This is a brief summary of the June 11, 2008,
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.
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OPENING REMARKS AND REPORT OF THE DIRECTOR
Dr. Elizabeth Nabel, Director of the National Heart, Lung, and Blood
Institute (NHLBI), welcomed members to the 230th meeting of the National
Heart, Lung, and Blood Advisory Council (NHLBAC).
Dr. Nabel introduced a new Council member: Dr. Marlene Rabinovitch,
Research Director, Vera Moulton Wall Center for Pulmonary Vascular Disease,
Stanford University School of Medicine.
Dr. Nabel welcomed Dr. Stephan Bour, who joined the Institute on May
11th as the Director of the Center for Biomedical Informatics. Previously,
Dr. Bour served as Head of the Bioinformatics Core Facility at the National
Institute for Allergy and Infectious Diseases (NIAID) Laboratory of Molecular
Microbiology, and in 2004, he created and subsequently led the NIAID
Bioinformatics and Scientific IT Program.
Dr. Nabel announced two other changes in personnel:
- Dr. Chris O'Donnell, Senior Advisor to the NHLBI Director for Genetics
and Genomics, has agreed to serve concurrently as Scientific Director
of the Institute's SNP Health Association Resource (SHARe) Program.
In this new position, Dr. O'Donnell will oversee the implementation
of the new NIH
Data Sharing Policy for data obtained in NIH supported or conducted
genome-wide association studies (GWAS). He will also play a key role
in steering the scientific direction of the SHARe program and coordinating
with other NHLBI genome programs.
- Dr. Keith Hoots will join the Institute in January as Director of
the Division of Blood Diseases and Resources. Dr. Hoots is currently
Professor of Pediatrics and Division Head, Pediatric Hematology, The
University of Texas Medical School at Houston; Section Head, Pediatric
Hematology, The University of Texas M.D. Anderson Cancer Center; and
Medical Director, Gulf State Hemophilia and Thrombophilia Treatment
Center. Dr. Hoots is a past president of the Hemophilia Research Society
of North America.
In March 2008, the NHLBI announced a comprehensive restructuring
of its research program in sickle cell disease (SCD) based on recommendations
from an extensive Council review of the Institute’s research
and training portfolio in SCD. The review took into account input from
patients and lay and professional constituencies about the top scientific
and
clinical priorities. Dr. Katherine High presented the report
of the Council Subcommittee review at the February Council meeting.
An editorial in the May 15th issue of Blood, written by Dr.
Nabel and Dr. Susan Shurin, Deputy Director of the NHLBI, informs the
scientific community about the new directions envisioned for the sickle
cell research program.
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Budget Report
Dr. Nabel reported that no changes have been made to the Institute's
FY 2009 budget since it was presented to Council in February, and little
change is expected until the new Administration is in place. The Institute's
FY 2009 President's Budget is $2,924,942,000, essentially the same as
the FY 2008 budget (a 0.1 percent increase). The Institute's payline
for traditional research project grants (R01s) is now at the 15th percentile;
at the 25th percentile for new investigators' R01s (if expedited administrative
review resolves summary statement comments); and at the 20th percentile
for first-time renewal R01 applications from new investigators.
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UPDATE ON ENHANCING PEER REVIEW
 Dr.
Nabel updated the Council on the recent NIH-led effort to study
the NIH peer review system and determine ways to enhance it. First-rate
peer review is a cornerstone of the NIH, but new challenges for peer
review are being created by the increasing breadth, complexity, and interdisciplinary
nature of biomedical science and exacerbated by tight budgetary times.
Four core priorities emerged from the study, along with suggested actions
for achieving related goals. The identified core priorities are:
- Engage the best reviewers.
- Improve the quality and transparency of reviews.
- Ensure balanced and fair reviews across scientific fields and scientific
career stages and reduce burden on applicants.
- Develop a permanent process for continuous review of peer review.
The NIH is currently beginning the phased implementation of selected
actions. Dr. Zerhouni is reviewing the proposed actions and
is expected to announce his recommendations soon.
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Related NHLBI Policy Issue
In an effort to reduce the burden currently imposed on applicants, reviewers,
and NHLBI staff by the large number of amended applications submitted
each year, the NHLBI is proposing to set different paylines for original
applications (i.e., A0s), first amendments (i.e., A1s), and second amendments
(i.e., A2s). Since a large percent of original applications with good
scores are ultimately awarded, the process of submitting and reviewing
revised applications for these projects seems an unnecessary burden.
Dr. Nabel presented Institute data showing the number of unpaid A0s and
A1s that could have been paid in FY 2007 from the dollars that would
have been freed up by raising the payline for A2s for R01 and Exploratory/Developmental
Research Grant (R21) applications.
Dr. Nabel requested input from Council on this potential policy change.
Council members discussed the issue, raised questions, and offered numerous
suggestions. The NHLBI plans to formulate a series of options, ask Council
to review them over the summer, and raise the topic again at the September
2008 Council meeting.
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REPORT ON THE PUBLIC INTEREST ORGANIZATION (PIO) MEETING
Ms. Paula Polite, Council member and Manager of Quality Programs, Division
of General Services for the City of Memphis, Memphis, Tennessee, reported
on the NHLBI Ninth Annual PIO Meeting held June 9-10 in Bethesda, Maryland.
Ms. Polite acknowledged that the PIO meetings are always a useful opportunity
for attendees to learn how their organizations and the NIH can work together
for their mutual benefit. Several PIO representatives also attended the
Council meeting. This year's PIO meeting agenda included:
- a keynote address by Dr. Robert Balaban, Scientific Director of the
NHLBI Division of Intramural Research, and Dr. Keith Horvath, leader
of research at the NIH Heart Center at Suburban Hospital, Chief of
Cardiothoracic Surgery at Suburban Hospital, and Director of Cardiothoracic
Surgery Research at the NHLBI.
- "Complementary and Alternative Medicine: Hope or Hype ... and
How to Tell the Difference," presented by Dr. Josephine Briggs,
Director of the National Center for Complementary and Alternative Medicine,
NIH
- an overview of genome-wide association studies, presented by Dr.
Nabel
- "Perspectives on NIH Research Support," which addressed
the state of the NHLBI budget; NIH research, condition, and disease
categorization; a new NIH research portfolio on-line reporting tool;
and peer review; and included the perspective of a PIO representative.
- "Marfan Syndrome: A Bench-to-Bedside Case Study," presented
by a researcher, a representative of the National Marfan Foundation,
and a member of the NHLBI scientific staff
- sessions on "Psychosocial Issues and Patients with Heart, Lung,
Blood, and Sleep Diseases and Disorders" and "Clinical Trials:
Reaching Out to Patients and Their Families"
- time to meet with NHLBI staff.
Dr. Nabel conveyed the Institute's pleasure in hosting members of the
PIOs each year.
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SCIENTIFIC AND CLINICAL IMPACT OF THE NHLBI CENTERS
FOR PROTEOMIC INNOVATION
 Dr.
Susan Old, Acting Deputy Director, Division of Cardiovascular Diseases,
NHLBI, reviewed the history and purpose of the NHLBI
Proteomics Initiative. In FY 2002, the Institute established a consortium
of 10 highly interactive, multi-disciplinary Proteomics Centers to enhance
and develop innovative proteomic technologies and apply them to relevant
biological questions to advance knowledge of heart, lung, blood, and
sleep health and disease. The Centers are entering their final year of
support.
Directors of three Centers discussed highlights of their research:
- Dr. Jennifer Van Eyk, Director of the Johns Hopkins University NHLBI
Proteomics Center
- Dr. Garry P. Nolan, Director of the Stanford University NHLBI Proteomics
Center
- Dr. Thomas Kodadek, Director of the University of Texas (UT) Southwestern
Center for Proteomics Research
They emphasized that the NHLBI Proteomics Initiative has revolutionalized
the field of proteomics.
A booklet providing an overview of the NHLBI Proteomics Initiative,
including summaries of Center activities, news articles, and metrics
on the productivity of the program, was distributed. The specific objectives
of the 10 Centers are:
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ACTIVITIES OF THE BOARD OF EXTERNAL EXPERTS (BEE)
The Board of External Experts (BEE), an advisory group to the NHLBI
Council, is charged with assisting the Institute in implementing its
Strategic Plan, discussing and prioritizing program ideas and potential
initiatives,
serving as
an incubator for new ideas and recommendations, recommending improvements
in the Institute's business operations, and providing advice on a program's
effectiveness on an ad hoc basis.
At its meeting on May 7, 2008, the BEE discussed and prioritized a number
of proposed initiatives. Because the NHLBI Idea Forum provides an opportunity
for scientific staff to present ideas and receive and incorporate input
from their colleagues early in the initiative development process, initiatives
are
mature and well-defined when they are presented to the BEE.
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PROPOSED INITIATIVES
NHLBI staff presented 18 new initiatives, all of which had been reviewed
and ranked by the BEE. The Council was supportive of the initiatives
but made a number of specific recommendations for consideration prior
to their release. Dr. Nabel 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
Initiative
|
Purpose
|
| Initiatives related to Sickle Cell Disease: |
| Exploratory
Studies in the Neurobiology of Pain in Sickle Cell Disease,
RFA |
To investigate pain syndromes in sickle
cell disease by using techniques that have been applied to the elucidation
of the nociceptive system in non-human and human studies of acute
and chronic pain. |
NHLBI-CDC Registry
and Surveillance System in Hemoglobinopathies (RuSH),
RFP
|
To develop and implement a national data system (surveillance
component and registry system) and biospecimen repository that will
provide data to describe the epidemiologic and clinical characteristics
of people with all genotypes of sickle cell disease, thalassemias,
and other hemoglobinopathies. This initiative will conduct the first
phase of the project, comprising pilot studies in 7 to 10 states
to test specific data collection methods, procedures, and organizational
structures, and to determine the feasibility of implementing RuSH
on a national level. |
| Translational Initiatives: |
| Translational Program
Project Grants (tPPG), PAR |
To encourage collaborative, translational science
that will help foster a research continuum from basic to applied
biomedical research to improve diagnosis and treatment. A two-cycle
program project is proposed: the first cycle requires a small clinical
research component, while the second cycle shifts to a program with
a significant clinical research component. |
| Phase II Clinical Trials
for Evaluation of Novel Therapies for Lung Diseases and Sleep
Disorders, RFA |
To support phase II clinical treatment trials (i.e.,
proof of concept, interventional studies) of innovative and novel
agents for lung diseases and sleep disorders, along with one or more
closely related, smaller ancillary mechanistic studies linked to
the clinical question. |
| Cardiac Translational
Research Implementation Program (C-TRIP), RFA |
To accelerate translation of promising new fundamental
research discoveries for the treatment and prevention of heart failure
and arrhythmias through well-designed clinical trials that demonstrate
efficacy and safety; a two-staged program to support (1) study development
and trial planning, and (2) clinical trials of new therapeutic interventions. |
| Initiatives related to Strategic Plan Goal
I: |
| Airway Smooth Muscle
Function and Targeted Therapeutics in Human Asthma, RFA |
To investigate the complex role of airway smooth muscle functions
in the development of human asthma and to identify new therapeutic
targets.
|
| Characterizing the Blood
Stem Cell Niche, RFA |
To develop approaches to dissect the cellular components
and factors involved in the hematopoietic stem cell niche, such as
the use of conditional genetic knock-out models to test the role
of factors from specific cell lineages, along with cellular imaging. |
| Crosstalk between Platelets
and Immune-competent Cells during Inflammation, RFA |
To improve understanding of the pathophysiological
mechanisms of immune cell and platelet interactions that lead to
thrombosis, and to use new technologies and research methodologies
to identify common regulatory pathways for cellular components of
immune and coagulation systems to develop targeted therapeutic interventions
for thrombotic events and inflammation. |
| Microbiome of the Lung
and Respiratory Track in HIV-infected Individuals and Controls,
RFA |
To characterize the microbiome in the lung alone,
or in combination with the microbiome of one of the nasal and/or
oropharyngeal cavities, in HIV-infected individuals and matched uninfected
controls, by using molecular techniques to identify bacteria and
possibly other organisms such as viruses, cell wall deficient organisms,
protozoa, and fungi. |
| Summer Institute for
Training in Biostatistics (SIBS) II, RFA |
To support up to seven universities to teach summer
courses in biomedical statistics for advanced undergraduates and
beginning graduate students to encourage them to pursue careers
in this area.
|
| The Role of Cardiomyocyte
Mitochondria in Heart Disease: An Integrated Approach,
RFA |
To improve understanding of cardiomyocyte mitochondrial
biology and its contributions to myocardial adaptations and disease
progression by combining functional data with information derived
from powerful new technologies, such as genomics, proteomics, metabolomics,
and imaging. |
| Ancillary
Studies in Clinical Trials — Renewal, RFA |
To conduct time-sensitive ancillary studies related
to heart, lung, and blood diseases and sleep disorders in conjunction
with ongoing large clinical studies. An accelerated review/award
process will be an integral part of this initiative to support
the crucial time frame in which these ancillary studies must be
performed.
|
| Initiatives related to Strategic Plan Goal
II: |
| PUMPs for
Kids, Infants, and Neonates (PumpKIN) — Renewal ,
RFP |
To translate the advances developed through the
Pediatric Circulatory Support Program into clinical benefit for
neonates, infants, and small children. The staged, milestone-driven
process includes: (1) pre-clinical testing and analyses
sufficient for FDA Investigational Device Exemption (IDE) approval;
(2) development of an FDA-approved clinical trial design; (3) manufacturing
of devices for the pre-clinical and clinical studies; and (4) clinical
trials for the most promising advanced ventricular support devices
for young pediatric patients.
|
| Interagency
Registry for Mechanically Assisted Circulatory Support (INTERMACS) — Renewal ,
RFP |
To continue support for a data and clinical coordination
center to manage INTERMACS (the established national registry of
patients receiving mechanical circulatory support device therapy
to treat advanced heart failure) and associated activities; extend
the registry into pediatric populations; and continue to publish
and disseminate results to the scientific, medical, and lay communities.
|
| Clinical
Proteomics Program — Renewal, RFA |
To encourage systematic, comprehensive, large-scale
validation of existing and new candidate protein markers for use
in predicting disease susceptibility, diagnosis, disease staging,
assessing response to therapy, and assessing prognosis; and to
develop an educational curriculum for physicians and scientists
to gain expertise in the clinical application of proteomics.
|
| Diuretic-induced
Dysglycemia in Treatment of Hypertension with Clinically Effective
Doses of Diuretics: Potential for Prevention, RFA |
To evaluate clinically feasible approaches to
preventing diuretic-induced increase in serum glucose levels (and
resulting new-onset diabetes) and to investigate mechanistic and
genetic underpinnings of diuretic-induced dysglycemia and its prevention.
|
| Production
Assistance for Cellular Therapies (PACT) — Renewal,
RFP |
To continue to support cellular therapy research
in the areas of regeneration of damaged/diseased tissues, organs,
and biologic systems, and targeted treatments for serious diseases
without effective therapies; to continue to provide the current
services of the three PACT cell-manufacturing facilities and to
include other services, such as adding up to six geographically
dispersed facilities to provide the consulting, manufacturing,
and regulatory expertise essential for the development of
cellular therapies
for heart, lung, and blood diseases and disorders.
|
| Initiatives related to Strategic Plan Goal
III: |
| Childhood Obesity Prevention
and Treatment Research Networks, RFA |
To support multiple controlled trials to test the
efficacy of innovative interventions that address issues germane
to the childhood obesity epidemic. The program would have two main
foci: (1) prevention of excess weight gain in non-overweight youth
and
additional
weight
gain in obese youth, and (2) weight loss in obese youth. |
|
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