NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL
This is a brief summary of the June 13,
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.
REPORT OF THE ACTING DIRECTOR, NHLBI
Dr. Susan B. Shurin, Acting Director of the National Heart, Lung, and
Blood Institute (NHLBI), welcomed members to the 246th meeting of the
National Heart, Lung, and Blood Advisory Council (NHLBAC).
Dr. Shurin updated the Council on NHLBI and NIH leadership appointments:
- Dr. Gary H. Gibbons has been appointed the next NHLBI Director. He
is expected to start in early August.
- Ms. Sandy Gault, NHLBI Financial Management Officer, is retiring
at the end of the month.
- Mr. Alex Hawkins is the new NHLBI Financial Management Officer.
- Ms. Debra C. Chew has been appointed Director, NIH Office of Equal
Opportunity and Diversity.
Dr Shurin updated the Council on member news:
- Mr. Jonathan Alger has been named President of James Madison University
in Harrisonburg, Virginia.
- Dr. Lanetta Jordan joined the faculty of the Miller School of Medicine
at the University of Miami.
Dr. Shurin discussed the FY 2013 President's Budget. The proposed NHLBI
budget remains relatively flat overall, with a total increase
of 0.02%, or approximately $700 thousand. However, the Research Project
Grant (RPG) line would decrease slightly, in part due to a mandated increase
in Small Business Innovation Research (SBIR)/Small Business Technology
Transfer Research (STTR) funding. Despite the RPG funding decrease, a
slight increase in numbers of competing RPGs is expected because of
The FY 2012 funding payline will remain at the 10th percentile for
established investigator R01s and R21s. Pending availability of funds,
the Institute intends to make use of the select pay option to fund some
Dr. Shurin discussed the SBIR/STTR programs. Their reauthorization mandated
increasing the set-aside percentages over the course of the next 6 years.
a Scientific Management Review
Board (SMRB) subcommittee is analyzing the SBIR/STTR program at the NIH.
Its charge is to recommend strategies for how the NIH can optimize its
use of the SBIR/STTR programs in keeping with the NIH mission.
The NHLBI convenes a Topic Review Advisory Committee with a charge to
assist NHLBI staff in identifying, assessing, and developing SBIR/STTR
for commercial development.
Dr. Shurin updated the Council on two other SMRB recommendations--(1)
translational medicine and therapeutics, and (2) substance use, abuse,
and addiction research
- The National Center for Advancing Translational Sciences (NCATS)
was created based on the SMRB recommendations. Programs in clinical
and translational science (CTSAs), rare diseases research and therapeutics,
and re-engineering translational sciences have been imported into NCATS.
It has new initiatives in tissue chips for drug screening, rescuing
and repurposing drugs, and target validation. Moving forward, NCATS
is looking to recruit permanent leadership, convene an advisory council
and Cures Acceleration Network board, and issue new RFAS for the CTSAs
and the Therapeutic Discoveries Program.
- The SMRB recommended that the NIH establish a new institute that
encompasses all substance use, abuse, and addiction-related research
the independent existence of NIAAA and NIDA. The new National Institute
of Substance Use and Addiction Disorders is expected to be included
in the FY 2014 budget and be launched in October 2013.
Dr. Shurin discussed the proposed policy at NIH for Special Council
Review--extra consideration before awarding a grant to a PI with $1.5
million or more annual total costs in NIH research support. This policy
will likely be a requirement of the FY 2013 budget.
BIOMEDICAL RESEARCH: HOW DO WE KNOW WE ARE ON TRACK?
Dr. Michael Lauer, Director, Division of Cardiovascular Sciences, NHLBI
presented an update of ongoing activities in the Institute's program
divisions on assessing impact and productivity of research investments.
discussed developing Results Based Accountability as a part of the NHLBI
NHLBI AIDS PROGRAM OVERVIEW
Dr. Monica Shah, NHLBI AIDS Coordinator, discussed the NHLBI AIDS program.
It has an independent budget ($68 million in FY 2012), a separate payline
that is approximately 10 percentile points higher than the regular payline,
specific receipt dates, and specific review. Success rates of AIDS applications
are much higher than those of non-AIDS applications--42% versus 18%
in FY 2011. The NHLBI hopes to encourage more submissions of AIDS projects
and hopes to understand the barriers to submission.
REPORT FROM THE PUBLIC INTEREST ORGANIZATION (PIO) MEETING
Dr. Lanetta Jordan, Assistant Professor, Department of Epidemiology
and Public Health, University of Miami, Miller School of Medicine, and
member, reported on the 13th annual NHLBI PIO
Council members attended the
in addition to representatives from PIOs and professional
societies, and NHLBI staff.
BACKGROUND AND SUMMARY OF THE EXPERT PANEL REPORT ON
MANAGMENT OF SICKLE CELL DISEASE
Dr. Joylene John-Sowah, Medical Officer, NHLBI, and Dr. George Buchanan,
Professor of Pediatrics, University of Texas Southwestern Medical Center,
and Co-Chair, Sickle Cell Guidelines Expert Panel, presented background
and a summary of the Panel's report on the management of sickle cell
disease. Dr. John-Sowah discussed the reasons why sickle cell disease
management guidelines are needed:
- Effective therapies are underutilized
- The patient community has clearly stated a need
- Guideline-based care improves outcomes and reduces
- A health care disparity requires addressing
- Improvement in quality of life for those affected is desired
- Comprehensive evidence-based guidelines are lacking for this disease
- Systematic review will inform the research agenda
At the request of the NHLBAC, the NHLBI convened
a multi-disciplinary panel to develop evidence-based sickle cell disease
guidelines for children and adults, targeting primary care providers,
to enhance sickle cell disease management. Dr. John-Sowah outlined the
guideline development steps and the review and approval process. Release
guidelines is expected in December 2012.
Dr. Buchanan discussed the goals of the panel--to generate implementable
evidence-based recommendations on managing sickle cell disease in clinical
practice and to identify gaps in knowledge for additional research. The
guidelines' five major topic areas are:
- Health maintenance
- Managing acute complications
- Managing chronic complications
- Use of hydroxyurea therapy
- Use of transfusion therapy
REPORT OF THE COUNCIL WORKING GROUP ON CLINICAL PRACTICE
Dr. Pamela Douglas, Ursula Geller Professor or Research in Cardiovascular
Diseases and Director, Cardiovascular Imaging Program, Duke University
School of Medicine, and Council member, presented a report of the Council
Working Group on Clinical
was asked whether the NHLBI should create guidelines. Dr. Douglas noted
that part of the NHLBI strategic plan is, "To promote the
development and implementation
of evidence-based guidelines." She offered a snapshot of the cost
of guideline creation and dissemination and presented pros and cons for
creation of guidelines by the NHLBI.
- A small portfolio of highly respected guidelines is maintained
- The guidelines are directed to general practitioners, not just specialists
- The guidelines fill important gaps in care
- Guideline development is part of the Institute's dissemination and
public health missions
- Guidelines can help define research needs
- Many other organizations produce guidelines
- The focus of NHLBI guidelines
is becoming narrower
- Rapid changes in care can lead to guideline obsolescence
- The complexity of the guideline development process is increasing
- Guideline development has potential clinical and reputational liability
- Cost of guideline creation is high
The working group recommended that the NHLBI:
- Continue to participate in the production of select clinical practice
guidelines, primarily by partnering with professional societies
- Continue to create very few stand-alone guidelines if the need is
great and no other sponsoring organization is available
- Establish a mechanism for topic selection and prioritization
RECOGNITION OF DR. SHURIN
Dr. Larry Tabak, Principal Deputy Director, NIH, and the Council recognized
Dr. Shurin's outstanding service as Acting Director for the past 2.5
REPORT OF THE BOARD OF EXTERNAL EXPERTS AND INITIATIVE CONCEPTS
NHLBI staff presented 7 new initiatives and 5 renewals, all of which
had been reviewed in May 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 Acting 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.
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
a National Resource to Study Myelodysplastic Syndromes
(MDS): The MDS Natural History Cohort Study (N01),
To establish a natural history
cohort study and create a prospective collection of genetically
and phenotypically well-characterized biospecimens from
patients with MDS to advance the understanding
of disease progression.
Assays to Screen Genomic Hits (R21, R33),
To conduct functional analysis of identified
genetic variations related to heart, lung, blood, and sleep
phenotypes, using amenable in vitro or animal model systems.
of Human HIV-Related Lung Disease Research
To define cellular and molecular events underlying
the pathogenesis of HIV-associated lung diseases using biospecimens
and clinical data from both HIV-infected patients and controls
with an emphasis on clinical translation.
of Lung Development (U01),
To build a molecular atlas of late-stage
lung development to serve as a critical platform for discovery
research to better understand critical events, including
Topics in Transfusion
Medicine (R01, R21, Renewal),
To allow for continuation of review by a
special emphaisis panel of applications focused on topics
Research Consortium for Trauma-Induced Coagulopathy (TIC)
To enhance an existing NHLBI/Department of
Defense collaboration by creating a novel trans-agency program
to coordinate research efforts and specimen and data sharing
in TIC, allowing for a comprehensive
study of the pathophysiological mechanisms underlying TIC
and for the translation of emerging mechanistic data into
new early diagnosis and effective treatment strategies.
Strategic Plan Goal II: To improve understanding of the clinical
mechanisms of disease and thereby enable better prevention, diagnosis,
and Data Repositories Information Coordinating Center
(BioLINCC) (N01, Renewal),
To promote and expand the existing
BioLINCC infrastructure to enhance the utility and scientific
value of the NHLBI Biologic Specimen Repository and the
NHLBI Data Repository.
Trial Pilot Studies
To facilitate the development
of clinical trials by investigators who already have identified
a testable hypotheses, a preliminary trial design, and a
plan for trial implementation, but lack critical information
about the intervention, outcome, recruitment criteria, or
other elements necessary to complete the design of the trial.
in Systems and Model-Guided Approaches to Pharmacogenomics
To develop a research program incorporating
systems medicine and quantitative approaches to assess adverse
human drug response and foster translational research.
Dataset Analyses in Heart, Lung, and Blood Diseases
and Sleep Disorders (R21),
To stimulate well-focused secondary analyses
using existing human datasets to test innovative hypotheses
concerning the epidemiology, pathophysiology, prevention,
or treatment of diseases and conditions relevant to the NHLBI
Study Core Support
(N01, Renewal), RFP
To support core functions of the Strong Heart
Study to: (1) enhance the scientific productivity of the
study by expanding and promoting use of the database, promoting
use of stored samples, facilitating development of ancillary
studies, and maintaining cooperation with the participating
communities; (2) extend identification and validation
of morbidity and mortality events to significantly increase
of analyses of lower frequency clinical events and younger
age groups; (3) enhance the use of biological material through
support of the central laboratory to maintain and distribute
stored study samples; and (4) promote training and career
development opportunities for early career investigators,
particularly American Indian investigators.
Programs in Lung Diseases (P01, Renewal),
To encourage collaborative, translational
science that will foster a research continuum from basic
to applied biomedical research to improve diagnosis and treatment
of lung and sleep diseases.
Last Updated July 2012