NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL

DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL INSTITUTES OF HEALTH
NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL

MEETING SUMMARY
October 22, 2014

The 260th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) was convened on Wednesday, October 22, 2014, in Building 31, Conference Room 10, National Institutes of Health (NIH), Bethesda, Maryland. The meeting was open to the public from 8:05 a.m. until 12:17 p.m. The closed session began at 12:45 p.m. and adjourned at 2:40 p.m. Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI) presided as chair.

Council Members attending
Mr. Jonathan R. Alger
Ms. Coletta C. Barrett
Dr. Ivor J. Benjamin
Dr. James D. Crapo
Dr. George Q. Daley
Dr. Pamela S. Douglas
Dr. Jonathan A. Epstein
Dr. Ron G. King
Dr. Barbara A. Konkle
Dr. Naomi L.C. Luban
Dr. Fernando D. Martinez
Dr. Polly E. Parsons
Dr. Bruce M. Psaty
Dr. Véronique Lee Roger
Dr. Anna Maria Siega-Riz
Dr. Gilbert C. White
Dr. Jeffrey A. Whitsett                                                                                                                    

Council Member attending
via teleconference
Dr. Bradford C. Berk                                                                                                              

Council Member unable to attend
Dr. Robert L. Jesse (ex officio)      

Members of the Public Attending
Dr. Josef Coresh, Johns Hopkins University
Dr. Ulyana Desiderio, American Society of Hematology
Mr. Dale Dirks, Health and Medical Council of Washington
Ms. Erica Froyd, Lewis-Burke Associates
Dr. Sharona Gordon, University of Washington
Dr. India Hook-Barnard, Institute of Medicine
Ms. Claudia Louis, American Heart Association
Dr. Richey Sharett, Johns Hopkins University
Dr. Douglas C. Wallace, University of Pennsylvania

NIH Staff Attending
Dr. Mariana Baz, National Institute of Allergy and Infectious Diseases
Dr. Lawrence Boerboom, Center for Scientific Review
Dr. Scott Janis, National Institute of Neurological Disorders and Stroke
Dr. Kathy Malinda, Center for Scientific Review

NHLBI Staff attending
A number of NHLBI staff were in attendance.

I. CALL TO ORDER

Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI), welcomed members to the 260th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC).

II. ADMINISTRATIVE ANNOUNCEMENTS

Dr. Stephen C. Mockrin, Director, Division of Extramural Research Activities (DERA), NHLBI, made the standard administrative announcements and outlined the agenda for the Council meeting.

III. REPORT OF THE DIRECTOR

Before beginning his Report of the Director, Dr. Gibbons thanked the six outgoing Council members – Mr. Jonathan Alger, Ms. Coletta Barrett, and Drs. Ivor Benjamin, Naomi Luban, Polly Parsons, and Gilbert White – for their Council service. He also announced that Ms. Lina Allen had officially been named the Institute’s new budget officer.

Dr. Gibbons began his report with a review of fiscal year (FY) 2014. He reminded members that while there was a roughly 2.5% increase in the FY14 budget over the FY13 budget, the Institute was still well below its FY12 baseline budget. He summarized some of the Institute’s guiding principles in the austere budget climate, which include prioritizing and investing more in investigator-initiated projects, raising the payline where possible, establishing a more predictable payline, protecting early-stage investigators, and sustaining career development and training opportunities.

Dr. Gibbons spoke about the Institute’s move toward more strategic investments and data-guided resource allocation decisions. He outlined some ways the Institute tries to support compelling and innovative science, for instance, by recognizing that while the payline may be a good marker of quality science, it may not be the only marker the Institute should use. He explained that Institute staff had been working to improve the "select pay" approach and criteria in order to identify high-risk high-reward investigator-initiated applications. He also spoke about how the Institute encourages a more diverse biomedical workforce, particularly by identifying gaps areas in which early stage investigators could get involved and have a more immediate impact.

Dr. Gibbons summarized the NHLBI’s use of the R56 Bridge Awards in FY14, and said that although the use of the R56 mechanism is still in a pilot phase at the NHLBI, he has received positive anecdotal feedback from the extramural community. He also spoke about how the short-term nature of the R56 Bridge Awards may help manage and stabilize the budget, which otherwise could be unpredictable because of the cyclical nature of many research awards.

Dr. Gibbons updated members about the status of previously presented initiatives and some funding decisions the Institute made based on their earlier recommendations and feedback.

Dr. Gibbons gave Council members an update on the Institute’s principles and strategies moving forward to FY15, which he predicted would be similar to FY14. As such, he stated one of the Institute’s goals will be to reduce the time between review and award.

Dr. Gibbons spoke of strategic priority setting activities, data-guided resource allocation, and portfolio review and management. He highlighted some portfolio and productivity analysis performed by staff that prompted conversations about potential limits of a payline-guided R01 investment strategy and possible merits of piloting the R35 Outstanding Investigator Award funding mechanism. He summarized the National Cancer Institute’s use of the R35 mechanism and stated that the Institute will seek Council and staff feedback on whether this mechanism might be an appropriate addition to the Institute’s portfolio.

Information from a portfolio review on the productivity and efficiency of Institute-supported clinical trials was presented and showed how that might help inform the fiscal management future trials.

Dr. Gibbons spoke about moving the NHLBI toward precision medicine, in part by creating a data commons that takes a more systematic approach and reaches across the Institute’s many cohorts.

Finally, he described how the Institute’s extramural and intramural programs have been committed to advancing the field of sickle cell disease. He hopes that, with continued investment, the NHLBI will be able to make significant contributions and advancements to the field.

IV. BEE-COUNCIL EPIDEMIOLOGY POPULATION SCIENCE WORKING GROUP

A Board of External Experts (BEE) − Council Epidemiology Population Science Working Group was charged in September 2013 with making actionable recommendations to Council on how the NHLBI could take advantage of new scientific opportunities and delineate future directions for epidemiology and population sciences research in heart, lung, blood, and sleep diseases. A combination of the unprecedented expansion of health information that presents new analytical challenges and complexities, and well-documented fiscal challenges were the rationale for change.

The final report, expected to be ready in November 2014, will be submitted to Dr. Gibbons for consideration of publication in a peer review journal and on the NHLBI website.

Dr. Véronique Roger presented the group’s report and summarized its seven recommendations and in no priority order said that the NHLBI should:

1. Convene a scientific forum to determine the major scientific questions and methodological needs in epidemiology and population science over the next 10 to 20 years.
2. Actively promote investigator-initiated testing of innovative approaches for data collection and analysis. In doing so, the NHLBI should support partnerships and programs to develop, validate, and share methods to use digital tools for research.
3. Help establish an adequate workforce to conduct population sciences of the future, in part by creating multifaceted and complementary career development grants, promoting team science, and focusing on dissemination research.
4. Create a dynamic compendium of epidemiology resources including cohort studies, clinical trials data sets, registries, and biorepositories. The NHLBI should actively seek partnerships with national and international organizations to accomplish what will be a multi-step process.
5. Encourage the integration of epidemiology studies and cohorts in clinical trials when it is scientifically justified and operationally practical, and when real efficiencies can be created.
6. Create a cohort consortium to support large-scale collaborations and provide a coordinated, interdisciplinary approach to address scientific questions, achieve economies of scale, create opportunities for collaboration, and accelerate the pace of research and the implementation of new methods.
7. Implement a competitive peer review-based model for its portfolio of large epidemiologic and population studies and to review infrastructure applications. The review of such applications should occur in an NHLBI-convened study section and the review criteria should emphasize innovation, validation of emerging study designs, and the evaluation of measurement technologies to achieve efficiencies.

The floor was then opened and several Council members provided positive feedback and discussed the issues of consent forms, privacy and confidentiality, data sharing, and proprietary information

Dr. Michael Lauer, Director, Division of Cardiovascular Sciences (DCVS), NHLBI, asked for a motion to accept the report, and the Council voted to do so unanimously.

V. NHLBI INITIATIVE CONCEPTS

Dr. Melissa Antman, Office of Extramural Policy and Training, DERA, NHLBI, led Council members as they scored and prioritized NHLBI Initiatives. She reviewed the criteria, which were developed by the Council/BEE Working Group and Institute staff, and explained the previous set of criteria had been reduced from four to three, with one sub criterion, to eliminate confusion and overlap. Each initiative was rated against the criteria.

NHLBI staff presented nine new initiatives, one co-funding request for a new initiative, four renewals, and one request to continue involvement in an established initiative as a secondary Institute. All initiative concepts were reviewed in September by the NHLBI Board of External Experts (BEE).

The Council engaged in detailed discussions of the initiatives presented, and while generally supportive, members had a number of questions and recommendations for consideration prior to their approval. The Director, NHLBI, will consider the recommendations of the BEE and the Council, as well as other budgetary and programmatic issues in determining which of the proposed initiatives, if any, to implement.

INITIATIVES: NON-HIV/AIDS, SBIR/STTR

Dr. Stephen C. Mockrin presented:

Initiative:

NHLBI SBIR Phase IIB Bridge Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44) – Renewal

Purpose:

To facilitate the capital-intensive steps that are required to transition SBIR Phase II projects to commercialization by promoting partnerships between Phase II awardees and third-party investors or strategic partners. This unique public-private partnership aims to encourage investors to make earlier investments in NHLBI mission-related technologies and to ensure that the Institute only funds the best technologies with the greatest chance of reaching the market.

INITIATIVES: NON-HIV/AIDS, NON-SBIR/STTR

Dr. Helena Mishoe, Associate Director for Research Training and Diversity, NHLBI, presented:

Initiative:

Limited Competition: Small Grant Program for NHLBI K01/K08/K23 Recipients (R03) – New Initiative

Purpose:

To support NHLBI- K01, K08, and K23 K award recipients primarily during the last two years of their K award. The proposed R03 pilot program will support research projects that can be carried out in a short period of time with limited resources and that provide or strengthen preliminary data to enhance the capability of mentored K award recipients to conduct research as they strive to complete their transition to independent investigator status.

Dr. Michael Lauer presented:

Initiative:

A Trans-NIH Network for Emergency Care: Strategies to Innovate EmeRgENcy Care Clinical Trials – SIREN (U01) – New Initiative/Co-funding Request

Purpose:

To partner with the National Institute of Neurological Disorders and Stroke (NINDS) to create a trans-NIH, multi-disciplinary network for emergency care trials. The proposed Network will leverage a renewal of a successful, existing network at the NINDS, the Neurological Treatment Trials Network (NETT). A key feature of the proposed new network will be the ability to support a diverse range of neurological, as well as heart, lung, and blood (HLB) related emergency care trials in adults, in both the pre-hospital and the hospital-based, emergency department (ED) settings. The RFA for this new network will be issued by the NINDS, with the NHLBI participating as a co-funding Institute.

Initiative:

Renewal of the Atherosclerosis Risk in Communities (ARIC) Cohort Study (N01) – Renewal

Purpose:

To (1) continue cohort follow-up to increase the number of cardiovascular (CV) events providing increased statistical power for analyses, (2) continue maintenance of its existing data and biorepository specimens enabling their use to test new hypotheses, and (3) provide a platform for independently-funded ancillary studies to implement new hypothesis-driven exam procedures in the ARIC cohort. The renewal supports the operations and follow-up of clinical events for the ARIC study with support for a basic core exam if ancillary study grants are funded. This initiative does not consider renewal of the Community Surveillance arm of the ARIC study which will be considered separately.

Initiative:

Atherosclerosis Risk in Communities (ARIC) Community Surveillance Renewal (N01) – Renewal

Purpose:

To (1) continue the biracial population-based surveillance in four U.S. communities at reduced sampling fractions to determine incidence of hospitalized myocardial infarctions (MI), case fatality rates, coronary heart disease (CHD) mortality rates, and incidence of hospitalized heart failure (HF) and HF case fatality rates; and (2) to determine feasibility and validity of using electronic health record (EHR) data to conduct cardiovascular disease (CVD) surveillance. The proposed renewal funds research critical for the transition to CVD surveillance using efficient EHR systems that provide complete and accurate data for surveillance.

Initiative:

Mortality Disparities in American Communities (Y01) – New Initiative

Purpose:

To (1) analyze social, economic, demographic, and occupational differentials in mortality by causes relevant to the NHLBI; (2) analyze the contribution and effect modification of the neighborhood environment to these relationships; (3) analyze social and economic differentials in health care utilization and outcomes among the elderly; and (3) examine healthcare encounters and outcomes among Medicaid beneficiaries.

Initiative:

Strategies to Increase Delivery of Evidence-Based Care to Populations with Health Disparities (R01) – New Initiative

Purpose:

To reduce the science-to-practice gap by accelerating the adoption of evidence into practice. Proposed strategies will focus on providers who care for clinical populations with excess burden of NHLBI diseases, in concert with the health care delivery systems in which they practice. This initiative will seek applications that test systems, infrastructures, and strategies to implement guideline-based care for NHLBI disorders in clinical care settings.

Initiative:

Summer Institute for Training in Biostatistics (R25) – Renewal

Purpose:

To support up to six awards to teach summer courses in biomedical statistics for advanced undergraduates and recent graduates in order to encourage them to pursue careers in biostatistics.

Initiative:

Trans-NIH K12 Career Development Program in Emergency Care Research (K12) – New Initiative

Purpose:

To develop a cadre of young emergency care investigators through a rigorous, integrated, and well-coordinated training program in emergency care research at universities with proven expertise in this field to meet the unique challenges to improving this evolving discipline.

Dr. James P. Kiley, Director, Division of Lung Diseases (DLD), NHLBI, presented:

Initiative:

Discovery of Genetic Causes of Mendelian/Monogenic HLBS Disorders (U54/X01) – Renewal/Secondary Participation

Purpose:

To (1) use advanced DNA sequencing technology to stimulate genetic discovery research on Mendelian and monogenic diseases relevant to NHLBI’s mission, and (2) provide the research community the knowledge base and resources necessary to conduct genetic research of Mendelian diseases leading to development of diagnostic tools and therapeutic treatments.

Initiative:

Genomics Portal (GenPort) (U24) – New Initiative

Purpose:

To facilitate widespread use of omics data by developing a user-friendly portal for access to omics and phenotypic data from the cohorts that will be chosen for sequencing through the NHLBI’s Whole Genome Sequencing (WGS) project.

Initiative:

Household Air Pollution (HAP) Health Outcomes Trial (U01) – New Initiative

Purpose:

To encourage trans-disciplinary international teams of researchers to leverage applied stove and fuel interventions to conduct a Phase III trial targeting improvements in health outcomes in Low and Middle Income Countries (LMIC) across diverse community and social and cultural settings.

Initiative:

Role of Ventilatory Control in Respiratory Outcomes in Premature Infants (U01) – New Initiative

Purpose:

To investigate the maturation of ventilatory control in premature infants and its role in respiratory outcomes using a prospective multicenter observational cohort. This is an important first step to understanding the instability of oxygenation and risk of morbidity and mortality in graduates of the Neonatal Intensive Care Unit (NICU).

Initiative:

The GI-Lung Microbiome Axis in Respiratory Health (R01) – New Initiative

Purpose:

To stimulate collaborative research to investigate the functions and mechanisms by which the diverse GI bacterial, viral, and fungal microflora and its derived factors modulate lung biology and physiology in events that are directly relevant to lung health and disease.

Dr. W. Keith Hoots, Director, Division of Blood Diseases and Resources (DBDR), NHLBI, presented:

Initiative:

Implementation Strategies to Optimize the Care of Adults with Sickle Cell Disease in Regional Systems (UH2/UH3) – New Initiative

Purpose:

To implement systems-wide interventions to improve the health and well-being of adolescents and adults with sickle cell disease (SCD) through the formation of geographically-based consortia consisting of community and academic based health care institutions that utilize a multilevel approach to implementation research in health care for SCD, which will lead to new models that would qualify for sustainable funding from government sources such as the Centers for Medicare & Medicaid Services (CMS) and the Health Resources and Services Administration (HRSA).

VI. CLOSED PORTION

This portion of the meeting was closed to the public in accordance with the determination that it concerned matters exempt from mandatory disclosures 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).

VII. REVIEW OF APPLICATIONS

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 1,012 applications requesting $1,459,229,205 in total direct costs, and recommended all 1,012 applications for a total of $1,459,229,205.

ADJOURNMENT

The meeting was adjourned at 2:40 p.m.