NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL

MEETING MINUTES
September 12, 2006

I. CALL TO ORDER AND OPENING REMARKS Dr. Elizabeth G. Nabel

Dr. Elizabeth Nabel, Director of the National Heart, Lung, and Blood Institute (NHLBI), welcomed members to the 223rd meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC).

Member Updates:

Dr. Nabel recognized five Council members who are retiring:

  • Dr. Gordon Bernard
  • Dr. Kim Eagle
  • Dr. Frances Henderson
  • Dr. Ngai Nguyen
  • Dr. Maria Costanzo

New Staff:

Dr. Nabel introduced Dr. Alan Michelson, the Institute's new Associate Director for Basic Research. Dr. Michelson comes to the NIH from the Howard Hughes Medical Institute and the Division of Genetics in the Department of Medicine at the Brigham and Women’s Hospital, Harvard Medical School. A highly respected researcher, his current research focuses on an aspect of heart and muscle development in Drosophila. He will have responsibility for NHLBI basic science policies, the development and integration of basic sciences initiatives within the NHLBI, and coordination of these policies and programs with other NIH institutes and federal agencies.

Other Announcements:

September is Sickle Cell Disease Awareness Month. Next year will be the 35th anniversary of the National Sickle Cell Anemia Control Act that led directly to the Institute's responsibility for developing, supporting, and coordinating a national program of research in sickle cell disease. The Institute has overseen many accomplishments in sickle cell disease research since the program began.

Dr. Nabel highlighted an NIH Request for Information that seeks public input (by October 31) on a proposed new NIH policy designed to facilitate the research community's access to data resulting from NIH-funded genome-wide association studies. Facilitating data sharing is an exciting opportunity for NIH leadership.

Two new NHLBI publications are available:

Your Guide to Physical Activity and the Heart - uses science-based information to help adults develop a safe and effective program of physical activity that can be sustained.

  • FYI from the NHLBI (September issue) - The FYI from the NHLBI is a collection of public interest news items, published three times a year, that began in response to suggestions from the February 2000 NHLBI Public Interest Organization Meeting.

Guest Speakers:

  • Dr. Keith Horvath
  • Dr. Susan Shurin
  • Dr. Christopher O'Donnell
  • Dr. Charles Friedman

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II. REVIEW OF CONFIDENTIALITY AND CONFLICT OF INTEREST - Dr. Elizabeth G. Nabel

The Council was reminded that according to Public Law 92-463, the Federal Advisory Committee Act, the meeting of the NHLBAC would be open to the public except during consideration of grant applications. A notice of this meeting was published in the Federal Register indicating that it would start at 8:30 a.m. and remain open until approximately 12:00 p.m. Dr. Nabel also reminded the Council members that they are Special Government Employees and are subject to Departmental conduct regulations.

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III. REPORT OF THE DIRECTOR - Dr. Elizabeth G. Nabel

Dr. Nabel emphasized that a primary reason for the recent decline in success rates of NIH grant applications is that the number of applications has increased substantially each year since the end of the NIH budget doubling, while the NIH budget has remained almost flat. The NIH anticipates another tight budget in FY 2007, with funding expected to remain flat at about $28.6 billion. After adjusting for inflation, this represents a loss in purchasing power of about 8.3 percent since FY 2004. NIH's challenge is to maintain research vitality during this period of reduced purchasing power and increased demand for grants.

The FY 2007 President’s Budget proposed for the NHLBI is almost $30 million less than NHLBI’s FY 2006 appropriation. One bright note is that the Institute expects to be able to support an increased number of competing research project grants in FY 2007 because fewer noncompeting research project grant awards are anticipated (since many 4-5 year awards will have just ended). The Institute expects to close FY 2006 with an R01 percentile payline of 14.0.

Strategic Plan Update

The Institute embarked on a strategic planning process about a year ago to develop a scientific working plan, or blueprint, for the next decade. The first step of the planning process, completed in August, comprised 23 meetings (that incorporated input from approximately 500 investigators) to identify scientific areas where the Institute is well positioned to make major contributions, and to evaluate Institute operational policies. A draft strategic plan with scientific goals and strategies for achieving them will be developed based on reports from the meetings. In October, Council members and other leaders of the research community will meet to finalize the draft plan, which will then be released for comments to patient advocacy groups, professional groups, and other members of the scientific community. A final strategic plan is expected in early Spring 2007.

New NHLBI Logo

The NHLBI has a new visual identity—a new logo. The Institute's previous logo served it well for almost 30 years. The new logo depicts a red heart, surrounded by two white lungs, encased in a red blood cell. It reflects the Institute's renewed commitment to supporting scientific discovery and improving the nation's health.

NHLBI Organization Update

Dr. Nabel described several offices within the Institute that provide crosscutting support:

  • Office of Biostatistics Research (OBR) - provides biostatistics support.
  • Office of Clinical Research (OCR) - provides clinical trials management support.
  • Center for Research Informatics and Information Technology (CRIIT) - provides bioinformatics and information technology support.
  • Office of Prevention, Education, and Control (OPEC) - supports the translation of research results.

The Institute has a new Division of Extramural Research Activities (DERA). The new Director of DERA is Dr. Stephen C. Mockrin. In addition to supporting existing Institute activities such as grants management and review, DERA will have a new Office of Staff Training and Communication and a new Office of Strategic and Innovative Programs.

At the request of the Institute, a panel of eminent researchers reviewed the organization of the Institute's extramural cardiovascular program. In response, the Institute has reorganized its cardiovascular program into two new Divisions:

  • Division of Cardiovascular Diseases (DCVD) - with five disease-oriented branches

    • Advanced Technologies and Surgery
    • Atherothrombosis and Coronary Artery Disease
    • Heart Development and Structural Diseases
    • Heart Failure and Arrhythmias
    • Vascular Biology and Hypertension

The new Acting Director of DCVD is Dr. Sonia Skarlatos.

  • Division of Prevention and Population Sciences (DPPS) - with two branches

    • Epidemiology
    • Clinical Applications and Prevention

    The new Acting Director of DPPS is Dr. Peter Savage.

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IV. NIH HEART CENTER AT SUBURBAN HOSPITAL - Dr. Keith Horvath

Dr. Keith Horvath, Director of the NHLBI intramural Cardiothoracic Surgery Research Program, which works closely with Suburban Hospital in Bethesda, Maryland, discussed his lab's current research interests, and described the facilities and capabilities of the NIH Heart Center at Suburban Hospital, which opened in May 2006. The NIH Heart Center at Suburban Hospital brings the clinical and scientific expertise of NIH researchers and Johns Hopkins Medicine physicians to heart patients in Bethesda. Dr. Horvath explained that research is performed in labs on the NIH campus, while the clinical effort takes place at Suburban Hospital. Currently,

Dr. Horvath's intramural cardiothoracic surgery research program is focusing on cellular surgery, biomechanical engineering, and xenotransplantation. The NIH Heart Center at Suburban Hospital provides cardiothoracic surgery, angioplasty, and diagnostic catheterizations. Its partnership with the NHLBI intramural research program brings state-of-the-art technologies and procedures not widely available to cardiac patients at Suburban Hospital.

 

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V. TRACKING CONDUCT OF CLINICAL TRIALS - Dr. Susan Shurin

Dr. Susan Shurin, Deputy Director of the NHLBI, explained that the Institute routinely monitors the accrual of patients for its clinical studies, in an effort to carry out its mission cost-effectively and in compliance with applicable rules and regulations. The Institute reviews the composition of its clinical study populations, assessing accruals compared with targets, as well as composition by sex and race/ethnicity. All clinical studies are monitored annually; some studies are monitored semi-annually (e.g., phase III studies; studies with 1,000 patients or more; and studies with total direct costs greater than $5 million). Data show that the Institute's studies seldom fall far behind their targeted enrollments. The Institute is modifying internal procedures to expedite monitoring and enhance accuracy of initial enrollment projections. In addition, the Institute is working with the grantee community to help them enhance the accuracy of their enrollment projections, develop mechanisms to aid recruitment, and enhance self-regulation by use of rewards for doing well and consequences for not meeting targets.

 

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VI. FRAMINGHAM SHARe PROJECT AND OTHER GENOMIC INITIATIVES - Dr. Christopher O'Donnell

Dr. Christopher O'Donnell, Senior Advisor to the Director for Genome Research and Associate Director of the Framingham Heart Study, explained how knowledge gained from the Human Genome Project and the recently completed HAPMAP Project have led to current opportunities for performing genome-wide association studies (i.e., studies of genetic variation across the entire human genome that are designed to identify genetic associations with observable traits, such as blood pressure or weight, or with the presence or absence of a disease or condition). A NHLBI-initiated working group held in September 2005 recommended that large-scale genome-wide association studies proceed and that study data be made immediately accessible to the research community.

The Framingham SNP-Health Association Resource (SHARe) is nearing realization. It will enable studies of connections between genetic variation and common diseases by providing access to genotype information and the wealth of phenotype data collected from the participants of the Framingham Heart Study, in a way that is consistent with the highest ethical standards and protects the privacy/confidentiality of participant data.

Other NHLBI genotyping and genome-wide association projects (planned or underway) include:

  • Women's Health Initiative GWA Study
  • Enhancing Development of Genome-Wide Association Methods (ENDGAMe)
  • Genome-Wide Association: SNP Genotyping and Analysis (STAMPEED)
  • Candidate Gene Association Resource (CARe)

 

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VII. INFORMATICS AND INFORMATION TECHNOLOGY - Dr. Charles Friedman

Dr. Charles Friedman, Director of the NHLBI's new Center for Research Informatics and Information Technology (CRIIT), presented the informatics and information technology (IT) goals of the Institute and the plan for reaching them. The long-term goal is to create and maintain an integrated information and knowledge environment for the diverse NHLBI community. (An integrated environment is one in which the "users" are engaged in complex tasks requiring information that resides in different places and different formats, and the "system" assembles the information with the appearance of it all coming from one place.)

The CRIIT work scope will include informatics research as well as IT support. The current CRIIT organization comprises four branches:

  • Planning, Architecture, Communication, and Evaluation
  • Applications Development and Support
  • Research and Biomedical Informatics
  • IT Resources

The initial steps toward building an integrated environment will entail:

  • Establishing informatics as part of the scientific portfolio of the Institute.
  • Developing a web strategy that makes it easy for "units" to maintain their own content; that anticipates that users will "log in" to Institute websites rather than accessing them anonymously; and that customizes home pages and other presentations to user needs.
  • Creating terminology and coding standards.

 

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VIII. CLOSED PORTION

This portion of the meeting was closed to the public in accordance with the determination that it concerned matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. appendix 2).

The session included a discussion of procedures and policies regarding voting and confidentiality of application materials, committee discussions and recommendations. Members absented themselves from the meeting during discussion of and voting on applications from their own institutions, or other applications in which there was a potential conflict of interest, real or apparent. Members were asked to sign a statement to this effect.

REVIEW OF APPLICATIONS

The Council considered 193 applications requesting $326,712,891 in total direct costs. The Council recommended 193 applications with total direct costs of $327,407,006. A summary of applications by activity code may be found in Attachment B.

ADJOURNMENT

The meeting was adjourned at 2:30 p.m. on September 12, 2006.

 

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