NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL

MEETING MINUTES
October 20, 2009

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

Dr. Elizabeth G. Nabel, Director of the National Heart, Lung, and Blood Institute, opened the meeting at 8:00 a.m., and welcomed members to the 236th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC).

Invited Guests:

Nabel welcomed representatives of other NHLBI Advisory Committees:

  • Dr. C. William Balke, representing the NHLBI Institutional Training Mechanism Review Committee
  • Dr. Charles Czeisler, representing the Sleep Disorder Research Advisory Board
  • Dr. Gary K. Owens, representing the Board of Scientific Counselors
  • Dr. John J. Reilly, Jr., representing the Clinical Trials Review Committee

Dr. Edward Benz of the Sickle Cell Disease Advisory Committee and Dr. Anne Marie Schmidt of the National Heart, Lung, and Blood Program Project Review Committee were unable to attend.

Dr. Nabel recognized five Council members who are retiring:

  • Dr. Victor Dzau
  • Dr. Helen Hobbs
  • Dr. Jennie Joe
  • Dr. Joseph Loscalzo
  • Dr. S. K. Rao Musunuru

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

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 and the review of intramural programs. A notice of this meeting was published in the Federal Register. 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

Budget Update

The NIH is currently operating under a Continuing Resolution, which means that the NHLBI must operate at its FY 2009 budget level of $3,014,552,000. Dr. Nabel reviewed the Institute's proposed FY 2010 President's Budget, which totals $3,050,356,000, a 1.3 percent increase over the FY 2009 actual budget. Total research project grants (noncompeting and competing) are proposed at $2,051,848,000, a 0.6 percent increase over FY 2009.

American Recovery and Reinvestment Act (ARRA) Update

The ARRA was signed into law by President Obama on February 17, 2009. It provides $10.4 billion to the NIH (available for 2 years—through September 2010) to support programs to stimulate the economy, create and preserve jobs, and advance biomedical research.

Dr. Nabel reviewed the Institute's FY 2009/FY 2010 ARRA funding plan. Most of the Institute's ARRA allotment has been obligated.

Update on Enhancing Peer Review

Dr. Nabel updated the Council on progress in implementing recommended actions resulting from the recent NIH-led study of the NIH peer review system. Several changes were implemented in 2009. For example, the NIH began phasing out second amendments (i.e., A2s); and study sections began using enhanced review criteria, a new scoring system, and structured critiques.

Investigators submitting competing applications for the January 25, 2010, submission date (and beyond) should be aware of several major additional changes:

  • restructured application forms
  • shorter page limits
  • new instructions

Investigators are cautioned to pay close attention to modified application instructions. Further information is available at Enhancing Peer Review at NIH.

NHLBI Global Health Programs

The Institute is participating in two new global health programs:

  • NHLBI Centers of Excellence: The goal of the NHLBI Centers of Excellence is to address non-communicable chronic cardiovascular and pulmonary diseases in developing countries. The Centers will develop research capacity; train investigators in chronic cardiovascular and pulmonary diseases; and conduct research on approaches, programs, and measures to prevent or treat such diseases. The NHLBI will support 8-10 Research Centers and an Administrative Coordinating Center. This program is a partnership between the NHLBI and UnitedHealth Group, which is also supporting several Centers.
  • Global Alliance for Chronic Diseases: The Alliance is the first collaboration of major international biomedical research funding agencies to address chronic noncommunicable diseases. Goals of the Alliance are to coordinate research activities that address prevention and treatment of chronic diseases worldwide; identify common approaches to guide policy and develop and share best practices for addressing chronic diseases; and build capacity in research, training, and healthcare delivery in low- and middle-income countries and among low-income and indigenous populations in developed countries.

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IV. MITOCHONDRIAL FUNCTION AND OXIDATIVE STRESS IN STEM AND PROGENITOR CELL BIOLOGY Dr. Toren Finkel

Dr. Toren Finkel, Chief of the Translational Medicine Branch, NHLBI Division of Intramural Research, discussed his laboratory's research. Dr. Finkel's primary research interests are oxidant or free radical-mediated diseases, aging, and the clinical cardiovascular implications of stem cells. His laboratory seeks to increase understanding of the role of reactive oxygen species as intracellular signaling molecules. Oxygen radicals have been implicated in a number of conditions ranging from aging to atherosclerosis. Dr. Finkel's research uses a molecular biological approach to address these issues.

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V. REINVENTING NHLBI'S TRANSLATIONAL PROGRAMS Dr. Elizabeth G. Nabel

Dr. Nabel reviewed the Institute’s established translational research programs and presented new and proposed translational approaches. Council was very enthusiastic about the programs.

Established translational research programs:

  • Clinical Research Networks: an established infrastructure of clinical centers and associated support center(s) to enable the rapid development and conduct of multiple clinical protocols to facilitate assessment of promising diagnostic and therapeutic approaches in major disease areas within the mandate of the NHLBI (e.g., Heart Failure Clinical Research Network, Asthma Clinical Network, Blood and Marrow Transplant Clinical Research Network).
  • Production Assistance for Cell Therapy (PACT): an established infrastructure to support cellular therapy research in the areas of regeneration of damaged/diseased tissues, organs, and biologic systems, and targeted treatments for serious diseases that do not have effective therapies. PACT provides cell-manufacturing facilities and consulting, manufacturing, and regulatory expertise essential for the development of cellular therapies for heart, lung, and blood diseases and disorders.

  • NIH Rapid Access to Intervention Development (RAID): an established NIH program to remove common barriers between laboratory discoveries and clinical trials of new molecular entities.

New translational approaches:

  • Bench to Bassinet Program: a new approach to create a critical mass of collaborative research across three interacting consortia.
    • Cardiovascular Development Consortium—will investigate the transcriptional regulatory networks that govern cardiac development, using complementary animal models.

    • Pediatric Cardiac Genomics Consortium—will recruit children into a protocol to speed discovery of causative genes and evaluate the effects of genetic variation on short- and long-term outcomes in patients with congenital heart disease.

    • Pediatric Heart Network (an NHLBI clinical research network)—has designed and conducted clinical trials since 2001.

  • Cardiac Translational Research Implementation Program (C-TRIP): a two-stage program to accelerate the translation of promising therapeutic interventions (derived from fundamental research discoveries) for the treatment and prevention of heart failure or arrhythmias.

  • Grand Opportunities Translational Research Implementation Program (GO TRIP): a two-stage program modeled on the C-TRIP, but applicable to all diseases and conditions within the mandate of the NHLBI. (Stage 1 will be supported with ARRA funds.)

  • Translational Program Project Grant (tPPG): a two-cycle program to promote the development and application of a specific product or deliverable (e.g., small molecule, biologic, methodology) to be used in the prevention, diagnosis, or treatment of lung and/or sleep diseases.

  • Phase II Clinical Trials of Novel Treatments for Lung Diseases: a program to support Phase II interventional treatment trials that have at least one related, small ancillary study (mechanistic study), with a clinical investigator leading the treatment trial and a basic investigator leading the ancillary study.

  • Science Moving TowArds Research Translation and Therapy (SMARTT): a program to remove common barriers between laboratory discoveries and clinical trials of new molecular entities (includes a Production Facility for biologics; a Production Facility for non-biologics and small molecules; a Pharmacology/Toxicology Center; and a Coordinating Center).

Proposed translational approaches:

  • Centers for Advanced Diagnostics and Therapeutics (CADET): a centers program to develop diagnostics and/or therapeutics for lung and sleep disorders that will emphasize structured interactions, collaborations, and data sharing among the individual centers, with a centralized database for phenotyping.
  • NHLBI Clinical Trial Pilot Studies: a program to support pilot studies designed to obtain data that are necessary and sufficient to permit the design of robust clinical trials. The program is expected to enable more competitive investigator-initiated clinical trial grant applications and more robust and successful clinical trials.

  • Planning Grants for Pivotal Clinical Trials in Hemoglobinopathies: a program to support activities necessary to assess feasibility and to develop pilot studies required for the design of a full-scale trial. This activity will address issues that are inherent to hemoglobinopathies and other rare disorders.

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VI. MEETING OF THE BOARD OF EXTERNAL EXPERTS Dr. Elizabeth G. Nabel

NHLBI staff presented 8 new initiatives, 11 renewals, and 4 requests by other ICs for secondary support, 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.

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VII. PRESENTATION OF INITIATIVES Dr. Elizabeth G. Nabel

Initiatives and Ideas Related to 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

Ancillary Studies in the ACCORD Clinical Trial or the ACCORD Follow-up Study (R01), PAR

To support ancillary studies that use stored biospecimens from the main ACCORD trial or that propose to collect new data from the ACCORD Follow-up Study.

Council recommended this initiative.

Molecular Phenotyping of Alpha-1 Antitrypsin (AAT) Deficiency (U01), RFA

To identify AAT-associated molecular abnormalities in individuals with and without clinical lung disease.

Council recommended this initiative.

Paracrine Signaling of Cardiac Electromechanical Activity (R01), RFA

To improve understanding of the molecular and physiological bases of paracrine signaling of cardiac function.

Council recommended this initiative.

PFINDR: Phenotype Finder IN Data Resources: A Tool to Support Cross-study Data Discovery among NHLBI Genomic Studies (UH2/UH3), RFA

To apply new informatics tools to categorize phenotype measurements from genome-wide association studies and other genomic studies to help researchers identify data sets of interest as well as potential future collaborations.

Council recommended this initiative.

Renewal of the Heart, Lung, and Blood Institute Biologic Specimen Repository (N01; renewal), RFP

To continue support of the NHLBI Biorepository, the purpose of which is to acquire, store, and distribute quality biospecimens to the scientific community using standardized processes and procedures.

Council recommended this initiative.

Sarcoidosis: Research into the Cause of Multi-organ Disease and Clinical Strategies for Therapy (R01; renewal), PA

To stimulate research on the etiology and management of sarcoidosis. Research to identify the cause of sarcoidosis, as well as related predisposing genetic factors, is encouraged.

Council recommended this initiative.

Severe Asthma Research Program (SARP) (R01; renewal), RFA

To expand SARP’s phenotypic analyses of individuals with severe asthma to include longitudinal characterization of molecular, cellular, and physiologic phenotypes. SARP is a multi-center collaborative research program to improve understanding about the subset of asthma patients whose disease is relatively refractory to existing therapies.

Council recommended this initiative.

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

Antihypertensive and Lipid-Lowering to Prevent Heart Attack Trial (ALLHAT) Extension (contract; renewal), RFP

To enable the ALLHAT coordinating center to support continued scientific contributions based on extensive ALLHAT data and to expand collaborations with relevant scientific communities outside of ALLHAT. The ALLHAT, a landmark comparative effectiveness trial, reported its main results in 2002.

Council recommended this initiative.

Ancillary Studies in Clinical Trials (R01; renewal), RFA

To conduct time-sensitive ancillary studies related to heart, lung, and blood diseases and sleep disorders in conjunction with ongoing clinical trials and other large clinical studies.

Council recommended this initiative.

Centers for Advanced Diagnostics and Experimental Therapeutics in Lung Diseases (U50), RFA

To accelerate the development of new agents for the diagnosis and treatment of lung and sleep disorders.

Council recommended this initiative.

Competitive Renewal of the Blood and Marrow Transplant Clinical Trials Network (U01; renewal), RFA

To continue support of a Blood and Marrow Transplant Clinical Trials Network, focused on reducing risks and improving outcomes for patients undergoing hematopoietic stem cell transplantation.

Council recommended this initiative.

Guided Antiplatelet Investigation of Therapy Trial: A Comparative Effectiveness Study of Antiplatelet Therapy Strategies (N01), RFP

To compare, in patients with moderate- to high-risk acute coronary syndromes, treatment with a well-established, safe, and inexpensive therapy versus treatment with a newer, more expensive therapy that is known to have a relatively high rate of bleeding complications. The trial also seeks to demonstrate that in vitro tests of platelet function can be used effectively to guide antiplatelet therapy.

Council recommended this initiative.

Heart Failure Clinical Research Network (U01; renewal), RFA

To accelerate research in the diagnosis and management of heart failure by continued support of the Heart Failure Clinical Research Network.

Council recommended this initiative.

National Longitudinal Mortality Study (renewal), IAA

To support a 4-year analysis phase of the National Longitudinal Mortality Study, the objectives of which are to: analyze social, economic, demographic, and occupational differentials in mortality relevant to the NHLBI; analyze trends in these relationships over time; and analyze social and economic differentials in healthcare utilization and outcomes.

Council recommended this initiative.

Planning Grants for Pivotal Clinical Trials in Hemoglobinopathies (R34), RFA

To support pilot studies that will answer research questions essential for the design of robust clinical trials related to major hemoglobinopathies, sickle cell disease, and thalassemias.

Council recommended this initiative.

The Pediatric Heart Network (U01; renewal), RFA

To continue support of the Pediatric Heart Network, the goal of which is to improve the health and quality of life of children, adolescents, and young adults with congenital and acquired heart disease.

Council recommended this initiative.

Initiatives Related to 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

Clinical Research Career Development Programs in Emergency Medicine (K12), RFA

To develop multidisciplinary clinical research training programs to prepare clinician-scientists for academic leadership roles and independent research careers in the study of innovative approaches to diagnose and treat patients with acute manifestations of cardiovascular, pulmonary, and hematologic diseases, and severe trauma in emergency settings.

Council recommended this initiative.

New Approaches to Arrhythmia Detection and Treatment (SBIR [R43/R44] and STTR [R41/R42]; renewal), PA

To encourage small businesses to develop improved diagnostic and therapeutic tools, products, or devices for cardiac arrhythmia monitoring, detection, and treatment.

Council recommended this initiative.

Research Dissemination and Implementation Grants (R18; renewal), PA

To support dissemination and implementation studies to: test the effectiveness of interventions that enhance health-promoting behaviors; compare the effectiveness of interventions to reduce risk factors for, and enhance prevention of, heart, lung, and blood diseases and sleep disorders; develop and test innovative implementation approaches for translating efficacious treatments for heart, lung, and blood diseases and sleep disorders; and compare specific approaches for dissemination, implementation, translation, and sustainability in defined populations in real-world settings.

Council recommended this initiative.

Requests for Secondary Support

NHLBI/NICHD Collaborations in Transfusion Medicine for Neonates (U10) [NICHD], RFA

To characterize and advance transfusion medicine therapies in neonatal medicine.

Council recommended this initiative.

NHLBI/NICHD Collaborations in Transfusion Medicine for Pediatric Critical Care Medicine (U10) [NICHD], Other

To characterize and advance transfusion medicine therapies in pediatric critical care medicine.

Council recommended this initiative.

Sleep-Disordered Breathing During Pregnancy and Risks to Cardiovascular Health (U10) [NICHD], Other

To elucidate the significance of sleep-disordered breathing during pregnancy as a risk to maternal cardiovascular health and related pregnancy outcomes.

Council recommended this initiative.

The Physical Activity to Prevent Disability Trial (U01) [NIA], RFA

To obtain outcome measures of clinical cardiovascular, lung, and sleep diseases from the participants in a trial designed to test the effect on mobility disability of a 2-year physical activity program compared with a successful aging health education program in elderly adults (ages 70-89).

Council recommended this initiative.

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).

This 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.

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VIII. INTRAMURAL REVIEW

Drs. Robert Balaban from the Division of Intramural Research, NHLBI and Gary Owens from the University of Virginia, School of Medicine presented reports prepared by the Board of Scientific Counselors, NHLBI, on the NHLBI intramural laboratories reviewed during FY 2009.

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IX. REVIEW OF APPLICATIONS

The Council considered 1,175 applications requesting $ 1,562,870,377 in total direct costs. The Council recommended 1,174 applications with total direct costs of $1,560,554,815.

The meeting was adjourned at 3:40 p.m. on October 20, 2009.

ADJOURNMENT

 

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