NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL

DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL INSTITUTES OF HEALTH
NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL


MEETING SUMMARY OF THE
NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL


November 28, 2012

The 248th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) was convened at 12:39 p.m. on Wednesday, November 28, 2012, in Conference Room 6, C Wing, Building 31, National Institutes of Health (NIH), Bethesda, Maryland. The meeting, which was rescheduled from October 30 due to Superstorm Sandy, was open to the public until 3:14 p.m. The meeting was closed to the public from 3:15 p.m. until adjournment at 5:15 p.m. Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI), presided as Chair.

COUNCIL MEMBERS ATTENDING VIA TELECONFERENCE:

Mr. Jonathan R. Alger
Ms. Coletta Barrett
Dr. Ivor J. Benjamin
Dr. Ingrid B. Borecki
Dr. Barry S. Coller
Dr. Pamela S. Douglas
Dr. Jack A. Elias
Ms. Beverly Hogan
Dr. Robert L. Jesse (ex officio)
Dr. Ron G. King
Dr. Barbara A. Konkle
Dr. Naomi Luban
Dr. Michael S. Parmacek
Dr. Polly E. Parsons
Dr. Gilbert C. White II

COUNCIL MEMBERS ABSENT:

Dr. Lanetta Jordan
Dr. Talmadge E. King
Dr. Leslee J. Shaw

CSR EMPLOYEES PRESENT:

Dr. Julia Krushkal Adkins
Dr. Larry Boerboom
Dr. Yuanna Cheng
Dr. Joy Gibson

INVITED GUESTS:

Dr. Robert S. Balaban
Scientific Director, NHLBI Division of Intramural Research

Dr. Michael I. Kotlikoff (via teleconference)
Chair, NHLBI Board of Scientific Counselors
Austin O. Hooey Dean of Veterinary Medicine
Professor, Department of Biomedical Sciences
Cornell University College of Veterinary Medicine

Dr. Douglas C. Wallace (via teleconference)
Member, Board of Scientific Counselors
Director, Center for Mitochondria and
  Epigenomic Medicine   
Michael and Charles Barnett Chair of   
   Pediatric Mitochondrial and Metabolic Disease   
Children’s Hospital of Philadelphia

MEMBERS OF THE PUBLIC PRESENT:

Ms. Michelle Rodriguez, SRI
Ms. Laura Uttley, Lewis-Burke Associates
Ms. Virginia Neale, Northwestern University

NHLBI EMPLOYEES PRESENT:

Numerous NHLBI staff members were in attendance or were able to view the meeting via closed circuit broadcast.


I.  CALL TO ORDER AND REPORT OF THE DIRECTOR, NHLBI

Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI), welcomed members to the 248th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC).

The meeting was held as a teleconference with an agenda that was modified from what had been planned for October 30, 2012. That meeting had been canceled because of Hurricane Sandy.

Dr. Gibbons and Dr. Susan B. Shurin, Deputy Director, NHLBI, recognized the retiring members of the Council:

  • Dr. Ingrid Borecki, Co-Director, Division of Statistical Genomics, Genome Science Center; Washington University in St. Louis
  • Dr. Barry Coller, Vice President for Medical Affairs, The Rockefeller University
  • Dr. Jack Elias, Waldemar Von Zedwitz Professor of Medicine, Chair, Department of Internal Medicine, Yale University School of Medicine
  • Ms. Beverly Hogan, President, Tougaloo College
  • Dr. Michael Parmacek, Herbert C. Rorer Professor of Medical Sciences, Director, Penn Cardiovascular Institute, Chief, Division of Cardiovascular Medicine, University of Pennsylvania.

New Council members have been invited.

Dr. Gibbons discussed with the Council the Institute's new policy on duration of R01s. The Institute's longstanding practice was to adjust duration of R01s to achieve a four year average for research project grants. Applications that received the very best percentiles and those from Early Stage Investigators (ESIs) received awards for the full length of their Council-recommended project periods. The Institute has made a decision that beginning in FY 2014, it will fund competing, investigator-initiated R01s for four years. Exceptions include ESIs, applications with timelines that cannot be accomplished within four years, and AIDS projects (which have a separate appropriation). Researchers are encouraged to submit for review only applications with a project period of four years or less.

REPORT OF THE BOARD OF EXTERNAL EXPERTS AND INITIATIVE CONCEPTS

NHLBI staff presented 13 new initiatives, 2 renewals, and 2 challenges, all of which had been reviewed in October by the Board of External Experts (BEE). Initiative development at the NHLBI is a two-cycle process. First, staff within each extramural division develops ideas and potential initiatives, which they present to the trans-NHLBI Idea Forum. Sufficiently developed initiatives are subsequently considered by the BEE, which ranks them 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.

Initiatives: Non-SBIR/STTR


Initiative

Purpose

Blood and Vascular Systems Response to Sepsis (R01), RFA

To conduct the multi-disciplinary science required to unravel the cellular and molecular mechanisms underlying the development of severe endothelial dysfunction that contributes to sepsis-related disseminated intravascular coagulopathy and cardiopulmonary failure.

Molecular Biology of Circadian Mechanisms in Heart, Lung, and Blood Diseases (R01), RFA

To develop new perspectives, insights and approaches to the study of heart, lung, and blood diseases by elucidating the contribution of clock-dependent molecular processes to health and human disease mechanisms, risk factors, and opportunities for treatment and prevention.

Cellular and Molecular Mechanisms Involved in the Evolution and Eventual Rupture or Dissection of Aortic Aneurysms (R01), RFA

To elucidate the cellular and molecular mechanisms involved in the evolution of thoracic and abdominal aortic aneurysms leading to rupture or dissection, and to develop methods to determine the optimal timing of surgical or endovascular interventions.

Redefining Pulmonary Hypertension through Pulmonary Vascular Disease Phenomics (U01), RFA

To define novel, clinically-relevant indices of disease risk, progression, and therapeutic responsiveness through comprehensive phenotyping and redefinition of pulmonary hypertension cohorts, leading to transformative clinical management for pulmonary vascular disease patients.

Promotion of Clinically-Integrated Randomized Controlled Trials (U01), RFA

To encourage the incorporation of randomized controlled trials into routine clinical care.

Research to Improve Evidence-Based Practice (R01), PAR

To encourage clinical research scientists to collaborate with payers and/or health care systems to conduct cost-efficient outcomes studies of scientifically important hypotheses to substantially improve both the delivery of evidence-based care and health outcomes for patients.

Research Dissemination and Implementation Grants in Heart, Lung, and Blood Diseases and Sleep Disorders (R18, Renewal), PAR

To test innovative implementation and dissemination strategies to enhance delivery of proven prevention or treatment approaches for heart, lung, and blood diseases and sleep disorders in community, public health, clinical practice, and other real-world settings.

Phenotypic Characterization of Chronic Pain in Sickle Cell Disease (R01), RFA

To develop methodologies to investigate pain phenotypes in subjects with chronic pain in sickle cell disease.

Determining Health Effects Attributable to HbAS (Sickle Cell Trait) Through Analysis of US Military Data (Y01), IAA

To create a mechanism for collaboration between the Department of Defense (DoD) and the NHLBI to conduct epidemiological research on the heterozygous state for the sickle hemoglobin beta-globin gene (HbAS), commonly called sickle cell trait (SCT). To investigate morbidity and mortality risks associated with SCT through analysis of existing DoD databases.


Initiatives: SBIR/STTR


Initiative

Purpose

Developing a Point-of-Care Device for the Diagnosis of Sickle Cell Disease in Low Resource Settings (R41,R42,R43,R44), RFA

To support the development of a point-of-care device for the diagnosis of sickle cell disease in infants and young children in low-income and low-resource settings.

New Treatments for Complications of Sickle Cell Disease (R43,R44), PAR

To develop and establish a technical and scientific approach for new treatments for the complications of sickle cell disease through the manufacture and testing of glycoproteins that bind free red blood cell constituents resulting from hemolysis.

Onsite Tools and Technologies for Heart, Lung, and Blood Clinical Research and Point-of-Care (R41,R42,R43,R44), PAR

To support the development and practical application of novel, innovative point-of-care technologies to guide diagnostic and therapeutic efforts in heart, lung, and blood clinical research settings.

Technologies to Assess Sleep Health in Populations (R43,R44), RFA

To develop and validate tests to assess and categorize individual "sleep health status" in relation to physical and mental functioning.

NHLBI Small Market Award: SBIR Phase IIB Competing Renewals for Technologies with Small Commercial Markets (R44), RFA

To provide incentive and support to Phase II SBIR awardees who are developing technologies important to the NHLBI mission, but who cannot compete successfully for a Phase IIB Bridge Award due to barriers associated with products that address small commercial markets.

Virtual Reality Technologies for Research and Education in Obesity and Diabetes (R21/R33, R41,R42,R43,R44, Renewal), RFA

To encourage small businesses, non-profit research organizations, and academic researchers to develop commercializable virtual reality technologies for use in management and prevention of diabetes and obesity.


Challenges


Initiative

Purpose

The IRB Quality Metrics Challenge

To develop metrics for the quality of IRB review to determine whether subjects have been adequately protected in research.

Web-based Patient Report Adverse Event Outcomes in Pediatric Clinical Studies

To develop a tool to facilitate electronic reporting of events by subjects (or observers) in real time, which should include a subject-user web interface, algorithms to convert open text responses to study site data tables, and an end-user interface.


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).

II. 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 and approved 1,221 applications requesting $1,765,346,792 in total direct costs.

III. INTRAMURAL REVIEW

Reports prepared by the Board of Scientific Counselors (BSC), NHLBI, on the  NHLBI intramural laboratories reviewed during FY 2012 were presented to the Council by Dr. Robert Balaban, Director, Division of Intramural Research, NHLBI, Dr. Michael I. Kotlikoff, (BSC Chair), Cornell University, and Dr. Douglas Wallace (BSC member), Children’s Hospital of Philadelphia.

ADJOURNMENT

The meeting was adjourned at 5:15 p.m.

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Last Updated March 2013



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