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SUBJECT: Immediate Action Needed on NIH Funding

Background:

• The economic recovery package passed yesterday by the Senate includes supplemental increased funding for NIH of billion over a two-year period.
• The package passed by the House provides significantly less--.5 billion over two years.
• House and Senate conferees will meet this week to resolve the differences between the House and Senate bills.

Recommended Action:

Please call or email your Senators and Representatives as soon as possible to express support for the billion increase for NIH provided in the Senate Economic Recovery package (HR 1).
Senate contact information is available at:

http://www.senate.gov/general/contact_information/senators_cfm.cfm

House contact information is available at:

http://www.house.gov/house/MemberWWW_by_State.shtml

These sites provide office telephone numbers as well as email addresses and/or webforms to submit comments. AFMR recommends that you call the offices of both Senators and your Representative in the House. When calling an office, ask to speak to the staff member who is handling health program spending in the economic recovery package.

Talking Points:

In expressing support for the billion increase for NIH included in the Senate bill, you may wish to include the following:
• The billion in the Senate bill is expected to create approximately 70,000 new jobs.
• Correcting for inflation, the NIH budget has been reduced by 10% since 2003.
• Briefly describe the importance of NIH funding to your institution and state.
• Briefly describe your own research and how it has been adversely affected by subinflationary growth in the NIH budget..

The AFMR will keep you informed about the outcome of the House/Senate negotiations on the economic recovery package.

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Action Alert: Urge Your Representative to Increase NIH Funding in Economic Stimulus Take Action!

The US House of Representatives Appropriations Committee released its draft bill for "American Recovery and Reinvestment," Thursday, January 15, 2009, which included $3.5 billion for research and infrastructure improvements at the National Institutes of Health (NIH). Listing "$1.5 billion for expanding good jobs in biomedical research... $500 million to implement the repair and improvement strategic plan developed by the NIH for its campuses...[and] $1.5 billion for NIH to renovate university research facilities and help them compete for biomedical research grants," the House bill will serve as a two-year stimulus to restore funding to the severely flat-funded research agency.

While ASN appreciates the House committee's dedication to advancing research to improve the lives of patients stricken by debilitating disease, the Society encourages even greater support for NIH in the economic stimulus package. To truly enhance the efforts at NIH, Congress must also provide funding for robust investigator-initiated research via the R-01 mechanism, training and career opportunities to support the next generation of investigators, and initiatives to improve the translation of research from the bench to the beside, particularly the Clinical and Translational Science Awards (CTSAs).

The House is planning to consider the bill shortly, and ASN urges its members to advocate for additional support for NIH. ASN believes stimulus funding is the agency's best hope for curbing the agency's declining budget trajectory. Please contact your member of Congress and urge additional support for NIH in the economic package!

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U.S. Department of Health and Human Services
NATIONAL INSTITUTES OF HEALTH NIH News
NIH Office of the Director (OD)
Office of Communications & Public Liaison (OCPL)

For Immediate Release: Tuesday, January 13, 2009

CONTACT: NIH News Media Branch, 301-496-5787, <e-mail: nihnmb@mail.nih.gov>

NIH Releases First Biennial Report of the Director

Dr. Raynard S. Kington, acting director of the National Institutes of Health (NIH), today announced the publication of the first Biennial Report of the Director, a document that provides an integrated portrait of NIH research activities. The report makes it easier for Congress, advocates and patient groups, and the general public to understand the many programs within the agency.

The report contains an assessment of the state of biomedical and behavioral research organized by disease category, investigative approach, or resource. To ensure that the document reflects the work of all 27 Institutes and Centers (ICs), 15 trans-NIH teams gathered, reviewed, and organized information into a standardized format. To best serve the public and the scientific and legislative communities, sections of the report include:
  • An introduction to the disease, disorder, field, or approach;
  • A summary of the scope of NIH's research activities referencing the ICs whose missions address the topic;
  • Related health statistics;
  • Aggregate data on NIH funding;
  • Notable examples of research activities, key programs, initiatives, studies and accomplishments; and
  • Strategic plans and directions for future research.
As mandated by Congress, the report includes chapters on the following diseases, disorders, health topics, and NIH activities:
  • Cancer;
  • Neuroscience and disorders of the nervous system;
  • Infections diseases and biodefense;
  • Autoimmune diseases;
  • Chronic diseases and organ systems;
  • Life stages, human development, and rehabilitation;
  • Minority health and health disparities;
  • Epidemiological and longitudinal studies;
  • Genomics;
  • Molecular biology and basic sciences;
  • Clinical and translational research;
  • Disease registries, databases, and biomedical information systems;
  • Technology development;
  • Research training and career development;
  • Health communication, information campaigns, and clearinghouses; and
  • Six congressionally-mandated NIH Center of Excellence programs.
The report is available through the Research Portfolio Online Reporting Tool (RePORT) Web site at . The Web version of the document contains PDFs and links to NIH programs, plans and publications referenced in the report. The print version of the report will be released in late January. Thumb drives loaded with PDFs of the print and web versions of the report also will be available. This public release follows the submission of an administrative pre-print of the report to Congress in early June.

The NIH Reform Act of 2006 (Pub. L. 109-482) affirmed the importance of NIH and its vital role in advancing biomedical research to improve the health of the nation. The legislation established new strategies to accomplish NIH's mission in an era when the scale and complexity of health issues require constant innovation and interdisciplinary efforts. To that end, the NIH Reform Act replaced many of the disparate reports required by law from NIH's ICs with one comprehensive biennial account to Congress. The NIH Biennial Report for Fiscal Years 2006 & 2007 is the agency's first under the new mandate.

The Office of the Director, NIH, provides leadership, oversight, and coordination for the entire NIH research enterprise. Also within the Office of the Director, many offices develop NIH policy and provide essential NIH-wide oversight and coordination. For more information, please visit http://www.nih.gov/icd/od/index.htm.

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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This NIH News Release is available online at: http://www.nih.gov/news/health/jan2009/od-13.htm.

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Institutional Clinical and Translational Science Award (U54) - Request for Applications
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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: Friday, October 31, 2008

New NIH Policy Establishes Goals To Support Scientists Early In Their Careers

The National Institutes of Health (NIH) announced today a new policy establishing goals to encourage funding for scientists new to NIH and those who are at an early stage in their careers. The involvement of new investigators is considered essential to the vitality of health-related research and has been the focus of several critically important NIH initiatives. NIH is hopeful that this new policy will nurture a new cadre of promising scientists and provide the continued expertise needed to foster the next generation of biomedical research. NIH expects this new policy will level the playing field, allowing new investigators to achieve success rates comparable to those of established scientists submitting new grant applications. Achievement of a comparable success rate should permit the NIH to support 1650 or more New Investigators across all Institutes and Centers in FY 2009, a number equivalent to that achieved in FY 2008.

"Exceptional scientists with new ideas are at the core of our success — we must invest in the future of our new scientists today if we expect to meet the nation's health challenges of tomorrow," said NIH Director Elias A. Zerhouni, M.D.

As a first step, NIH created a new 'Early Stage Investigator' category designed to accelerate the early transition of new scientists to research independence (announced Sept. 26 in NIH Guide Notice NOT-OD-08-121 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-121.html)). An Early Stage Investigator is defined as a New or First-time investigator who is within 10 years of completing his/her last research degree or is within 10 years of completing medical residency (or the equivalent). Beginning with R01 research grant applications received in February 2009, NIH will identify Early Stage Investigators and take into consideration their career stage at the time of review and award.

Under the policy:

  • New goals will be established to support new investigators at success rates comparable to those of established scientists submitting new applications
  • Early Stage Investigators should comprise a majority of the new investigators supported
  • Where possible, Early Stage Investigator applications will be clustered during review with the expectation that they will be evaluated more effectively when judged against applications from scientists at the same stage of their careers.
NIH strongly encourages Early Stage Investigators seeking NIH funding for the first time to apply for traditional research project (R01) grant awards, instead of applying for small grants (R03) or Exploratory/Developmental Research Awards (R21). R03s and R21s are limited in scope and period of support, and thus may not be the most effective way to launch an independent research career. NIH is responding to concerns that an increasing number of new investigator applicants are applying for these mechanisms, despite the fact that R21 success rates can be lower than R01 success rates, and a smaller proportion of individuals with initial R21 or R03 grant support subsequently apply for and obtain R01-equivalent funding.

The Early Stage Investigator policy stems, in part, from a major initiative underway at NIH to enhance the peer review process with a goal to "fund the best science, by the best scientists, with the least amount of administrative burden." (See Enhancing Peer Review at NIH (http://enhancing-peer-review.nih.gov/index.html)).

This new policy is also a continuation of NIH's deep and longstanding commitment to new investigators, to ensure the pipeline of promising scientists will be steady and strong in the coming years. NIH established the New Innovator Award (http://nihroadmap.nih.gov/newinnovator/index.asp) in 2007 with the twin goals of stimulating highly innovative research and supporting promising new investigators. NIH launched the Pathway to Independence Award (http://grants.nih.gov/grants/new_investigators/pathway_independence.htm) in January 2006 as an opportunity for promising postdoctoral scientists to receive both mentored and independent research support from the same award.

These two initiatives, coupled with the new policy, are sure to solidify the lasting legacy of the departing NIH Director, Dr. Elias Zerhouni, whose commitment to new investigators was a core of his six-and-a-half year tenure at NIH.

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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This NIH News Release is available online at: (http://www.nih.gov/news/health/oct2008/od-31.htm).

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Deputy Division Director, Division for Clinical Research Resources
National Center for Research Resources
National Institutes of Health
Department of Health and Human Services

THE POSITION: The National Center for Research Resources (NCRR) is seeking exceptional candidates for the position of Deputy Division Director, Division for Clinical Research Resources (DCRR). The incumbent will help lead NCRR efforts to integrate basic discoveries with clinical research and ensure that the resources supported by NCRR catalyze the advancement of biomedical research. He/She will advise the Division Director and the Director, NCRR, on the policy implications and program significance of current clinical and translational research issues, including translation of basic research into pre-clinical studies, clinical trials and on into community implementation, recommending changes in policy/operations, or follow-up actions. The NCRR provides scientists and clinical researchers with the environments and tools needed to understand, detect, treat, and prevent a wide range of diseases. The DCRR is responsible for the Clinical and Translational Science Award (CTSA) program that enables discoveries that begin at a molecular and cellular level to move through animal-based studies before their translation to patient-oriented clinical research. This position offers an exciting opportunity for an extremely capable individual to contribute to the leadership of an organization dedicated to enhancing our understanding of health and disease, translating basic research into medical care, and improving human health. The Deputy Division Director, DCRR will represent DCRR and NCRR on a broad range of NIH and extramural committees related to Clinical and Translational Science Awards. For more information about this position as well as other senior leadership positions at the NCRR, please visit the NCRR website at www.ncrr.nih.gov.

QUALIFICATIONS REQUIRED: Applicants must possess an M.D. or equivalent degree, as well as independent research experience. They should be acquainted with programs that move research from the laboratory sciences through pre-clinical models to clinical trials and application in the community. Candidates should be outstanding communicators with extensive experience of clinical research career development in academic health centers. Applicants should also demonstrate the ability to think strategically, work collaboratively and use a consultative approach to problem solving and decision making.

SALARY/BENEFITS/OTHER INFORMATION: Salary is commensurate with experience and a full package of Civil Service benefits is available, including: retirement, health and life insurance, long term care insurance, leave and savings plan (401K equivalent). The National Institutes of Health inspires public confidence in science by maintaining high ethical principles. In addition to the Federal government's code of ethics, we have our own agency specific standards. They can be found at the NIH Ethics web site, http://ethics.od.nih.gov/. This position is subject to a background investigation.

HOW TO APPLY: A 2-3 page cover letter describing your interest in, and qualifications for this position, a Curriculum Vitae with bibliography, and three to five references must be received by midnight October 31, 2008. Application packages should be sent to the National Institutes of Health, National Center for Research Resources, ATTN: Tamar Boghosian, 6701 Democracy Boulevard, Room 9113, Bethesda, Maryland 20892.

For further information, please call (301) 435-0801. All information provided by candidates will remain confidential and will not be released outside the NCRR search process without a signed release from candidates.

DHHS and NIH are Equal Opportunity Employers

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U.S. Department of Health and Human Services
NATIONAL INSTITUTES OF HEALTH NIH News
NIH Office of the Director (OD)
For Immediate Release: Wednesday, September 24, 2008

CONTACT: NIH News Media Branch, NIH OCPL, 301-496-5787,

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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September 17, 2008
MEMO TO:     NIH Grantee Community
FROM: Director, NIH
SUBJECT:     Enhancing NIH Peer Review Activity Implementation Timeline

The NIH Peer Review Oversight Committee and three subgroups consisting of NIH program, review, grants management and evaluation staff have developed an initial implementation timeline for the Enhancing Peer Review activity. The recommendations that are being implemented are based on the result of the diagnostic phase and significant dialogue with both the internal and external communities regarding enhancements to the review system (please see http://enhancing-peer-review.nih.gov <http://enhancing-peer-review.nih.gov> for an overview of the Enhancing Peer Review effort). I view these enhancements as progress towards ensuring the continuation of NIH’s world renowned peer review system.

Although the subgroups are continuing to work out specific details of the implementation plans, I want to share with you the first of the preliminary implementation plans for the 2009 through 2010 calendar years as follows:

Priority Area 1 – Engage the Best Reviewers
  • Improve Reviewer Retention: In 2009, new reviewers will be given additional flexibility regarding their tour of duty, and other efforts will be undertaken to improve retention of standing review members.
  • Recruit the Best Reviewers: A toolkit, incorporating best practices for recruiting reviewers, will be made available to all ICs in 2009.
  • Enhance Reviewer Training: In spring 2009, training will be available to reviewers and SROs related to the changes in peer review.
  • Allow Flexibility through Virtual Reviews: Pilots will be conducted in 2009 on the feasibility of using high-bandwidth support for review meetings to provide reviewers greater flexibility and alternatives for in-person meetings.
Priority Area 2 – Improve the Quality and Transparency of Review
  • Improve Scoring Transparency and Scale: Review criteria-based scoring on 1 to 7 scale commences in May 2009. Reviewers will provide feedback through scores and critiques for each criterion in a structured summary statement.
  • Provide Scores for Streamlined Applications: In 2009, streamlined applications will receive a preliminary score.
  • Shorten and Restructure Applications: Shorter (12-page research plan) R01 applications (with other activity codes scaled appropriately) will be restructured to align with review criteria for January 2010 receipt dates.
Priority Area 3 – Ensure Balanced and Fair Reviews across Scientific Fields and Career Stages, and Reduce Administrative Burden
  • Fund the Best Science Earlier and Reduce Need for Resubmissions: To ensure that the largest number of high quality and meritorious applications receive funding earlier and to improve system efficiency, NIH is considering separate percentiling of new and resubmitted applications and permitting one amended application.
  • Review Like Applications Together: NIH is establishing an Early Stage Investigator (ESI) designation. In 2009, NIH will evaluate clustering ESI applications for review. The same approach will be considered for clinical research applications.
Thank You
The enhancing peer review activity has been an intensive year-long effort. Many of you have contributed valuable feedback and input and I’d like to take this opportunity to convey my appreciation and specially thank you for your input.

Updates and details will be posted at http://enhancing-peer-review.nih.gov <http://enhancing-peer-review.nih.gov/> and published in the monthly Extramural Nexus (subscribe at https://list.nih.gov/cgi-bin/wa?SUBED1=extramuralnexus&A=1 <https://list.nih.gov/cgi-bin/wa?SUBED1=extramuralnexus&A=1> ) as they are known. Also, several notices will be posted in the NIH Guide detailing specific elements of this implementation.

Elias A. Zerhouni, M.D.

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NIH News Release

FOR IMMEDIATE RELEASE
Monday, September 22, 2008
12:01 a.m. EDT
  CONTACT:
Ann Dieffenbach, NIGMS
301-496-7301
dieffena@nigms.nih.gov

Karen Silver, NIH OPASI
301-435-2435
silverk@mail.nih.gov

NIH Extends Its Commitment to Transformative Research with $138 Million for Director’s Pioneer and New Innovator Awards in 2008

The National Institutes of Health announced today that it has increased its support of high-impact research with 2008 NIH Director’s Pioneer and New Innovator Awards to 47 scientists, many of whom are in the early stages of their careers. The grants, estimated to be up to $138 million over five years, enable recipients to pursue exceptionally innovative approaches that could transform biomedical and behavioral science.

“Nothing is more important to me than stimulating and sustaining deep innovation, especially for early career investigators and despite challenging budgetary times. These highly creative researchers are tackling important scientific challenges with bold ideas and inventive technologies that promise to break through barriers and radically shift our understanding,” said NIH Director Elias A. Zerhouni, M.D.

While scientists at any career level can receive Pioneer Awards, only early career investigators who have not held an NIH regular research (R01) or similar NIH grant are eligible for New Innovator Awards. Both programs are key components of the NIH Roadmap for Medical Research.

Now in its fifth year, the Pioneer Award program has made 63 awards, 16 of them in 2008. The New Innovator Award program, launched in 2007, supports 61 investigators—30 selected last year and 31 more this year.

Each Pioneer Award provides $2.5 million in direct costs over five years. New Innovator Awards are for $1.5 million in direct costs over the same time period.

“These programs are central elements of NIH efforts to encourage and fund especially novel investigator-initiated research, even if it might carry a greater-than-usual degree of risk of not succeeding. The awards also reflect our goal of supporting more investigators in the early stages of their careers,” Zerhouni noted.

Zerhouni will announce the 2008 award recipients today at the start of the NIH Director’s Pioneer Award Symposium on the NIH’s Bethesda, Md., campus.

The recipients’names, institutions, and research plans are listed below.

For both programs, NIH selects the recipients through special application and evaluation processes. Distinguished outside experts identify the most highly competitive applicants. The Advisory Committee to the Director, NIH, performs the second level of review and Zerhouni makes final decisions based on the outside evaluations and programmatic considerations.

“These nontraditional application and review processes are serving as models in our efforts to enhance the NIH peer review system so that we can fund the best science, by the best scientists, while reducing the administrative burden for both applicants and reviewers,” Zerhouni said.

Biographical sketches of the new Pioneer Award recipients are at http://nihroadmap.nih.gov/pioneer/Recipients08.aspx. The symposium agenda is at http://nihroadmap.nih.gov/pioneer/symposium2008. More information on the Pioneer Award, including details on the 47 scientists who received awards in the first four years of the program, is at http://nihroadmap.nih.gov/pioneer.

Information on the New Innovator Award is at http://nihroadmap.nih.gov/newinnovator. Details on the research plans of the new recipients are at http://nihroadmap.nih.gov/newinnovator/Recipients08.asp.

# # #

The NIH Roadmap for Medical Research, launched in 2004, is a series of initiatives designed to address fundamental knowledge gaps, develop transformative tools and technologies, and/or foster innovative approaches to complex problems. Funded through the NIH Common Fund, these programs cut across the missions of individual NIH Institutes and Centers (ICs) and are intended to accelerate the translation of research to improvements in public health. The Office of Portfolio Analysis and Strategic Initiatives (OPASI), in collaboration with all NIH ICs, oversees programs funded by the Common Fund. Additional information about the NIH Roadmap and Common Fund can be found at http://nihroadmap.nih.gov. Additional information about OPASI can be found at http://opasi.nih.gov.

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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2008 NIH Director’s Pioneer Award Recipients

James K. Chen, Ph.D., Stanford University assistant professor of chemical and systems biology, who will develop and use synthetic probes to examine the regulation of embryonic development at the molecular level.

Ricardo Dolmetsch, Ph.D., Stanford University assistant professor of neurobiology, who will study the development and function of neurons from children with autism.

James Eberwine, Ph.D., University of Pennsylvania Elmer Bobst Professor of Pharmacology and co-director of the Penn Genome Frontiers Institute, who will use groups of RNA molecules to modify cellular properties.

Joshua M. Epstein, Ph.D., Brookings Institution Center on Social and Economic Dynamics director and Santa Fe Institute external professor, who will integrate behavioral factors into models of the development and progression of infectious and chronic diseases.

Bruce A. Hay, Ph.D., California Institute of Technology associate professor of biology, who will pursue a strategy for preventing malaria in humans by introducing disease transmission-blocking genes into mosquito populations.

Ann Hochschild, Ph.D., Harvard Medical School professor of microbiology and molecular genetics, who will use bacterial systems to study infectious particles called prions.

Charles M. Lieber, Ph.D., Harvard University professor of chemistry, who will develop interfaces between nanoelectronic devices and cells to create new biomaterials and tools for studying the brain.

Barry London, M.D., Ph.D., University of Pittsburgh professor of medicine, who will develop new techniques to image electrical activity of the heart and identify those at risk of sudden cardiac death.

Tom Maniatis, Ph.D., Harvard University professor of molecular and cellular biology, who will use stem cells to examine the mechanisms of amyotrophic lateral sclerosis, a neurodegenerative disease of motor neurons.

Teri W. Odom, Ph.D., Northwestern University associate professor of chemistry and materials science and engineering, who will create metallic nanomaterials to improve the ability to study subcellular structure in three dimensions.

Hongkun Park, Ph.D., Harvard University professor of chemistry and of physics, who will develop new nano- and microelectronic tools that enable the meticulous study of the design principles of the brain.

Aviv Regev, Ph.D., Massachusetts Institute of Technology and Broad Institute assistant professor of biology, who will examine how the regulatory networks that control cell function change over time in development, disease, and evolution.

Aravinthan D.T. Samuel, Ph.D., Harvard University associate professor of physics, who will develop new biophysical and imaging techniques to link behavioral responses with neuronal activity.

Saeed Tavazoie, Ph.D., Princeton University associate professor of molecular biology, who will explore how intracellular networks allow microbes to carry out cognitive behavior.

Alice Y. Ting, Ph.D., Massachusetts Institute of Technology associate professor of chemistry, who will develop new technologies to image and study proteins in living cells.

Alexander van Oudenaarden, Ph.D., Massachusetts Institute of Technology professor of physics, who will explore the role of random variables in gene expression during cellular development and specialization.

2008 NIH Director’s New Innovator Award Recipients

Zev Bryant, Ph.D., Stanford University assistant professor of bioengineering, who will study biological energy consumption and force generation by re-engineering the mechanical functions of molecular machines found in cells.

Ronald J. Buckanovich, M.D., Ph.D., University of Michigan Comprehensive Cancer Center assistant professor of internal medicine and gynecologic oncology, who will develop a mouse model of cancer that expresses human tumor vessels and can be used to develop new treatments targeting these structures.

Timothy Cardozo, M.D., Ph.D., New York University School of Medicine assistant professor of pharmacology, who will design novel molecules intended to slow or kill malaria parasites.

Karen L. Christman, Ph.D., University of California, San Diego, assistant professor of bioengineering, who will develop patterned surfaces that will provide step-by-step cues for directing cell fate and behavior.

Brian A. Cobb, Ph.D., Case Western Reserve University School of Medicine assistant professor of pathology, who will develop new tools to study how the immune system recognizes carbohydrate molecules and how they may be used in vaccine development.

Ronald D. Cohn, M.D., Johns Hopkins University School of Medicine assistant professor of pediatrics and neurology at the McKusick-Nathans Institute of Genetic Medicine, who will study the mechanisms underlying the ability of hibernating mammals to maintain skeletal muscle mass despite prolonged periods of immobility.

Xiangfeng Duan, Ph.D., University of California, Los Angeles, assistant professor of chemistry and biochemistry, who will develop a new generation of integrated nanoprobes for monitoring, mapping, and manipulating neural activities with unprecedented speed and sensitivity.

Seth J. Field, M.D., Ph.D., University of California, San Diego, assistant professor of medicine, who will develop a multipronged, systematic approach to understand the function of lipid molecules that transmit signals within cells.

Zemer Gitai, Ph.D., Princeton University assistant professor of molecular biology, who will use novel imaging methods to identify new classes of antibiotic drugs and drug targets.

Aaron D. Gitler, Ph.D., University of Pennsylvania School of Medicine assistant professor of cell and developmental biology, who will use novel genetic screening and cell biological approaches to define the mechanisms of human neurodegenerative diseases, such as Parkinson's and amyotrophic lateral sclerosis.

David H. Gracias, Ph.D., Johns Hopkins University assistant professor of chemical and biomolecular engineering, who will develop mobile, micro- to nanoscale tools and devices for medicine.

Christy L. Haynes, Ph.D., University of Minnesota McKnight Land-Grant Assistant Professor of Chemistry, who will build an immune system-on-a-chip to illuminate the mechanisms of, and possible therapeutic approaches to, allergic conditions.

Shelli Kesler, Ph.D., Stanford University School of Medicine assistant professor of psychiatry and behavioral sciences, who will develop and test intervention programs for preventing and treating cognitive impairments related to chemotherapy in women with breast cancer.

Yuriy Kirichok, Ph.D., University of California, San Francisco, assistant professor of physiology, who will study molecular mechanisms of cell energy production and cell death to open new avenues in the treatment of age-related metabolic and degenerative diseases.

Sanjay Kumar, M.D., Ph.D., University of California, Berkeley, assistant professor of bioengineering, who will combine approaches from biophysics, systems biology, and oncology to study how cells sense and process mechanical forces in human health and disease.

Chay T. Kuo, M.D., Ph.D., Duke University Medical Center assistant professor of cell biology and pediatrics, who will develop new genetic and chemical screening approaches in mice to identify signals regulating repair and remodeling after brain injuries.

Lara K. Mahal, Ph.D., University of Texas at Austin assistant professor of chemistry and biochemistry, who will develop a systems-based approach to decode how sugar molecules on cell surfaces encode information such as cell type and health.

Coleen T. Murphy, Ph.D., Princeton University/Lewis-Sigler Institute assistant professor of molecular biology and genomics, who will study the causes of reproductive aging and help identify candidates for the treatment and prevention of age-related reproductive decline and maternal age-related birth defects.

Ken-ichi Noma, Ph.D., Wistar Institute assistant professor in gene expression and regulation, who will develop a new methodology to map the three-dimensional structure of the human genome as a means of identifying the molecular basis for many diseases, including various cancers.

Melanie D. Ohi, Ph.D., Vanderbilt University Medical Center assistant professor of cell and developmental biology, who will take a multidisciplinary approach toward understanding the structure and function of large molecular complexes called spliceosomes.

Karin S. Pfennig, Ph.D., University of North Carolina, Chapel Hill, assistant professor of biology, who will use an experimental approach to understand how an individual’s health status and external environment influence his or her behavior.

Miguel Ramalho-Santos, Ph.D., University of California, San Francisco, assistant professor of obstetrics, gynecology and reproductive sciences and researcher in the Institute for Regeneration Medicine, who will study the control and function of stem cell pluripotency, which has implications for regenerative medicine and cancer biology.

Samara Reck-Peterson, Ph.D., Harvard Medical School assistant professor of cell biology, who will couple genetics with biophysics to discover biomedically important molecules that control how molecular motors deliver diverse cargo to the right place at the right time within cells.

Erik M. Shapiro, Ph.D., Yale University School of Medicine assistant professor of diagnostic radiology and biomedical engineering, who will use cellular and functional magnetic resonance imaging to aid in the development of novel strategies for manipulating stem and progenitor cell migration in the brain, particularly in response to injury and disease.

William M. Shih, Ph.D., Dana-Farber Cancer Institute assistant professor of biological chemistry and molecular pharmacology, who will develop tools for atomic-resolution imaging of membrane proteins to enable structure-based drug design.

Amy J. Wagers, Ph.D., Joslin Diabetes Center and Harvard University assistant professor of stem cell and regenerative biology, who will study the mechanisms by which aging impairs blood cell function and develop strategies to prevent or reverse these age-acquired defects.

Jue D. Wang, Ph.D., Baylor College of Medicine assistant professor of molecular and human genetics, who will identify new ways that the cell controls how DNA is copied, which will give insights into many diseases.

Lei Wang, Ph.D., Salk Institute for Biological Studies assistant professor of chemical biology and proteomics, who will design and incorporate novel amino acids in roundworms to study how a class of proteins transmits signals regulating development and cancer.

Joseph C. Wu, M.D., Ph.D., Stanford University School of Medicine assistant professor of medicine and radiology, who will develop a microRNA-based approach for reprogramming induced pluripotent stem cells.

Sean M. Wu, M.D., Ph.D., Massachusetts General Hospital and Harvard Medical School assistant professor of medicine, who will employ mechanisms of embryonic development to engineer functional tissues for organ regeneration using pluripotent stem cells from different species.

Julia Zeitlinger, Ph.D., Stowers Institute for Medical Research assistant investigator, who will analyze the relationship between the DNA-packaging state of a cell and its developmental potential.

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Receive Up to $35,000 Annually –December 1, 2008 Deadline

Dear Colleague:

The National Institutes of Health (NIH) will repay your outstanding student loans through its extramural Loan Repayment Programs (LRPs) if you are or will be conducting nonprofit biomedical or behavioral research and meet eligibility requirements. The application cycle for the extramural LRPs opened September 1 and includes programs for Clinical Research, Pediatric Research, Health Disparities Research, Contraception and Infertility Research, and Clinical Research for Individuals from Disadvantaged Backgrounds. Applications will be accepted online until 8:00 PM on December 1, 2008 at www.lrp.nih.gov.

Please share this e-mail with researchers in your organization who may benefit from this career-enhancing opportunity. The December 1 deadline will approach quickly.

BENEFITS: New LRP contracts are awarded for a two-year period and repay up to $35,000 of qualified educational debt annually. Tax offsets also are provided as an additional benefit. Participants may apply for competitive renewals which are issued for one or two years. Undergraduate, graduate, medical school, and other health professional school loans qualify for repayment. An NIH grant or other NIH funding is not required to apply for or participate in the LRPs.

ELIGIBILITY: Applicants must possess a doctoral-level degree (except for the Contraception and Infertility Research LRP); be a U.S. citizen or permanent resident; devote 20 hours or more per week to conducting qualified research funded by a university, nonprofit organization, or federal, state, or local government entity; and have qualified educational loan debt equal to or exceeding 20 percent of their institutional base salary.

AWARDS: Each year, some 1,600 research scientists benefit from the more than $70 million NIH invests in their careers through the extramural LRPs. Twenty-six percent of awards are made to individuals within one to five years after receiving their doctoral degree. More than 75 percent of awards go to individuals within 10 years after receiving their doctoral degree. Approximately 40 percent of new applications and 70 percent of renewal applications are funded.

QUESTIONS? Visit the LRP website at www.lrp.nih.gov for more information and to access the online application. For additional assistance, call or e-mail the DLR Information Center at (866) 849-4047 or lrp@nih.gov.

Sincerely,
Stephen J. Boehlert
Director of Operations
NIH Division of Loan Repayment

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Fourth Annual NIH Director's Pioneer Award Symposium

September 22-23, 2008

You are invited to attend the fourth annual NIH Director's Pioneer Award Symposium on September 22-23, 2008. The event will feature a keynote address by NIH Director Dr. Elias A. Zerhouni plus research talks by the 2007 Pioneer Award recipients (http://nihroadmap.nih.gov/pioneer/Recipients07.aspx), poster sessions by Pioneer and New Innovator Award recipients and members of their labs, roundtable discussions on highly innovative research, and announcement of the 2008 Pioneer awardees.

The NIH Director's Pioneer and New Innovator Award programs—key components of the NIH Roadmap for Medical Research—support exceptionally creative scientists who take highly innovative, and potentially transformative, approaches to major challenges in biomedical or behavioral research.

The symposium, in the Natcher Conference Center (Building 45) on the NIH campus, begins at 8:30 a.m. each day. An agenda is posted at http://nihroadmap.nih.gov/pioneer/symposium2008. Attendance is free and no registration is required. The event will also be videocast live and archived at http://videocast.nih.gov.

The NIH Roadmap for Medical Research is a series of far-reaching initiatives designed to transform the nation’s medical research capabilities and speed the movement of research discoveries from the bench to the bedside. It provides a framework of the priorities the NIH must address in order to optimize its entire research portfolio and lays out a vision for a more efficient and productive system of medical research. For more information about the NIH Roadmap, please visit the Web site at http://nihroadmap.nih.gov.

The National Institutes of Health (NIH) — The Nation's Medical Research Agency — is comprised of 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 investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

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Office of Director

Clinical and Translational Science Awards (CTSA) – The Committee has watched with interest the implementation of the CTSA program and believes it has the potential to create a new paradigm for clinical and translational research. The Committee has been disappointed, however, in the management of the initial grants. Despite a long-term budget target and a growth plan, awards for later years have been unexpectedly reduced, perhaps calling into question the viability of the program. The Committee would like a report by August 1, 2008 identifying the projected average grant award for each round of awards for each year through 2012; the total projected annual CTSA funding; the share of funding for each year proposed to be derived from the NCRR, Common Fund, and other institutes; and comparable data for the general clinical research centers. The Committee also remains interested in NIH’s plans to evaluate the program. The Committee understands that a formal evaluation will not take place until the program has been in place a number of years, but expects some evaluation information to be periodically presented to it as the program expands. Using periodic site visits, annual project reports, or other sources, the Committee expects an annual report detailing the clinical research conducted in each center, including clinical trials, the number of patients seen, the number of academic disciplines and investigators participating in the research, and other measures NIH considers relevant.

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NIH Director Announces Enhancements to Peer Review

U.S. Department of Health and Human Services NATIONAL INSTITUTES OF HEALTH
NIH News
NIH Office of the Director (OD)

For Immediate Release: Friday, June 06, 2008

CONTACT: NIH News Media Branch, 301-496-5787, <e-mail: nmb@od.nih.gov>

NIH DIRECTOR ANNOUNCES ENHANCEMENTS TO PEER REVIEW
NIH Will Commit $1 Billion over Next Five Years to Investigator Initiated High Risk, High Impact Transformative Research

National Institutes of Health (NIH) Director Elias A. Zerhouni, M.D., announced today at the 96th Meeting of the Advisory Committee to the Director (ACD) critical changes to enhance and improve the NIH peer review system. This marks the end of a year-long effort to determine ways to further enrich the process. An important component of the new plan is an increased commitment to investigator initiated high-risk, high-impact research to prevent a slowdown of transformative research, despite difficult budgetary times.

"The scientific community became truly engaged in this comprehensive effort to figure out how to make peer review work better for both the reviewers and the applicants," Zerhouni said. "The results of this collective effort are concrete solutions that will maximize flexibility, remove any unnecessary burden, stimulate new innovation, and promote transformative research."

There was a remarkable response to the director's call-to-action by both the internal and external NIH communities. The initiatives presented to the ACD by Lawrence Tabak, D.D.S., Ph.D., Director of the National Institute of Dental and Craniofacial Research (NIDCR) and co-chair of the two peer review working groups, reflect NIH's response to thousands of comments, opinions, and criticisms received throughout the year. Taken together, these proposals bring to fruition the original charge, "to fund the best science, by the best scientists, with the least administrative burden."

Collaborative teams of participants worked to tackle challenges of the system and discover solutions. A comprehensive framework was created and implementation will be carried out over the next 18 months.

The Implementation Plan Report consists of four main priorities and highlights include:

  • Priority 1 - Engage the Best Reviewers: Increase flexibility of service, formally acknowledge reviewer efforts, further compensate time and effort, and enhance and standardize training

  • Priority 2 - Improve Quality and Transparency of Reviews: Shorten and redesign applications to highlight impact and to allow alignment of the application, review and summary statement with five explicit review criteria, and modify the rating system

  • Priority 3 - Ensure Balanced and Fair Reviews Across Scientific Fields and Career Stages

  • Support a minimum number of early stage investigators and investigators new to NIH, and emphasize retrospective accomplishments of experienced investigators

  • Encourage and expand the Transformative Research Pathway

  • Create a new investigator-initiated Transformative R01 Award program funded within the NIH Roadmap with an intended commitment of a minimum of $250 million over five years

  • Continue the commitment of -- and possibly expand the use of -- the Pioneer, EUREKA, and New Innovator Awards. NIH will invest at least $750 million in these three programs over the next 5 years.

  • Reduce the burden of multiple rounds of resubmission for the same application, especially for highly meritorious applications

  • Priority 4 - Develop a Permanent Process for Continuous Review of Peer Review
"As we contemplated possible changes, we were guided by several fundamental principles. First, while improving the system, do no harm. That is, ensure that any changes to the peer review system bring significant value and outweigh costs," said Zerhouni. "Second, continue to maximize the freedom of scientists to pursue high-risk, high-impact research. Moreover, we want to cultivate a sense that we continuously re-evaluate the peer review system to ensure that it is the best that it can be."

For more information about enhancing peer review at NIH and to learn about the implementation plan, please visit http://enhancing-peer-review.nih.gov.

The ACD advises the NIH Director on policy matters important to the NIH mission of conducting and supporting biomedical and behavioral research, research training, and translating research results for the public. Additional information is available at http://www.nih.gov/about/director/acd/index.htm.

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 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.

##

This NIH News Release is available online at: http://www.nih.gov/news/health/jun2008/od-06.htm.

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NIH Clinical Collection Now Available at www.nihclinicalcollection.com

The NIH Clinical Collection (NCC), a plated array of approximately 450 clinically tested compounds, is now available for distribution through www.nihclinicalcollection.com. There is a cost recovery charge of $805.00 for the collection.

Similar collections of FDA approved drugs have proven to be rich sources of undiscovered bioactivity and therapeutic potential. The clinically tested compounds in the NCC are highly drug-like with known safety profiles. These compounds can provide excellent starting points for medicinal chemistry optimization and, for high-affinity targets, may even be appropriate for direct human use in new disease areas. The compounds come as a ready-to-screen kit with the following features:

Format: The collection contains approximately 450 compounds arrayed in six 96-well plates. Compounds are supplied as 50ul of a 10mM solution in 100% DMSO.

Selection criteria: The NCC consists almost entirely of drugs that have been in phase I-III clinical trials and have not been represented in other available collections. These compounds also have favorable attributes for inclusion in a screening collection, such as purity, solubility and commercial availability for re-supply.

Drug-likeness: By definition, compounds that have been tested in human clinical trials have highly developed properties of drug-likeness, such as bioavailability and stability. Having been used in humans, most of these compounds also have well-characterized safety profiles.

Extensive Bioactivity Profiles: The NCC compounds are part of the screening library for the NIH Roadmap Molecular Libraries Screening Centers Network (MLSCN). Thus, extensive bioactivity data on these compounds from dozens of high throughput screens will be publicly available through PubChem. Through ongoing screening within and outside the MLSCN, the body of knowledge about these compounds will be continually expanding.

Resupply: All of the compounds in the NCC are commercially available for re-supply. Sources of compounds for the NCC are listed in the compound database.

The NCC was assembled by the National Institutes of Health through the Molecular Libraries Roadmap Initiative as part of its mission to enable the use of compound screens in biomedical research.

The NIH Roadmap for Medical Research is a series of far-reaching initiatives designed to transform the nation’s medical research capabilities and speed the movement of research discoveries from the bench to the bedside. It provides a framework of the priorities the NIH must address in order to optimize its entire research portfolio and lays out a vision for a more efficient and productive system of medical research. For more information about the NIH Roadmap, please visit the Web site at http://nihroadmap.nih.gov.

The National Institutes of Health (NIH) — The Nation's Medical Research Agency — is comprised of 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 investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

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Action Needed on NIH Funding

Background: The President has proposed a $310 million cut in the NIH budget below the FY 2007 level. NIH program spending would be effectively reduced by over $500 million because the President proposes to add $201 million to the Global AIDS transfer. The AFMR is recommending an NIH budget increase of 6.7%, which would put NIH at $30.9 billion in FY 2008.

Recommended Action: The House HHS Appropriations Subcommittee is expected to take up funding for NIH before Memorial Day. You are encouraged to call your Representative as soon as possible to express concern about the President’s proposed NIH budget cut and to encourage support for a 6.7% increase in the NIH budget to a level of $30.9 billion. In addition to articulating the budget recommendation above, you should tell the staff person about the importance of NIH funding to your institution and state. Briefly describe how your institution and state have benefited from NIH support.

You can reach your Representative’s office by dialing the Capitol Hill Switchboard at 202-224-3121 and asking to be connected to his or her office. Once connected, ask to speak to the person who handles appropriations for the Department of Health and Human Services.

For additional information, contact Lynn Morrison or Peter Banks at Peter.Banks@whaonline.org. AFMR will keep you informed as the NIH appropriations process moves forward during the spring and summer.

Thank you for participating in this effort.

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NIH Launches National Consortium to Transform Clinical Research

BETHESDA, Md. - National Institutes of Health (NIH) Director Elias A. Zerhouni, M.D., today announced the launch of a national consortium that will transform how clinical and translational research is conducted, ultimately enabling researchers to provide new treatments more efficiently and quickly to patients. This new consortium, funded through Clinical and Translational Science Awards (CTSAs), begins with 12 academic health centers (AHCs) located throughout the nation. An additional 52 AHCs are receiving planning grants to help them prepare applications to join the consortium. When fully implemented in 2012, about 60 institutions will be linked together to energize the discipline of clinical and translational science.

"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."

Applicants were encouraged to develop institutes, centers or departments for these awards and were challenged to devise innovative and far-reaching approaches to build academic homes for clinical and translational science. In response, the CTSA institutions are planning to:
  • Develop better designs for clinical trials to ensure that patients with rare as well as common diseases benefit from new medical therapies

  • Produce enriched environments to educate and develop the next generation of researchers trained in the complexities of translating research discoveries into clinical trials and ultimately into practice

  • Design new and improved clinical research informatics tools

  • Expand outreach efforts to minority and medically underserved communities

  • Assemble interdisciplinary teams that cover the complete spectrum of research-biology, clinical medicine, dentistry, nursing, biomedical engineering, genomics, and population sciences

  • Forge new partnerships with private and public health care organizations
"The impact of the CTSA consortium will be far greater than the number of awards made," said Barbara M. Alving, M.D., NCRR Acting Director. "We're already seeing transformative changes and new partnerships developing at institutions as they prepare to participate. This consortium will spur innovation, integration, inclusion, and dissemination-not only among institutions receiving these awards-but at all organizations involved in health care throughout the country."

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 CTSA consortium will be led by the National Center for Research Resources (NCRR), a part of the NIH. Funding for the CTSA initiative comes from redirecting existing clinical and translational programs, including Roadmap funds. Total first year funding for the awards announced today will be approximately $100 million. When fully implemented in 2012, the initiative is expected to provide a total of $500 million annually to 60 academic health centers.

The following institutions will receive the first set of awards for nearly a five-year period:       Columbia University Health Sciences (New York, N.Y.)
      Duke University (Durham N.C.)
      Mayo Clinic College of Medicine (Rochester, Minn.)
      Oregon Health & Science University (Portland, Ore.)
      Rockefeller University (New York, N.Y.)
      University of California, Davis (Davis. Calif.)
      University of California, San Francisco (San Francisco, Calif.)
      University of Pennsylvania (Philadelphia, Pa.)
      University of Pittsburgh (Pittsburgh, Pa.)
      University of Rochester (Rochester, N.Y.)
      University of Texas Health Science Center at Houston (Houston, Texas)
      Yale University (New Haven, Conn.)

For complete project descriptions, please visit http://www.ncrr.nih.gov/osptemp/ncrrprog/roadmap/CTSA_9-2006X.asp.

In addition, the list of planning grant recipients is available at http://www.ncrr.nih.gov/osptemp/ncrrprog/roadmap/CTSA_Planning_9-2006X.asp. A second Request for Applications (RFA) for CTSAs has been issued, calling for the next round of submissions to be made by January 17, 2007, with awards expected in fall 2007. The RFA is available at http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-07-002.html.

The CTSA initiative was developed with extensive input from the research community. For more information, visit http://www.ncrr.nih.gov/clinicaldiscipline.asp.

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About the NIH Roadmap for Medical Research
The NIH Roadmap for Medical Research is a series of far-reaching initiatives designed to transform the Nation's medical research capabilities and speed the movement of scientific discoveries from the bench to the bedside. It provides a framework of the priorities the NIH must address in order to optimize its entire research portfolio and lays out a vision for a more efficient and productive system of medical research. Additional information about the NIH Roadmap can be found at http://nihroadmap.nih.gov .

About NCRR
NCRR provides laboratory scientists and clinical researchers with the environments and tools they need to understand, detect, treat, and prevent a wide range of diseases. With this support, scientists make biomedical discoveries, translate these findings to animal-based studies, and then apply them to patient-oriented research. Ultimately, these advances result in cures and treatments for both common and rare diseases. Through collaborations and networks, NCRR connects researchers with one another, and with patients and communities across the nation. These connections bring together innovative research teams and the power of shared resources, multiplying the opportunities to improve human health. For more information, visit www.ncrr.nih.gov.

About NIH
The National Institutes of Health (NIH) - The Nation's Medical Research Agency - is comprised of 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 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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Mentored Clinical Scientist Research Career Development Award (K08)

The objective of the Mentored Clinical Scientist Research Career Development Award (K08) is to continue the long standing NIH support of didactic study and mentored research for individuals with clinical doctoral degrees. This award provides support and “protected time” for an intensive, supervised research career development experience in the fields of biomedical or behavioral research, including translational research. For the purpose of this award, translational research is defined as application of basic research discoveries toward the diagnosis, management, and prevention of disease.

An award is for a period of 3 to 5 years and provides support for salary and research-related costs. The amount funded as salary for a career development award varies among the NIH participating Institutes and Centers (ICs). Therefore, the applicant is strongly advised to contact the relevant IC for any distinct guidelines, requirements, and allowable funds. Candidates for K08 award must have a clinical doctoral degree. Applications must contain a career development plan as well as a research plan. The participating NIH Institutes and Centers may have distinctive guidelines, requirements, and funding amounts for this announcement in order to accommodate the career needs of researchers working in fields related to their specific research missions.

For more information, please go to: http://grants.nih.gov/grants/guide/pa-files/PA-06-512.html#SectionI

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Read Dr. Zerhouni's latest update on the NIH Roadmap and the CTSA.


NCRR News

The National Center for Research Offers Clinical and Translational Science Awards

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NIH 2006 Budget


By Institute
By Mechanism

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Stem Cell Research Enhancement Act
The AFMR and The Coalition for the Advancement of Medical Research, along with others, have recently supported H.R. 810, the Stem Cell Research Enhancement Act of 2005. Click here to view the letter to Representatives Michael Castle (R-DE) and Diana DeGette (D-CO).

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