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NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL

MEETING MINUTES
October 20, 2009

I. CALL TO ORDER AND OPENING REMARKS - Dr. Elizabeth G. Nabel
II. REVIEW OF CONFIDENTIALITY AND CONFLICT OF INTEREST - Dr. Elizabeth G. Nabel
III. REPORT OF THE DIRECTOR - Dr. Elizabeth G. Nabel
IV. MITOCHONDRIAL FUNCTION AND OXIDATIVE STRESS IN STEM AND PROGENITOR CELL BIOLOGY – Dr. Toren Finkel
V. REINVENTING NHLBI'S TRANSLATIONAL PROGRAMS – Dr. Elizabeth G. Nabel
VI. MEETING OF THE BOARD OF EXTERNAL EXPERTS – Dr. Elizabeth G. Nabel
VII. PRESENTATION OF INITIATIVES – Dr. Elizabeth G. Nabel
VIII. INTRAMURAL REVIEW
IX. REVIEW OF APPLICATIONS

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
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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.