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NHLBAC Meeting Minutes - October 18, 2011

I. CALL TO ORDER AND OPENING REMARKS - Dr. Susan B. Shurin

Dr. Susan B. Shurin, Acting Director of the National Heart, Lung, and Blood Institute (NHLBI), welcomed members to the 244th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC).

Council Updates:

Dr. Shurin recognized three Council members who are retiring:

  • Dr. C. Noel Bairey-Merz
  • Dr. Andrew Marks
  • Dr. Marlene Rabinovitch

Three new Council members are expected to participate at the next Council meeting:

  • Dr. Ron King, President and Chief Scientific Officer, BioAccel, who was able to attend the meeting
  • Dr. Pamela Douglas, Professor of Research in Cardiovascular Diseases, Duke University School of Medicine
  • Dr. Barbara Konkle, Director, Translational Research, Puget Sound Blood Center

Advisory Committees Updates:

Dr. Shurin welcomed representatives of three NHLBI Advisory Committees:

  • Dr. Sairam Parthasarathy, representing the Sleep Disorders Research Advisory Board
  • Dr. David Pinsky, representing the Heart, Lung, and Blood Program Project Review Committee
  • Dr. Amy Shapiro, representing the Clinical Trials Review Committee

Dr. C. William Balke of the NHLBI Institutional Training Mechanism Review Committee and Dr. Edward Benz of the Sickle Cell Disease Advisory Committee were unable to attend.

NHLBI Updates:

Dr. Shurin introduced Ms. Kate O’Sullivan, the new NHLBI Executive Officer. Dr. Shurin thanked Mr. Tim Wheeles for his devoted and wonderful service as the Acting Executive Officer for 25 months.

The search for the new Director of the NHLBI is ongoing.

NIH Updates:

Dr. Shurin noted with sadness the recent deaths of two important leaders of NHLBI activities:

  • Dr. Bernadine Healy, a former NIH Director, who launched the Women's Health Initiative in 1991.
  • Dr. William Kannel, a former Director of the Framingham Heart Study.

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II. REVIEW OF CONFIDENTIALITY AND CONFLICT OF INTEREST - Dr. Susan B. Shurin

The Council was reminded that under Public Law 92-463, the Federal Advisory Committee Act, a portion of the meeting would be closed to the public, for the consideration of grant applications. Dr. Shurin 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 ACTING DIRECTOR - Dr. Susan B. Shurin

Budget Update:

The NHLBI is very concerned about the impact of current budget constraints on the future of biomedical research. The NIH received a one percent cut in its budget for FY 2011 and is preparing for budget decreases again this year and next. The Institute plans to continue its policy of making strategic budget cuts as necessary, rather than across-the-board cuts. It will continue to look closely at potential investments. The Institute will begin FY 2012 with a research project grant (R01) payline at the 10th percentile and plans to have one payline for both new applications (A0s) and resubmissions (A1s).

HHS Updates:
Dr. Shurin summarized the Department of Health and Human Services (HHS) Sickle Cell Disease Initiative. The HHS has charged six agencies (NIH, CDC, HRSA, FDA, AHRQ, and CMS) and the Offices of Minority Health and Planning and Evaluation to improve the health of people with sickle cell disease. Each agency is taking action to:

  • Enhance implementation of research advances.
  • Provide evidence-based guidelines to families, health care providers, and payers.
  • Facilitate new drug development.
  • Provide public health data to impact both the health care delivery and research agendas.

Dr. Shurin noted two HHS policy issues:

  • An HHS Advance Notice of Proposed Rulemaking (ANPRM) on Human Subject Research Protection was published on July 26, 2011. See ANPRM for Revisions to the Common Rule.
  • HHS financial conflict of interest regulations have been revised.

Dr. Shurin offered Council members an opportunity to discuss their concerns about the effects of the new NIH policy to allow only one resubmission of a grant application (i.e., no A2s). Dr. Shurin offered to raise the issue with NIH leadership and to convey the concerns and suggestions of Council members.

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IV. MOVING COMPLEX CELL THERAPIES FROM THE BENCH TO THE BEDSIDE: HEMATOPOIETIC STEM CELLS AS A PARADIGM – Dr. Cynthia Dunbar

Dr. Cynthia Dunbar, Hematology Branch, NHLBI Division of Intramural Research, discussed three areas of research involving cell therapy in which her lab has been involved:

  • Hematopoietic stem cell gene therapy --- insights from the non-human primate model.
  • Stem cell-niche interactions --- research on improving mobilization, homing, and engraftment for transplant and gene therapy.
  • Reprogrammed stem cells (iPSC) --- studies of iPSC and their utility as regenerative medicine models and their suitability for preclinical development.

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V. DIVISION OF INTRAMURAL RESEARCH UPDATE: PROGRESS IN CLINICAL RESEARCH – Dr. Robert S. Balaban

Dr. Robert S. Balaban, Scientific Director, NHLBI Division of Intramural Research, summarized NHLBI collaborative activities with the new NIH Center for Regenerative Medicine. The Center, supported by the NIH Common Fund and located within the NIH Intramural Research Program, was established to accelerate the development of cell-based therapies for repairing or replacing tissue damaged by disease or injury. Several NHLBI intramural research projects are being funded by the Center, and the NHLBI iPSC Core Facility has been established to serve as the main research site focusing on the applications of iPSC for NHLBI mission-oriented projects.

Dr. Balaban discussed the success of the NIH Stadtman Tenure-Track Investigator Program to recruit outstanding tenure-track scientists and the Lasker Clinical Research Scholars Program to help increase the pool of talented clinical/translational researchers. Dr. Balaban also mentioned the Intramural Division's new Clinical Research Strategic Plan, developed to:

  • Support investigator-initiated research.
  • Support small first-in-human trials, especially with respect to safety, reporting, and regulatory standards.
  • Develop and maintain infrastructure for clinical research at all levels: FDA interaction, protocol development, research nurse support, data management and analysis.
  • Partner with regional clinical programs (e.g., partnerships with Johns Hopkins University/Suburban Hospital and Children's National Medical Center; extramural/intramural partnerships; and the NIH Center for Human Immunology and Inflammation).
  • Hire, train, and mentor the next generation of physician-scientist leaders

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VI. UPDATE FROM THE NIH PRINCIPAL DEPUTY DIRECTOR – Dr. Lawrence A. Tabak

Dr. Lawrence A. Tabak, Principal Deputy Director, NIH, discussed the continuing efforts of the NIH to improve the diversity of the NIH funded scientific workforce. Dr. Tabak reported that despite efforts spanning 30 years, the NIH has had a less than impressive impact on the diversity of the NIH-funded workforce. As part of an ongoing effort to examine and improve the situation, the NIH has commissioned several recent studies, one of which (published in Science, August 19, 2011) provides data on the differences in success rates for NIH research project grants (R01s) experienced by white applicants vs. underrepresented minority applicants.

Dr. Tabak and Dr. Francis S. Collins, NIH Director, responded in the same edition of Science, emphasizing NIH’s commitment to a diverse biomedical workforce and discussing the steps it is taking to address the situation.

Dr. Tabak reiterated that the NIH takes these data seriously and is determined to discern the causes of differential success rates and to undertake interventions to reduce them. NIH actions include:

  • The NIH is engaged in vigorous communication outreach to all stakeholders.
  • Because review experience correlates with application success, the NIH has recently established an "Early Career Reviewers" program to increase exposure of investigators from diverse institutions to the review process (and to increase diversity of review panels).
  • The NIH will conduct experiments on the review process to determine if bias exists.
  • The NIH will work with academic institutions to encourage creation or strengthening of pre-application mentoring programs for junior faculty.
  • The NIH has funded several extramural grants, including the NIH Pathfinder Award, designed to study different interventions to strengthen the pipeline in a manner that will help improve workforce diversity.
  • The NIH Director formed two high level groups to recommend actions to help the Agency increase the diversity of its workforce and create a sustainable environment that supports diversity.
  • NIH Diversity Task Force (Part of the NIH Director’s Steering Committee) – internal group of NIH leaders.
  • Advisory Committee to the Director Working Group on Diversity in the Biomedical Research Workforce – provides an external perspective and advice.

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VII. PATHWAYS TO INDEPENDENCE AWARD (K99/R00) – Dr. Susan B. Shurin

Dr. Shurin discussed the possibility of using the K99/R00 mechanism to support Early Stage Investigators (ESIs) who do not have much preliminary data. She reminded Council members that the Institute recently decided it will no longer participate in the Parent Announcement for the NIH Exploratory Developmental Research Grant Program (R21). The Institute determined that the R21 mechanism was not affecting its research grant portfolio in the manner for which it was originally intended. Moreover, although the R21 mechanism may have seemed an attractive opportunity for ESIs, it provided insufficient time for them to obtain results needed to support an R01 grant.

NHLBI analysis provided information on the Institute's recent use of the K99/R00 program. It found that the success rate for K99 applications has been reasonable over the past several years, ranging from about 25 to 45 percent annually. Of the 118 K99 NHLBI awardees from FY 2007-2010, most held PhD degrees. Most K99 applicants with a PhD or MD/PhD degree received their K99 award much sooner after receiving their degree (within about 5 years) than MD applicants, while MD applicants transitioned more quickly to the R00 award than PhDs and MD/PhDs.

Data show that ESI MD applicants seem to be transitioning smoothly to the R01 mechanism. The K99/R00 mechanism will probably be most useful to ESI PhD and MD/PhD applicants.

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VIII.  REPORT OF THE BOARD OF EXTERNAL EXPERTS AND INITIATIVE CONCEPTS FOR FISCAL YEARS 2012 AND BEYOND – Dr. Susan B. Shurin

Council considered seven new initiatives, seven renewals, and one request by another IC for secondary support, all of which had been reviewed in September by the Board of External Experts (BEE).  Initiative development at the NHLBI is a two-cycle process.  First, staff within each extramural Division develop ideas and potential initiatives, which they present to the trans-NHLBI Idea Forum.  Sufficiently developed initiatives are subsequently considered by the BEE, which ranks each and provides accompanying advice.

The Council was mostly supportive of the initiatives presented, but made a number of specific recommendations for consideration prior to their release.  The Director, NHLBI, will consider the recommendations of the BEE and the Council and other budgetary and programmatic issues in determining which of the proposed initiatives, if any, to implement.

Strategic Plan Goal I: To improve understanding of the molecular and physiological basis of health and disease, and to use that understanding to develop improved approaches to disease diagnosis, treatment, and prevention

Career Development Program in Omics of Lung Diseases (K12; renewal), RFA

To develop multidisciplinary career development programs that will equip new investigators with the knowledge and skills to apply pan-omics and integrated approaches to elucidate genomic and molecular bases of lung disease heterogeneity, key gene regulatory networks, and relevant disease biomarkers in order to increase understanding of lung disease pathobiology and lung disease personalized medicine.

Council recommended this initiative.

Career Enhancement Award for NHLBI Selected Topics (K18; renewal), PA

To renew the parent program announcement for the K18 mechanism. The current NHLBI K18 program supports training in stem cell research; this initiative will broaden the scope to include training in other areas where a retraining mechanism would be useful to help retool investigators to be able to pursue new and innovative areas of research.

Council recommended this initiative.

NHLBI Systems Biology Collaborations (R01; renewal), PAR

To support high impact, collaborative systems biology research projects to advance understanding of normal physiology and perturbations associated with heart, lung, and blood diseases and disorders.

Council recommended this initiative.

Strategic Plan Goal II: To improve understanding of the clinical mechanisms of disease and thereby enable better prevention, diagnosis, and treatment

Clinical Studies Using Health Information Technology for Pediatric Pulmonary Vascular Disease (U01), RFA

To create a virtual cohort of children with pulmonary arterial hypertension, by using electronic health information, a bioinformatics infrastructure, and computational science that will allow the elucidation of phenotypes and longitudinal outcomes, queries on therapy and the responses, and investigation of other research questions.

Council recommended this initiative.

Coronary Artery Risk Development in Young Adults (CARDIA) Study Renewal (N01; renewal), RFP

To leverage the NHLBI’s long-term investment in CARDIA and its 25 years worth of clinical, psychosocial, environmental, and genotypic data and findings to focus primarily on early-onset heart failure.

Council recommended this initiative.

Engine for Fast Execution of Clinical Trials (N01), RFP

To establish a virtual network involving a large number of sites to conduct a clinical trial of triple therapy ICS/LABA/LAMA combination for COPD exacerbations in an inpatient setting and immediate post-discharge period.  Additional task orders will be issued to support additional peer-reviewed trials in the same inpatient setting, depending on the success of the first trial.

Council recommended this initiative.

Pregnancy as a Window to Future Cardiovascular Health: Adverse Pregnancy Outcomes as Predictors of Increased Risk Factors for Cardiovascular Disease (U10), RFA

To leverage the NICHD-sponsored study entitled "Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be" to test the hypothesis that women who experience preeclampsia and other adverse pregnancy outcomes in their first pregnancy have elevated cardiovascular risk profiles at approximately two years postpartum compared to women who do not experience an adverse pregnancy outcome in their first pregnancy.

Council recommended this initiative.

Strategic Plan Goal III: To generate an improved understanding of the processes involved in translating research into practice and use that understanding to enable improvements in public health and to stimulate further scientific discovery

 Cardiothoracic Surgical Trials Network (UM1; renewal), RFA

To continue the Cardiothoracic Surgical Trials Network in order to maintain an environment and infrastructure that promotes the advancement of cardiothoracic surgical research through the use of evidence-based medicine.

Council recommended this initiative.

Cardiovascular Risk Reduction in Underserved Rural Communities (R01), RFA

To build the evidence base and accelerate the implementation and translation of evidence- or practice-based interventions into practice in rural communities by planning and conducting well-designed controlled trials.

Council recommended this initiative.

National Health and Nutrition Examination Survey (NHANES), Cardiovascular and Sleep Component (Y01; renewal), IAA

To support the continued collection of data in children and adults, including measures of blood pressure, total cholesterol, triglycerides, HDL-cholesterol, and Apo(B); results of DEXA scans and accelerometry measures; and responses to questions about weight loss and sleep disorders. In addition, a urine collection subsample will be added to measure urinary sodium excretion, a biomarker for sodium intake.

Council recommended this initiative.

NHLBI SBIR Phase IIB Bridge Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44), RFA

To provide support to enable promising SBIR Phase II projects to pursue the next appropriate milestone(s) toward commercialization.

Council recommended this initiative.

Summer Institute for Training in Biostatistics II (T15; renewal), RFA

To support up to eight universities to teach summer courses in biomedical statistics for advanced undergraduates and beginning graduate students to encourage them to pursue careers in the area.

Council recommended this initiative.

Transcatheter Cerclage Mitral Valve Annuloplasty for Secondary Mitral Regurgitation (N43/N44), RFP

To translate an NHLBI intramural research program invention into a commercial solution for catheter-based non-surgical treatment of secondary ("functional") mitral valve regurgitation.

Council recommended this initiative.

Transitions in Care of NHLBI Diseases (R01), PAR

To test the effectiveness of various approaches to improve transitional care, especially for the transition from hospital acute care to the outpatient setting, in order to improve post-acute-care outcomes, such as unplanned hospital re-admissions, in adults and children with cardiovascular, pulmonary, or blood diseases and conditions.

Council recommended this initiative

Request for Secondary Support

Paul D. Wellstone Muscular Dystrophy Cooperative Research Center and Multisite Clinical Studies (U54 or UM1; renewal) [NIAMS, NINDS, and NICHD], RFA

To encourage clinical research directed at the cardiac morbidities suffered by patients with muscular dystrophy.

Council recommended this initiative.

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IX. INTRAMURAL REVIEW

Reports prepared by the Board of Scientific Counselors (BSC), NHLBI, on the NHLBI intramural laboratories reviewed during FY 2011 were presented to the Council by Dr. Robert Balaban, Director, Division of Intramural Research, NHLBI and Dr. Michael I. Kotlikoff, (BSC Chair), Cornell University.

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X. REVIEW OF APPLICATIONS

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.

The Council considered 2,039 applications requesting $2,667,283,274 in total direct costs. The Council recommended 2,039 applications with total direct costs of $2,667,283,274.

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ADJOURNMENT

The meeting was adjourned at 2:45 p.m. October 18, 2011.

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