- I. CALL TO ORDER
- II. ADMINISTRATIVE ANNOUNCEMENTS
- III. REPORT OF THE DIRECTOR
- IV. WORKING GROUP UPDATES
- V. NHLBI EPIDEMIOLOGY: STRATEGIC VISIONING
- VI. IMPLEMENTATION SCIENCE
- VII. REPORT OF THE BOARD OF EXTERNAL EXPERTS AND INITIATIVE CONCEPTS
- VIII. DELEGATED AUTHORITIES
- IV. MODELING CHANGES IN NIH FUNDING LEVELS (WEBINAR)
- X. REVIEW OF APPLICATIONS
The 251st meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) was convened at 8:02 a.m. on Wednesday, June 19, 2013, in Conference Room 10, C Wing, Building 31, National Institutes of Health (NIH), Bethesda, Maryland. The meeting was open to the public until 2:00 p.m. Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI), presided as Chair.
Council Members attending in person:
Ms. Coletta C. Barrett
Dr. Ivor J. Benjamin
Dr. George Q. Daley (ad hoc)
Dr. Pamela S. Douglas
Dr. Jonathan A. Epstein (ad hoc)
Dr. Lanetta B. Jordan
Dr. Ron G. King
Dr. Barbara A. Konkle
Dr. Naomi L.C. Luban
Dr. Polly E. Parsons
Dr. Bruce M. Psaty (ad hoc)
Dr. Veronique Lee Roger
Dr. Leslee J. Shaw
Dr. Anna Maria Siega-Riz
Dr. Gilbert C. White II
Dr. Jeffrey A. Whitsett (ad hoc)
Council Members attending via videoconference:
Dr. Talmadge E. King
Council Members Absent:
Mr. Jonathan R. Alger
Dr. Robert L. Jesse (ex officio)
CSR Employees Present:
Dr. Larry Boerboom
Dr. Robert Freund
Dr. Kathy Malinda
Dr. Eduardo Montalvo
Dr. Navid Ghaffarzadegan, Massachusetts Institute of Technology (via videoconference)
Dr. Richard Larson, Massachusetts Institute of Technology (via videoconference)
Members of the Public Present:
Mr. Dane Christansen, Health and Medical Counsel of Washington
Ms. Julie Croxford, Research Triangle Institute
Ms. Claudia Louis, American Heart Association
Ms. Karen Mowrer, Association of Independent Research Institutes
Ms. Lori Pellnitz, SRI International
Mr. Rick Stout, Westat
Dr. Philip Wolf, Boston University
NHLBI Employees Present:
Numerous NHLBI staff members were in attendance or were able to view the meeting via closed circuit broadcast.
Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI), welcomed members to the 251st meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC).
Dr. Jodi B. Black, Deputy Director, Division of Extramural Research Activities, NHLBI, introduced new Council members, who joined the meeting as ad hoc members because their paperwork is still in progress, but who should be full voting members by the September meeting:
- Dr. George Q. Daley, Samuel E. Lux IV Professor of Hematology, Harvard Medical School, and Director, Stem Cell Transplantation Program, Howard Hughes Medical Institute, Children's Hospital Boston
- Dr. Jeffrey A. Whitsett, Co-Director, Perinatal Institute, Cincinnati Children's Hospital Medical Center
Dr. Black updated the Council on member and staff appointments and transitions:
- Council member Ivor Benjamin has been named Chief of the Division of Cardiovascular Science at the Medical College of Wisconsin. He also serves as Director of the College’s Cardiovascular Research Center and Vice Chair for Translational Research.
- Dr. George Mensah has joined the Institute as a Special Advisor in the Immediate Office of the Director.
- Dr. Larry Mahan has been appointed Director of the Office of Translational Alliances and Coordination within the Division of Extramural Research Activities.
- Dr. Tim Moore is the new Branch Chief for the Lung Biology and Disease Branch within the Division of Lung Diseases. He replaces Dr. Dorothy Gail, who is retiring from the NHLBI after 37 years at NHLBI.
- Dr. Diane Bild, the Associate Director for Prevention and Population Sciences in the Division of Cardiovascular Sciences, is leaving the NHLBI after more than 20 years to become a Senior Program Officer at the Patient-Centered Outcome Research Institute.
- Dr. Denise Simons-Morton has left the Institute after more than 20 years to join the NIH Office of Disease Prevention.
Dr. Gibbons began his Report of the Director with a fiscal update, the impact of the sequester, and the $175 million (5 percent) budget cut that NHLBI has absorbed. The NHLBI has been able to achieve an R01 payline at the 11th percentile. He spoke of the need for strategic priority setting based on NHLBI’s enduring principals of valuing investigator-initiated fundamental discovery science; maintaining a balanced, cross-disciplinary portfolio; supporting implementation science to improve health; training a diverse new generation of scientific leaders; and elucidating and eliminating health inequities in this country and around the world.
Dr. Michael S. Lauer, Director of the Division of Cardiovascular Sciences spoke about the Council Working Group Report on Clinical Guidelines. The group was convened in early 2012 and made three recommendations at the June 2012 Council meeting: 1) continue participating in the production of select clinical practice guidelines, primarily by partnering with societies; 2) continue to create a very few stand-alone Guidelines if the need was great and there were no other sponsoring organizations: 3) and establish a mechanism for top selections.
A second group, formed in October 2012, with three Council members and three Board of External Experts (BEE) members, was charged with developing recommendations for proceeding with the draft documents on cholesterol, hypertension, lifestyle, risk assessment, and obesity. After considering a range of options, the working group recommended:
- Endorsing the June 2012 recommendations
- Discontinuing release of stand-alone cardiovascular guidelines
- Engaging both the ACC and AHA in in-depth discussions on a process that could lead to a public release of systematic evidence reviews without practice recommendations.
NHLBI will publish the five draft documents as evidentiary reviews and subsequently collaborate with others to produce practice guidelines. Dr. Lauer noted the Institute appreciation for the service, time and efforts of the panel’s leaders and members.
Dr. Lauer also spoke about strategic visioning for transforming epidemiology in an era of big data and small budgets. A Council and BEE Working Group will be created to look at short term renewals of both the Framingham Heart Study and Multi-Ethnic Study of Atherosclerosis (MESA), and to consider models for cohorts and other opportunities.
Dr. George Mensah’s presentation focused on the global burden of disease and the disparities of disease. Implementation science is the body of knowledge that can inform, facilitate, or promote the integration of evidence-based strategies and interventions to improve practice patterns in specific settings of clinical care of public health practice. The behavior of health care professionals and other stakeholders is a critical variable in the adoption and execution of evidence-based interventions. It includes the testing of strategies intended to improve the delivery of evidence-based care or programs to improve health income. Implementation science creates generalized knowledge that can be applied across settings and contexts. He spoke of ways the NHLBI can make a difference in population health impact.
NHLBI staff presented 11 new initiatives and 3 renewals, all of which had been reviewed in April by the Board of External Experts (BEE). Initiative development at the NHLBI is a two-cycle process. First, staff within each extramural division develops ideas and potential initiatives, which they present to the trans-NHLBI Idea Forum. Sufficiently developed initiatives are subsequently considered by the BEE, which ranks them 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.
Initiative: Basic Research in the Pathogenesis of HIV/AIDS-Related Heart, Lung, and Blood Diseases (R01, R21)
Purpose: To stimulate investigator-initiated basic research focused on the fundamental mechanisms of HIV-related heart, lung, and blood (HLB) diseases in the context of antiretroviral therapy (ART).
Initiative: Clinical Research in the Prevention, Diagnosis, and Treatment of HIV-Related Heart, Lung, and Blood Diseases (R01)
Purpose: To stimulate investigator-initiated, R01 clinical research applications on the prevention, diagnosis, and treatment of HIV-related HLB diseases through various approaches such as observational studies, quasi-experimental designs, and single-center, pilot trials.
Initiative: Beyond HAART: Innovative Approaches to Cure HIV-1 (U19)
Purpose: To support translational research on innovative approaches beyond highly active anti-retroviral therapy to cure HIV-1.
INITIATIVES: NON-HIV/AIDS, NON-SBIR/STTR
Initiative: Production Assistance for Cellular Therapies (PACT) (N01)
Purpose: To provide translational research services for NHLBI cell-therapy related projects that cannot be performed under the R01 grant mechanism. The goal of PACT is to enable NHLBI cell therapy researchers to move their products into human efficacy studies.
Initiative: Consortium of Lung Cell Therapy (CLCRx) (UH2/UH3)
Purpose: To support: 1) preclinical studies of cell therapy in appropriate lung disease models to enable Investigational New Drug (IND) filing and approval; 2) early phase clinical studies; and 3) ancillary mechanistic studies to lead to a better understanding of how cell therapeutic approaches exert biological activity.
Initiative: Developmental Pathways in the Pathogenesis of Adult Chronic Lung Diseases (R01)
Purpose: To support mechanistic studies to understand the roles of developmental pathways in the pathogenesis of human adult chronic lung disease.
Initiative: Innovative Technologies to Study Alveolar Epithelial Cells in Interstitial Lung Diseases (UH2/UH3)
Purpose: To apply innovative technologies to study human alveolar epithelial cells in interstitial lung diseases.
Initiative: Proteostasis and Heart, Lung, and Blood Disorders (R21)
Purpose: To explore protein misfolding, trafficking, and degradation in heart, lung, and blood cells and seek to identify misfolded proteins or dysregulated proteostasis associated with late-onset heart, lung, and blood diseases.
Initiative: Advancing Research in Exercise Therapy for Chronic Heart Failure (R01)
Purpose: To investigate which exercise training regimens work best to reduce morbidity and improve quality of life and physical functioning in chronic heart failure patients, taking into account different heart failure subpopulations, such as those based on heart failure type (reduced and preserved ejection fraction, respectively) and severity, concomitant heart failure therapy, comorbidities, age, and gender. It would also address the impact of interventions directed towards enhancing heart failure patients’ adherence to exercise.
Initiative: Programs to Increase Diversity among Individuals Engaged in Health Related Research II (PRIDE II) Renewal (R25)
Purpose: To renew the Programs to Increase Diversity among Individuals Engaged in Health-Related Research (PRIDE) which aims to increase diversity among independent biomedical research scientists focused on heart, lung, blood, and sleep (HLBS) disorders.
Initiative: Value of Information for Clinical Evaluations (VOICE) (R01)
Purpose: To develop and test Value of Information (VOI) analysis to heart, lung, and blood clinical research to help prioritize research and improve trial design.
Initiative: Framingham Study – Renewal (N01)
Purpose: To renew the Framingham Study to support: 1) follow-up of participants for clinical events, 2) core study operations, and 3) transition of the program into an NHLBI Cohort Resource. The overall objective is to continue the study as a scientific resource for the research community to expand knowledge about the determinants of health and diseases in heart, lung, blood, and sleep (HLBS) disorders.
Initiative: Renewal of the Multi-Ethnic Study of Atherosclerosis (MESA) (N01)
Purpose: To (1) enhance statistical power to perform analyses of predictors of clinical events, particularly in informative subgroups; (2) study the progression of subclinical to clinical cardiovascular disease (CVD); and (3) identify new risk factors or interactions among factors that inform disease pathophysiology. The operational goals are to (1) support continued cohort follow-up and data collection on clinical events, (2) continue to foster scientific collaborations, and (3) transition the program into an NHLBI Cohort Resource.
Initiative: Development of a Microfluidic Platform for Blood Testing in Neonatal and Pediatric Patients (R41/R42/R43/R44)
Purpose: To develop a digital microfluidic device that analyzes microliter quantities of blood to quantitate thrombotic, transfusion, and hemostatic laboratory values. The proposed device should generate laboratory-quality data and facilitate clinical monitoring, research, and the conduct of clinical trials in neonates and pediatric patients that are not otherwise possible. Development of a single, multifunctional device capable of analyzing a panel of hematologic assays simultaneously is a high priority.
Delegated authorities allow NHLBI staff to perform specific functions without Council involvement, thereby adding flexibility and decreasing the burden on the Council. Dr. Jodi B. Black, Deputy Director, Division of Extramural Research Activities, presented the delegated authorities to the Council. The Council was asked to continue the current policy of Delegated Authorities for another year and it agreed.
Drs. Richard Larson and Navid Ghaffarzadegan of the Engineering Systems Division of the Massachusetts Institute of Technology joined the meeting via webinar. They have conducted a series of multidisciplinary projects on scientific workforce development and recently published “Magnified Effects of Changes in NIH Research Funding Levels” in the INFORMS journal, Service Science. Their talk reviewed and extended the paper and modeled NHLBI research funding levels.
There have been major changes in NIH funding in the last 15 years: the budget doubled between 1998 and 2003 and the current sequestration has resulted in a five to eight percent decline in funding. The talk looked how those changes affect funding. Because grants are multiyear, funds available in one year are often obligated to grants awarded in previous years, so less funding is available for new projects.
Dramatic changes in budget from year to year can lead to swings in availability of funding for new projects. The model also has applicability for sequestration. No single variable can fix the problem, but one can use different policy variables, such as cut in commitments or duration of grants, to reduce funding swings. The problem needs more complex modeling in order to make better policy decisions.
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).
The 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. The Council considered and approved 1,136 applications requesting $1,878,671,566 in total direct costs.
The meeting was adjourned at 3:15 p.m.
Last Updated August 2013