists with the resources, time, and freedom to pursue creative ideas.

TRANSFORMATIVE R01 PROGRAM
Dr. Zerhouni launched the Transformative R01 (TR01) program in September 2008 to provide support for individual scientists or collaborative investigative teams who propose transformative approaches to major contemporary challenges. The primary objective of the T-R01 initiative is to create a program that is specifically designed to support exceptionally innovative, high risk, original and/or unconventional research with the potential to create new or challenge existing scientific paradigms. The program is a High Risk/High Reward Demonstration Project with support from the NIH Common Fund.

HUMAN MICROBIOME PROJECT
In December 2007, NIH launched the Human Microbiome Project under Dr. Zerhouni. The human microbiome is the collective genomes of all the microorganisms in or on the human body and is largely unexplored. The project has the potential to transform scientific understanding of human health and to prevent, diagnose, and treat a wide range of conditions. The project is part of the NIH Roadmap for Medical Research and was chosen by NIH leadership as a major research opportunity that no single Institute or Center could address alone.

EPIGENOMICS PROJECT
In January 2008, NIH announced a 5-year, $190 million investment for the study of epigenomics: the analysis of epigenetic changes across many genes in a cell or an entire organism. Epigenetics focuses on the processes that regulate how and when certain genes are turned on and turned off. "Epigenomics will build upon our new knowledge of the human genome and help us better understand the role of the environment in regulating genes that protect our health or make us susceptible to disease," said Dr. Zerhouni at the announcement of the program's start.

STRUCTURAL BIOLOGY ROADMAP
The Structural Biology Roadmap is a strategic effort to create a comprehensive gallery of three-dimensional shapes of proteins in the body. The program seeks to develop methods or producing protein samples for use by scientists in determining the three-dimensional structure or shape of a protein. During the first phase of the Structural Biology Roadmap (FY2004-2008), the NIH funded two Centers for Innovation in Membrane Protein Production that enabled interdisciplinary groups of scientists to develop innovative methods for producing large quantities of membrane proteins. The NIH program is designed to catalyze what is currently a hit-or-miss process into an organized, coordinated, systematic, and streamlined routine, helping researchers clarify the role of protein shape in health and disease. A number of small exploratory and regular research grants were also awarded to individual investigators to broaden the base of innovative ideas under development.


ORGANIZATIONAL REFORMS
During his tenure, Dr. Zerhouni embarked on a wide array of efforts to make NIH more responsive to changes and challenges in the scientific landscape and more nimble as an organization. Under Dr. Zerhouni's leadership, NIH initiated a number of important and unprecedented programs to improve how science is conducted and to ensure that the agency takes full advantage of the progress made to date in improving people's health.

NIH GOVERNANCE IMPROVEMENT-STEERING COMMITTEE
In July 2003, Dr. Zerhouni announced the formation of the NIH Steering Committee, with a rotating membership of ten directors derived from the 27 Institutes and Centers to provide a more strategic direction to the agency and streamline its decision-making process. The committee is chaired by the NIH director. As the agency had grown in size and complexity in recent years, there had been an increased need for a more efficient trans-NIH coordination. The Steering Committee transformed NIH's ability to manage and address the complex issues facing the agency.

SCIENCE MANAGEMENT REVIEW BOARD
In September 2008, Dr. Zerhouni announced formation of the NIH Scientific Management Review Board (SMRB) as an outgrowth of the NIH Reform Act of 2006. The SMRB brings together NIH leaders with outside experts to examine NIH's organizational structure and make recommendations for greater agency flexibility and responsiveness.

EFFORTS TO ENHANCE THE NIH PEER REVIEW SYSTEM
In June 2008, Dr. Zerhouni announced major changes to improve and enhance the NIH peer review system, marking the end of a year-long effort to determine ways to further enrich the traditional NIH peer review system. NIH is now implementing the programmatic results of Dr. Zerhouni's original charge, "to fund the best science, by the best scientists, with the least administrative burden." The formal review process involved consultation with and comment from internal staff, patient groups, and the broad scientific community, as well as analysis of thousands of comments, feedback, and opinions about the current NIH peer review system.

PUBLIC ACCESS TO NIH-FUNDED PUBLISHED RESEARCH
In February 2005, Dr. Zerhouni announced an unprecedented policy designed to expand and accelerate public access to published articles resulting from NIH-funded research. The policy was the first of its kind and called on scientists to release manuscripts from research supported by NIH as soon as possible, and within 12 months of publication. Publications are made available in a web-based archive managed by the National Library of Medicine. At a time when demand for such information is on a steady rise, the online archive increases the public's access to health-related publications.

ENHANCED TRANSPARENCY
NIH's responded to a call by Congress and the public for enhanced transparency and accessibility regarding disease funding by creating the Research, Condition, and Disease Categorization (RCDC) system. RCDC utilizes a computer-based tool that applies a uniform process of accounting for NIH funding for diseases and conditions. The process produces a fully transparent list of grants underlying and supporting the dollar amounts for each reporting area. NIH will unveil the first RCDC reports as part of the release of the President's 2010 budget request.

SWEEPING REFORM OF NIH ETHICS
In February 2005, Dr. Zerhouni announced a set of ethics regulations to address outside consulting between some NIH employees and representatives of the pharmaceutical and biotechnology sectors. Dr. Zerhouni launched the revised rules to help NIH (1) preserve its historic role as the primary source of unbiased scientific health information for the country and (2) maintain the highest ethical standards, both while sustaining the agency's ability to support and conduct the best medical research in the world.

PUBLIC TRUST INITIATIVE
In October 2007, Dr. Zerhouni announced release of a new Request for Applications (RFA) for the Partners in Research Program, which supports studies of innovative ways to increase science literacy, improve public understanding of health research, and engage the public through community-based organizations. The program is one of several programs initiated by NIH to maintain and enhance public trust in medical research.

REACHING OUT TO THE PUBLIC
Under Dr. Zerhouni's leadership, NIH reached to the public in an unprecedented way with the communication of science-based health information and scientific results. He led efforts to make the incomparable resources of the NIH and its grantees, resources accessible to the public. Key to these efforts are the health education programs across the agency. With more than 2 million visits a day to the NIH websites, including the NIH's NLM vast collection materials available through comprehensive clearinghouses and #800, use of new resources of podcasting, vodcasting, Research Matters, NIH: News in Health, YouTube, and radio resources to reach audiences who depend upon radio more than the web, materials for people who have challenges of literacy, language or access were also developed. He worked closely with the Council of Public Representatives in encouraging these efforts. In two important messages to NIH and the public, Dr. Zerhouni encouraged open discourse about science noting: "Timely and accurate research results and science-based health communications are an integral part of the NIH mission."

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This NIH News Release is available online at:
<http://www.nih.gov/news/health/sep2008/od-24.htm>.

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