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

MEETING SUMMARY OF THE
NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL

June 11, 2025

The 311th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) convened in-person on Tuesday, June 11, 2025. The Council meeting began with a closed session that started at 8:10 a.m. and ended at 9:54 a.m. The open session reconvened from 11:28 a.m. and ended at 3:42 p.m. Dr. Gary H. Gibbons, Director of NHLBI, presided as chair.

NHLBAC Members Attending
Olveen Carrasquillo, M.D., M.P.H.
Amanda Mae Fretts, M.D., M.P.H.
Allison King, M.D., M.P.H.
Eldrin Lewis, M.D., M.P.H.
Solomon Ofori-Acquah, Ph.D.
Merritt Raitt, M.D., Ex Officio
Susan Redline, M.D., M.P.H.
Lynn M. Schnapp, M.D.
Susan Spencer

Members of the Public Attending
The total number watching online was reported by NIH Videocast to be 425.

NHLBI Employees Attending
Several NHLBI staff members attended virtually via Teams

CLOSED SESSION

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.

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 and recommended 3,837 applications requesting $10,065,154,900 in total costs. For the record, it is noted that secondary applications were also considered en bloc.

OPEN SESSION

I. CALL TO ORDER

Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI), called the meeting to order at 11:28 a.m. He welcomed Council members, NHLBI staff, and public attendees to the Open Session of the meeting.

II. ADMINISTRATIVE ANNOUNCEMENTS

Dr. Charisee A. Lamar, Director, Division of Extramural Research Activities, NHLBI informed attendees that the meeting would be publicly broadcast and archived on videocast. She reviewed the agenda.

III. REPORT OF THE DIRECTOR

Accountable Stewardship. Dr. Gibbons provided an update on the NHLBI budget. The federal government is operating under a full-year continuing resolution that carries over congressional guidance from Congress from fiscal year (FY) 2024 to 2025, resulting in a flat NHLBI budget of $3.98 billion.

New Administration Transition. Dr. Gibbons expressed his appreciation to NHLBI’s Board of Scientific Counselors, including Dr. Alexis Thompson, whose service was terminated in the new administration transition. Dr. Gibbons described proposed organizational changes to NIH Institutes and Centers under the new administration.

The president’s FY 2026 budget includes a 43% reduction in appropriations for NIH. However, the new administration has expressed interest in topic areas that influence chronic conditions, many of which are in NHLBI’s mission area. Dr. Gibbons remained hopeful that stakeholders engaged with Congress will advance the administration’s agenda to address chronic disease through a shared, sustained commitment to a growing investment in NIH funding that outpaces inflation.

Since the new administration began, the reductions in force implemented by the Department of Government Efficiency have affected NHLBI’s staffing and functional areas. Dr. Gibbons recognized the impact of the administration’s executive orders on NHLBI’s research portfolio. Centralization, funding cuts, and personnel actions have had significant impacts on the research community, including challenges for supporting NHLBI research affecting certain subgroups and special populations disproportionately affected in health and disease.

Dr. Gibbons welcomed the new NIH Director, Dr. Jayanta (Jay) Bhattacharya, whose vision for NIH is to restore public trust in science. Differences among segments of the population in distrust in science indicate the need to engage all parts of the U.S. population. To fulfill the mission and priorities of this administration, scientists need to be better communicators, thereby engendering a sense of trust and service to the community, listening to the needs of communities, and bringing science to bear in a way that benefits Americans in their communities.

Advancing Scientific Priorities. Dr. Gibbons outlined NHLBI’s research agenda, which aligns with the new administration’s priorities and concerns, including the role of chronic disease in the slowing of U.S. life expectancy growth. The prevalence of two or more chronic conditions among relatively younger adults is increasing. In addition to aggregate changes, it is important to appreciate the diversity of the United States and the heterogeneity of life expectancy among different communities and populations.

Compared to other peer nations, the decline in cardiovascular deaths in the United States has flattened, and Americans are much more likely to die prematurely of cardiovascular disease. Within those aggregate statistics, premature cardiovascular disease mortality shows overlaying racial and social determinants.

Hypertension-related cardiovascular disease mortality in younger adults shows differences in certain populations and geographies. A complex array of risk factors related to biology, social determinants of health, and lifestyle interact to drive premature cardiovascular disease mortality. Therefore, NHLBI is taking a holistic, multilevel systems approach to reducing the burden of chronic disease, particularly cardiovascular risk. NHLBI is well positioned to address Making America Healthy Again by leveraging trans-NIH community-engaged research platforms created in the context of COVID-19. NHLBI has made progress in health education about hypertension, but there are communities that lag in treatment and control. Dr. Gibbons advocated for NHLBI scaling up community-engaged research interventions that have shown promise in promoting hypertension control in at-risk communities.

Dr. Gibbons described NHLBI’s progress in leveraging data from primary care to enhance research and health outcomes. NHLBI will continue to build on the Community Engagement Alliance (CEAL)-CARENet platform to optimize health in burdened communities through primary care. Progress is being made to connect the data ecosystem of CEAL-CARENet with primary care-based research networks. Data resources from electronic health records are being used to assess factors affecting blood pressure control and inform personalized prevention strategies. CEAL-CARENet is conducting a clinical trial that uses community health workers to provide evidence-based care for patients who have uncontrolled hypertension or diabetes. NIH CEAL is part of a cycle of discovery integrating different components to support a healthier population

The role of discovery science in promoting health is illustrated by the work by Dr. Oliver Smithies, which elucidated the genetics of hypertension. This work was translated into a novel therapy and enhanced screening for hypertension.

Maternal health is another area with major disparities between the United States and comparable nations and is an important problem to address to Make America Healthy Again. Adverse pregnancy outcomes are associated with long-term cardiovascular risks for mothers and children. This is a ripe area for further study to define who is most at risk to prevent these complications. The Chronic Hypertension and Pregnancy Trial was an opportunity to intervene with anti-hypertensive medications for at-risk pregnant women. Lifestyle changes such as diet also are being explored to improve maternal health outcomes.

These opportunities in the virtuous cycle of discovery science to improve health are well aligned with the new administration’s Make America Healthy Again agenda.

Dr. Gibbons concluded his presentation and thanked everyone for their attention.

IV. INTEGRATIVE STRUCTUAL BIOLOGY USING CRYO-EM

Dr. Naoko Mizuno, Senior Investigator, Laboratory of Structural Cell Biology, Division of Intramural Research, NHLBI

Dr. Mizuno presented on integrative structural biology using cryo-electron microscopy (cryo-EM). Integrative imaging uses different magnifying lenses to describe the phenomenon of interest. The technologies of cryo-EM and cryo-electron tomography (cryo-ET) were not available until 2015 and 2020, respectively. Now, with cryo-EM-related techniques, imaging can be performed from the atomic to the cellular level. An example of using cryo-EM to study disease is imaging focal adhesion machinery, an important target for cancer treatment.

Five years ago, Dr. Mizuno moved into the field of in situ cryo-EM and cryo-ET, which can be used to visualize molecules in action in the cell at molecular resolution. They were the first to see ribosomes functioning in the part of a neuron where a new neurite is coming out. Dr. Mizuno described the typical cryo-ET strategy and workflow.

Dr. Mizuno presented examples of applications of cryo-ET to integrative structural biology that her team has been working on. They have imaged red blood cells to understand the mechanism of sickle cell formation through the formation of hemoglobin fibers. They found that the ligand RGD is involved in platelet activation and initiation.

They are studying recovery from axon injuries in brain neurons. They observed positive effects of epothilone B (EpoB) on ex vivo axon regeneration. They saw abnormal regeneration of the axon develop over time in regeneration induced by EpoB. They hypothesized that microtubules were pushing on the plasma membrane. They found that EpoB was associated with an increase in membrane tension at the regenerating site. They studied the role of the microtubules in axon regeneration by performing axotomy on the samples. They found that shooting microtubules are stabilized by EpoB. They studied where the microtubules were generated. They concluded that tubulin likely was transported from the precut site, and microtubules were formed at the regeneration site. They visualized the spiral-like tubulin oligomers participating in microtubule polymerization in situ. They concluded that EpoB-induced tubulin oligomers are transported from the axon proximal to the injury site, and the microtubules are formed at the regeneration site. In this project, they were able to use cryo-ET to determine the mechanism of EpoB-based axon regeneration.

V. NHLBI CONCEPT CLEARANCE

NHLBI staff presented 18 concepts for clearance. Members of the Advisory Council were asked to rate each concept on six criteria using Decision Lens.

1. Strengthening Health Systems – A Global Alliance for Chronic Diseases (GACD) Program Supporting Implementation Research in Low- and Middle-Income Countries (LMICs) and U.S. Tribal Populations (R61, R33 – Clinical Trial Required)
2. Beyond Health Systems – A Global Alliance for Chronic Diseases (GACD) Program Supporting Implementation Research in Low- and Middle-Income Countries (LMICs) and U.S. Tribal Populations (R33, R61 – Clinical Trial Required)
3. Scaling-up Early Prevention and Intervention – A Global Alliance for Chronic Diseases (GACD) Program Supporting Implementation Research in Low- and Middle-Income Countries (LMICs) and U.S. Tribal Populations (R33, R61 – Clinical Trial Required)

Description: These concepts address the growing burden of non-communicable diseases—including heart, lung, blood, and sleep (HLBS) disorders—in LMICs and U.S. Tribal populations. Their overarching mission is to use implementation research in LMICs and U.S. Tribal populations to overcome barriers to the scale up and spread of proven strategies, and build resilient health systems for chronic disease prevention and control.

4. Strong Heart Study (SHS) Renewal (N01)

Description: This renewal aims to continue the SHS, the longest running and largest multicenter perspective study of American Indian people. The SHS is a vital resource for epidemiologic research on HLBS disorders and beyond, as well as for studying risk factors and diseases in this population. The next phase of the study would continue to identify health needs and challenges faced by aging American Indian populations while expanding the cohort to a younger generation.

5. Cardiothoracic Surgical Trials Network Renewal (U01)

Description: This concept supports the renewal of the highly impactful Cardiothoracic Surgical Trials Network, the largest cardiac surgical research network in the world, whose trial results have influenced national and international guidelines and clinical practice. The aim of this initiative is to expand the scope of the network to include a greater emphasis on implementation science, circadian medicine, and mechanistic science efforts while increasing the network’s efficiency.

6. nuMoM2b Heart Health Study (HHS) renewal (N01)

Description: This renewal continues the nuMoM2b HHS. The objective of this renewal is to follow this richly phenotyped cohort of women who have been part of this study since their first pregnancy, to further understand the relationship between adverse pregnancy outcomes and cardiovascular disease. It would allow the capture of additional data as the women enter perimenopause and menopause.

7. Secondary Participation in Renewal of PAR-21-356: Limited Competition: National Swine Resource and Research Center (U42)

Description: This renewal enables NHLBI to participate as a secondary sign-on in an NIH-wide initiative led by the NIH Office of Research Infrastructure Programs and the NIH Office of the Director. There is a growing awareness of the value of large animal models, and domestic swine are closely related to humans in anatomy, genetics, and physiology. The center is the only publicly funded swine facility to serve as both a repository for new swine models and a resource for inbred or genetically altered swine models.

8. Stimulating Access to Research in Residency Transition Scholar (StARRTS) (K38)

Description: This concept supports individual mentored awards to retain and support clinician investigators who have successfully completed the R38 Stimulating Access to Research in Residency program. The StARRTS opportunity helps ensure that multiple pools of highly trained scientists will be available in appropriate scientific disciplines to address the nation’s biomedical, behavioral, and clinical research needs.

9. Secondary Analysis of Existing Datasets in Heart, Lung, and Blood Diseases and Sleep Disorders (R21)

Description: This initiative aims to continue encouraging innovative secondary data analyses to address gaps in knowledge and important scientific questions within NHLBI’s mission. This cost-effective and productive program has been immensely popular with the investigator community of the last decade or so and has successfully increased the data usage of more than 250 unique datasets.

10.  Administrative Supplements to Promote Research Continuity and Retention of NIH Mentored Career Development (K) Award Recipients and Scholars (K01, K02, K07, K08, K12, K18, K22, K23, K24, K25, K30, K38, K43, K99)

11. Administrative Supplement for Continuity of Biomedical and Behavioral Research Among First-Time Recipients of NIH Research Project Grant Award (DP1, DP2, DP5, R01, R00, R15, R16, R21, R34, R35, R37, U01)

Description: These concepts enable NHLBI to participate as a secondary sign-on in an NIH-wide initiative to promote research continuity and retention of NIH mentor career development award recipients and scholars and first-time recipients of NIH research project grant awards. They provide additional resources to NHLBI’s career development awardees and first-time recipients of NHLBI research project grant awards who are facing a critical life event that takes them away from their research for extended periods.

12.  Secondary Participation in PAR-22-056: Research Resource for Human Organs and Tissues (U42 – Limited Competition)

Description: This concept supports NHLBI’s secondary participation in the NIH-wide initiative of the Research Resource for Human Organs and Tissues (HTORR). HTORR will complement other NIH-wide organ and tissue resources with a focus on rare diseases, including sickle cell disease, hemophilia, lymphomatosis, and sarcoidosis, as well as heart disease.

13. Renewal for Limited Competition Small Grant Program for NHLBI K01/K08/K23/K25 Recipients (R03 – Clinical Trial Optional)

Description: This concept continues support of current or recently completed NHLBI career development (K) awards to expand their current research objectives or branch out to a new area of study that resulted from the research conducted under their K awards. The overall objective is to provide small grant support for NHLBI K award recipients who have high potential but who face challenges and need additional support to help generate critical preliminary data and/or publications to facilitate their K-to-R transition.

14. Secondary Participation in HIV and Aging Basic Science Initiative Concept (R21 – Clinical Trial Not Allowed)

Description: This concept enables NHLBI to participate as a secondary sign-on in an NIH-wide initiative led by the National Institute on Aging on people living with HIV who are age 50 and older. Although the lifespan of patients living with HIV is increasingly similar to those without HIV, the health span has not significantly changed. This initiative addresses mechanisms for the increased incidence of comorbidities in people living with HIV.

15. Maximizing the Scientific Value of the NHLBI Biologic Biospecimen Repository: Scientific Opportunities for Exploratory Research (R21)

Description: This concept renews support for maximizing the scientific value of the 62 unique biospecimen collections stored in the NHLBI Biologic Biospecimen Repository (NHLBI Biorepository). Experience with this request for application (RFA) has demonstrated its ability to promote the scientific utility of the archived biospecimen collections, to bring awareness of the biorepository to the public, and to provide a rich resource for early-stage investigators to obtain preliminary data to help launch scientific careers.

16. Renewal of the BioLINCC Resource (N01)

Description: This renewal will strengthen and expand the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) platform resource. BioLINCC facilitates access and promotes use of two unique NHLBI resources—the NHLBI Biorepository and the Data Repository managed by the Epidemiology Branch, Division of Cardiovascular Sciences.

17. Clonal Hematopoiesis in People Living with HIV (R01)

Description: This new RFA targets the impact of clonal hematopoiesis of indeterminate potential (CHIP) on HLBS diseases among people living with HIV. The RFA aims to understand how chronic inflammation and HIV-related factors contribute to CHIP, its impact on HLBS health and diseases, and the broader biological implications of chronic viral infections on hematopoietic stem cell biology and clonal evolution.

18. SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (R44 – Clinical Trial Not Allowed)

Description: This concept supports the CRP, a trans-NIH program that facilitates the transition of previously funded Small Business Innovation Research/ Small Business Technology Transfer Phase II/IIB projects to the commercialization stage. The CRP awards cover the costs of activities that are not typically supported through Phase II or Phase IIB grants or contracts but are necessary for product development.

VI. CLOSING REMARKS

Dr. Gibbons adjourned the meeting at 3:42 p.m.