Description
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
October 30, 2024
The 309th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) convened in-person on Tuesday, October 30, 2024. The Council meeting began with a closed session that started at 8:02 a.m. and ended at 10:30 a.m. The open session convened from 10:40 a.m. and ended at 3:00 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., Ph.D.
Eldrin Lewis, M.D., M.P.H.
Edward E. Morrisey, Ph.D.
Merritt Raitt, M.D., Ex Officio
Susan Redline, M.D., M.P.H.
Lynn M. 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 342.
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 3,064 applications requesting $8,752,932,413 in total costs. For the record, it is noted that secondary applications were also considered en bloc.
OPEN SESSION
I. CALL TO ORDER
Dr. Charisee A. Lamar (Director, Division of Extramural Research Activities, NHLBI) called the meeting to order 10:40 a.m. and welcomed Council members, NHLBI staff, and public attendees.
II. ADMINISTRATIVE ANNOUNCEMENTS
Dr. Lamar informed attendees that the meeting would be publicly broadcast and archived on videocast. She reviewed the agenda and made the required announcements for the Council meeting, including the publication of a notice in the Federal Register as well as reminders to Council members regarding conflict of interest and lobbying activities.
III. REPORT OF THE DIRECTOR
Divisional News. Dr. Gibbons acknowledged the retirement of Dr. Jim Kiley, former director of the Division of Lung Diseases (DLD), thanking him for 40 years of public health service. He welcomed six NHLBI division leadership appointees: Division of Lung Diseases (DLD), Dr. Gustavo Matute-Bello as Acting Director and Dr. Sumita Khatri as Chief Medical Research Officer; Division of Cardiovascular Sciences, Dr. Vandana Sachdev as Associate Director and Dr. Yves Rosenberg as Chief Medical Research Officer; and in the Division of Extramural Research Activities, Dr. Charisee Lamar as Director. He additionally thanked five Advisory Council members whose terms are ending: Drs. Victoria Bautch, Kristen Bibbins-Domingo, Mercedes Carnethon, Tina Hartert, and Edward Morrisey.
Accountable Stewardship. Dr. Gibbons reported that NHLBI fiscal year 2024 (FY 2024) appropriations granted by Congress are under a continuing resolution. NHLBI is funded through December 20, 2024. FY 2024 NHLBI appropriations total $3.98 billion, unchanged from FY 2023.
Strategic Vision Refresh. Dr. Gibbons reported briefly on NHLBI’s retreat on the prior day, October 29, 2024. Over the past year, the Institute engaged in a refresh of its strategic vision, which involved a renewed look at the framework of strategic goals, objectives, and the identification of several compelling questions and critical challenges for the next five to 10 years. The charge is to understand human biology, reduce human disease, advance translational research, and develop the workforce and resources.
Attendees discussed the need to catalyze innovation to advance science and promote health in all communities. This will involve new tools and technologies that could be paradigm shifting, especially in cell- and gene engineering and data science—including artificial intelligence (AI)/omics, multidimensional/multilevel systems, and interdisciplinary teams/partnerships.
Fit for Purpose Approaches. Dr. Gibbons discussed NHLBI’s recent progress in accelerating discovery science and translational research, highlighting the role of other transactional authority (OTA) opportunities. This mechanism of cocreation with the awardee is especially valuable when a project involves extensive innovation, such as during the COVID-19 pandemic. Examples of innovative heart, lung, blood, and sleep (HLBS) research platforms via OTAs include BioData Catalyst, Cure Sickle Cell, NIH NIH Community Engagement Alliance (CEAL,) Catalyze, and Trans-Omics for Precision Medicine (TOPMed).
Dr. Gibbons provided further details about the TOPMed Artificial Intelligence Initiative (TOPMed-AI), which NHLBI staff developed to leverage the power of AI and machine learning (ML), to accelerate the understanding of HLBS disorders and drive advancements in predictions, diagnoses, and treatments. Research focus areas include women’s health, chronic lung disease, and radiomics.
Council AI Working Group. Dr. Gibbons discussed the Council AI Working Group to be established and its goal to advise the NHLBI community on integrating AI as it advances the Institute’s public service, scientific, and public health mission. More details will be shared in 2025.
Address Knowledge Gaps and Enhance Evidence-Based Medicine. Dr. Gibbons reviewed NHLBI’s suite of clinical trials and related projects and ongoing efforts to enhance their design, evidence base, and monitoring. In particular, he described the R34 program, which staff developed so that PIs can pilot-test the viability of a proposed major multicenter trial. A survey in 2016 to assess this program’s impact found that among 24 PI responses, about 50 percent said that they would proceed with a trial, 25 percent would not, and 25 percent were unsure. About 80 percent of R34 investigators published results within 5 years. Dr. Gibbons said that this program adds value for investigators and for NHLBI’s accountable stewardship.
Dr. Gibbons briefly reviewed continuing strategic investments in NHLBI’s clinical trial enterprise, noting that FY 2024 budget models aim to provide $114 million in funding support for:
- 10 typical multisite clinical trials
- One extra-large multisite clinical trial every three years, with the next in FY 2026
- Six R34 pilot studies
- One early-phase clinical trial
Dr. Gibbons commented on NHLBI’s Circle of Partners, stating that each of the nine elements is critical and will be part of the investment decisions made at the NHLBI Council. He concluded his talk and thanked everyone for their attention.
IV. PRESENTATION: “Women’s Health Research: The Time is Now”
Dr. Jamie Austin Clayton, M.D., FARVO, Director, Office of Research on Women’s Health (ORWH), NIH
Dr. Clayton presented on the myriad ways that NIH—in particular, ORWH—is addressing the historic absence of women in biomedical research. Not only does science need to study the biological mechanisms underlying sex differences in common conditions, such as cardiovascular health and hypertension, but many other health areas specific to women have been neglected.
Dr. Clayton cited the example of polycystic ovary syndrome (PCOS), a multisystem condition in which diagnosis is commonly delayed due to vague initial symptoms. This delay raises the risk of outcomes such as endometrial cancer, cardiometabolic disease, infertility, mental health issues, and dermatological conditions. Prompt, effective treatment would improve the lives of women with PCOS and also significantly curb medical costs. New technologies could help advance the understanding of this condition, she said, citing a study in which AI accurately diagnosed PCOS as well as, or better than, clinicians.
In another example, Dr. Clayton noted that critical gaps exist in women’s sleep research, which includes identifying health disparities and clarifying biological mechanisms. Sleep involves a common silent pathogenic pathway to several conditions, including heart diseases, hypertension, obesity, and depression.
Dr. Clayton described ORWH’s mission and NIH’s vision to improve women’s health. ORWH has advanced NIH collaborations on sex and gender in several key ways, for example:
- Building Interdisciplinary Research Careers in Women’s Health
- SCORE: Specialized Centers of Research Excellent on sex differences
- U3: Understudied, Underrepresented, and Underreported issues
- R01 Intersection of Sex and Gender Influences on Health and Disease
- NASEM report – Advancing Research in Chronic Conditions in Women
The White House Initiative on Women’s Health Research, adopted in March 2024, is spurring efforts by U.S. government agencies, including NIH, to improve research data and standards, and open paths to funding and innovation. The NIH-wide effort will include $200 million in investments to fund new, interdisciplinary women’s health research that cuts across traditional mandates. Dr. Clayton reviewed some of the many steps already underway.
She pointed to pregnancy-related deaths as an area needing urgent attention, with the U.S. rate highest among peer countries. The importance of studying racial and ethnic differences was underscored by 2017–2019 U.S. data: mental health causes were significant among Hispanic, non-Hispanic white, and American Indian/Alaska Native persons; hemorrhage was more common among Asians, and cardiovascular complications occurred more in non-Hispanic Black persons than other groups.
Dr. Clayton concluded by thanking Dr. Gibbons and the NHLBI team for their collaboration in improving women’s health in many different ways.
V. WORKGROUP REPORT
Dr. Tina Hartert, NHLBI Advisory Council
Dr. Hartert reported on the prior day’s retreat to review NHLBI’s strategic vision refresh. The overarching vision is to achieve optimal cardiovascular, pulmonary, blood, and sleep heath across the lifespan for all U.S. populations. Discussions focused on innovative research, paradigm-shifting endeavors, the workforce, and the spectrum of research considerations—from molecular mechanisms to implementation—with the goal of leveraging science and technology to achieve health equity.
Dr. Hartert cited examples of two emerging technologies and their potential promise to promote equal health research:
- AI can identify at-risk populations, predict disease development, enable targeted interventions for personalized medicine, and tailor treatments to improve health for underserved communities. AI can also join existing datasets; for instance, AI algorithms have been used in public health to predict influenza trends and facilitate timely resource allocations in vulnerable areas. AI systems trained on diverse datasets can help prevent some data biases. AI decision-making processes must be transparent to build trust among communities and research communities.
- ML is important in data utilization because it can process existing data in electronic health records to identify trends, algorithm biases, and disparities in treatment outcomes. ML can analyze social media data for real-time public sentiment regarding health interventions in marginalized communities.
Dr. Hartert reviewed discussions about how to enhance collaboration and research. Innovative pilot programs can test new technologies in real-world settings and ensure broader impact and effectiveness. There can be increased funding aimed at research focused on health equity. And steps can be taken to encourage partnerships between academic institutions, healthcare providers, community organizations, primary care, and industry.
Dr. Hartert summarized the key takeaways and calls to action, as follows:
- Collaboration: Multidisciplinary teams are vital for innovative solutions and the application of emerging technologies in health equity.
- Ethics: Prioritize fairness and transparency in technology applications, to build trust and develop unbiased data sources.
- Communities: Involve community members in all stages of research, for sustainable impact.
VI. NHLBI CONCEPT CLEARANCE
NHLBI staff presented 28 concepts for clearance. Members of the Advisory Council were asked to rate each concept on six criteria using Decision Lens.
Titles: SickleInAfrica Scientific Research Hubs Clinical Optional (U01); SickleInAfrica Clinical Coordinating Center Clinical Trial Optional (U24); SickleInAfrica Data Coordinating Center Clinical Trial Optional (U24)
Description: These concepts will promote funding for the development of up to six scientific hubs in Africa and continue to support the SickleInAfrica Clinical Coordinating Center and Data Coordinating Center. The overarching Consortium was created in 2015 to support capacity-building activities and infrastructure development for a future regional research consortium to advance epidemiologic, translational, and clinical studies related to sickle cell disease.
Titles: Secondary participation in NIAID Martin Delaney Collaborations for HIV Cure Research (UM1 Clinical Trial Not Allowed); Secondary participation in NIAID Martin Delaney Collaboratory for Pediatric NIH Cure Research (UM1 Clinical Trial Not Allowed)
Description: These concepts renew NHLBI’s secondary participation in a program aiming to overcome major obstacles to eradicating persistent HIV infection and to control remission in people living with HIV therapy-free, including children. The dynamic structure of MDCswill accelerate the pace of HIV cure research, leverage common resources, facilitate new collaborations, and engage the next generation of researchers in this field.
Title: The Recipient Epidemiology and Donor Evaluation Study (REDS) (N01)
Description: This concept renews support for this initiative to ensure that the U.S. blood supply is safe, focusing on previously understudied vulnerable populations, including neonates and children. The strategy will involve translational and clinical research to proactively address potential emerging threats to the blood supply, enhance the effectiveness and safety of transfusions, and serve as a resource for ongoing work in transfusion research.
Title: NHLBI TOPMed: Omics Phenotypes of Heart, Lung, and Blood Disorders (X01)
Description: This concept reissues funding to provide a peer-reviewed process for selecting the best HLBS studies for generating genomics data, including whole-genome sequencing, transcriptome, methylome, metabolome, and proteome. The goal is to generate genomics data and advance an understanding of how genetic factors contribute to HLBS diseases at the molecular and cellular levels.
Title: Secondary Participation in FIC International Research Training Award (NCD-LIFESPAN) Program (D43 Clinical Trial Optional)
Description: This concept supports NHLBI’s secondary participation in the renewal of a Fogarty International Center training award aimed at creating chronic, noncommunicable diseases and disorders across the lifespan. The award will create a seamless pipeline from training to independence for early-career scientists in low- and middle-income countries who are researching HLBS diseases across the lifespan and translational spectrum.
Title: Dissemination and Implementation Research in Health (DIRH) (R01 Clinical Trial Optional)
Description: This concept supports NHLBI’s secondary participation in innovative approaches to identifying, understanding, and developing strategies for improving involvement of evidence-based interventions, tools, and guidelines for HLBS diseases and disorders, especially in under-served populations. This initiative is NHLBI’s primary funding opportunity to support dissemination and implementation research. Since the 2021 renewal, NHLBI has received 134 applications and awarded about 25 grants, of which 55 percent went to new and early investigators.
Titles: Dissemination and Implementation Research in Health (R03 Clinical Trial Not Allowed); Dissemination and Implementation Research in Health (R21 Clinical Trial Not Allowed)
Description: These concepts supports NHLBI’s participation for the first time in this NIH-wide initiative supporting the dissemination and implementation research pipeline, specifically in the global health arena. In the past decade, only one R01 award went to a foreign institution, highlighting the need for smaller award mechanisms to support formative work, methodological innovations, and smaller-scale empirical questions, particularly in low- and middle-income countries (LMICs) to prepare for competitive R01 applications.
Title: Strategies to Prevent and Control Rheumatic Heart Disease (StoP RHD) (R33/R61 Clinical Trial Optional)
Description: This concept aims to stimulate the development and testing of scalable strategies that improve the sustained uptake in LMICs of evidence-based or guideline-directed interventions for acute rheumatic fever and rheumatic heart disease. This disease is one of the most neglected yet preventable chronic disorders, causing more than 300,000 deaths annually. The initiative calls for a transdisciplinary, multi-PI model, with community-based representatives and strategic partnerships with health ministries or local and district government agencies.
Title: Renewal of NHLBI Participation in the International Epidemiology Database to Evaluate AIDS (U01 Clinical Trial Not Allowed)
Description: This concept renews NHLBI’s secondary participation in the NIH-wide IeDEA program, which supports seven regional cohorts that collect observational data on people living with, or at risk for acquiring, HIV. NIHLBI also has a strategic investment in the IdEA Sentinel Research Network, to aggregate data on HIV comorbidities. The Network plans to expand its work into more longitudinal and implementation science studies. It is essential to continue collecting data on key comorbidities, including many involving HLBS conditions.
Title: National Health and Nutrition Examination Survey (NHANES) HLBS Component: Renewal 2026–2030 (Y01)
Description: This concept renews funding for this long-running, multistakeholder cohort, to gather nationally representative data on the current prevalence and trends in HLBS health, disorders, diseases, and key risk factors. This support, for 2026–2030, will include spirometry for pulmonary function data and measurements for pediatric blood pressure. NHLBI has funded key components of the continuous NHANES for 23 years.
Title: Opportunities for Collaborative Research at the NIH Clinical Center (U01)
Description: This renews NHLBI support for this initiative, along with 12 other NIH institutes and centers, to support collaborative research projects between intramural and extramural investigators, who are aligned with NIH efforts to enhance the translation of basic biological discoveries into clinical applications. The aim is to strengthen patient-centric translational research collaborations between basic and clinical researchers, both within and outside NIH.
Titles: Clinical Centers for HeartShare 2.0: Refining Heart Failure Subtypes and Treatment Targets for Personalized Clinical Trials (U01); Clinical Centers for HeartShare 2.0: Refining Heart Failure Subtypes and Treatment Targets for Personalized Clinical Trials (U24); Data Translation Center for HeartShare 2.0: Refining Heart Failure Subtypes and Treatment Targets for Personalized Clinical Trials (U54 Limited Competition)
Description: These concepts renew support for a suite of programs to address the large gap in heart failure with preserved ejection fraction (HFpEF) therapeutics and define novel HFpEF subtypes and treatment targets, using deep phenotyping, imaging, multiomics, electronic health records, and advanced analytics. This funding covers a retrospective and prospective studies, and the data will be available through the NHLBI BioData Catalyst platform.
Title: Strategic AI Integration for HLBS Advancements: Fostering Research Excellence and Personalized Care (R01)
Description: This concept aims to advance HLBS science by engaging pioneers in the use of AI tools and methodologies to create a collaborative, open-source AI ecosystem. Given the promise of AI to revolutionize HLBS research, this program aims to facilitate a systematic, collaborative approach to AI tool development and foster a consortium that will serve as a nexus for knowledge exchange.
Title: Renewal of NOT-HL-21-024: Bold New Bioengineering Research for Heart, Lung, Blood, and Sleep Disorders and Diseases (R21)
Description: This concept renews NHLBI’s support for this 2-year program to encourage prototype and proof-of-concept research needed to advance bioengineering approaches for HLBS disorders and diseases. Bioengineering demands cross-disciplinary collaboration. NHLBI-funded bioengineering investigators have transformed medicine by creating artificial hearts, pacemakers, implantable devices, and cell and/or gene product therapies, among others.
Titles: Optimizing Investigator-Initiated Single-Site Clinical Trial FOA (R33, R61); Optimizing Investigator-Initiated Multi-Site Clinical Trial FOAs–Clinical Coordinating Center (UG3, UH3); Optimizing Investigator-Initiated Multi-Site Clinical Trial FOAs–Data Coordinating Center (U24)
Description: These concepts renew funding for single-site clinical trials in Phase 2 and beyond, to continue implementing NHLBI’s optimized approach to soliciting, funding, and managing trials; and to gain the additional data, information, and experience needed to assess the impact of this approach and identify if modifications are warranted. NHLBI began efforts to optimize its clinical trials enterprise in 2015.
Title: NHLBI Cohorts Collaborative Consortium (3C) (U24)
Description: This concept aims to strategically align NHLBI’s diverse cohorts for cost-effective functioning, maximum scientific output, greater equity in research opportunities, and coordinated response to NHLBI data collection priorities. The intent is for a single U24 award for an initial 6-year funding period. The 3C initiative will complement, not duplicate, existing NHLBI investments. The program aims to obviate many of the problems that can arise in trials, leading to a much greater return on NHLBI’s research investment.
Title: Renewal of NHLBI Participation in the Pediatric NIH/AIDS Cohort Study (U19 Clinical Trial Not Allowed)
Description: This concept renews funding for PHACS, which focuses scientific inquiry on the developmental and clinical course of persons living with HIV and perinatally acquired HIV. There are about 500 targeted well-phenotyped participants, now adolescents through young adults, who will be studied the effects of HIV or long-term HIV treatment on complications and co-morbidities, among other topics. NICHD is leading the study.
Title: Lung Health Cohort
Description: This concept renews funding for studying a cohort of 4,000 community-dwelling U.S. residents from 17 metropolitan regions to understand how a range of factors are associated with lower or higher lung function. This initiative will continue to follow these clinically phenotyped participants as they approach middle age, producing data on the impact of newer inhaled nicotine and cannabis products.
Titles: Innovations for Promoting the Health and Research of Women Experiencing Health Disparities (R41/R42 Clinical Trial Optional); Innovations for Promoting the Health and Research of Women Experiencing Health Disparities (R43/R44 Clinical Trial Optional)
Description: These concepts aim to support entrepreneurial research and the development of innovative products that alleviate barriers in health research and also support interventions that focus on promoting the health of women experiencing disparities in HLBS diseases throughout the life course. NHLBI aims to bolster the number of applications to address gaps in technology development for women’s health.
VII. CLOSING REMARKS
Dr. Gibbons adjourned the meeting at 3:00 p.m.