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

April 23, 2025

The 310th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) convened virtually on Wednesday, April 23, 2025. The Council meeting began with a closed session that started at 10:03 a.m. and ended at 11:13 a.m. The open session reconvened from 11:34 a.m. and ended at 2:21 p.m. Dr. Gary H. Gibbons, Director of NHLBI, presided as chair.

NHLBAC Members Attending
Victoria L. Bautch, Ph.D.
Mercedes R. Carnethon, Ph.D.
Olveen Carrasquillo, M.D., M.P.H.
Amanda Mae Fretts, M.D., M.P.H.
Tina V. Hartert, M.D., M.P.H.
Allison King, M.D., M.P.H., Ph.D.
Edward E. Morrisey, Ph.D.
Solomon Ofori-Acquah, Ph.D.
Merritt Raitt, M.D., Ex Officio
Susan Redline, M.D., M.P.H.
Lynn Schnapp, M.D.
Martha C. Sola-Visner, M.D.
Susan Spencer

Members of the Public Attending
The total number watching online was reported by NIH Videocast to 364.

NHLBI Employees Attending
Several NHLBI staff members were in-person and virtually via Zoom

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 3,365 applications requesting $8,629,176,753 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 11:34 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 (DERA), 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.

NHLBI News. Dr. David Goff (Deputy Director for Precision Medicine and Data Science) and Dr. Blanca Himes (Senior Advisor, Data Science) are leading strategic efforts in data science and driving precision medicine toward optimal heart, lung, blood and sleep (HLBS) health. Dr. Gibbons commented that NHLBAC members provide guidance and expertise in these important strategic areas. In the Division of Cardiovascular Science (DCVS), Dr. Gina S. Wei is Acting Director, Dr. Vandana Sachdev is Associate Director of the Adult and Pediatric Cardiac Research Program, Dr. Nicole Redmond is Acting Associate Director of Prevention and Population Sciences Program, and Dr. Michelle Olive is Associate Director of Basic and Early Translational Research.

Strategic Vision Refresh. The Institute’s overarching goal is to pursue optimal HLBS health for all. The Institute is in the final stages of refreshing its strategic vision. The document reflects NHLBI’s enduring principles, affirms its strategic goals, and describes the Institute’s roadmap for making America healthy through innovative, evidence-based research. NHLBI will work to advance the strategic vision’s two key themes: (1) enhancing HLBS health through prevention and early intervention, and (2) preempting chronic disease through integrative systems biology and analytical approaches, such as those that use artificial intelligence/machine learning (AI/ML).

Chronic Conditions. Dr. Gibbons presented data on the extension of the U.S. life expectancy, which has slowed due to the increasing burden of chronic disease. In some populations and geographic regions, the trend of increased longevity has flattened or is reversing. NHLBI sees an opportunity to reduce these trends by targeting prevention and early intervention efforts among high- and highest-risk groups. Lifestyle modifications can improve outcomes for everyone, including people at high genetic risk for chronic disease (e.g., coronary artery disease)—with action earlier in the life course more effectively moving outcomes closer to the optimal trajectory. Multilevel life course efforts should address social determinants of health (SDOH), lifestyle and behavioral factors, and environmental exposures that drive chronic conditions. This approach has been particularly effective at improving the health of women, with further health benefits for their children. For example, the Early Intervention to Promote Cardiovascular Health of Mothers and Children program in Northern Appalachia shows that it is possible to enhance multigenerational cardiovascular health as a component of addressing chronic disease. To reduce chronic disease in the United States, NHLBI will continue to expand knowledge about effective interventions (e.g., more aggressively treating chronic hypertension before, during, and after pregnancy) and to test their implementation in clinical practice.

Addressing Chronic Disease at Scale. NIH will leverage its Community Engagement Alliance (CEAL)- CAREnet, which provides many opportunities to intervene with populations that are disproportionately affected by these conditions in primary care settings. Engagement with communities ensures that the relevant health issues and needs are addressed. The CEAL-CAREnet footprint includes 40 states and territories, and encompasses existing primary care links, offering an opportunity to unite networks and generate high-quality, real-world, practice-based data for advancing primary care research. AI and data science will play major roles in analyzing this data to understand the intersection of a particular clinical problem with SDOH and outcomes, such as uncontrolled hypertension. NHLBI also sees an opportunity to use real-world data to identify modifiable risk factors and inform tailored prevention and treatment strategies.

NHLBI supports research to discover the etiology, risk factors, and novel treatments for chronic diseases, such as idiopathic pulmonary fibrosis (IPF). Although medications are available to treat the symptoms of IPF, we currently do not have treatments that modify disease course. NHLBI aims to integrate AI to advance the cycle of innovation—including the identification of new biological targets and therapies— that will change the natural history of IPF, and other chronic diseases rather than only treat symptoms. Advancing these efforts will involve partnerships with the private sector. The NIH “discovery science sandbox strategy” for predicting, preventing, and preempting chronic disease supports a systems-level approach. This strategy advances AI technologies, enhances data ecosystems and infrastructure, leverages AI for operational efficiency, fosters collaborative programs and partnerships, and promotes responsible and clinically impactful use of AI. NHLBI aims to create AI-ready data resources for HLBS researchers to advance precision medicine, but it will be necessary to bolster the supporting infrastructure and to link HLBS research projects with integrated SDOH information and the lifespan perspective to model factors relevant for HLBS conditions.

IV. PRESENTATION: The Triennial Inclusion Report FY2022–2024
Katherine Kavounis, Director, Office of Clinical Research, DCVS, NHLBI

Ms. Kavounis provided an overview of NHLBI’s Triennial Inclusion Report FY2022–2024, which certifies that the Institute is in compliance with the requirement by the NIH Revitalization Act of 1993 to submit inclusion enrollment data to Congress every 3 years. The law aims to ensure that NIH-supported clinical investigators are enrolling the appropriate participants for studying the health topic of interest and that the benefits of biomedical research are distributed. Council’s awareness and discussion of the report constitutes certification of NHLBI’s triennial report and the NIH inclusion policy.

Ms. Kavounis briefly reviewed NHLBI’s procedures for evaluating inclusion and stated that NHLBI will submit the triennial report to Congress and post the document on its public website. She also presented highlights of prospective enrollment in NHLBI clinical research during FY2022–2024. NHLBI has successfully complied with the NIH and NHLBI policies, and will continue its efforts to enhance enrollment monitoring and data analyses (e.g., delving into data by Branch and specific research portfolio). The Office of Clinical Research team will identify lessons learned and develop resources with best practices to guide investigators and NHLBI staff members regarding study participant recruitment and retention. The team also will examine what NHLBI is doing well and areas for improvements in clinical research enrollment.

Attendees discussed the report’s highlights on enrollment among different populations, noting that inclusion requirements facilitate the scientific imperative to conduct subgroup analysis and oversampling to understand disease propensity. NHLBAC members applauded the data on the levels of enrollment for female participants. A domain relevant for health, particularly chronic disease, but not covered by the congressional directive is the population with intellectual and physical disability. Ms. Kavounis agreed that this is an important segment of the population and noted that NHLBI has relevant initiatives (e.g., congenital heart disease and Down syndrome), and it has convened workshops on this topic.

V. V. PRESENTATION: “NIH CIT and OCIO: Enabling Access and Innovation with Advanced Technology” 
Dr. Sean Mooney, Director, Center for Information Technology (CIT) and Office of the Chief Information Officer (OCIO)

Dr. Mooney reviewed computing at NIH—which encompasses many different levels to support the agency’s staff, administration, and enterprise, as well as the data platforms, informatics, and AI underpinning biomedical science. Computing and the cyberinfrastructure ecosystem at NIH represent a major area of investment. The crucial activities of science, such as data sharing and analysis, rely on computational infrastructure and computer-based tools. NIH is always advancing enterprise computing that enables the next generation of biomedicine. He briefly explained the organization, with OCIO led by Dr. Adele Merritt (Associate Director of IT, Cyberinfrastructure, and Cybersecurity) and CIT led by Dr. Mooney with Ivor D’Souza (Deputy Director).

Dr. Mooney reviewed NIH computing achievements. For example, NIH high-performance computing (100,000+ core supercomputer with Biowulf) supports many research applications and more than a million hours monthly. The NIH Science and Technology Research Infrastructure for Discovery, Experimentation, and Sustainability (STRIDES) Initiative is a partnership with commercial Cloud service providers that allows NIH-supported researchers to access affordable Cloud services and environments. Cloud environments support rich and varied datasets and advanced computational infrastructure, tools, and services so that researchers do not need large-scale on-premises computational facilities—realizing significant cost savings and efficiencies for the research community. Data is crucial to advancing the NIH mission, and the NIH cyberinfrastructure saves $126 million, trains more than 5,500 people, and handles 364 petabytes of data. The cyberinfrastructure supports major NIH and NIH-funded research programs. Building on the STRIDES Initiative, the Cloud Lab is an experiment that allows NIH investigators to use the Cloud and receive training on bioinformatics in this environment. Cloud data repositories (for data collection, analysis, and sharing across many NIH research projects) offer standard platforms to support the development of AI models.

NIH is using AI in areas such as research and development, natural language processing, and productivity enhancement. AI will likely play an increasing role in NIH operations to improve the efficiency of common processes and support decision making, in addition to other benefits. Dr. Mooney emphasized that NIH is committed to ensuring that the implementation of AI tools is effective, safe, legal, ethical, and equitable. It will require appropriate oversight and governance processes for NIH to implement AI appropriately and minimize the risks. NIH envisions its digital ecosystem and cyberinfrastructure to be like toy building blocks—reusable and interoperable. A forthcoming newsletter will be available to keep the NIH community apprised of computing developments.

Attendees discussed electronic health record systems as a rich source of information for clinical trials, noting the use of this data in AI models. There is a need to connect real-world data to research studies and conduct research on how AI is being used in health care. Enhanced access to electronic health record data—and broader community data on SDOH—would facilitate research on important clinical questions, but the data must be better standardized. A key issue is the integration of datasets to bolster population-level studies.

VI. ESTABLISHING AN NHLBI ARTIFICIAL INTELLIGENCE WORKING GROUP
Dr. Charisee A. Lamar, Director, Division of Extramural Research Activities (DERA)

NHLBI aims to harness the potential of AI approaches to analyze complex biological data to improve the understanding, prevention, and treatment of HLBS conditions. Dr. Lamar described the plan for establishing an NHLBAC Artificial Intelligence Working Group (AI WG) to efficiently and effectively capitalize on AI/ML advancements within the Institute’s mission and aligned with NIH priorities. To drive rapid and sustainable advances in HLBS research and health, the AI WG members will become familiar with the Institute’s current AI portfolio and identify gaps and opportunities for future investments. The AI WG also will enable NHLBAC to maintain an evergreen prioritized list of recommendations for strategic investments and advise on the implementation strategy. The members will outline an efficient framework for the emerging AI scientific landscape for HLBS conditions. The AI WG will develop recommendations on a rapid-cycle basis and report its activities and recommendations to NHLBAC.

Council members expressed favorable views on the proposal. They highlighted some missing topics, such as using AI/ML for physiologic signal analysis in HLBS conditions (e.g., relationship between sleep disorders and cardiovascular outcomes) and mentioned potential applications of AI-based technology. Any AI-related effort that NHLBI undertakes must be aligned with the Institution’s values and principles and consider the community. Dr. Gibbons stressed that the NHLBAC’s AI WG will be vital to guiding the Institute’s efforts in this area.

Council members unanimously approved the proposal to move forward with the NHLBAC AI WG.

VII. DELEGATION OF AUTHORITY

Delegated authorities allow NHLBI staff to perform specific functions without Council involvement, adding flexibility and decreasing the burden on the Council. NHLBAC members approved the annual delegated authorities presented, with no changes.

VIII. CLOSING REMARKS

Dr. Gibbons adjourned the meeting at 2:21 p.m.