NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL

MEETING MINUTES
October 26, 2005

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 220th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC).

Guests:

Dr. Nabel introduced representatives from three of the Institute's five Federal Advisory Committees:

  • Dr. Mark Gladwin, NIH, NHLBI, Vascular Therapeutics Section
  • Dr. Shelly Carter, a member of the Clinical Trials Review Committee
  • Dr. Jeffrey Fredberg, a member of the Heart, Lung, and Blood Program Project Review Committee
  • Dr. Rafael Pelayo, Chair of the Sleep Disorders Research Advisory Board

Representatives from the Board of Scientific Counselors and the Sickle Cell Disease Advisory Committee were unable to attend.

Member Updates:

The following Council members were unable to attend the meeting:

  • Dr. Roberto Bolli
  • Dr. Maria Costanzo
  • Ms. J. Hoxi Jones
  • Dr. Robert Lemanske
  • Dr. Patricia Wahl

Dr. Nabel recognized four Council members who are retiring from the Council:

  • Dr. Robert Mason
  • Dr. Jane Newburger
  • Dr. George Thomas
  • Dr. Linda Van Horn

Dr. Nabel presented each retiring member with an NHLBI crystal, an official plaque from the Institute, and a letter of appreciation from Secretary Leavitt. She thanked each member for their dedicated service to the Institute.

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II. DIRECTOR’S REPORT - Dr. Elizabeth G. Nabel

Dr. Nabel highlighted several recent activities of the Institute:

The Working Group on Genome Wide Association in NHLBI Cohorts met on September 12, 2005 and developed several constructive recommendations for the Institute. The group’s report was included in the Council briefing book.

The first three grants were awarded in a new program of Specialized Centers for Cell-Based Therapy for Heart, Lung, and Blood Diseases, which focuses on clinical applications of cell-based therapy and involves both basic and clinical research. Copies of the press releases were included in the Council briefing book.

Staff Update:

Ms. Maria Stagnitto, who has led the Office of Clinical Affairs in the NHLBI intramural program since 2000, has been selected to direct a new Office of Clinical Research, which will coordinate the many regulatory activities of the Institute's extramural clinical research program.

Electronic Submission of Grants:

Dr. Nabel reviewed NIH plans to require electronic submission of all competing grant applications via Grants.gov by the end of May 2007. Using Grants.gov, organizations can find and apply (electronically) for competitive grant opportunities from all Federal grant-making agencies. As announced in the NIH Guide, the NIH will move its competing grant programs one by one from paper application (form PHS 398) to electronic application (form SF 424), starting with the December 2005 submission deadlines for SBIR/STTR (R41, R42, R43, R44) and conference grant (R13, U13) applications. Applicants for R01 awards will be required to apply electronically beginning with the October 2006 submission date. In order to submit electronic applications to the NIH, applicant institutions must register with Grants.gov, and institutions and principal investigators must be registered in the NIH eRA Commons.

Budget Report:

The NIH is currently being funded by a Continuing Resolution, so the NHLBI will conservatively begin awarding grants for FY 2006. The current payline for R01 grants is the fourteenth percentile and the new investigator R01 payline for R01 grants is the nineteenth percentile.

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III. NHLBI POLICY ON NEW INVESTIGATORS - Dr. Elizabeth G. Nabel

Dr. Nabel summarized the new NHLBI policy on new investigators, which was developed to help investigators receive a first independent research award earlier in their careers. The policy affects new investigator percentile paylines for FY 2006 as follows:

  • The new investigator payline will be 5 percentile points beyond the established RPG payline.
  • New investigators whose applications receive scores > 5 percentile points and < 10 percentile points beyond the RPG payline will be offered expedited administrative reviews of their responses to reviewers' concerns. This process is expected to expedite funding by 6 months for those applications with easily addressable concerns.

In addition, the awards for new investigators will not be reduced in years from the recommended duration.

Council was enthusiastic about the new policy. A concern was expressed about the success of K awardees. Dr. Nabel responded that Dr. Helena Mishoe, who is the Chair of the NHLBI Training Committee, will investigate this issue.

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IV. NHLBI STRATEGIC PLAN - Dr. Elizabeth G. Nabel

The NHLBI will undertake a strategic planning process over the next 12 to 15 months to develop a scientific working plan for the next decade. The Institute will identify scientific areas where it is well positioned to make major contributions and evaluate its operational policies. NHLBI grantees, Council members, and other constituents will be asked to contribute to the development of the plan. A final strategic plan is expected in Spring 2007.

Council was very supportive of the plan and the process and looks forward to participating.

 

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V. 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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VI. UNRAVELING THE REACTIONS OF NITRIC OXIDE, NITRITE, AND HEMOGLOBIN IN HUMAN PHYSIOLOGY, DISEASE, AND THERAPEUTICS – Dr. Mark Gladwin

Dr. Mark T. Gladwin, Senior Investigator, Vascular Medicine Branch, Intramural Division, NHLBI, summarized recent findings about nitric oxide, nitrite, and hemoglobin in human disease and therapeutics. Nitric oxide is a potent vasodilator. Hemolysis-associated pulmonary hypertension has been shown to affect seriously a subset of sickle cell disease patients, who may benefit from nitric oxide-based therapies. Several related clinical studies are ongoing. The NHLBI has recently released a Request for Proposals (RFP) for a Phase II/III Trial of Sildenafil for Sickle Cell Disease-associated Pulmonary Hypertension. Dr. Gladwin is also involved in cutting-edge research investigating nitrite therapy for cardiac ischemia-reperfusion injury, as well as ischemia-reperfusion injury associated with liver or lung transplantation.

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VII. BEA INITIATIVES

NHLBI staff presented nine new initiatives, all of which had been reviewed in September by the Board of Extramural Advisors. The Council was mostly supportive but made a number of specific recommendations for consideration prior to their release. The Director of the NHLBI will consider the recommendations of the BEA and the Council and other budgetary and programmatic issues in determining which of the proposed initiatives, if any, are implemented.

Academic Career Awards in Pediatric Transfusion Medicine, RFA

The purpose of this initiative is to support the career development of investigators in the field of pediatric transfusion medicine. Council strongly recommended this initiative and suggested expanding it to include cell-based therapy.

Atherosclerosis Prevention Trial (APT), RFP

The purpose of this initiative is to conduct a randomized clinical trial to determine whether maximal lowering of low density lipoprotein cholesterol (LDL-C) reduces major adverse cardiovascular events in patients at elevated risk but without known coronary or cerebrovascular disease. Council thought that this initiative was extremely important and suggested building in pilot studies for imaging and non-invasive techniques.

Career Development Program in the Genetics and Genomics of Chronic Lung Diseases (K12), RFA

The purpose of this initiative is to support a multi-disciplinary approach to the early research career development of both physician and non-physician scientists who are interested in increasing understanding of the genetic bases of lung diseases. The mechanism of support for this initiative will be institutional training awards. Council thought that this initiative was timely and of appropriate size to address the need for a cadre of young scientists in genetics and genomics.

Collaborative Program for Research on Cell-based Therapy in the Lung, RFA

The purpose of this initiative is to accelerate multi-disciplinary study on the potential for delivery of cell-based therapy to the lung. Council supported this timely and important initiative.

COPD Phenotypes and Outcome Measures, RFA

The purpose of this initiative is to examine various measures of the severity of COPD and to determine their usefulness for identifying subgroups of COPD patients with fairly homogeneous characteristics and for assessing the efficacy of putative therapies. Council thought that the spirit of this initiative was excellent but that COPD is a difficult field to decipher and that the data were too disparate. In general Council did not think this was the right mechanism and urged that it should go through BEA again.

Introduction to Computational Modeling for Heart, Lung, Blood, and Sleep Biologists, RFA

The purpose of this initiative is to support the development, implementation, and subsequent evaluation of short courses to introduce computational modeling to biomedical researchers and clinician-scientists. The courses are expected to increase the number of researchers with knowledge and skills to apply both experimental and computational approaches to heart, lung, blood, and sleep research. Council fully supported this initiative.

Preventing Weight Gain in Young Adults, RFA

The purpose of this initiative is to support several single-center studies to develop and evaluate promising intervention approaches for preventing weight gain in young adults. Council was enthusiastic for this very timely initiative.

Regulation of the Cerebral Microcirculation in Health and Disease, RFA

The purpose of this initiative is to stimulate collaborative research on the cellular and molecular mechanisms regulating cerebral microvascular blood flow in the neural environment, with the goal of clarifying how alterations in these mechanisms contribute to cerebrovascular disease. Council thought this initiative was important but that it should be better focused.

Systolic Blood Pressure Intervention Trial (SPRINT), RFA

The purpose of this initiative is to conduct a multicenter randomized trial to determine whether treating systolic blood pressure to a lower goal than currently recommended will reduce cardiovascular disease mortality and morbidity. Council felt that this was a very critical issue and supported this initiative.

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VIII. REVIEW OF APPLICATIONS

The Council considered 806 applications requesting $976,263,888 in total direct costs. The Council recommended 805 applications with total direct costs of $974,992,584. A summary of applications by activity code may be found in Attachment B.

ADJOURNMENT

The meeting was adjourned at 3:30 p.m. on October 26, 2005.

CERTIFICATION

I hereby certify that the foregoing minutes are accurate and complete.

_________________

Elizabeth G. Nabel, M.D. Date

Chairperson

National Heart, Lung, and Blood Advisory Council

_________________

Deborah Beebe, Ph.D. Date

Executive Secretary

National Heart, Lung, and Blood Advisory Council


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