NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL

This is a brief summary of the November 28, 2012, meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC). It will be replaced by the full minutes of the meeting when they become available.

Welcome from the Director, NHLBI
Report of the Board of External Experts and NHLBI Initiative Concepts

WELCOME FROM 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.

[To Top]

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 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.

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.

[To Top]

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.

[To Top]

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 Reported 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.