National Heart, Lung, and Blood Advisory Council | NHLBI

• August 18 (Grant review only - Virtual)
• October 28 (Wednesday - Hybrid)

• February 2 (Tuesday - Virtual)
• June 2 (Wednesday w/BEE – In-person)
• June 3 (Thursday – In-person)
• August 17 (Grant review only – Virtual)
• October 21 (Thursday - Hybrid)

The 316th meeting of the National Heart, Lung, and Blood Advisory Council was convened on Thursday, June 25, 2026, at 1:05 p.m. as a closed virtual event. David C. Goff, M.D., Ph.D., Acting Director of the National Heart, Lung, and Blood Institute (NHLBI), presided as chair.

NHLBAC Members Attending

Olveen Carrasquillo, M.D., M.P.H.
Eldrin F. Lewis, M.D., M.P.H.
Merritt H. Raitt, M.D., Ex Officio
Susan S. Redline, M.D., M.P.H.
Lynn M. Schnapp, M.D.
Susan Spencer

NHLBI Employees Attending

There were 128 NHLBI staff attending through Teams.

CLOSED SESSION

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.

CALL TO ORDER AND OPENING REMARKS

Dr. Goff welcomed members and called the 316th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) to order at 1:05 p.m.

ADMINISTRATIVE ANNOUNCEMENTS

Dr. Charisee A. Lamar, Director, Division of Extramural Research Activities, NHLBI, reviewed the agenda and made the required announcements for the Council meeting, including the publication of a notice in the Federal Register and reminders to Council members regarding conflicts of interest and lobbying activities.

REVIEW OF APPLICATIONS

The session included a discussion of procedures and policies regarding voting and the confidentiality of application materials, as well as committee discussions and recommendations. Members absented themselves from the meeting during the 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 166 applications requesting $294,364,294 in total costs. Secondary applications were also considered en bloc.

ADJOURNMENT

The meeting was adjourned at 1:51 p.m.

The 315th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) convened in person on Tuesday, June 9, 2026, at 8:39 a.m. Eastern Daylight Time. The open session convened from 8:39 a.m. and adjourned at 11:04 a.m. The meeting was closed to the public from 12:00 p.m. until adjournment at 1:10 p.m. David C. Goff, M.D., Ph.D., Acting Director of the National Heart, Lung, and Blood Institute (NHLBI), presided as chair.

NHLBAC Members Attending
Olveen Carrasquillo, M.D., M.P.H.
Allison A. King, M.D., M.P.H., Ph.D.
Eldrin F. Lewis, M.D., M.P.H.
Solomon Fiifi Ofori-Acquah, Ph.D.
Merritt Raitt, M.D. (Ex Officio)
Susan Redline, M.D., M.P.H.
Martha C. Sola-Visner, M.D.
Susan Spencer

Members of the Public Attending
Four members of the public attend in-person: Stanley Rockson M.D., Stephanie Dreyer, and Alexa Ercolano representing the Lymphatic Working Group; and Gabby Vidaurre Ph.D. representing People for the Ethical Treatment of Animals (PETA).

The number of people watching online was reported by the National Institutes of Health (NIH) VideoCast as 109.

NHLBI Employees Attending
Forty-three NHLBI staff members attended in person and virtually via Teams.

OPEN SESSION
Welcome

Dr. Goff called the meeting to order at 8:39 a.m. and welcomed Council members, NHLBI staff members, and public attendees.

ADMINISTRATIVE ANNOUNCEMENTS

NHLBI Division of Extramural Research Activities Director Charisee A. Lamar, Ph.D., M.P.H., R.R.T., informed attendees that the meeting would be publicly broadcast and archived on the NIH VideoCast. She reviewed the agenda and made the required announcements for the Council meeting, including the publication of a notice in the Federal Register and reminders to Council members regarding conflicts of interest and lobbying activities.

REPORT OF THE DIRECTOR

NHLBI Leadership Updates—Dr. Goff noted the retirement of Gustavo Matute-Bello, M.D., who was the Acting Director of the Division of Lung Diseases and had a distinguished career in pulmonary medicine, research, and scientific leadership spanning more than 30 years. On behalf of NHLBI staff members, Dr. Goff expressed his gratitude to Dr. Matute-Bello for his dedication to the field and wished him all the best in retirement. Dr. Goff announced other leadership changes, as follows: in the immediate Office of the Director, Gina S. Wei, M.D., M.P.H., serves as NHLBI’s Acting Deputy Director Clinical Research and Strategic Initiatives; Mike Pieck, Ph.D., is the Acting Associate Director of Science Strategy and Operations. In the Division of Cardiovascular Sciences, Vandana Sachdev, M.D., serves as the Acting Director; Renee Wong, Ph.D. is the Acting Associate Director of the Adult and Pediatric Cardiac Research Program. In the Division of Lung Diseases, Marishka Brown, Ph.D., serves as the Acting Director, as well as the Director of the National Center on Sleep Disorders Research, and John T. Sheridan, Ph.D., of the Restrictive and Vascular Lung Diseases Branch, is the Acting Deputy Director.

Strategic Vision—The NHLBI Strategic Vision guides the Institute’s mission to provide global leadership for a research, training, and education program to promote the prevention and treatment of heart, lung, and blood diseases and sleep disorders, and enhance the health of all individuals so that they can live longer and more fulfilling lives. In the updated Strategic Vision, cross-cutting themes—Women’s Health; Data Science and New Technologies; Addressing Health Disparities; Importance of Lifestyle; and Community and Patient Engagement—were added to the established goals and objectives. Additionally, NHLBI continually updates its areas of scientific interest via the list of Highlighted Topics (HTs). The HTs support a more efficient funding application process and scientific integration across NIH. Other scientific questions related to the Institute’s topics of interest were developed by NHLBI staff members with community input.

Researchers interested in applying for NHLBI funding to study heart, lung, blood, and sleep (HLBS) disorders can consult the HTs and Strategic Vision to align their submissions with the Institute’s priorities. Dr. Goff provided an update on the status of peer review meetings. The October 2026 Council meeting (covering the June and July review meetings) will typically involve discussion of the top third of applications. The middle third will be designated “competitive but not discussed” and available to Institutes and Centers (ICs) for funding consideration. Summary statements will use a bulleted format for the “Resume of Discussion” section. The NIH Center for Scientific Review (CSR) intends to meet the usual summary statement deadlines.

The 2026 Strategic Visioning Retreat with members of the NHLBAC and NHLBI’s Board of External Experts (BEE) occurred on June 8, 2026. Dr. Goff noted that today’s meeting agenda includes a presentation on the retreat. NHLBI is integrating its resources within the NIH Make America Healthy Again (MAHA) Strategic Framework to support chronic disease research through infrastructure development (e.g., real-world data and artificial intelligence [AI], clinical and community networks, and life-course cohorts). The overarching goal is to coordinate and integrate activities across NIH to result in a more impactful effort. NIH has established MAHA thematic coordination groups to facilitate integration, leverage resources, and to collaborate on key chronic disease research areas. NHLBI leads or co-leads in four of the seven MAHA focus areas.

Dr. Goff discussed NHLBI’s clinical trial stewardship, part of the Institute’s evergreen strategic vision, which includes feasibility, pragmatic, and network studies. He highlighted the clinical trial development continuum and remarked that multi-site clinical trials provide translational insights into NHLBI’s research priorities for a broad array of health conditions and practice issues—such as heart failure, standard of care, respiratory failure, precision medicine, and lung injury. For fiscal year (FY) 2017 to 2025, the Institute received 262 unique applications working with clinical coordinating centers and funded 54 (note that the success rate is higher because of second reviews). Dr. Goff briefly described the results and clinical impact of nine NHLBI-funded studies (in one case, the Institute supported the basic science underlying the clinical trial).

These trials impacted clinical practice in the following areas: blood transfusions and acute myocardial infarctions, efficacious treatment for a rare disease (hereditary hemorrhagic telangiectasia), answers to key questions about heart failure therapies, management of HIV and cardiovascular disease risk, implementation strategies for HIV care, effective hypertension control strategies in real-world settings, assessment of functional outcomes for preterm infants at risk for bronchopulmonary dysplasia, improvement for patients with mild sleep-disordered breathing, and characterization of the neuromuscular mechanism mediating obstructive sleep apnea.

The Council agenda also includes a description of a “Multi-IC”, multi-site clinical trial, as part of the suite of forecasted Notice of Funding Opportunities (NOFOs) in which NHLBI will participate. This Multi-IC multi-site clinical trial opportunity will target efficacy, effectiveness, and implementation trials. It will request applications that propose a large and/or complex clinical trial conducted at either a single site or at multiple locations, but without physical clinical sites (e.g., decentralized or virtual trials). This NOFO will complement other types of clinical trials—feasibility, pragmatic, and network—and optimize NHLBI’s clinical trials enterprise to advance science, transform practice, and impact health.

Dr. Goff emphasized that NHLBI’s partners—including patients, researchers, policymakers and government agencies, academic health centers, professional societies and foundations, the private sector and industry, primary care, and community organizations—form a collaborative ecosystem that drives scientific innovation and better health for all. He affirmed the Institute’s commitment to continuing these partnerships to generate new knowledge on HLBS conditions and address the informational needs of decision makers, such as the professional societies that write clinical practice guidelines. Dr. Goff also expressed gratitude for the partnership of NHLBAC.

NATIONAL COMMISSION FOR LYMPHATIC DISEASES REPORT

Stanley Rockson, M.D., Stanford University School of Medicine; Stephanie Dreyer, The LAM Foundation; and Alexa Ercolano, The Lymphie Life

Ms. Ercolano described her experiences as a person with primary lymphedema. She underscored that for many biomedical experts and clinicians the lymphatic system is not top of mind—although it should be. Lymphatic disease produces manifestations across all body systems. Ms. Ercolano’s experiences with the impacts of delayed diagnosis and the need to manage symptoms of her condition due to the lack of a cure or disease-modifying treatment are not unusual among people with lymphatic diseases. The lymphatic system is crucial to health, and this topic has a well-developed body of science and sufficient expertise. However, integration is lacking. The National Commission for Lymphatic Diseases (NCLD) report calls for a National Lymphatic Collaborative Network, and Council members can help advance this effort.

Dr. Rockson explained that the report from the National Commission on Lymphatic Diseases (NCLD), a working group of the NHLBAC, originated from a congressional request to NIH in response to patient advocates. NHLBI agreed to support the work of the Commission on behalf of NIH. Lymphatics can be thought of as the hidden network of health and disease, as it manifests in every organ system in the body. NIH-supported research on lymphatic biology and disease is increasingly robust at $967 million in FY 2023. However, the magnitude of the problem is huge. The NCLD is not asking for funding, but it is important to acknowledge the challenge facing the field. After reviewing the establishment of the NCLD in 2023, Dr. Rockson described the charge of the Commission. The NCLD is a transparent, comprehensive, and accessible public forum that assessed critical challenges and scientific and clinical opportunities and gathered input from an overarching spectrum of stakeholders. It aimed to provide an actionable plan to improve health and prevent, preempt, diagnose, and treat lymphatic diseases across the life course. Co-chaired by Dr. Rockson and Stephanie Dreyer, M.B.A., who is a patient and advocate living with lymphangioleiomyomatosis, NCLD members included clinicians, clinician scientists, and basic researchers.

Since its inception, the group has been gathering information through multiple ongoing activities (e.g., monthly committee meetings, co-chair meetings, planning activities, town hall forums, quarterly meetings, and key informant sessions). The NCLD issued a Request for Information and received 208 responses from the community. An NIH portfolio analysis indicated that 23 NIH Institutes support lymphatic research. Many stakeholders, including patients and caregivers, advocacy groups, industry, and professional associations, were engaged to share their perspectives with the NCLD and envision a blueprint for the lymphatic community. Dr. Rockson emphasized that the community voice is very important, as lymphatic conditions often go unrecognized.

Dr. Rockson shared the outline of the draft NCLD’s report and encouraged NHLBAC members to review the entire report. The report’s most important message is in “Chapter 7: Pathway for Future Progress,” in which the NCLD details the proposed Integrated National Lymphatic Network, cross-cutting priorities, measurable milestones, a collaborative approach, and a transformative vision if the described priorities are implemented. “Chapter 8: Conclusion and Call to Action” recaps the key findings that millions are affected by lymphatic dysfunction and that this goes underrecognized; dedicated leadership is needed for progress; there is an urgent need for collaboration and innovation; and the field must prioritize research, care, and policy for equitable outcomes.

The NCLD envisions a future in which there is timely, effective, and compassionate care for all patients affected by lymphatic dysfunction. Dr. Rockson introduced a proposed blueprint for a National Lymphatic Collaborative Network, which would have three layers and a phased development. The Network would have a nested structure with a board of trustees, executive office, and scientific council providing governance. A Virtual Coordinating Forum would be the central layer of the nested structure, surrounded by the National Lymphatic Network Core. Public-private partnerships constitute the expansion ring of the National Lymphatic Collaborative Network’s structure.

In conclusion, Dr. Rockson stressed that the Network should be built once and scaled as funds allow, but the work must start now. The envisioned Network would have a phased ecosystem with discovery labs, diagnostics, education, data commons, and a payer liaison as part of its structure from day one. The NCLD has presented the case that this is the only model that can lift lymphatic science out of obscurity, deliver reimbursable diagnostics and therapies, and achieve such results in an era of constrained NIH budgets. He presented a quotation from a patient that touched on the many missed opportunities for correct diagnosis of lymphedema to underscore the reason for the proposed Network. Dr. Rockson acknowledged the work of the Commission and thanked the NHLBI groups and individuals supporting NCLD activities, particularly the NIH-wide Lymphatic Coordinating Committee, especially Lenora Johnson, Dr.P.H., M.P.H., and Selen Catania, Ph.D.

In response to a question about elevating the profile of lymphatics as crucial to health, Dr. Rockson suggested that medical and health science education should convey that the body’s internal environment is created by lymphatic architecture. Once clinicians understand the importance of the lymphatic system, they will need tools to address these conditions. Basic science is necessary to develop those tools. Participants expressed appreciation to Ms. Ercolano for her powerful message.

Dr. Goff added that the next steps are for Council members to review the NCLD’s report and submit comments to Dr. Lamar. Feedback will be presented to the Commission, and then NHLBI will prepare the document for appropriate reviews, clearances and for reporting back to Congress. He thanked the co-chairs of the NCLD and Dr. Catania, noting that the Institute is looking forward to presenting the report to Congress on NIH’s behalf.

RETREAT RECOMMENDATION REPORT

Olveen Carrasquillo, M.D., M.P.H., University of Miami, Miller School of Medicine
Dr. Carrasquillo highlighted that the slowing of U.S. life expectancy growth relative to peer countries—which is related to the increasing burden of chronic disease, including among people ages 18 to 34—set the context for the retreat discussion. Through the MAHA agenda, NIH has established a strategic approach to transform chronic disease research to identify and address its root causes. This approach focuses on leveraging and aligning existing NIH assets (e.g., cohorts, platforms, and expertise), improving NIH coordination in this area, and generating actionable results on chronic disease among children and adults. NHLBI aims to leverage its assets to advance a holistic, multi-level systems approach to preempt and prevent chronic disease across the lifespan.

Council and BEE members were charged to recommend specific, actionable, alternative, and innovative ideas to advance health and prevent chronic disease. The four research topics were
(1) Disease Prevention Through Early Life Intervention; (2) Metabolic, Immune, and Inflammatory Pathways for HLBS Solutions; (3) Nutrition & Lifestyle Interventions for HLBS Health; and (4) Science of Environmental Exposure for HLBS Health. For each of the research topics, retreat participants considered six cross-cutting themes: (1) Chronic Disease Burden; (2) Community Engagement and Implementation Science; (3) Health Disparities; (4) Lifespan Considerations; (5) Workforce Development; and (6) Tools/Resource Needs. These were considered in terms of NHLBI’s eight Strategic Vision objectives.

Dr. Carrasquillo summarized some of the high-priority recommendations from the retreat discussions. NHLBI/NIH might aim to do the following:

Near term (0–2 years)
Harmonize data and develop common data elements across existing cohorts
Issue guidelines for a prospective consent framework covering new cohort studies
Act as a neutral facilitator in structured convenings with insurers and policymakers
Leverage stored environmental samples and biospecimens from the Environmental Influences on Child Health Outcomes program for exposome analyses
Establish key performance indicators for high-priority initiative areas
Medium term (2–5 years)
Establish an integrated nutrition-sleep-activity-circadian consortium
Develop a digital health validation program (prize competition or accelerator) for priority populations
Expand the life-course exposome cohort and individual-level measurement platform
Establish a cross-Institute inflammation/immune consortium with the relevant NIH partners
Establish a systems biology program for heavily transfused populations
Long-term (5+ years)
Collaborate with international rare disease research networks
Develop scalable real-time environmental exposure measurement platforms
Develop sustained long-term follow-up funding mechanisms for curative therapies
Transform the T32 training ecosystem (e.g., cross-silo, AI-fluent, economist- and communicator-inclusive)
Dr. Carrasquillo noted that retreat participants recommend that the Institute should consider the most appropriate partnerships and coordination with other NIH ICs, as well as specification of roles and mechanisms when implementing the recommendations. Council and BEE members emphasized that workforce needs go beyond traditional biomedical scientists to include experts in data, health economists, communications professionals, community health workers, and implementation scientists. Key elements highlighted during the retreat must be structural design features rather than add-ons, and validated tools are needed for priority populations.

The policy environment must be considered, with continual monitoring of federal directives. In addition to the traditional financial support, flexible rapid-response funding mechanisms are needed. Funding should require sustainability milestones. During the retreat, Council and BEE members also identified gaps and open questions, such as delivery models for people with disabilities, enhancing the representation of basic science/pathobiology in the framing of prevention, and specific HLBS health recommendations for occupational context (e.g., shift and gig work). The field lacks an implementation readiness framework and needs a better understanding of the stability of non-genetic -omics measures over time. Additionally, key performance indicators are needed to ensure alignment with NHLBI’s strategic vision.

The recommended next steps are to establish and convene two Council working groups: (1) one to map the life-course chronic disease research and assess existing resources, and (2) a second consisting of insurers, policymakers, and health economists. NHLBI should address near-term recommendations and explore international collaborations to advance research on rare diseases within the current policy context. The Institute should develop a guidance framework for dissemination readiness, address the gaps identified during the retreat, and establish key performance indicators for high-priority initiatives. Across all sessions, Council and BEE members emphasized that integration—of data, disciplines, and stakeholders—is the path forward for NHLBI.

Dr. Goff thanked members of the NHLBAC and BEE for their input during the retreat and NHLBI staff for their hard work organizing the event. He added a cross-cutting theme of importance: horizontal (i.e., across HLBS) and vertical integration (i.e., across the translational spectrum and implementation science). NHLBI will use the retreat feedback in its efforts to reduce NOFOs and simplify the process for applying for support. The Institute will continue to release NOFOs, and information from the retreat will help in their development, as well as in identifying new HTs.

Feedback from the retreat will inform the monthly e-blast newsletter to communicate the Institute’s priorities, which are important for the broader scientific community. Finally, input from members of the Council and BEE will help NHLBI as it engages in the MAHA initiative. Dr. Goff expressed gratitude to Dr. Lamar for leading efforts for an inspiring and invigorating scientific retreat.

NHLBI CONCEPTS

Dr. Charisee A. Lamar, Director, DERA, NHLBI
Dr. Lamar presided over the Council concept review process. Members of Council voted and approved the following concepts:
The Women’s Health Initiative Renewal Initiative—This is a 10-year renewal starting in 2028. This is a landmark, long-term national health study that focuses on strategies for preventing heart disease and other chronic conditions that represent the major causes of death, disability, and frailty in older women. Its findings have changed women’s health and how medicine is practiced around the world. The ongoing study will continue to advance women’s health research across the lifespan.

Renewal of the Adolescent Brain Cognitive Development (ABCD) Study—NHLBI co-funds this National Institute on Drug Abuse initiative along with 10 other ICs. The ABCD Study is the largest longitudinal study of brain development and child health in the United States—tracking nearly 12,000 youth from ages 9–10 into early adulthood. Cardiovascular, lung, and sleep function measurements are included in this scientifically productive study, which has identified novel risk factors (e.g., screen time) for HLBS health. The initial waves of participants are now entering young adulthood.

Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required)—This clinical trial targets phase 2 and above (implementation clinical trials) and is part of NHLBI’s efforts to reduce the number of NOFOs. This effort aims to advance high-priority research questions with the potential to change clinical practice and outcomes. The requirements that were in the preceding NOFO (e.g., community engagement) will remain.

Renewal of Secondary Participation in the Fogarty International Center (FIC) International Research Training Award (NCD-LIFESPAN) Program (D43) and Secondary Participation in FIC Emerging Global Leader Award (D43)—This effort empowers multidisciplinary research with large sample sizes, allowing researchers to examine risk exposures. Many of the documented solutions found in international research are broadly applicable in the United States.

PUBLIC COMMENT

A representative from People for the Ethical Treatment of Animals, Dr. Gabby Vidaurre, read a statement urging NHLBI to prioritize the use of nonanimal models in biomedical research, along with continuing education programs and infrastructure. She referred meeting participants to the organization’s science webpage.

CLOSING REMARKS AND ADJOURNMENT

Dr. Goff thanked Council members and expressed appreciation for their service, which is crucial to guiding NHLBI’s plans, and commitment to NIH’s mission. With no further business, Dr. Goff adjourned the open session at 11:04 a.m.

CLOSED SESSION
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.

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 the 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 prior to the meeting.

The Council considered and recommended 3,985 applications requesting $11,045,781,561 in total costs. For the record, it is noted that secondary applications were also considered en bloc.

The 314th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) convened virtually on Wednesday, March 25, 2026. The Council meeting began with a closed session that started at 10:09 a.m. and ended at 11:39 a.m. The open session reconvened from 12:00 p.m. and ended at 12:28 p.m. Dr. David C. Goff, Acting 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., Ph.D.

Eldrin F. Lewis, M.D., M.P.H.

Solomon Ofori-Acquah, Ph.D.

Merritt Raitt, M.D., Ex Officio

Susan Redline, M.D., M.P.H.

Martha C. Sola-Visner, M.D.

Susan Spencer

Members of the Public Attending

The total number watching online was reported by NIH Videocast to be 229.

NHLBI Employees Attending

Several NHLBI staff members attended 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 3,885 applications requesting $10,161,229,570 in total costs. For the record, it is noted that secondary applications were also considered en bloc.

OPEN SESSION

CALL TO ORDER

Dr. David C. Goff, Acting Director of the National Heart, Lung, and Blood Institute (NHLBI), called the meeting to order at 12:00 p.m. He welcomed Council members, NHLBI staff, and public attendees to the Open Session of the meeting.

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.

REPORT OF THE DIRECTOR

Focusing his remarks on accountable stewardship, Dr. Goff provided an update on NHLBI’s leadership transition. Gary H. Gibbons, M.D., recently retired as NHLBI director after serving as an exceptional leader of the Institute for more than 13 years. Dr. Goff commented on Dr. Gibbons’s unwavering dedication to fulfilling NHLBI’s scientific and public health mission. NHLBI continues to embrace the path charted by Dr. Gibbons with the Strategic Vision Refresh. Among Dr. Gibbons’s accomplishments was establishing NHLBI’s Center for Translation Research and Implementation Science, which positioned the Institute to contribute to the launch of the NIH Community Engagement Alliance (CEAL) during the early stages of the COVID-19 pandemic and maintain this research network’s relevance as a platform for community-engaged studies that will improve the health of Americans. Dr. Gibbons helped to ensure that the NIH RECOVER: Researching COVID to Enhance Recovery Initiative is responsive to the ongoing science of long COVID-19. With his interest in precision medicine, Dr. Gibbons was a champion of the Trans-Omics for Precision Medicine (TOPMed) program to advance the scientific understanding of the fundamental biological processes that underlie heart, lung, blood, and sleep (HLBS) disorders. Dr. Gibbons also was instrumental in advancing several NHLBI initiatives—such as the COPDGene Study®, the NIH Systolic Blood Pressure Intervention Trial, BioData Catalyst, and the Chronic Hypertension and Pregnancy (CHAP) study. His bold vision for the Cure Sickle Cell Initiative facilitated the development of two U.S. Food and Drug Administration–approved gene therapies for this condition.

NHLBI will continue to uphold its enduring principles in times of change. The Institute values investigator-initiated fundamental discovery science and maintaining a balanced, cross-disciplinary portfolio of basic, translational, clinical, and population research. NHLBI makes every effort to train a robust, new generation of leaders in science. The Institute supports implementation science that empowers patients and enables partners to improve the health of the nation. Finally, NHLBI supports innovations and solutions-oriented approaches for the evidence-based elimination of health disparities in the United States and around the world.

Fiscal Stewardship. In the final fiscal year (FY) 2026 budget, Congress appropriated $3.99 billion for NHLBI. This amount represents a 0.20 percent ($8 million) increase over FY2025. The Institute’s budget has been flat for the past 4 years, which presents a challenge to support a historic number of awards given inflation in the cost of conducting biomedical research. NHLBI also co-leads several key NIH programs (e.g., Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone Initiative). Dr. Goff noted that multiyear funding for FY2026 is limited to the FY2025 amount and that indirect costs are maintained at current rates. NHLBI prioritizes investments in investigator-initiated science, but its flat budget has resulted in a decrease in the success rates of R01 and Early-Stage Investigator awards—mostly due to an increasing number of applications. K awards for training have not shown a drop off in success rates because the number of applications has remained constant. NHLBI continues to invest in early-career investigators and maintain support for individual career development.

NHLBI’s established funding practices are consistent with NIH efforts to advance its Unified Funding Strategy. NHLBI’s long-standing funding practices focus on the scientific and technical merit of the proposed project as determined by scientific peer review, NHLBAC recommendations, and relevance to the Institute’s strategic research priorities. Additionally, NHLBI seeks to maintain an overall programmatic portfolio balance and address needs. Development of the biomedical workforce is a priority, as well as supporting proposals with the potential for high scientific or public health impact.

NIH Strategic Plan. The NIH-Wide Strategic Plan for FY2027–2031 is under development. NIH has established a framework that outlines three key priorities: (1) Research Areas (i.e., address emerging and critical biomedical research areas); (2) Research Capacity (i.e., build and maintain the capacity to conduct biomedical research); and (3) Research Operations (i.e., operate with the highest integrity to oversee gold standard science). The public may submit comments to the Request for Information for the FY2027–2031 NIH Strategic Plan through May 16, 2026. Additionally, NIH is hosting a webinar on the development of the NIH-Wide Strategic Plan for FY2027–2031 on April 8, 2026 (2:30 p.m.–3:30 p.m. EDT).

NHLBI-NIH-HHS Alignment. NIH Director Jayanta (Jay) Bhattacharya, M.D., Ph.D., has outlined NIH priorities, which are aligned with NHLBI’s mission, as well as the broader goals for the U.S. Department of Health & Human Services. NHLBI’s research portfolio and efforts are well aligned with these priorities, which are as follows:

• Chronic Disease—NIH is focusing on research to close critical research gaps and improve the health of all Americans. NHLBI is pursuing a multidimensional, systems biology research approach to close the gaps in health outcomes and improve health for all people through prevention and early intervention for chronic HLBS conditions.
• Nutrition, Diet, and Lifestyle—NIH is prioritizing the role of maternal and infant dietary exposures on health outcomes across the lifespan—including exploring the role of poor diets and identifying healthy diets. Many chronic HLBS conditions are influenced by nutrition, diet, and lifestyle.
• Artificial Intelligence (AI)—NIH is prioritizing alternative testing models and real-world data platforms to expedite the research, development, and translation of discoveries to benefit patients. To improve outcomes with AI-enabled precision health, NHLBI is advancing human systems biology and the development of AI tools. Priority areas include the molecular drivers of heart disease, women’s health during periods of transition (e.g., pregnancy and menopause), and early biomarkers of lung health. NHLBI research in this area aims to link rich sources of behavioral, environmental, -omics, and imaging data.
• Implementation Science—NIH is testing, advancing, and scaling innovative evidence-based interventions to address poor health outcomes, including the HIV/AIDS epidemic. The priority of implementation science resonates with NHLBI’s support of research on promising strategies for adopting, integrating, sustaining, scaling, and spreading evidence-based HLBS interventions in clinical and public health settings such as clinics, worksites, and communities.
• Health Disparities Research—NIH is shifting to solutions-oriented approaches, continuing to support global research partnerships, and prioritizing gold-standard science. Many NHLBI programs take a solutions-oriented approach to addressing health disparities—including those related to living in a rural area—in HLBS conditions.
• Train the Next Generation—NIH is focusing on supporting future physicians and scientists in designing and conducting high-quality research. NHLBI continues to support initiatives that bolster training across career stages—from high school and undergraduate students through mid-career and established investigators. The Institute understands the particular importance of supporting early-stage investigators.

AI-Enabled Precision Health. NHLBI is leveraging its comprehensive data resources—including TOPMed’s multimodal data and BioData Catalyst cloud resource—for a systems-level approach to better HLBS health for all. The Institute recently funded a coordinating center for NHLBI AI-enabled precision health and will soon fund a data center. These efforts are supported by AI tool development and applications and AI-driven precision prevention. The first module program, Pioneering Research for Early Evaluation and Mechanistic PreempTion of Pulmonary Fibrosis (PREEMPT-PF), focuses on identifying early biomarkers of lung health. These efforts will establish a foundation for identifying pulmonary fibrosis at its earliest stages and discovering biological targets for potential pharmacotherapies. Subsequent modules will address precision nutrition research and women’s health during periods of transition (e.g., pregnancy and menopause) with the aims of preventing chronic diseases earlier and discovering biological targets for potential pharmacotherapies.

NHLBI empaneled the NHLBAC AI Working Group (External) to advise the Institute on integrating this technology to advance its public service, scientific, and public health missions. The Working Group will provide reports to NHLBAC, and Council members can reach out with comments. The Working Group will issue an initial report to the Council later this year—based on its ongoing meetings and a workshop this summer—with an additional report expected. By incorporating diverse perspectives to pursue human systems biology at scale with AI integration, NHLBI aims to accelerate new discoveries in HLBS science for years to come.

Cycle of Innovation. Dr. Goff explained how NHLBI implements the cycle of innovation and provides specific programmatic examples for illustration. Discovery science (e.g., PREEMPT-PF) involves identifying molecular targets for intervention, which are then validated and translated (e.g., the multimodal sleep foundation model for disease prediction from the Sleep Heart Health Study) into potential interventions that are tested in clinical trials. But it is not enough to conduct successful clinical trials (e.g., Cure Sickle Cell initiative). Effective interventions must be implemented in practice (e.g., a percutaneous aorto-coronary bypass graft) and integrated into health systems to result in a healthier population. NIH CEAL—along with Community Engagement Alliance Consultative Resources—are crucial to the integration of effective interventions into health systems to improve population health, as illustrated by the dissemination clinical practice guidelines based on CHAP results.

Dr. Goff emphasized that NHLBI’s partners—including patients, researchers, policymakers and government agencies, academic health centers, professional societies and foundations, the private sector and industry, primary care, and community organizations—form a collaborative ecosystem that drives scientific innovation and better health for all. He affirmed the Institute’s commitment to continue these partnerships to generate new knowledge on HLBS conditions and address the informational needs of decisionmakers, such as the professional societies that write clinical practice guidelines. Dr. Goff also expressed gratitude for the partnership of NHLBAC.

There were no questions, but a Council member commented on the leadership contributions of Dr. Gibbons, noting that it was great to see NHLBI continuing his work.

PRESENTATION

Dr. Charisee A. Lamar, Director, Division of Extramural Research Activities, NHLBI

Dr. Lamar remarked that NHLBAC members have access to the full operating procedures and authorities in the Electronic Council Book (ECB). She explained that the delegated authorities from NHLBAC allow NHLBI to take administrative actions and use scientific or professional services of not more than 100 special experts appointed by the NHLBI Director. They also permit NHLBI to expedite Council concurrence using procedures outlined in the delegated authorities document for program plans and en bloc actions, as well as to make certain administrative decisions regarding selecting and funding competing grant applications in the event of a federally declared emergency. These delegations apply if ECB and en bloc procedures are not feasible. Dr. Lamar provided a list of relevant source documents.

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.

CLOSING REMARKS

Dr. Goff adjourned the meeting at 12:28 p.m.

The 313th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) convened virtually on Wednesday, December 10, 2025. The Council meeting began with a closed session that started at 10:09 a.m. and ended at 12:47 p.m. The open session convened from 1:11 p.m. and ended at 2:05 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., Ph.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.
Martha C. Sola-Visner, M.D.

Members of the Public Attending
The total number watching online was reported by NIH Videocast to be 176.

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 prior to the meeting. The Council considered and recommended 3,203 applications requesting $9,712,952,521 in total costs. For the record, it is noted that secondary applications were also considered en bloc.

OPEN SESSION

CALL TO ORDER

Dr. Gary Gibbons, Director, National Heart, Lung, and Blood Institute (NHLBI), called the meeting to order at 1:11 p.m. and welcomed Council members, NHLBI staff, and public attendees.

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.

REPORT OF THE DIRECTOR

Dr. Gibbons thanked Valerie Prenger, Ph.D., acting director for NHLBI’s Division of Extramural Research Activities (DERA), for her many years of service at NIH. Dr. Prenger served in many roles at DERA, including as acting director, deputy director since 2019, and previously as director of the Office of Scientific Review. This acknowledgement was based upon Dr Prenger’s retirement in September. Currently, Dr. Charles W. Joyce is the acting deputy director of the Division of Extramural Research Activities (DERA).

The federal government furlough and lapse in appropriations affected the fiscal year (FY) 2026 Council Rounds. NHLBI has rescheduled the October 2025 and November 2025 peer reviews for December 2025 and January 2026, respectively. Application due dates affected by the furlough were extended to December 8, 2025. The Center for Scientific Review (CSR) is making progress to clear the backlog, but ripple effects continue. Dr. Gibbons expressed his appreciation to staff members and people in the extramural community for their patience and adaptability.

NHLBI Budget. Dr. Gibbons remarked that NHLBI is funded at FY2025 levels and operating under a continuing resolution until January 30, 2026. Proposed FY2026 congressional appropriations for NHLBI are $3.982 billion (Senate) and $3.990 billion (House). These proposed amounts from the Senate and House of Representatives represent a flat or slightly increased budget for the Institute, respectively. Although the president’s budget called for NIH Institute and Center consolidation or elimination, the proposed FY2026 congressional appropriations do not pursue these actions—a result of stakeholder engagement, bipartisan relationships, and the importance of the NIH mission in improving the health of the American people. Negotiations continue on the proposed NIH appropriations, with both the Senate ($48.7 billion) and House ($47.8 billion) amounts being higher than the president’s budget.

NHLBI-NIH-HHS Alignment. NIH Director Jayanta (Jay) Bhattacharya, M.D., Ph.D., has outlined NIH priorities, which are aligned with NHLBI’s mission, as well as the broader goals for the U.S. Department of Health & Human Services and the “one NIH” approach.

NHLBI’s alignment with these focus areas includes:

Chronic Disease. NIH focuses on research to close critical research gaps and to improve the health of all Americans. NHLBI is pursuing a multidimensional, systems biology research approach to close the gaps in health outcomes and improve health for all people through prevention and early intervention for chronic heart, lung, blood, and sleep (HLBS) conditions. Dr. Gibbons welcomed the opportunity to continue working with Richard Woychik, Ph.D., who has been tapped to serve as senior advisor for NIH’s Make America Healthy Again strategy. Dr. Woychik formerly served as director of the National Institute of Environmental Health Sciences, and NHLBI is well-positioned to contribute to research on the exposome and its effects on chronic diseases.

Artificial Intelligence (AI). AI is a government-wide priority, and NIH supports testing models and real-world data platforms to expedite the research, development, and translation of discoveries to benefit patients. To improve outcomes with AI-enabled precision health, NHLBI is advancing human systems biology and the development of AI tools. Priority areas include the molecular drivers of heart disease, women’s health during periods of transition (e.g., pregnancy and menopause), and early biomarkers of lung health. NHLBI research in this area aims to link rich sources of behavioral, environmental, -omics, and imaging data.

Implementation Science. NIH supports research to test, advance, and scale innovative evidence-based interventions that address poor health outcomes. The priority of implementation science resonates with NHLBI’s support of research on promising strategies for adopting, integrating, sustaining, scaling, and spreading evidence-based HLBS interventions in clinical and public health settings such as clinics, worksites, and communities.

Health Disparities Research. NIH is addressing well-documented health disparities by focusing on solutions-oriented approaches and gold-standard science. NHLBI will continue to provide support for global research partnerships that benefit the health of the American people. Many NHLBI programs address health disparities—including those related to living in a rural area—in HLBS conditions.

Training the Next Generation. NIH is helping future physicians and scientists to design and conduct high-quality research. NHLBI continues to support initiatives that bolster training across career stages—from high school and undergraduate students through mid-career and established investigators. The Institute understands the particular importance of supporting early-stage investigators.

Transitions in Peer Review. NIH has significantly reduced the number of Notice of Funding Opportunities (NOFOs), which will allow Institutes, Centers, and Offices (ICOs) to increase investigator-initiated applications. NIH peer review is now centralized through CSR, which allows ICOs to maintain a balance of workforce and research programs. NHLBI is working through a process to operationalize these changes, and staff and the extramural community will adapt to the logistical changes. NHLBI’s established funding practices align with NIH’s new funding policy core tenets. For example, NIH prioritizes scientific merit and suggests that ICOs consider peer-review information in its entirety and integrate a breadth of topics and approaches. Other factors for consideration include investigator's career stage, geographic balance, and the broad distribution of scientific excellence and talent. These funding principles are familiar to NHLBI and have been followed for years. NHLBAC plays an important role in aligning and ensuring that the Institute’s overall portfolio is across HLBS topics and research types (e.g., basic, clinical, and implementation science). Dr. Gibbons reviewed NHLBI’s strategic and holistic approach to supporting the biomedical approach, showing data on the FY2025 percentile R01 awards by score. The R01 payline is at the 12th percentile, while the early-stage investigator R01 payline is at the 22nd percentile. The payline with selective pay is at the 23rd percentile. This approach facilitates flexible decision-making across the spectrum and contributes to a balanced portfolio.

Funding. Given current policies, NHLBI’s FY2025 strategic approach to multiyear funding was implemented in the last quarter. There has been some variability in implementation across NIH. Dr. Gibbons showed data comparing NHLBI’s multiyear funding in FY2024 and FY2025. These awards considered geographic balance and included multiyear funding for projects with scientific merit led by early-stage investigators. Historically, NHLBI has used multiyear funding selectively and strategically. There has been a decline in early-stage investigator funding rates at NIH and NHLBI (e.g., 20.9 percent in FY2025). NHLBI tried to mitigate impacts of budget changes on early-stage investigators and aims to protect them in the future. NIH awaits FY2026 multiyear funding guidance. There is bipartisan support for strategic and flexible multiyear funding rather than an arbitrary funding level for these awards. ICOs need flexibility in the execution of the policy on multiyear funding. For examples, NIH needs to ensure that clinical trials hit milestones, so a multiyear funding approach would be inappropriate. NHLBI is working to balance institute-solicited and investigator-initiated research (i.e., 14–86 percent, respectively). Other Transaction Authority (OTA) research ($68.7 million in FY2025) is a flexible funding strategy that is neither a grant nor contract. OTAs accelerate discovery and translation by maximizing the Institute’s flexibility to adapt, work creatively, and negotiate with nontraditional entities. They support research when their characteristic features are most appropriate for generating discovery. Using OTAs, NHLBI has made robust and transparent investments in programs that need to be nimble and flexible (e.g., Catalyze and BioData Catalyst).

NHLBAC AI Working Group. Dr. Gibbons noted that NHLBI is building a foundation of leadership and integrating AI to advance innovative HLBS science by forming the NHLBAC AI Working Group (external). This group will advise the NHLBI community on the integration of AI to advance the Institute’s service, scientific, and public health missions. AI tool development and applications combined with AI-driven precision prevention will help NHLBI leverage TOPMed multimodal data and the BioData Catalyst resource to advance deep phenotyping and human systems biology to complement research findings from preclinical models. Such an approach will yield discoveries on the molecular drivers of heart disease, early biomarkers of lung health, and women’s health during transition periods (e.g., pregnancy and menopause).

Dr. Gibbons concluded by remarking that NHLBI will continue to work with its many partners—including patients and citizen scientists, researchers, professional societies, the private sector, and community organizations—to improve health for all. He expressed appreciation to all of the Institute’s partners.

NHLBI CONCEPT CLEARANCE

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

Title: Summer Institute for Research Education in Biostatistics and Data Science

Description: Aims to invite applications for grants to develop, conduct, and evaluate summer courses in the basic principles and methods of biostatistics and data science as employed in biomedical research. The objective of this initiative is to support up to six short-term training awards for skills development in biomedical statistics and data science among advanced undergraduates and recent graduates in a six- to seven-week summer course. The curriculum includes an innovative, hands-on introduction to methods in biostatistics and data science, as well as career counseling. The program strives to recruit students from across the country and provides resources for travel, housing, and tuition. There is a strong demand for statisticians and data scientists, with a good projected job growth rate. This renewal aims to continue to support the pipeline for future statisticians and data scientists, and includes plans for a comprehensive review of the program to understand its direct and indirect benefits, as well as participant characteristics.

CLOSING REMARKS

Dr. Gibbons adjourned the meeting at 2:05 p.m.

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., Ph.D.
Eldrin F. Lewis, M.D., M.P.H.
Solomon F. Ofori-Acquah, Ph.D.
Merritt H. Raitt, M.D., Ex Officio
Susan S. Redline, M.D., M.P.H.
Lynn M. Schnapp, M.D.
Martha C. Sola-Visner, M.D.
Susan Spencer

NHLBI Employees Attending
A number of NHLBI staff members attended via Teams.

I. CALL TO ORDER AND OPENING REMARKS

Dr. David C. Goff, Deputy Director for Precision Medicine and Data Science, National Heart, Lung, and Blood Institute (NHLBI), welcomed members and called the 312th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) to order at 1:02 p.m. The meeting was held via video conference for the members.

II. ADMINISTRATIVE ANNOUNCEMENTS

Dr. Charisee A. Lamar, Director, Division of Extramural Research Activities, NHLBI, 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. 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 806 applications requesting $444,327,779 in total costs. For the record, it is noted that secondary applications were also considered en bloc.

ADJOURNMENT

The meeting was adjourned at 2:03 p.m.

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.

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.

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.

The 308th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) was convened on Tuesday, August 20, 2024 at 1:01 p.m. as a virtual Zoom Event. The meeting was closed to the public from 1:03 p.m. until adjournment at 1:42 p.m. Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI), presided as Chair.

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

NHLBI Employees Attending
A number of NHLBI staff members were in attendance.

I. CALL TO ORDER

Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI), welcomed members and called the 308th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) to order at 1:01 p.m. The meeting was held via video conference for the members.

II. ADMINISTRATIVE ANNOUNCEMENTS

Dr. Valerie Prenger, Acting Director, Division of Extramural Research Activities, NHLBI, 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. 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 871 applications requesting $1,510,748,782 in total costs. For the record, it is noted that secondary applications were also considered en bloc.

ADJOURNMENT

The meeting was adjourned at 1:42 p.m.

The 307th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) convened in-person on Tuesday, June 4, 2024.  The Council meeting began with a closed session that started at 8:02 a.m. and ended at 10:42 p.m.  The open session reconvened from 10:54 a.m. and ended at 2:26 p.m. Dr. Gary H. Gibbons, Director of NHLBI, presided as chair.

NHLBAC Members Attending 
Mercedes R. Carnethon, Ph.D.
Amanda Mae Fretts, M.D., M.P.H.                                   
Tina V. Hartert, M.D., Ph.D.
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
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 be 281.

NHLBI Employees Attending
Several NHLBI staff members attended 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 3,635 applications requesting $1,941,591,766 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 10:54 a.m.  He welcomed Council members, NHLBI staff, and public attendees to the Open Session of the meeting.

II. ADMINISTRATIVE ANNOUNCEMENTS

Dr. Valerie L. Prenger (Acting 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 reported that NHLBI fiscal year 2024 (FY 2024) appropriations granted by Congress are unchanged from FY 2023 at $3.98 billion. Given current inflationary pressures, this calls for spending constraints. In early discussions about FY 2025, the proposed budget is expected to be similar to the prior two years.

NIH Director Dr. Monica M. Bertagnolli, at a Senate Appropriations Committee hearing about the budget, cited the following areas of focus in FY 2025: Rural health, women’s health/maternal mortality, heart disease, next generation, artificial intelligence/machine learning, Asian American and Native Hawaiian/Pacific Islanders, and the Long Covid/RECOVER Initiative.

In light of the austere budget for FY 2024, NHLBI instituted a 2% cut in non-competing awards, in order to support next generation scientists, including via early-stage investigators, career development awards, and other elements related to trainees, as well as an 8% increase in postdoctoral stipends.

Divisional News. Dr. Gibbons welcomed three new NHLBI division leaders: Drs. Traci Mondoro, Michelle Olive, and Courtney Thornburg. He also welcomed two new branch chiefs in the Division of Lung Diseases (DLD), which has made structural changes to further capture the spectrum of evolving science: Drs. Marrah Lachowicz-Scroggins and John Sheridan. He additionally welcomed Rear Admiral Richard Childs, new Scientific Director in the Division of Intramural Research. Dr. Gibbons congratulated, and made special mention of, DLD Director, Dr. James P. Kiley, for his 40 years of service in advancing the NHLBI mission.

Scientific Opportunities.  Dr. Gibbons gave an update on some of NHLBI’s research opportunities. The strategic vision refresh is progressing, incorporating diverse perspectives, and developing 26 new critical challenges and six new compelling questions.

Sickle Cell Disease.  Dr. Gibbons cited NHLBI’s progress in turning discovery into curative therapies for rare diseases, for instance through the Cure Sickle Cell initiative. The FDA approved gene therapies for Sickle Cell Disease (SCD) and researchers found that treating severe SCD with BCL 11A eliminated vaso-occlusive events. He noted that Sickle Cell Branch Chief Swee Lay Thein received the Shaw Prize in Life Science and Medicine, 2024.

Dr. Gibbons also discussed the Catalyze program, which supports the translation of discoveries at scale via commercialization.

He mentioned the potential opportunities offered by the White House Initiative on Women’s Health, to produce more research in women’s health across the lifespan. For instance, the cardiovascular disease (CVD) risk profile is different in women from men, and a better understanding of menopause and vasomotor symptoms, such as hot flashes, as well as mechanisms underlying CVD risk, could lead to new targeted therapies.

Idiopathic Lung Disease.  Dr. Gibbons noted that part of the strategic plan refresh is to better understand the molecular basis of chronic lung disease. Idiopathic pulmonary fibrosis is one of the areas of unmet need and NHLBI scientists are working to elucidate the molecular mechanisms of lung fibrosis in a novel mouse model of conditional cell senescence. Intriguingly, selectively targeting senescent cells resulted in enhanced lung fibrosis, giving important insight into lung function. Familial pulmonary models can help in the identification of new, relevant genes and pathways that mediate disease risk.

Dr. Gibbons cited emerging opportunities for radiomics and deep learning for phenotypic, clinical, molecular, and prognostic characterization of idiopathic lung disease. Research in this area might produce subtle, preclinical biomarkers for some of the disease processes. Investigators have begun revealing genetic and environmental risk factors for early radiologic interstitial lung abnormalities. Several other studies are underway to better understand the disease in the preclinical context, its pathogenesis, and genetic contributors, which will hopefully lead to new therapeutics.

He discussed the application of machine learning (ML) and artificial intelligence (AI) to imaging. The implications of these technologies for clinical medicine over the next 5-10 years are likely to be profound and the NHLBI needs to incorporate ML and AI investments in its portfolio.

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

IV. CLONAL HEMATOPOIESIS FOLLOWING CURATIVE THERAPIES FOR SICKLE CELL DISEASE

Dr. Courtney Fitzhugh, Lasker Clinical Research Scholar, Laboratory of Early Sickle Mortality Prevention, NHLBI

Dr. Fitzhugh presented on Sickle Cell Disease (SCD) treatments and associated comorbidities. Her research includes exploring new avenues for hematopoietic cell transplantation (HCT) for SCD and the long-term health effects of curative therapies.

Dr. Fitzhugh noted that in patients with SCD, the median survival is 48 years. Lung, kidney, or heart impairments raise the risk of early death. Patients also face a higher risk of acute myeloid malignancies and scientists are investigating why, including the role of clonal hematopoiesis (CH), a premalignant condition with somatic mutations that can lead to blood cancers.

She discussed several studies of patients with SCD and their findings. One identified an increased risk of 2.3-fold for leukemia and 3.6-fold for acute myeloid leukemia, with the risk higher for those who were older or had more severe SCD. Hydroxyurea treatment was not a risk factor.

Another study examined patients who underwent myeloablative HLA-matched sibling HCT. The 5-year event-free survival was 91.4%, but 14.3% had chronic graft-versus-host disease (GVDH).

A new approach avoided chemotherapy before HCT but instead suppressed the immune system with Alemtuzumab, radiation, and Sirolimus. However, in a study of 120 patients who underwent a nonmyeloablative HCT, 5 developed aggressive myeloid malignancies later, after GVDH.

Dr. Fitzhugh then discussed autologous gene therapy strategies, which are another curative option for SCD but also show a risk of aggressive myeloid malignancies. She and her team found that in most patients who developed these malignancies, pathogenic TP53 mutations were present before curative therapies. Controls without the mutations typically did not develop myeloid malignancies.

Further studies found that SCD status was independently associated with an increase in CH, especially in older individuals and patients with severe disease. Dr. Fitzhugh is studying how this might happen and how to mitigate the risk.

The absolute risk of aggressive myeloid malignancies remains low but is significantly higher in adults following HCT and graft failure, or gene therapy, compared with patients who do not receive curative therapies. The presence of CH may guide therapeutic decisions in patients with SCD, for instance, preferring mixed donor/recipient chimerism to full donor chimerism and changing the dosage of immunosuppression, Dr. Fitzhugh concluded.

V. NHLBI CONCEPT CLEARANCE

NHLBI staff presented 16 concepts for clearance. Members of the Advisory Council were asked to rate each concept on six criteria using Decision Lens.

Titles: Viral Infections in the Young Lung-The VINYL Clinical Consortium (UG3, UH3).  Viral Infections in the Young Lung-The VINYL Clinical Consortium (U24)

Description: These concepts aim to build a new consortium focused on lower respiratory tract viral infections, which annually cause many hospitalizations, especially of young children, who can suffer long-term impact on lung and airway health. The RFAs will establish coordination centers and conduct extensive deep phenotyping and follow-up in a cohort of 1,500 very young children into preschool years.

Title: National Sleep Research Resource (NSRR) (N01)

Description: This contract renewal continues this highly accessed resource, currently with 11,000 users worldwide and 18 funded projects across NIH that focus on sleep and circadian research. The renewal will add new datasets and facilitate hypotheses with AI and ML approaches.

Title: Short-Term Research Experience Program to Unlock Potential (STEP-UP) (R25 Clinical Trial not allowed)

Description: This concept enables NHLBI to participate as a secondary sign-on in an NIH-wide initiative led by NIDDK. STEP-UP supports short-term research experiences for high school-level students, to attract them into research careers and help grow a diverse biomedical workforce. Established in 2002, STEP-UP has coordinating centers in geographically neglected U.S. areas and annually matches mentors and 25 high school students for an 8-week internship.

Title: Bench to Bassinet Congenital Heart Disease Advancing New Understanding in Genomics Cohort (B28 CHANGE Cohort) (U01)

Description: This concept renews support of a cohort that has increased understanding of congenital heart disease genetics and identified the origin of 25% of previously unexplained disease. Continuing this large cohort would allow long-term follow-up of participants, to assess clinical outcomes and encourage mechanistic studies.

Title: Global Cardiovascular Research Funders Forum/Women’s Cardiovascular Health Research Initiative (WCHR) (Other)

Description: This concept would enable funding of women’s CV health research through a consortium of 12 major CV research groups in the United States, Canada, Australia, and New Zealand. NHLBI’s contribution for the $10-million, 5-year program would be $1.9 million. The FY 2026 award is expected to be multi-disciplinary, multi-institutional, and multi-country. The lead institution can partner outside the consortium.

Title: Renewal of the MACS/WIHS Combined Cohort Study (MWCCS) of HIV in the United States (U01)

Description: This concept renews support for NHLBI’s participation in MWCCS for another 7 years. In 2019, the NIH merged two long-standing HIV-based cohorts and reoriented them to study long-term survival of men and women living with HIV/AIDS. Several key areas of science will be expanded to account for evolving HIV knowledge and aging of the cohorts.

Title: Stimulating Access to Research in Residency (StARR) Program Renewal (R38)

Description: This concept renews support for this research in residency program, for which NHLBI is the lead institute, with participation from NIAID, NCI, NIA, and NEI, among others. This program is designed to develop more physician-scientists, to engage in research. Residents are supported for between 12 and 24 months.

Title: Whole Person Research and Coordination Center (Whole Person RCC) (U24)

Description: This concept renews secondary NHLBI participation in an NIH-wide program led by NCCIH. The goal is to build an integrated framework covering research ranging from molecular studies to patient, cultural, and societal level data. NHLBI will contribute $100,000 per year for 5 years, which is 4% of the project’s overall budget.  

Titles: NHLBI SBIR Phase IIB Bridge Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood and Sleep Disorders and Diseases (R44).  NHLBI SBIR Phase IIB Small Market Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood and Sleep Disorders and Diseases (R44)

Description: These two concepts renew support for the commercialization of technologies that can help NHLBI-related conditions. These awards are particularly important in the current environment because external funders have become increasingly risk adverse.

Titles: Catalyze Enabling Technologies Transformative Platforms (R33).  Catalyze: Product Definition for Small Molecules and Biologics – Target Identification and Validation, and Preliminary Product/Lead Series Identification (R61/R33 – Clinical Trials Not Allowed).  Catalyze: Product Definition for Small Molecules and Biologics – Preliminary Product/Lead Series Identification (R33 – Clinical Trials Not Allowed).  Catalyze Product Definition – Medical Device Prototype Design/Testing and Disease Target Identification and Assay Development (R61/R33).  Catalyze: Product Definition – Medical Device Prototype Testing, Design Modification, Characterization and Validation (R33 – Clinical Trials Not Allowed)

Description: These concepts renew funding for a suite of programs, supports, and services, to efficiently and effectively help investigators bring their NHLBI-related innovations from the product definition stage through clinical research and regulatory submissions. The program, launched 5 years ago, has attracted 253 applications, funded 51, and led to 60 publications, 23 U.S. patent applications, and six international patent applications.

VI. CLOSING REMARKS

Dr. Gibbons adjourned the meeting at 2:26 p.m.

CERTIFICATION

I hereby certify that the foregoing minutes are accurate and complete.

The 306th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) convened virtually on Tuesday, February 6, 2024.  The Council meeting began with a closed session that started at 10:10 a.m. and ended at 12:04 p.m.  The open session reconvened from 12:15 p.m. and ended at 1:06 p.m. Dr. Gary H. Gibbons, Director of NHLBI, presided as chair.

NHLBAC Members Attending 
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.
David H. Ingbar, M.D.
Allison King, M.D., M.P.H., Ph.D.
Eldrin Lewis, M.D., M.P.H.
Edward E. Morrisey, Ph.D.
Kiran Musunuru, M.D., Ph.D.
Solomon Ofori-Acquah, 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 be 288.

NHLBI Employees Attending
Several NHLBI staff members attended 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 3,442 applications requesting $7,952,524,985 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 12:15 p.m.  He welcomed Council members, NHLBI staff, and public attendees to the Open Session of the meeting.

II. ADMINISTRATIVE ANNOUNCEMENTS

Dr. Valerie L. Prenger (Acting 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

Dr. Gibbons welcomed the new Council members: Dr. Olveen Carrasquillo, University of Miami; Dr. Allison King, Washington University at St. Louis; Dr. Eldrin Lewis, Stanford University; Dr. Solomon Ofori-Acquah, University of Pittsburgh; Dr. Susan Redline, Harvard University; and Ms. Susan Spencer, Avōq.

Accountable Stewardship. Dr. Gibbons reported that the proposed fiscal year 2024 (FY 2024) NIH funding allocation by the House represents an 8-percent reduction from FY 2023. The proposed FY 2024 NIH funding allocation by the Senate would be relatively flat given the current inflationary environment. Proposed FY 2024 NHLBI appropriations by the House and Senate are unchanged from FY 2023. These appropriations will usher in a period of austerity. NHLBI will navigate this challenge by reducing noncompeting commitments, protecting the next generation of investigators by preserving the number of K and F awards – as well as awards made to early-stage investigators, and ensuring that clinical trials have the necessary funds to maintain their scientific integrity and the safety of participants.

Advancing Scientific Priorities. Dr. Gibbons observed that February is American Heart Month, in which NHLBI raises public awareness about the number-one killer of men and women in the U.S. He emphasized important actions that everyone can take to keep their hearts healthy. Heart health education emphasizes Life’s Essential 8TM: eating heart-healthy foods; being more active; quitting smoking; getting adequate sleep; and managing stress, weight, cholesterol, blood sugar, and blood pressure levels.

Dr. Gibbons welcomed NIH’s new Director, Dr. Monica M. Bertagnolli. Dr. Bertagnolli has established guiding principles for NIH that align with the recent White House initiative on women’s health research. Many of Dr. Bertagnolli’s key themes are part of NHLBI’s strategic vision, including health and health-related issues exhibiting population differences, such as sex as a biological variable and health disparities.

NHLBI has a long-standing commitment to women’s health beginning with the Framingham Heart Study, and it has played a leading role in the Women’s Health Initiative. NHLBI’s portfolio has been extended to address women’s health across their life span, emphasizing not only menopausal and postmenopausal women but also women of reproductive age and young women.

The current maternal health crisis in the U.S. includes a troubling increase in maternal morbidity and mortality, particularly in communities of color. NHLBI has focused its efforts on communities where morbidity and mortality are greatest and is leveraging the NIH Community Engagement Alliance (CEAL) research network to address maternal morbidity and mortality. Other examples of NHLBI programs disseminating community-embedded interventions to address maternal health disparities include the Maternal Health Community Implementation Project and the Implementing a Maternal and Pregnancy Outcomes Vision for Everyone Community Implementation Program.

NHLBI’s clinical trial, Chronic Hypertension and Pregnancy (CHAP), demonstrated that treating chronic hypertension reduces the risk of preeclampsia without compromising fetal growth. CHAP’s results have been put into practice through new guidelines for clinicians.

Millions of women live in maternal care deserts where primary care providers provide their maternal care. Through the Network for Community-Engaged Primary Care Research, NHLBI plans to extend its CEAL network to involve partners in community-based organizations to address such health disparities.

Technologies such as remote health care monitoring might be particularly helpful in low-resource settings. Studies have shown that monitoring parameters of health improves pregnancy outcomes. Personal sensors monitor heart rate, beat-to-beat blood pressure, and contours of blood pressure. Data exist to suggest that beat-to-beat blood pressure monitoring could predict preeclampsia. Opportunities are emerging for continuous human dynamic monitoring using personal sensor technology overlaid by machine learning and artificial intelligence for the prediction of complications and the development of interventions for maternal health.

Human dynamic monitoring can be combined with biomarker discovery from genomics, proteomics, and transcriptomics, to increase the understanding of biological mechanisms driving disorders like preeclampsia. This is consistent with NHLBI’s long-standing agenda in precision medicine in which a multimodal, multidimensional approach will better predict health outcome trajectories. Over the next 5 years, Dr. Gibbons envisioned pairing computational models with extensive monitoring via sensors to provide early warnings of complications.

NHLBI’s current strategic refresh effort will serve to align its vision with that of the new NIH Director to go where the burden is greatest, addressing such needs as geographic disparities, maternal care deserts, and communities of color overburdened by disorders.

IV. 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.

V. CLOSING REMARKS

Dr. Gibbons adjourned the meeting at 1:06 p.m.

The 305th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) convened hybrid on Tuesday, October 24, 2023.  The Council meeting began with a closed session that started at 8:02 a.m. and ended at 9:57 a.m.  The open session convened from 10:18 a.m. and ended at 2:01 p.m.  Dr. Gary H. Gibbons, Director of NHLBI, presided as chair.

NHLBAC Members Attending
Victoria L. Bautch, Ph.D.
Kirsten Bibbins-Domingo, M.D., Ph.D.
Mercedes R. Carnethon, Ph.D.
Amanda Mae Fretts, M.D., M.P.H.
Tina V. Hartert, M.D., Ph.D.
David H. Ingbar, M.D.
Edward E. Morrisey, Ph.D.
Kiran Musunuru, M.D., Ph.D.
Merritt Raitt, M.D., Ex Officio
Lynn M. Schnapp, M.D.
Martha C. Sola-Visner, M.D.
Zachariah P. Zachariah, M.D.

Ad Hoc Members Attending
Olveen Carrasquillo, M.D., M.P.H.
Allison King, M.D., M.P.H., Ph.D.
Eldrin Lewis, M.D., M.P.H.
Solomon Ofori-Acquah, Ph.D.
Susan Redline, M.D., M.P.H.
Susan Spencer

Members of the Public Attending
The total number watching online was reported by NIH Videocast to 316.

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 2,974 applications requesting $8,428,407,375.00 in total costs. For the record, it is noted that secondary applications were also considered en bloc.

OPEN SESSION

I. CALL TO ORDER

Dr. Laura K. Moen (Director, Division of Extramural Research Activities, NHLBI) called the meeting to order 10:18 a.m. and welcomed Council members, NHLBI staff, and public attendees. She recognized people retiring from the Council: Drs. Ingbar, Musunuru and Zachariah.

II. ADMINISTRATIVE ANNOUNCEMENTS

Dr. Moen informed attendees that the meeting would be publicly broadcast and archived on videocast. She reviewed the agenda.

III. REPORT OF THE DIRECTOR

Dr. Gibbons acknowledged three departing Advisory Council members: Dr. David Ingbar, University of Minnesota; Dr. Kiran Musunuru, University of Pennsylvania; and Dr. Zachariah Zachariah, University of Miami Health System. He thanked them for their service and contributions.

Accountable Stewardship. Dr. Gibbons reported that NHLBI fiscal year 2024 (FY 2024) appropriations proposed by Congress are unchanged from FY 2023 at $3.98 billion, and the President’s FY 2024 proposed budget is lower, at $2.8 billion. For the NIH as a whole, Dr. Gibbons indicated that the President’s proposed FY 2024 funding allocation was up 3 percent from FY 2023, but the House proposed an 8 percent reduction and the Senate a 2 percent increase. Dr. Gibbons noted that funding in the upcoming year could be very challenging in many ways.

Dr. Gibbons briefly discussed the Other Transaction Authority (OTA) Research, a mechanism that is neither a grant nor strictly a contract, but involves other, nontraditional entities. The OTA is intended to promote agility in discovery and translation, including through unique partnerships. Examples include BioData Catalyst and Cure Sickle Cell.

Dr. Gibbons noted that the September retreat to discuss the re-envisioning of the Strategic Vision for the next 5 to 10 years produced important insights and ideas along the various domains of NHLBI’s strategic goals and objectives, and a report will be forthcoming. He reviewed the Strategic Vision’s three key elements: Understanding Human Biology, Reducing Human Disease, and Translation and Implementation.

Understanding Human Biology.  In discussing the transformative potential of basic science discoveries, Dr. Gibbons cited work by Dr. Robert Lefkowitz, who was awarded the 2012 Nobel Prize in Chemistry for his work on G-protein-coupled receptors. Dr. Lefkowitz came to NIH first as an intramural program fellow and later received NHLBI support. The impact of his discoveries has significantly influenced the NHLBI portfolio and benefited patients, and other transformational innovations could catalyze in the next 5 to 10 years, Dr. Gibbons said.

He cited the example of work by Dr. Patrick T. Ellinor and his team to amass all the transcriptome data that exist publicly and identify and characterize the state of each cell in the human body over the lifespan in health and disease.

Dr. Gibbons also mentioned the complex, cross-disciplinary work underway on heart failure with preserved ejection fraction (HFpEF). The HF Accelerating Medicines Partnership (AMP) approach involves nine groups of stakeholders and provides an opportunity to optimize discovery with team science, he noted.

Reducing Human Disease. Dr. Gibbons commented on the potentially transformative research in tackling human disease, citing work by Dr. Justin Cosentino and his team to use machine learning (ML) to identify chronic obstructive pulmonary disease (COPD) phenotypes from electronic health records (EHRs). This work, he said, could lead to improved disease prediction and genomic discovery.

Dr. Gibbons said that ensuring health equity in this era of precision medicine is essential. This means robust testing, cross-validations, population diversity, and other steps to ensure that AI systems used are free from bias and discrimination.

Translation and Implementation. Establishing the most appropriate research agenda requires a multilevel approach and extensive engagement with communities, essentially an integrated holistic approach at scale, Dr. Gibbons said. This involves building on community partnerships, addressing misinformation, increasing trust in science, and accelerating the uptake of beneficial interventions.

Dr. Gibbons showed a conceptual model to advance health equity through transformed systems for health, which could be employed across the NHLBI portfolio. He mentioned the DECIPHeR program, which has adapted the CEAL approach to test multilevel interventions to reduce or eliminate cardiovascular health disparities. Another example is the Alliance for Community Engagement on Climate and Health, which is promoting climate resilience and adaptive capacity in indigenous populations in Alaska.

Dr. Gibbons concluded that NBLBI will continue to look for opportunities for synergies and collaborations and advance its strategic priorities.

IV. PRESENTATION: “ALL OF US” RESEARCH PROGRAM OVERVIEW

Dr. Joshua C. Denny, Chief Executive Officer, “All of Us” Research Program, NIH

Dr. Denny gave an overview of the All of Us program, which has a mission to accelerate health research and medical breakthroughs enabling individualized prevention, treatment, and care for everyone. To date, more than 719,000 participants have enrolled, representing a broad range of race and ethnicity; 80 percent reflect groups that are underrepresented in biomedical research.

Dr. Denny described how All of Us has met participants in their localities to encourage engagement, using outreach vans and mobile units, employing Spanish as well as English, and enabling virtual enrollment as well.

The data types collected from All of Us participants include annual survey responses, physical measurements, biosamples, and EHRs, if authorized. A broad range of data is collected via wearable devices, including more than 30,000 FitBits supplied to participants. The teams also record participants’ social determinants of health, such as neighborhood safety, loneliness, and food security.

An essential part of All of Us is to give participants feedback where feasible—for instance, genetic information, comparative survey data, EHR data, ongoing study updates, scientific findings, and other information.

Dr. Denny cited examples of results in genomic health, including one study analyzing seven genes that can affect how bodies metabolize medicines. Among the more than 66,200 participants, 27 percent had an actionable result for a drug they had been exposed to. All of Us now has nearly 250,00 whole-genome sequences intended to advance precision medicine, the world’s largest such set widely available for research, he noted.

Dr. Denny described the public data browser and researcher workbench access, usage, and diversity, and cited some of the publications and projects based on All of Us data. For example, he mentioned a study by Dr. Patrick K. Wu repurposing drugs using gene expression signatures and EHR data and another study on APOL1 genetic variants and their link to end-stage kidney disease in people of African ancestry.

In conclusion, Dr. Denny briefly described All of Us ancillary studies, which include randomized-controlled trials, observational trials, devices, new biospecimen collection, and biospecimen access. He added that All of Us plans to include pediatric participants soon.

V. NHLBI CONCEPT CLEARANCE

NHLBI staff presented 24 concepts for clearance. Members of the Advisory Council were asked to rate each concept on six criteria using Decision Lens.

Title: Continuation of NHLBI Secondary Participation in the Native American Research Centers for Health (NARCH) Program (S06)

Description: This concept proposes renewed support for secondary participation in NARCH, a program that funds grants focused on the research and development needs and health priorities of American Indian/Alaska Native communities. This NIH-wide initiative, led by NIGMS, partners 19 NIH Institutes and Centers with federally recognized tribes and tribal organizations. NHLBI participated in 2021 and 2022.

Title: Framingham Heart Study (FHS) Contract Renewal (N01)

Description: This concept supports continuation of an NIH-wide initiative on novel epidemiological research covering heart, lung, blood, sleep, and other diseases. The objectives of this renewal are to continue participant retention, follow-up, and clinical event adjudication, as well as core study functions. FHS has an astounding collection of multigenerational data, Dr. Goff noted.

Title: Secondary Participation to Senator Paul D. Wellstone Muscular Dystrophy Specialized Research Centers

Description: This concept proposes renewed support publicizing a competition for centers researching this understudied group of hereditary, progressive degenerative disorders, which have a particular impact on heart and lung health. NHLBI began co-funding this NIH-wide initiative in 2008.

Title: T32 Training Program for Institutions that Promote Diversity

Description: This concept proposed continued support of institutions to train individuals from nationally underrepresented backgrounds in cardiovascular, pulmonary, hematologic and sleep disorders, thereby expanding diversity in research capacity. NHLBI has supported this program since 1992.

Title: NHLBI Secondary Participation in the Intervention Research to Improve Native American Health (IRINAH) Program (R01)

Description: This concept proposes renewed support of the IRINAH program to support intervention research to enhance the health of Native American populations and reduce disparities. NHLBI expects to make two to three new awards per year. This NIH-wide program is led by NIDA.

Title: Jackson Heart Study (JHS) Renewal (N01)

Description: This concept proposes renewed support for novel epidemiological research on HLBS diseases in a cohort of multigenerational African Americans. The program was launched in 1999 to examine factors behind the high prevalence of cardiovascular disease in African Americans living in Jackson, and it continues to provide opportunities to discover novel indications.

Title: NHLBI Career Transition Award for Intramural Postdoctoral Fellows and Research Trainees (K22)

Description: This concept proposes renewed support for highly qualified NHLBI intramural postdoctoral fellows to facilitate their transition to independent faculty positions and develop their own research. The goal of this NIH-wide program is to prepare a diverse pool of individuals to impact the health of the nation.

Titles: Phased Multi-Site Clinical Trial: Testing Prevention of Cardiovascular Disease in Young Adults With High Lifetime Risk Using Surrogate Outcomes (U24); Phased Multi-Site Clinical Trial: Testing Prevention of Cardiovascular Disease in Young Adults With High Lifetime Risk Using Surrogate Outcomes (UG3/UH3)

Description: These concepts propose trans-NHLBI focus on a clinical trial testing whether earlier pharmacological intervention on cardiovascular risk factors can reduce or delay the onset of related clinical disease in adults with a high lifetime risk. The focus of Phase I is on screening, and Phase II is on testing the effectiveness of select interventions.

Title: Risk Underlying Rural Areas Longitudinal (RURAL) Study (N01)

Description: This concept proposes renewed support for an ongoing program to enroll—via a mobile examination unit—6,600 participants in the US South, including from Hispanic/Latin populations, to facilitate studying the rural health penalty. This is an NIH-wide program.

Title: NHLBI R35 Programs – Outstanding Investigator Award (OIA) and Emerging Investigator Award (EIA) (R35) Renewal

Description: These concepts propose continued support for the NHLBI R35 programs, which aim to allow NHLBI-supported investigators stable long-term funding and the flexibility to pursue new research directions as they arise. The goal is to promote productivity and facilitate ambitious, creative HLBS research. NHLBI established this initiative in 2017 and has approved an average of 68 OIA and 19 EIA applications annually.

Title: Mentored Career Development Award to Promote Faculty Diversity in Biomedical Research (K01)

Description: This concept proposes renewed support for an award designed to raise the number of highly trained junior faculty from diverse backgrounds, in an effort to address national and global health disparities. This NIH-wide program will support 20 awards per year.

Title: Secondary Participation in Renewal of Rare Diseases Clinical Research Network (RDCRN) (U54)

Description: This concept proposes renewed support for clinical research in 165 rare diseases and disorders, fostering collaborations between physicians, scientists, and their multidisciplinary teams in association with patient advocacy groups. This NIH-wide program is led by NCATS and aims to produce a robust pipeline of research in rare diseases.

Title: A National Lung Biorepository for Lung-Disease Specific iPS Cells (N01)

Description: This concept proposes renewed support, without change, for the national biorepository of normal and lung-disease-specific induced pluripotent stem cells and their derivatives. The goal is to facilitate research in this high-cost, technically complicated field.

Titles: NHLBI Early Phase CT for Therapeutics and/or Diagnostics for HLBS Disorders (R33 CT required);
NHLBI Early Phase CT for Therapeutics and/or Diagnostics for HLBS Disorders (R61/R33 CT required)

Description: These concepts propose renewed support for investigator-initiated, early-phase clinical trials in translational research, with the aim of accelerating the development of new clinical interventions to advance diagnoses and therapeutic interventions for HLBS disorders in both adults and children. NHLBI supported 33 awards over the past year.

Title: Developing a Pipeline of Cell and Gene Therapies for HIV Cure (U19)

Description: This concept would support translational research in innovative approaches beyond antiretroviral therapy, to cure HIV-1. Long-term adherence to, and side effects of, antiretroviral therapies can be problematic; and elimination of the virus in a few patients has laid the groundwork for further research. Two awards will be from NHLBI and two from NIAID.

Titles: Renewal of Secondary Participation: Stimulating Hematology Investigation: New Endeavors (SHINE) (R01 Clinical trial not allowed); Renewal of Secondary Participation: New Directions in Hematology Research (SHINE II) (R01) PAS21-150

Description: These concepts proposed renewed support for investigator-initiated grant applications in basic and translational hematology research, to encourage more research in nonmalignant hematology. Partnering in this program, initiated by NIDDK, are NHLBI and NIA.

Title: Advancing HIV Testing, Prevention, and Care Through Pharmacists and Pharmacies (R01)

Description: This concept would support expanding access to HIV testing, prevention, and care services through pharmacists and pharmacy settings, thereby reducing HIV-associated comorbidities, including in HLBS. Such settings are generally regarded non-stigmatizing, locally convenient, and offer expanded hours, thereby encouraging access to healthcare. This is an NIH-wide program.

Title: NHLBI Co-Funding Support for the World Health Organization’s WHO Science Council Genomics Report Activities (U01)

Description: This concept proposes support for WHO’s program to expand access to genomics for global health, especially in low- and middle-income countries (LMICs) and strengthen genomics capacity at the regional and country levels. The program is for 2 years, and eight NIH entities are participating.

Titles: Renewal of Secondary Participation in FIC Emerging Global Leader Award (K43 Clinical Trial Not Allowed); Renewal of Secondary Participation in FIC Emerging Global Leader Award (K43 Independent Clinical Trial Required)

Description: These concepts propose continued support for capacity building in LMICs. This initiative provides early-career scientists in those countries with protected time and funding for research, mentoring, and career development. This NIH-wide initiative is led by FIC.

Title: Secondary Participation in the Renewal of RFA-MD-22-003: Innovations for Healthy Living SBIR RFA (R43, R44)

Description: This concept proposes renewed support for the development, optimization, adaptation, and repurposing of new devices, digital health, and diagnostic tools to meet the health needs of underserved populations. This NIH-wide initiative supports small businesses and is led by NIMHD.

VI. CLOSING REMARKS

Dr. Gibbons adjourned the meeting at 2:01 p.m.

The 304th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) convened as a hybrid meeting via videoconference on Tuesday, September 12, 2023. In addition to NHLBAC members, the meeting included the ad hoc Board of External Experts (BEE), scientists with research expertise in National Heart, Lung, and Blood Institute (NHLBI) mission areas, who were recruited for this meeting as a special NHLBAC working group. The Council meeting began at 9:12 a.m. and ended at 4:34 p.m., EDT. The meeting was open to the public between 9:12 a.m. to 12:45 p.m. and 3:30 p.m. to 4:34 p.m. to hear reports and recommendations from each working group.

NHLBAC Members Attending
Mercedes R. Carnethon, Ph.D.
Amanda Mae Fretts, M.D., M.P.H.
Tina V. Hartert, M.D., Ph.D.
David H. Ingbar, M.D.
Edward Morrisey, Ph.D.
Kiran Musunuru, M.D., Ph.D.
Merritt Raitt, M.D., Ex Officio
Lynn Schnapp, M.D.
Martha Sola-Visner, M.D.
Zachariah P. Zachariah, M.D.

BEE Members Attending 
Michelle A. Albert, M.D., M.P.H.
Judy L. Aschner, M.D.
Timothy S. Blackwell, M.D.
Joanne Chikwe, M.D.
Randi Foraker, Ph.D.
Annetine A. Geliujns, Ph.D., J.D.
Nadia Hansel, M.D.
Bertha Hidalgo, Ph.D., M.P.H.
Hans-Peter Kiem, M.D.
Darrell N. Kotton, M.D.
Elizabeth McNally, M.D., Ph.D.
Brian S. Mittman, Ph.D.
Matthias Nahrendorf, M.D., Ph.D.
Ellis J. Neufeld, M.D., Ph.D.
Laura Kristen Newby, M.D.
Herman Taylor, M.D.
Griffin M. Weber, M.D. 
Kenneth Wright, Jr., Ph.D.

Members of the Public Attending 
The total number watching online was reported to NIH Videocast to 380.

NHLBI Employees Attending
Several NHLBI staff members were present and in attendance via Zoom.

I. CALL TO ORDER

Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI), called the meeting to order at 9:12 a.m. He welcomed members of the National Heart, Lung, and Blood Advisory Council (NHLBAC) and the ad hoc Board of External Experts (BEE) to this joint meeting.

II. ADMINISTRATIVE ANNOUNCEMENTS

Dr. Laura K. Moen, Director of the Division of Extramural Research Activities at NHLBI, 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.

In addition, Dr. Moen stated that the meeting objective is to engage the NHLBAC and BEE, as representatives of the NHLBI research community, to advise the Institute on thought-provoking opportunities to allow a more comprehensive discussion of the NHLBI Strategic Vision.

III. DIRECTOR’S REMARKS

Dr. Gary Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI) gave his opening remarks. This year’s combined meeting was intended to address a refresh of the NHLBI Strategic Vision, so he emphasized addressing key questions and developing bold cross-cutting ideas to advance heart, lung, blood, and sleep (HLBS) health. Priorities for this refresh of the Strategic Vision included understanding human biology, reducing human disease through preemptive measures, and identifying strategies for translation and implementation. These priorities were highlighted to address inequities and reduce the burden of disease across heterogenous populations.

Dr. Gibbons emphasized better use of predictive modeling and data science strategies which incorporate artificial intelligence (AI) and machine learning (ML). Such practices would enable the leveraging of data to prevent disease and begin interventions earlier.  Additionally, fuller understanding of human biology would enable the identification of more precise risk factors and targets for treatment and prevention of specific HLBS diseases and disorders. Collective collaboration and competition through team science was encouraged to drive innovation and develop new technologies for precision medicine and health equity.

IV. DIVISION UPDATES

Division of Lung Diseases – James P. Kiley, Ph.D., M.S.

Dr. James Kiley provided the update from the Division of Lung Diseases (DLD). He presented programs that have been successful under the guidelines of the current Strategic Vision as well as certain lessons learned and how the DLD plans to move forward to over the next 5-10 years.

Precision medicine is a key focus of the DLD to better understand and manage lung disease and sleep-disordered breathing. Using powerful tools to identify biomarkers and develop pathobiology approaches is key to earlier detection and treatment. The model developed during the Severe Asthma Research Program (SARP) integrated data with other programs to push precision medicine. This model was then used to build out the research and treatment infrastructures for other diseases and the heterogeneity among the diseases. The Precision Interventions for Severe and/or Exacerbation-Prone Asthma (PrecISE) Network was developed as the first adaptive trial design. This led to the selection of specific antibodies as predictive biomarkers through combining predictive methods with pathobiology to develop tailored therapies.

The lung health cohort may use such tools and strategies to examine diseases in utero and early childhood to determine which factors might impact health and influence disease later in life. Predictive models and precision medicine would be of further importance to develop genotype stratified trials that are designed to determine how to get the correct treatment to the right people at the right time. By using adaptive clinical pathways, significant therapeutic interventions can be identified within heterogenous disease populations.

As part of the strategic refresh, the DLD aims to better incorporate communities in the discovery process to implement discoveries and improve translation of interventions. Technology and large data sets should be leveraged more effectively through new data science tools to discover novel phenotypes and explore heterogeneity among populations. By better understanding human biology and disease mechanisms, the DLD aims to identify risk factors and prevent lung disease in as many populations as possible, while also identifying targeted treatments and effective interventions.

Division of Blood Diseases and Resources – Traci Heath Mondoro, Ph.D.

The Division of Blood Diseases and Resources (DBDR) has focused on cell and gene therapies for all blood disorders. Systems blood science has been embraced to establish a more holistic approach to prevention, diagnosis, and treatment of blood diseases which involves investigating the roles played by human biology, social determinants of health (SDOH), environmental stressors, and more. Understanding the mechanisms of mutations that drive clonal expansion in healthy humans has been useful in determining how these mutations affect diseases. Progress has been made in better understanding of the mechanisms of sickle cell disease (SCD) and thalassemia by focusing on mutations, as well as the development of gene therapy vector techniques to support clinical trials. Such techniques are important in developing precision medicine approaches.

Precision medicine and systems science are important tools to optimize clinical trials, leverage opportunities with new partners, and engage predictive modeling more effectively. Leveraging data sets from both public and private settings can lead to better understanding of blood disorders and subgroups across heterogeneous populations. Improved data analyses can then expand the capabilities of predictive modeling to identify better therapeutic targets and determine which patients would most benefit from curative therapy.

To implement all of these methods, a diverse workforce must be trained and retained as part of the multi-disciplinary teams that are key to driving innovation. The Pride Mentorship Program was established as a 15-year program to increase representation and retention within the area of blood science. Programs such as this, combined with partnerships in industry and other agencies, are vital to building multi-disciplinary teams with broad impacts. Greater engagement and partnership with community input panels are also needed to understand barriers to care and which resources are needed to address disparities. Community input panels provide a better opportunity for investigators to understand what a positive outcome (“positive health”) means to different disease populations versus what investigators deem a positive outcome.

The DBDR emphasized translation of innovations from the bench to bedside and vice versa. Understanding SDOH plays a vital in translation and implementation since multiple factors and stressors, including those from the environment in which one lives, can affect disease patterns. SDOH also influence how treatments and innovations reach communities. Potential barriers to care, participation, and information access must be considered for the implementation process in blood health interventions. SDOH are among many stressors, including sleep health and environmental factors, that contribute to inflammatory responses which negatively impact blood health. There is a great need to better understand inflammation and its contribution to disease profiles for the future of preventative care and therapeutic treatments of blood diseases.

Division of Cardiovascular Sciences – David C. Goff, Jr., M.D., Ph.D.

The Division of Cardiovascular Sciences (DCVS) accomplished much over the past several years while supporting NHLBI’s priorities such as workforce development, precision medicine, and COVID response. Multiple programs and cohorts were engaged to drive innovation and promote equity in cardiovascular health across lifespans. Programs such as HeartShare and the Accelerating Medicines Partnership (AMP) have leveraged data from multiple sources and utilized precision medicine to identify new treatment targets for specific endotypes. Partnerships with other agencies and private industry have also enabled innovation.

Cardiovascular health (CVH) across the lifespan has been promoted through programs such as the Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH), and the RURAL and Asian American-Pacific Islander-Native Hawaiian (AAPINH) cohorts. These programs all have a focus on addressing SDOH in various populations to promote early interventions and close health equity gaps.

Over the next several years, DCVS aims to continue collecting data across the spectrum to understand mechanisms of CVH and identify specific targets for intervention and therapeutics. This data should include cardiovascular sensor and mobile health data, as well as SDOH, imaging, phenotype, clinical, and molecular data. The application of AI, ML, and other data science methods to these large data sets should allow for better understanding of cell-specific omics, phenotypes, and endotypes to develop more effective and equitable interventions. Overall, the Division’s goal is to reestablish the decline in cardiovascular disease mortality by expanding the size of the cohorts, engaging with more partners, and working with communities to close health equity gaps and develop more effective interventions.

Center for Translational and Implementation Science – George Mensah, M.D., FACC

Implementation science is required to get innovations to communities so that they can thrive and meaningful community-engaged research is important to successfully implement innovations. The Community Engagement Alliance (CEAL) exists to drive meaningful community engagement in a bi-directional manner. Listening to community needs and challenges helps to build trust while also developing pathways for effective implementation. Funding implementation science awards has increased to aid in developing more tools and methods to bring effective and meaningful research to communities.

Telehealth has been an important tool for implementation, particularly in geographic or socioeconomic areas that cannot easily access health care or innovations. Partnerships in non-traditional settings have been useful for various implementation strategies, including establishing programs in schools for children and in faith-based settings for some areas. Training and career development opportunities have been an additional focus of the Center for Translational and Implementation Science (CTRIS)  through building partnerships and developing training and career opportunities.

The strategic vision of CTRIS for the next several years includes continuing to build workforces and accelerate the implementation of discoveries for improved health. New areas of science include the examination of how implementation science and SDOH intersect, and how this knowledge can be leveraged by investigators to make the best use of theories and frameworks. The Gravity Project is a program currently developing standards for the sharing of SDOH data to assist investigators. By centering communities, research can be better implemented for those who need it most and reduce disease burdens. On a global scale, the infrastructure established through the Fogarty study can be leveraged to build a global workforce that reinforces the NHLBI Strategic Vision through a focus on non-communicable diseases and community health worldwide.

V. DIRECTOR’S CHARGE TO THE NHLBAC AND BEE

Charge: Refreshing Key Priorities of NHLBI’s Strategic Vision

Group A: Understanding Human Biology

How can we feed the knowledge gained from complex genetics, omics, and cohorts back into hypothesis-driven research on basic mechanisms of disease? 
To which fundamental underlying mechanisms that regulate biological processes may we expand our currently disease-specific cohort and data studies and how can we leverage these to move HLBS science forward? 
How can we generate data-driven hypotheses for understanding biological mechanisms through data science or epidemiological studies such as new cohorts?   
What emerging scientific areas may benefit from novel cohort studies? 
Group B: Reducing Human Disease

What new directions can we take to approaches of human disease given the newer understanding/treatments developed over the past 5 years?
What new directions and approaches can we take to reverse the trend of widening health inequities in many areas of HLBS diseases and related risk factors?
What new approaches and desired changes in the strategic plan can capitalize on changes in the research ecosystem in the past 5 years, such as increased AI/ML capabilities, or increased access to other new technologies?
What applications and implementation of AI technologies could be developed to reduce human disease?
Group C: Translation and Implementation

In HLBS mission areas where successful implementation of scientific advances have occurred, what have been the primary facilitators and drivers of success and how can NHLBI disseminate and scale these successes?
What barriers still exist to implementation of scientific advances and how can we address and remove them to speed translation?
How can we best support meaningful community engagement, especially in underserved minority populations, to grow a trust in science and accelerate translation and implementation of HLBS scientific advances?
How can we best measure translation and implementation processes in HLBS research and evaluate their outcomes and impact?
VI.  REPORTS FROM THE WORKING GROUP DISCUSSIONS

Group A: Co-Facilitators: Bertha Hidalgo, Ph.D., M.P.H. and Gustavo Matute-Bello, M.D.

The focus of this breakout group was to identify strategies that advance the understanding of human biology. There was a great emphasis on team science spanning multiple disciplines to drive innovation. Optimizing team science mechanisms and encouraging funding models to incentivize multi-disciplinary teams were highlighted as keys to driving greater understanding of human biology. Additionally, grant reviewers must also be trained to eliminate bias and follow the NHLBI vision and mission to encourage team science. Cross-training between disciplines is another way to push innovation forward and partially address the current bottleneck in research and data science due to the lack of data scientists. Through the proper utilization of data scientists, enormous data sets can be leveraged to identify targets for next steps in research and innovation.

Encouraging partnerships with Historically Black Colleges and Universities (HBCUs) as leaders of science can also drive recruitment of diverse researchers and participant populations. Partnerships with non-traditional partners can further drive innovation through the development of regional and cross-regional incubators of knowledge. Improving communication across disciplines will also encourage forward thinking in the design of critical trials. The inclusion of biospecimens and variables from other studies will increase data sets available for use by other investigators. In future clinical trials, the ability to tease out factors related to race from other SDOH, as well as environmental, geographic, and climate factors will be important to advance the understanding of human biology and effects of real-world settings.

Group B: Co-Facilitators: Mercedes Carnethon, Ph.D., M.S. and Larry Fine, M.D., Ph.D.

One way to reduce human disease is to prevent it from ever developing. This breakout group focused on strategies including treatments that don’t require constant follow up or medication, policy changes to support interventions from birth through childhood, and a special focus on preventative approaches that begin with families and infants. Focusing on the origins of disease and healthy behaviors in early life is also a priority to reduce and even prevent human disease. When developing patterns for prevention efforts, investigators must also be conscious of the environments in which people live so ensure access and reduce inequities.

Leveraging big data is key to achieving big goals. As many subgroups as possible must be included in data sets and the uncommon occurrences should be examined more closely, rather than discarded or ignored. Better strategies are needed for working with data, including responsible use of AI and machine learning so that disparities are not worsened through bias. To continue this work, the next generation of data scientists is needed, and user interfaces should be designed for non-experts to effectively use data mining tools. Leveraging surveillance data from wearable medical devices can also help with timing studies to determine when interventions may be most effective in regards to circadian rhythms and lifespan.

Team science approaches were emphasized to drive innovation by bringing together ideas and expertise from different fields. Through partnerships with schools, community organizations, prenatal care providers, and federally qualified health centers, interventions can reach populations where they are and at earlier life stages. A desire to distribute grant money in a more equitable and efficacious manner was indicated to further close equity gaps and reduce disease.

Group C: Co-Facilitators: Judy Aschner, M.D. and Patrice Desvigne-Nickens, M.D.

Examining and addressing barriers to translation and implementation of scientific advances were the priorities of this breakout group. Breaking down silos and focusing on team science were proposed to translate findings from research to the real world. However, not all researchers speak the same language and may be resistant to collaboration. Incentivization of team science and cross-training through funding opportunities could encourage more team science frameworks. An opportunity for the future would be to study the science of team science and to optimize such collaborative strategies.

The future of translation and implementation may require leveraging social media and AI to drive participant recruitment and facilitate dissemination of information and innovations. Barriers to access and underrepresentation in clinical trials are contributing factors that exacerbate inequities in health. However, working with communities can further increase participation and determine which scientific questions are most important to improve health outcomes. Mandating dissemination and implementation plan within funded research can help address some barriers and encourage communities to participate further.

Building and maintaining partnerships with non-traditional partners can also drive innovation in translation and implementation strategies.  Professional society databases can be used to find investigators, build teams, and gather research data while also leveraging electronic health records and developing harmonization strategies. Developing adequate funding models to incentivize team science and implementation, while also de-incentivizing harmful practices, are key strategies to break down barriers to translation and implementation of scientific advances across various populations.

VII: COMBINED SUMMARY OF REPORTS FROM THE WORKING GROUP DISCUSSIONS

Throughout the division presentations and breakout working groups, there were common themes to be included in the strategic refresh – encouraging team science, increasing the data science workforce, and prioritizing community engagement to close health equity gaps. Team science must be encouraged with funding models reflecting the importance of such multi-disciplinary workforces. Fostering collaboration within and between teams encourages the breaking of silos and exchanging information. Investigators with different experiences and areas of expertise can build on each other’s strengths, facilitate new discoveries, and drive innovation to improve health outcomes.

The field of data science is important to all divisions, however, there is a great need for data scientists and cross-training opportunities. Without a workforce that knows how to analyze and leverage data, significant bottlenecks in innovation and discovery will persist.  The influx of data from EHRs, wearable devices, clinical data, imaging, and more must be analyzed in a responsible and effective way that minimizes bias and maximizes utility. Reducing human disease requires a more preventative mindset that accounts for a variety of factors across heterogeneous populations. New tools and technologies such as AI and ML can facilitate advanced prediction models through expanded access to data and inclusion of more data sources, but this must be done in an appropriate way that does not exacerbate inequities.

Addressing the specific needs of communities is important to address health disparities and ensure that they can thrive. Improved community engagement is one way to develop interventions that close equity gaps and improve health in a culturally relevant manner. Community-based cohorts can identify what communities consider positive health, understand specific challenges, and develop implementation strategies that can be optimized and tailored to populations to have the best positive impact. Moving forward, there needs to be a collective commitment to advance health equity, driven by multi-disciplinary team science, expanded use of data science, and greater engagement with communities and subpopulations.

CLOSING REMARKS AND ADJOURNMENT

Dr. Gibbons thanked everyone for the rich dialogue and discussion.

Dr. Moen thanked everyone and adjourned the meeting at 4:34 p.m.

The 303rd meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) was convened on Tuesday, August 22, 2023 at 1:01 p.m. as a virtual Zoom Event. The meeting was closed to the public from 1:05 p.m. until adjournment at 1:24 p.m. Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI), presided as Chair.

Council Members attending via Zoom

Dr. Kristen Bibbins-Domingo  
Dr. Mercedes Carnethon 
Dr. Amanda Fretts    
Dr. Tina Hartert     
Dr. David Ingbar     
Dr. Edward Morrisey  
Dr. Kiran Musunuru Dr. Mohandas Narla 
Dr. Merritt Raitt (Ex Officio)  
Dr. Lynn Schnapp 
Dr. Martha Sola-Visner  
Dr. Kevin Thomas 
Dr. Zachariah Zachariah

Council Members unable to attend

Dr. Victoria Bautch

NHLBI employee attending

A number of NHLBI staff members were in attendance.

I. CALL TO ORDER AND OPENING REMARKS

Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI), welcomed members and called the 303rd meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) to order at 1:01 p.m. The meeting was held via video conference for the members.

II. ADMINISTRATIVE ANNOUNCEMENTS

Dr. Laura K. Moen, Director, Division of Extramural Research Activities, NHLBI, 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. 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 878 applications requesting $533,110,113 in total costs. For the record, it is noted that secondary applications were also considered en bloc.

ADJOURNMENT

The meeting was adjourned at 1:24 p.m.

NHLBAC Members Attending

Mercedes R. Carnethon, Ph.D.
Amanda Mae Fretts, M.D., M.P.H.
Tina V. Hartert, M.D., Ph.D.
David H. Ingbar, M.D.
Edward Morrisey, Ph.D.
Kiran Musunuru, M.D., Ph.D.
Lynn M. Schnapp, M.D.
Martha C. Sola-Visner, M.D.
Zachariah P. Zachariah, M.D.

Members of the Public Attending

The total number watching online was reported by NIH Videocast to 331.

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 3,304 applications requesting $10,370,150,147 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 11:44 a.m. He welcomed Council members, NHLBI staff, and public attendees to the Open Session of the meeting.

II. ADMINISTRATIVE ANNOUNCEMENTS
Dr. Laura K. Moen (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 gave an update of NHLBI’s budget status for fiscal year (FY) 2023, an increase of 4.6% over 2022. For the FY 2024 appropriations hearings, the NIH has highlighted several topics, including next generation approaches, health disparities, inclusive excellence/workforce diversity, rural health, diabetes and Down Syndrome. All those topics are relevant to NHLBI’s portfolio and priorities, he noted. Nonetheless, FY 2024 is expected to bring leaner budget increases than in the past 5-6 years, due to economic and political factors, placing some tension on NHLBI’s programs. For example, applications for investigator-initiated programs and projects have been rising, as have grant costs, making it more challenging to hit award targets and maintain the success rates of recent years.

Dr. Gibbons welcomed new Deputy Directors, Dr. Cara Lewis and Ms. Cindy Caughman, and new Division of Lung Disease (DLD) leadership, Dr. Gustavo Matute-Bello and Dr. Sumita Khatri.

As part of ongoing adaptations to its organizational structure, the NBLBI has proposed the reorganization of its DLD. The agency remains mindful of evolving scientific needs and aims to respond accordingly. This includes the alignment of expertise, science knowledge translation, effective leadership oversight, operational sustainability and succession planning.

Dr. Gibbons also mentioned the NBLBI’s intramural program and its exceptional research, which complements and extends the work undertaken in the extramural portfolio. The diversity of tenure- track investigators has been increasing, as part of inclusive excellence across the Institute.

Lastly, Dr. Gibbons thanked the Council for supporting the NHLBI’s 75th anniversary and welcomes its participation in the agency’s 2016 strategic vision document reexamination this fall. He added that he hopes stakeholders will help determine the best path forward for the next 5-10 years, to enhance and advance the NHLBI’s science portfolio and accelerate discoveries to improve public health.

A key focus of the strategic refresh will be persistent health disparities across NHLBI’s portfolio, for instance, geographical disparities in rates of hypertension, chronic obstructive pulmonary disease (COPD), obesity, diabetes and maternal mortality. Tackling these persistent problems will probably necessitate novel, multi-dimensional approaches. The strategic vision refresh will also study how to leverage the tools, analytics and capacity to understand science at a basic level and in an integrated way. Overall, the refresh is an opportunity to reflect on investments in research platforms and how to incorporate different models and paradigms to address health disparities on many levels, including individual, family, community and environment.

Dr. Gibbons reviewed the NIH Community Engagement Alliance (CEAL) program, which is pivoting focus from Covid to a trans-NIH platform, to enhance community engaged research relevant to health equity, including outreach to indigenous populations.

Several programs are underway to address maternal care deserts, including the Maternal Health Community Implementation Project and Enhancing Nutrition Services to Improve Maternal and Child Health in Africa and Asia (ENRICH) program, and efforts in precision medicine and data science to reduce adverse pregnancy outcomes.

In conclusion, Dr. Gibbons said a key element of the strategic vision refresh for the next 5 years will be devising how to harnessing diverse data resources leverage new capabilities, to fulfill the NHLBI mission and preempt heart, lung, blood and sleep disorders. The Council will play a critical role in discussions with its creative energy, commitment and sustained participation.

IV. NHLBI/DIVISION OF LUNG DISEASE (DLD), PROPOSED REORGANIZATION
Dr. James Kiley (Director, DLD) presented on his Division’s proposed reorganization. Significant growth has occurred in pulmonary and critical care research as new science has emerged, increasing the need for the Division to collaborate and integrate broader research. This has also produced challenges in areas such as staff development, promotion and retention.

The DLD plan proposes four branches dealing with the lung: Acute and infectious lung diseases; Lung development and pediatric diseases; Obstructive lung diseases; and Restrictive and vascular lung diseases, in addition to the current National Center for Sleep Disorders Research branch. The Division currently has three branches on airwaves, lung and sleep.

The new structure would allow the Division to align disease areas with disease agnostic areas and meet administrative requirements. The plan makes sense scientifically and administratively. The changes would be incremental and foster expanded communication within and across all branches.

Dr. Kiley noted that DLD is seeking community feedback, which it will incorporate before submitting the final proposal for NIH approval. Implementation of the reorganization is expected to take at least a year.

V. PRESENTATION: “REDEFINIG ACUTE REJECTION TO IMPROVE TRANSPLANT OUTCOMES: INSIGHTS TO DIAGNOSIS AND TREATMENT”
Dr. Sean Agbor-Enoh (Lasker Clinical Research Fellow, NIH Distinguished Scholar, DIR, The Laboratory of Applied Precision Omics, NHLBI) presented his research in novel approaches to detect and prevent transplant rejection, which is a major contributor to the high mortality of lung transplant patients.

Specifically, Dr. Agbor-Enoh described his work on plasma levels of cell-free DNA (cfDNA), or DNA fragments that are continuously shed into body fluids. Spiking levels of these fragments can signal organ rejection months before routine, more invasive bronchoscopy screening is conducted. Dr. Agbor-Enoh aims to exploit this finding to develop novel and better diagnostic tools for organ failure. In the future, he hopes to redefine acute rejection and more rapidly identify patients needing treatment.

Dr. Agbor-Enoh told the Council about the work of the Genomic Research Alliance for Transplantation (GRAfT) consortium, sponsored by NHLBI. GRAfT embarked on two studies in heart and in lung, to assess the cfDNA tool’s effectiveness. The initial approach was to standardize sample collection, assign adjudication committees to characterize transplant conditions, and test 130,000 samples from 690 patients.

The studies found that cfDNA detected organ dysfunction 2-4 months before biopsy screening. Bronchoscopy identified only a quarter of clinically relevant elevations of cfDNA. However, the cfDNA test is currently non-specific, unable to distinguish if a fragment spike is due to rejection or an infection. To bring more clarity, researchers are investigating the epigenetic fingerprints of cfDNA, which are distinct from the DNA sequence.

Current outcomes from Dr. Agbor-Enoh’s work:

• GRAfT research has discovered that molecular injury often occurs before lung transplant, raising the risk of early allograft failure. The team is profiling injury states to identify optimal times to treat patients.
• The cfDNA protocol has been added to routine clinical care in many places around the world to identify rejection, even as the team moves toward Phase II intervention studies.

VI. NHLBI CONCEPT CLEARANCE
NHLBI staff presented 16 concepts for clearance. Members of the Advisory Council were asked to rate the concepts on six criteria using Decision Lens.

Title: Short-Term Research Education Program to Increase Diversity in Health-Related Research (R25)

Description: This concept supports short-term research education activities that enhance the diversity of the biomedical, behavioral and clinical research workforce. The NHLBI aims to enrich the pool of individuals from nationally under-represented groups who will be available to compete for research opportunities in topics of interest to the NHLBI. Up to nine meritorious awards a year would be approved, each lasting up to 5 years.

Title: Secondary Participation in Multi-sectoral preventive interventions that address social determinants of heath in populations that experience health disparities. (UG3/UH3, PAR)

Description: This concept supports an NIH-wide initiative to test prospective, multi-sectoral, preventive interventions that address social determinants of health. Each project must focus on health equity in communities. Projects will be part of a research network that will share approaches, data and methods, to facilitate the generation of research evidence on preventing common risk factors for multiple health conditions across different populations. Seven NIH institutes/centers are participating.

Title: Secondary Participation in Fogarty HIV Research Training Program for Low- and Middle-Income Country Institutions (D43 Clinical Trial Optional)

Description: This concept supports the goal of strengthening human capacity at institutions in low- and middle-income countries conducting HIV-related research. It is designed to leverage the HIV-AIDS investments and capacity built by other funders, to train in-country experts on the science of heart, lung and blood comorbidities. This is a trans-NIH-wide initiative led by the Fogarty International Center and is open to in-country or U.S. institutions.

Titles: Data Coordinating Center for Cardiovascular Risk Reduction in Type 1 Diabetes Clinical Trial (Collaborative U24 Clinical Trial Required). Efficacy and Implementation of Cardiovascular Risk Reduction in Type 1 Diabetes Mellitus (UG3/UH3)

Description: These concepts support a collaborating Data Coordinating Center for an investigator-initiated, multi-site clinical trial. This trial will test interventions to reduce cardiovascular disease (CVD) risk in people with Type 1 diabetes (T1D) and fill evidence gaps, ultimately contributing to CVD prevention guidelines for T1D. NIDDK is leading the initiative.

Title: Multi-Ethnic Study of Atherosclerosis (MESA) Renewal (N01)

Description: This concept renews support of the MESA study infrastructure as a publicly available resource for Precision Health and novel epidemiologic research on heart, lung, blood, sleep, and related disorders. The MESA cohort is a diverse NHLBI initiative established 23 years ago. This renewal would support regular contact with study participants and other key needs.

Title: Secondary Participation in Understanding Chronic Conditions Understudied Among Women (R01 Clinical Trial Optional)

Description: This concept supports research aims to increase knowledge about chronic conditions that are understudied among women or those that disproportionately affect women who are understudied, under-represented and under-reported in biomedical research. The initiative is led by the Office of Research on Women’s Health.

Title: Proposed Renewal of the National Gene Vector Biorepository (NGVB) Contact (N01)

Description: This concept renews support for the gene therapy resource, NGVB, which provides critical help to NHLBI investigators performing preclinical and clinical gene therapy research. NGVB has proactively anticipated the needs of gene therapy investigators over the past 15 years. This initiative would enable NGVB to continue operating as a cost-effective center of gene therapy excellence for NHLBI and other NIH teams.

Title: Proposed Renewal of the Gene Therapy Resource Program (GTRP) (N01)

Description: This concept renews the NHLBI’s GTRP, to continue providing resources to researchers and facilitate the translation of gene therapy discoveries into clinical advancements for heart, lung, blood, and sleep disorders. GTRP has made numerous contributions across the translational spectrum of gene therapy research since its launch in 2007. This renewal would support the existing three cores and additionally a new reagent core.

Title: National Ferret Resource and Research Center (N01)

Description: This concept renews support for existing, and some new, ferret animal models and tissues. This resource is valuable in the research of novel disease mechanisms and the testing of therapeutics for a variety of human health conditions, particularly of the pulmonary system but also of heart and blood. Historically, this model has been productive in the study of cystic fibrosis and is currently used to study respiratory disease and infections. It has potential for use in cardiovascular disease and other NHLBI research.

Titles: Secondary participation in Advancing Methods for 24-hour Behavioral Patterns: Diet, Physical Activity, and Sleep (U01). Secondary participation in Advancing Methods for 24-hour Behavioral Patterns: Diet, Physical Activity, and Sleep (U24)

Description: These concepts support research integrating the temporal patterns of diet, physical activity and sleep, to determine how the timing of these interconnected behaviors combine to affect health outcomes, trajectory and treatment across the lifespan. This holistic approach, suggested initially by the White House, includes cardiopulmonary and cardiometabolic disease risk, aligning with NHLBI’s objectives. The NCI is leading the initiatives, with support also from NIDDK and OBSSR.

Title: NHLBI Program Project Application (P01 Clinical Trial Optional)

Description: This concept renews, without changes, support for investigator-initiated program project grant applications to advance understanding of fundamental processes and disease in heart, lung, blood and sleep. The NHLBI encourages collaborative research efforts to accelerate the acquisition of knowledge in integrated research projects .This initiative also encourages the careers of junior investigators.

Title: NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional)

Description: This concept renews support for investigators planning to conduct a future Phase II or higher clinical trial, who need additional research to produce critical information necessary to complete the design, for instance, on efficacy, safety, clinical management or implementation of interventions. The NHLBI has used the R34 mechanism since 2010 and funds 20-25 grants per year.

Title: Subpopulations and Intermediate Outcome Measures in COPD Study (SPIROMICS) (N01)

Description: This concept renews support for the long-standing NHLBI study to identify different subpopulations of individuals with COPD and ultimately define endotypes within this heterogenous disease that are responsive to mechanism-specific interventions. This renewal charges investigators to obtain additional longitudinal data from the existing cohort, to address three critical topics highlighted by recent research findings. A parallel study in younger smokers will be rolled into this study.

Title: Maintenance of Canine Models of Human Bleeding Disorders Program (N01)

Description: This concept renews support for maintaining the canine hemophilia model, to ensure this unique resource can continue to serve the research community studying inherited bleeding disorders. This model began in 1947 and has yielded strong predictive accuracy for successful translational research.

VII. OPEN DISCUSSION
Discussion was initiated by Council members about the areas of overlap between the two gene therapy programs, including the new Reagent core. Dr. Goff cited prior discussions about whether to bring those two programs under a larger umbrella, perhaps an overarching award with subawards, and reduce further the possibility of redundancy. Additional comments included that some needs are generic and apply across many different organs but others are organ-specific. Dr. Gibbons followed up, saying that the NHLBI must remain adaptive and nimble, keeping focus on what support the gene therapy community needs in the next 5-10 years. There are many commercial cores, vendors and biomanufacturers able to make products and NHLBI should assess, with the gene therapy community, when to adjust focus. Dr. Goff mentioned an increasing number of diversity-related R01 offerings from other NIH institutes and centers and asked if the NHLBI was planning more participation in this area. Dr. Moen replied that the NHLBI has participated in many of those initiatives and is continuing to develop its own potential new offerings. Dr. Gibbons added that the NHLBI are open ideas and concepts in this area and, like many NIH institutions, has led the field in inclusion. It is important to appreciate that executing these programs appropriately involves significant legal consultation to ensure the NIH is aligned with what is appropriately inclusive. Dr. Moen suggested that the diversity program be on the agenda for a future NHLBAC meeting.

Dr. Mensah suggested a discussion at the September joint sessions about the science of health disparities research, what could be approached differently to improve inclusion, not only as an institute but as a nation. Dr. Moen said that regarding the September meeting, the NHLBAC will have an opportunity to comment on proposed topics, including the strategic plan refresh and how to adapt programs to remain attractive.

VIII. CLOSING REMARKS
Dr. Gibbons adjourned the meeting at 2:59 p.m.

The 301st meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) convened hybrid on Wednesday, February 8, 2023. The Council meeting began with a closed session that started at 9:02 a.m. and ended at 10:01 a.m. The open session reconvened from 10:24 a.m. and ended at to 1:06 p.m. Dr. Gary H. Gibbons, Director of NHLBI, presided as chair.

NHLBAC Members Attending

Victoria L. Bautch, Ph.D.
Kristen Bibbins-Domingo, M.D., Ph.D.
Mercedes R. Carnethon, Ph.D.
Jennifer E. DeVoe, D.Phil., M.D.
Amanda Mae Fretts, M.D., M.P.H.
Tina V. Hartert, M.D., Ph.D.
David H. Ingbar, M.D.
Kiran Musunuru, M.D., Ph.D.
Lynn M. Schnapp, M.D. Martha C. Sola-Visner, M.D. Mohandas Narla, D.Sc.
Zachariah P. Zachariah, M.D.

Members of the Public Attending

The total number watching online was reported by NIH Videocast to 423.

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 3,099 applications requesting $7,759,718,842 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 10:24 a.m. He welcomed Council members, NHLBI staff, and public attendees to the Open Session of the meeting.

II. ADMINISTRATIVE ANNOUNCEMENTS
Dr. Laura K. Moen (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
Dr. Gibbons informed the Council that Dr. Julie Panepinto has been appointed as the new Director of the Division of Blood Diseases and Resources, and Dr. Gustavo Matute-Bello is the new Deputy Director of the Division of Lung Diseases. Dr. Gibbons welcomed them to their new leadership roles.

Accountable Stewardship. Dr. Gibbons reported that Congress has approved fiscal year 2023 (FY 2023) appropriations, including new NHLBI funding dedicated to advancing valvular research. Dr. Gibbons indicated that the FY 2023 NIH funding allocation was increased over its FY 2022 level. He will update the Council on NHLBI’s funding guidelines at the next meeting when the Institute will have received its appropriations.

Dr. Gibbons observed that February is American Heart Month, which provides an opportunity to address gaps in heart health awareness. A key element of improving heart health is not only involving the public through awareness campaigns but also developing a deeper understanding of the patient perspective in both common and rare disorders.

Dr. Gibbons recognized the essential role that patient advocates and policy members play as partners with NHLBI in the goal of advancing cardiovascular research. Congress recently enacted the Cardiovascular Advances in Research and Opportunities Legacy (CAROL) Act in honor of Carol Barr, who was diagnosed with mitral valve prolapse and suffered sudden cardiac death. NHLBI plans new research activities that will take a precision medicine approach to increasing knowledge about risk factors for, and detection of, valvular heart diseases.

Dr. Gibbons pointed to another example of transforming specific appropriations into programmatic elements. NHBLI is building on the community engagement experience of the NIH Community Engagement Alliance (CEAL) to perform transdisciplinary, transformative research on climate and health.

Advancing Scientific Priorities. Dr. Gibbons commented that NHLBI strives to maintain a diverse workforce in investigator-initiated science. The rising costs of R01 grants have presented a challenge to the Institute.

Dr. Gibbons reminded Council that this year marks an important milestone: the NHLBI’s 75th anniversary. He also noted that the upcoming combined meeting in September will provide Council with the opportunity to refresh the Institute’s evergreen strategic vision, which is a framework for accelerating discoveries for public health impact. This year, the Council will play a critical role in evaluating how well NHLBI’s portfolio has performed in mapping to the strategic vision and identifying gaps.

Dr. Gibbons observed that an ongoing dialogue with partners is critical to fulfilling NHLBI’s mission. Patients raised concerns about the need to better understand and prevent lymphatic disorders. NHLBI has led NIH in the characterization of lymphatic disorders but learning more about lymphatics and various organs and tissues relevant to disease processes will necessitate a coordinated, trans-NIH effort. To this end, NHLBI established a working group to develop a framework for a National Commission on Lymphatic Diseases.

Dr. Gibbons spoke about NHLBI’s mission to translate discovery science into the health of the nation. NHLBI’s Catalyze Program was founded to help address the challenges in this transition by supporting innovators in academic institutions and small businesses.

Dr. Gibbons briefed the Council on NHLBI’s role in the trans-NIH response to the new post-COVID multisystem disorder known as long COVID. NIH’s Researching COVID to Enhance Recovery (RECOVER) initiative is NIH’s contribution to a government-wide research effort. RECOVER’s goals are improving the understanding of, and ability to predict, treat, and prevent, long COVID. NHLBI brings assets to the initiative from its research platforms that include community engagement, well-characterized cohorts, pathobiology research, clinical research assets, and data integration. Key research components of RECOVER include observational cohorts, pathobiology, and clinical trials on a spectrum of potential interventions. NIH has used the assets and principles of community engagement to develop the largest and most diverse set of cohorts that exist to address long COVID, leveraging NHLBI assets in community- based cohorts. NIH’s pathobiology research will continue to extend across mechanisms, approaches, and systems. Adaptive master protocols developed for clinical trials will lead to high-throughput and cost- effective research on multiple clinical domains.

IV.THE LYMPHATICS WORKING GROUP REPORT
Dr. Victoria Bautch (Beverly Long Chapin Distinguished Professor of Biology at the University of North Carolina, Chapel Hill (UNC) and the Co-Director of the McAllister Heart Institute at UNC) and Dr. James Kiley (Division Director, Division of Lung Disease, NHLBI)

Dr. Bautch reported on the results of the working group that was formed to establish a National Commission on Lymphatic Diseases. She reviewed the legislative language that charged NIH to establish a National Commission on Lymphatic Diseases. The working group was tasked with developing a charge for the National Commission and develop a report to NHLBAC that included the charge, a slate of Commission members, operational guidance, and objectives. The working group’s process included inviting members to serve on the working group, convening working group meetings, consulting with the NHLBI Office of Committee Management in coordination with the NIH Committee Management Office, and drafting the report. The final draft report was submitted to NHLBAC on February 8, 2023. To develop the Commission’s charge, the working group examined directives or charges of similar NIH efforts. The working group defined Commission objectives, including defining the disease burden, examining inequities among patients, understanding the state of the science, and evolving approaches to optimize research. The working group defined the Commission’s charge as being to advance the understanding of lymphatics, with a goal of improving the care of, and health benefits to, patients living with these diseases. The Commission’s deliverable was to be a comprehensive report about the lymphatic dysfunction and disease burden in the United States, completing its work in no more than 2 years with the help of ad hoc subcommittees, as needed.

The working group recommended a Federal Advisory Committee Act (FACA) structure for the Commission. The Commission membership would represent researchers, clinicians and clinician researchers, patient representatives, patient and professional educators, caregivers, federal agency partners (ex-officio), advocacy and professional societies, and others with unique specialties. Membership would be assembled through a public process, with final vetting of appointments by the NHLBI Director. Finally, the working group strongly encouraged the Commission to operate fully and openly, reach broadly, and inform its report with a wide spectrum of ideas and perspectives.

Dr. Bautch concluded by recognizing the working group members, especially Dr. Lenora Johnson (Director, Office of Science Policy, Engagement, Education and Communications, NHLBI); the support members of the NHLBI Workshop Support Team, NHLBI Office of Committee Management, and NHLBI staff; and her co-chair, Dr. James P. Kiley (Director, Division of Lung Diseases, NHLBI).

V. THE NHLBI CATALYZE PROGRAM OVERVIEW
Dr. Mike Pieck (Director, NHLBI Catalyze Program, Division of Extramural Research Activities, NHLBI) presented an overview of the NHLBI Catalyze Program. He noted that the goal of Catalyze is to provide a bridge from basic to clinical research across NHLBI’s research spectrum through training investigators in how to turn a discovery into a product that is commercially successful. Translational research faces the challenges of a funding gap between discovery and technology development, investigators’ lack of knowledge about how to develop new commercial technologies, and a need to access technology development and commercialization experts.

Dr. Pieck gave a brief overview of the Catalyze program, beginning with discussions prior to initiating the current pilot phase. He noted that in accord with its mission, NHLBI has taken the lead in piloting ways to support investigators who are trying to advance early translation, supported by NHLBI’s Innovation Office. The Translational Implementation Working Committee met several years ago to streamline the process into a single disease-, technology-, and geography-wide framework. Thus, Catalyze was established with the intent of leveraging NHLBI investments with matching commitments, taking a coordinated approach throughout product development, using milestone-driven project management, and having the flexibility to disseminate lessons learned.

Catalyze’s governance structure ensures that the program is meeting NHLBI’s broader goals. The program components include different funding opportunities based on technology type and maturity level. Five funding opportunities are offered per year. Product definition awards have special requirements that are unique to Catalyze but consistent for the different funding opportunities, including a focus on project management, as well as a requirement for matching funds and an Accelerator Partner at the later stages. Each awardee receives individualized support. The Catalyze Coordinating Center provides product development support, including expertise in regulatory affairs; commercialization support; and skills development. Over the 3-year course of an award, the awardee develops a Product Development Plan in the initial period of the award, meets quarterly with Catalyze staff during the kickoff period of the first year, and meets virtually at the end of years 1 and 2 to evaluate progress meeting project milestones.

Project management strategies emphasize early corrective action, communication, milestone review prior to issuing an award, and progress tracking that tracks risk across the Catalyze portfolio. Catalyze is tracking differences in the support needed between projects focused on therapeutics and devices/tools. RTI Innovation Advisors offer a valuable resource through the Catalyze Coordinating Center. For example, RTI Innovation Advisors assisted with premarket interviews to allow investigators to achieve Catalyze milestones for prototype development. Catalyze’s entrepreneurial education and training approach includes integrating early-career researchers, producing a monthly webinar, convening an annual meeting, and providing online resources.

Data show that Catalyze is expanding NHLBI’s reach geographically compared to previous programs. Catalyze also is funding a higher percentage of early-career researchers than previous efforts. Catalyze’s portfolio is well balanced by technology type and across disease areas. In February 2023, Catalyze will launch preclinical services. Dr. Pieck concluded by recognizing the support that Catalyze has received across NHLBI.

VI. 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 delegated authorities presented, with no changes.

VII. OPEN DISCUSSION
Dr. David C. Goff (Director, Division of Cardiovascular Sciences, NHLBI) presented the question to the Council of the most effective use of the funds related to the CAROL Act. One idea is to use Notices of Special Interest (NOSIs) related to valvular heart disease to provide administrate supplements to existing funded studies. Possible NOSI topics include developing polygenic risk scores for developing mitral valve prolapse or sudden cardiac death and examining the molecular foundations of valve development. Other mechanisms are working with BioData Catalyst and TOPMed to stimulate data sciences approaches. Council members agreed that these are good conceptual approaches to the effective use of these funds.

VIII. CLOSING REMARKS
Dr. Gibbons adjourned the meeting at 1:06 p.m.

The 300th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) convened hybrid on Tuesday, October 25, 2022. The Council meeting began with a closed session that started at 9:02 a.m. and ended at 10:24 a.m. The open session reconvened from 10:45 a.m. and ended at to 12:57 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.
Jennifer E. DeVoe, D.Phil., M.D.
Amanda Mae Fretts, M.D., M.P.H.
Martha U. Gillette, Ph.D.
Tina V. Hartert, M.D., Ph.D.
David H. Ingbar, M.D.
Edward E. Morrisey, Ph.D.
Kiran Musunuru, M.D., Ph.D.
Lynn M. Schnapp, M.D.
Martha C. Sola-Visner, M.D.
Mohandas Narla, D.Sc.
Kevin L. Thomas, M.D.
Zachariah P. Zachariah, M.D.

Members of the Public Attending
The total number watching online was reported to NIH Videocast as 190.

NHLBI Employees Attending
Several NHLBI staff members were present and in attendance 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 2,781 applications requesting $7,539,379,695.00 in total costs. For the record, it is noted that secondary applications were also considered en bloc.

OPEN SESSION

I. CALL TO ORDER
Dr. Laura K. Moen (Director, Division of Extramural Research Activities, NHLBI) called the meeting to order 10:45 a.m. and welcomed Council members, NHLBI staff, and public attendees. She recognized people retiring from the Council: Drs. DeVoe, Gillette, Narla, Schofield, and Thomas.

II. ADMINISTRATIVE ANNOUNCEMENTS
Dr. Moen informed attendees that the meeting would be publicly broadcast and archived on videocast. She reviewed the agenda.

III. REPORT OF THE DIRECTOR
Dr. Gibbons remarked that this 300th meeting of the NHLBAC is a key milestone and heralds the 75th anniversary of NHLBI, which was one of the first Institutes established at NIH.

Dr. Gibbons expressed his gratitude for the service and expertise provided by the five Council members who are rotating off the Council. He then welcomed three new Council members: Drs. Fretts, Schnapp, and Sola-Visner.

Dr. Gibbons commented on the benefits of in-person interactions among Council members attending meetings and welcomed their resumption after stopping during the COVID-19 pandemic.

Accountable Stewardship. Dr. Gibbons reported that the accounting of NHLBI’s fiscal year 2022 (FY 2022) is still being processed, and he will update the Council at the next meeting. He commented that this is a period of uncertainty about FY 2023. The federal budget is under a continuing resolution, which holds the NIH funding allocation at its FY 2022 level until Congress passes the FY 2023 budget.

Advancing Scientific Priorities. Dr. Gibbons commented that NHLBI always works to ensure balance across its investment portfolio, and between investigator-initiated science and other investments, including intramural and R&D. The rising costs of R01 grants have presented a challenge, but NHLBI strives to ensure consistency in the investigator-initiated pool, while remaining open and adaptive to new opportunities and needs.

Dr. Gibbons spoke at length about NHLBI’s investment mechanism, “Other Transactional Authority” (OTA), which enables nimble and flexible funding responses to evolving science. This approach can advance strategic investments that are not amenable to more traditional types of grants.nParticularly over the past 5 years, NHLBI has approved OTA investments to solve problems via innovative programmatic platforms and structures. This has involved unique partnerships that are not readily formed through traditional solicitations and mechanisms. Some examples of the way the NHLBI has utilized the flexibilities afforded by OTA:

NHLBI leveraged OTAs to advance science and also focus on disproportionately affected populations to rapidly respond to the public health crisis caused by the COVID-19 pandemic. It established CONNECT, a network of existing networks, to rapidly enroll patients in clinical trials. It also helped create the trans-NIH platform of academic and community partners, CEAL, and establish the novel consortium RECOVER to study Long COVID.
NHLBI has leveraged OTAs to widen access to its data and capabilities, including artificial intelligence and machine learning, in the BioData CATALYST initiative. It also established CURE Sickle Cell to advance progress on sickle cell disease, via a partnership that includes patients, the U.S. Food and Drug Administration, and biotech and pharmaceutical companies. Also, CATALYZE handles high-risk, new preclinical projects aiming to develop technologies and products by including a transactional capability as a complement to the grants.
OTAs are helping foster community-engaged research platforms in several areas. One example involves American Indian, Alaska Native, Native Hawaiian, and Pacific Island communities, to improve understanding of health needs and address health inequities. Another example is in maternal health, where patient-provider relationships are integral to develop and test effective interventions. A third example is in climate and health, where collaboration with communities is essential to co-create solutions.
Dr. Gibbons spoke about NHLBI’s pending 75th anniversary and the opportunity to celebrate the Institute’s laudable accomplishments in pursuit of its mission. NHLBAC will celebrate this milestone when it meets in September 2023 to review and refresh NHLBI’s strategic vision, among other planned activities.

NHLBI CONCEPT CLEARANCE
NHLBI staff presented 14 concepts for clearance. Members of the Advisory Council were asked to rate the concepts on six criteria using Decision Lens.

Titles: Identifying the Role of Sleep Deficiency in Persons with Type 1 Diabetes: Sleep, Glycemic Control, and Cardiovascular (R01) and Defining the Role of Sleep Deficiency in Persons with Type 1 Diabetes: Sleep, Glycemic Control, and Cardiovascular Risk (R34 Clinical Trial Optional)

Description: These two concepts are part of multidisciplinary clinical research and pilot studies investigating how sleep deficiency and circadian disruption are linked to type 1 diabetes and related cardiovascular conditions. The goals are to improve understanding of the mechanisms involved and identify potential therapeutic targets. The National Institute of Diabetes and Digestive and Kidney Diseases will provide support.

Title: Secondary Sign-on for Galvanizing Health Equity Through Novel and Diverse Education Resources (GENDER) Research Education Program (R25 Clinical Trial Not Allowed)

Description: This concept supports the development and dissemination of courses and curricula on topics relevant to sex and gender in health and disease. Many diseases and conditions covered by NHLBI disproportionately affect women. This program is led by the NIH Office of Research on Women’s Health (ORWH).

Title: Secondary Participation/Renewal – The Intersection of Sex and Gender Influences on Health and Disease (R01 Clinical Trial Optional)

Description: This concept will renew NHLBI’s support for the successful trans-NIH ORWH-led program targeting sex-gender research. The goal is to stimulate research on the influences and intersection of sex and gender. NHLBI has received the highest number among 13 NIH Institutes and Centers of total applications for this RFA.

Titles: Secondary Participation in All of Us RFA “Enhancing the Use of the All of Us Research Program’s Data” (R03 Clinical Trial Not Allowed). Secondary Participation in All of Us RFA “Enhancing the Use of the All of Us Research Program’s Data” (R21 Clinical Trial Not Allowed)

Description: These concepts renew support for participation in the trans-NIH All of Us Research Program Data. One approach analyzes the data using established and widely accepted tools and methods, whereas the other is developing new methods, models and tools, which will be broadly disseminated to the research community.

Title: Molecular Atlas of Lung Development Program (LungMAP) (U01, U24) Renewal

Description: This concept supports renewed participation in the LungMAP consortium, which aims to build a comprehensive molecular and cellular atlas of the human lung, to serve as a reference platform and advance understanding of both normal biology and disease pathology. The next phase, which permits hypothesis testing, will tackle pediatric and adult lung diseases.

Title: Data Management and Coordinating Center for Diagnostic Centers of Excellence (U2C Clinical Trial Not Allowed) Renewal

Description: This concept requests participation in a program led by the National Institute of Neurological Diseases and Stroke, with the goal of helping establish a new network of clinical sites to provide diagnostic services for patients with hard-to-diagnose diseases. Many of these diseases involve multiple organ systems, including those covered by NHLBI.

Titles: The Blood and Marrow Transplant Clinical Trials Network – Data Coordinating Center (U24) (UH1). The Blood and Marrow Transplant Clinical Trials Network – Core Clinical Centers (UH1) Renewal

Description: These concepts request a renewal of support to advance research in hematopoietic cell transplantation and novel adoptive cell therapies for all patients, especially those with rare, acquired, and congenital non-malignant blood diseases. These include sickle cell disease, aplastic anemia, bone marrow failure, and telomere diseases. NHLBI is partnering with the National Cancer Institute to build a biospecimen repository and launch new clinical trials.

Titles: Secondary Participation to Harnessing Data Science for Health Discovery and Innovation in Africa (DS-I Africa): Partnershipfor Innovation Research Projects (U01 Clinical Trial Not Allowed). Secondary Participation to Harnessing Data Science for Health Discovery and Innovation in Africa (DS-I Africa): Partnership for Innovation Research Projects (UE5 Clinical Trial Not Allowed)

Description: These two concepts support research projects led by investigators in Africa, and provide related education and training. The goal is to advance population-relevant, affordable, acceptable, and scalable data science solutions to heart, lung, blood, and sleep-related health problems in Africa. The DS-I Africa program is supported by the NIH Common Fund.

Title: Renewal of NHLBI Secondary Participation in MD-22-004: Innovations for Healthy Living SBIR (R43/R44 Clinical Trial Optional)

Description: This concept renews NHLBI’s support for this trans-NIH program led by the National Institute on Minority Health and Health Disparities. The goal is to encourage small businesses to develop, optimize, adapt, and repurpose new devices, digital health, and diagnostic tools, to improve health of people in underserved populations who are living with heart, lung, blood, and sleep conditions.

Title: Renewal of the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) (N01)

Description: This concept renews support for the landmark trans-NIH longitudinal study of Hispanic/Latino health and disease in the United States. NHLBI would continue supporting the infrastructure established in four major metropolitan areas to advance epidemiological research on heart, lung, blood, sleep, and related diseases and conditions.

V. CLOSING REMARKS
Dr. Gibbons adjourned the meeting at 12:57 p.m.

The 299th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) convened as a hybrid meeting via videoconference and at 6705 Rockledge Drive, Bethesda, MD, on Tuesday, September 13, 2022. In addition to NHLBAC members, the meeting included the ad hoc Board of External Experts (BEE), scientists with research expertise in National Heart, Lung, and Blood Institute (NHLBI) mission areas, who were recruited for this meeting as a special NHLBAC working group. The meeting was open to the public from 9:13 a.m. to 12:00 p.m. and from 3:00 p.m. to 4:14 p.m. to hear reports and recommendations from each working group.

NHLBAC Members Attending
Mercedes R. Carnethon, Ph.D.
Amanda Mae Fretts, M.D., M.P.H.
Martha U. Gillette, Ph.D.
Tina V. Hartert, M.D., Ph.D.
David H. Ingbar, M.D.
Kiran Musunuru, M.D., Ph.D.
Mohandas Narla, D.Sc.
Lynn Schnapp, M.D.
Kevin L. Thomas. M.D.
Zachariah P. Zachariah, M.D.

BEE Members Attending
Timothy S. Blackwell, M.D.
Annetine A. Gelijns, Ph.D., J.D.
Bertha Hidalgo, Ph.D., M.P.H.
Mukesh K. Jain, M.D.
Darrell N. Kotton, M.D.
Brian S. Mittman, Ph.D.
Matthias Nahrendorf, M.D., Ph.D.
Ellis J. Neufeld, M.D., Ph.D.
Laura Kristen Newby, M.D.
Bruce M. Psaty, Ph.D., M.D., M.P.H.
Susan S. Redline, M.D., M.P.H.
Herman A. Taylor, Jr., M.D.
Griffin M. Weber, M.D.

Members of the Public Attending
The total number watching online was reported to NIH Videocast as 396.

NHLBI Employees Attending
Several NHLBI staff members were present and in attendance via Zoom.

• Centers of excellence could facilitate this goal.
• Community engagement and early implementation are critical to establishing the public’s trust in scientific recommendations.
• The involvement of various stakeholders is needed, including community representatives, the scientific community, policymakers, social/behavioral scientists, and the private sector. Use innovative approaches to involve the right stakeholders to break down barriers, particularly in new areas of health such as threats related to climate change.
• The implementation of climate-related studies should be a priority. Partnerships with schools should be created to implement education about climate change and heat-related effects starting in early childhood. Schools should be supported through infrastructure investments for training and internships. Climate education communication could also be improved by engaging communication scientists and inviting communication experts to the discussion.
• The impact of climate change on health equity should address race and ethnicity and aim to be inclusive to ensure the expansion of the evaluations and the solutions to all populations (such as geographically disadvantaged populations, individuals with different socioeconomic statuses, different societal positions, etc.).
• The NHLBI should strive to train and develop a skilled workforce. This is an opportunity for the NHLBI and academic institutions to create strategic programs to expand such a workforce and educate the next generation of researchers by incorporating climate change and its effects in the medical education curriculum.

VII. CLOSING REMARKS

Dr. Gibbons thanked everyone for the rich dialogue and discussion, especially on expanding and enhancing the use of datasets and leveraging existing resources. Dr. Moen thanked everyone and adjourned the meeting at 4:14 p.m.

The 298th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) was convened on Tuesday, August 23, 2022 at 1:01 p.m. as a virtual Zoom Event. The meeting was closed to the public from 1:05 p.m. until adjournment at 1:15 p.m. Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI), presided as Chair.

Council Members attending 
Dr. Kristen Bibbins-Domingo 
Dr. Mercedes Carnethon 
Dr. Amanda Fretts
Dr. Martha Gillette NHLBI employees attending
Dr. Tina Hartert A number of NHLBI staff members were
Dr. David Ingbar in attendance.
Dr. Edward Morrisey
Dr. Kiran Musunuru
Dr. Mohandas Narla
Dr. Lynn Schnapp
Dr. Martha Sola-Visner
Dr. Kevin Thomas
Dr. Zachariah Zachariah

Council Members unable to attend via Zoom
Dr. Victoria Bautch
Dr. Jennifer DeVoe
Dr. Richard S. Schofield (ex officio)

NHLBI employees attending
A number of NHLBI staff members were in attendance.

I. CALL TO ORDER AND OPENING REMARKS
Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI), welcomed members and called the 298th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) to order at 1:01 p.m. The meeting was held via video conference for the members.

II. ADMINISTRATIVE ANNOUNCEMENTS
Dr. Laura K. Moen, Director, Division of Extramural Research Activities, NHLBI, 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. 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 850 applications requesting $292,275,982 in total costs. For the record, it is noted that secondary applications were also considered en bloc.

ADJOURNMENT
The meeting was adjourned at 1:15 p.m.

The 297th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) convened virtually and in person on Tuesday, June 14, 2022. The meeting began in a closed session that started at 10:00 a.m. and ended at 11:07 a.m. The open session convened at 12:16 p.m. and ended at 3:12 p.m. Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI), presided as chair.

NHLBAC Members Attending
Victoria L. Bautch, Ph.D.
Mercedes R. Carnethon, Ph.D.
Martha U. Gillette, Ph.D.
Tina V. Hartert, M.D., Ph.D.
David H. Ingbar, M.D.
Edward E. Morrisey, Ph.D.
Kiran Musunuru, M.D., Ph.D.
Richard S. Schofield, M.D. (Ex Officio)
Zachariah P. Zachariah, M.D.

Ad Hoc Members Attending
Lakiea Bailey, Ph.D. (Ad Hoc)
Amanda Mae Fretts, M.D., M.P.H. (Ad Hoc)
Lynn Schnapp, M.D. (Ad Hoc)
Martha C. Sola-Visner, M.D. (Ad Hoc)

Members of the Public Attending
The total number watching online was reported by NIH Videocast to 273.

NHLBI Employees Attending
Several NHLBI staff members were in attendance 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 3,211 applications requesting $7,107,864,374 in total costs. For the record, it is noted that secondary applications were also considered en bloc.

REVIEW OF INTRAMURAL RESEARCH

A report prepared by the Board of Scientific Counselors (BSC), NHLBI, on the NHLBI staff and intramural laboratories was presented to the Council by Dr. Donald M. Bers, BSC Chair.

OPEN SESSION

I. CALL TO ORDER
Dr. Gibbons called the meeting to order at 12:16 p.m. in an Open Session. He welcomed Advisory Council members, NHLBI staff, and public attendees to the Open Session of the meeting.

II. ADMINISTRATIVE ANNOUNCEMENTS
Dr. Laura K. Moen (Director, Division of Extramural Research Activities, NHLBI) noted that the meeting would be publicly broadcast and archived on videocast. She reviewed the agenda.

III. REPORT OF THE DIRECTOR
Dr. Gibbons addressed elements of accountable stewardship and scientific opportunities that are in accordance with NHLBI priorities.

Accountable Stewardship. Dr. Gibbons reviewed NHLBI’s fiscal year 2022 (FY 2022) budget. During the appropriation hearings, the appropriators expressed interest in the issues of the
long-term effects of COVID-19, the next generation, health disparities, maternal morbidity and mortality, climate change and health, and structural racism—topics that align with NHLBI priorities. NHLBI’s FY 2022 appropriations represent an increase of 3.9 percent over FY 2021, in keeping with rising appropriations for NIH. This budget increase allows NHLBI to pursue its priorities in promoting investigator-initiated science. The number of R01 awards grew in 2022, although the overall success rate decreased slightly due to an increase in the number of applications. As part of NHLBI’s commitment to the next generation, the Institute was able to sustain a success rate for early-stage investigators in the mid-thirties and a robust success rate for K awards.

Advancing Scientific Priorities. NHLBI is committed to building on the vigorous scientific legacy of its Department of Intramural Research (DIR). Dr. Robert Balaban, who has served as the Director of DIR for 20 years, plans to step down as Director to return to research, and a search for his replacement is ongoing. Dr. Gibbons noted that Dr. Balaban is an excellent scientist, and his research focuses on mitochondrial biology, taking a systems biology approach, and using state-of-the-art optical techniques. Dr. Balaban’s greatest legacy for the intramural research program is the team of talented, diverse young investigators he has recruited. This legacy and many other accomplishments have transformed and reengineered the intramural program.

Dr. Gibbons also informed the Council about:

• NHLBI efforts to translate discovery science into public health impact. He pointed out that NHLBI embraces the social ecological model of health, which recognizes the multilevel inputs to the social determinants of health. Building on lessons learned from the pandemic, NHLBI’s Community Engagement Research Initiative creates a research platform to advance health equities. NHLBI is extending the model developed for COVID-19 by the Community Engagement Alliance (CEAL) to advance health equity in the trans-NIH initiatives in maternal health and climate and health.
• NHLBI actions to advance its global health research portfolios for public health impact. He noted that rates of noncommunicable diseases are rising globally, on track to dominate the global disease burden. Low- and middle-income countries are struggling with rising rates of noncommunicable diseases. NHLBI is a global leader in heart, lung, blood, and sleep research, particularly in the strategic areas of chronic lung disease, hypertension, and sickle cell disease (SCD). Dr. Gibbons highlighted the work led by Dr. George A. Mensah (Director, Center for Translation Research and Implementation Science, NHLBI) to drive the implementation of NHLBI’s global health agenda, including through participation in the multinational Global Alliance for Chronic Diseases (GACD) Multimorbidity Research Program, which addresses hypertension, among other concerns. He noted that investments in Sub-Saharan Africa provide an opportunity to translate SCD interventions that have proven to be effective in the United States to address SCD mortality, particularly in children. NHLBI is engaging scientists in Africa to build capacity for screening, clinical research, and treatment of SCD. Hopefully, this infrastructure will provide settings for new curative technologies in Sub-Saharan Africa. Curing SCD will require broad collaboration among institutions. NHLBI is building a community of practice that focuses on the most vulnerable populations in the United States and the world to the tackle heart, lung, blood, and sleep disorders.

IV. LOCATION MATTERS: UNEXPECTED ROLES FOR THE COMPLOSOME IN HEALTH AND DISEASE
Dr. Claudia Kemper (Section Chief, CIRS, DIR, NHLBI) introduced the complosome and provided an overview of the CIRS research program, which uses new pre-clinical model systems and therapeutic modulation to understand the regulation and function of the complosome, as well as its role in disease. CIRS’s goals are to answer two simple questions—how the complosome functions and how it is regulated—that have complex answers. They found that the complosome operates in all immune cells, and perturbations in the complosome across immune cells drive human diseases from infection to autoimmunity to sterile inflammation.
Normalization of Th1 and macrophage hyperactivity in vitro points to the complosome being amenable to pharmacological intervention. CIRS is collaborating with the pharmaceutical industry in evaluating a cell-permeable drug that targets intracellular C3.

In parallel to attacking an intracellular target, CIRS is seeking to understand cell surface regulation of C3 and C5 gene transcription. Researchers found that tissue-resident immune cells have a complosome gene expression signature, and the integrin lymphocyte function- associated antigen 1 (LFA-1) is the master regulator of immune cell C3 induction. This finding led to a refined model of complosome engagement and activities in which circulating immune cells move into tissue, receive a signal from LFA-1, and have induction of effector function.
Immune cells undergo Th1 cell contraction when the pathogen danger is cleared. Further research in the scientific community has found that the complosome is not immune cell specific. CIRS has collaborated on studies regarding the importance of the complosome in colon cancer and severe COVID-19.

Dr. Kemper presented selected snapshots of ongoing work in her laboratory, which uses cutting-edge technologies in the interdisciplinary study of the interface of innate and adaptive immunity. The lab developed a new single-cell RNA sequencing (sc-RNA-seq) pathway analysis tool and is using it to define new Th1 shutdown pathways. CIRS researchers found that Th1 contraction is controlled at the translational rather than the transcriptional level. They are studying the balance between Th1 induction and shutdown and are also investigating the role of the complosome in CD4+ and CD8+ T cell memory.

In addition, CIRS researchers are focusing on the CD46 receptor, which is expressed in different isoforms with distinct cytoplasmic domains (CYT-1 and CYT-2). When they are cleaved, they are hypothesized to interact with transcription factor complexes. CIRS researchers are studying the molecular mechanisms of CD46-mediated Th1 induction and have identified proteins that interact with CYT-1 in the cytosol and have found CYT-1 target genes in the nucleus. The top DNA motif in the CYT-1 bound regions was the SP/KLF family. C46 was found to regulate gene expression via chromatin remodeling. CIRS scientists are developing a small animal model of C46 deficiency using the zebrafish. More that 90 percent of C46-deficient zebrafish die at a young age, and survivors develop cardiomyopathy.

Also, researchers in Dr. Kemper’s laboratory are studying the role of the complosome in meningeal immunity. Dr. Kemper concluded that the complosome is not fully explored. The intracellular complement system might explain why therapeutics have been unsuccessful and indicates that targeting the cellular complement might be a new way to treat chronic inflammatory disease states. NHLBI DIR is the ideal research environment for this effort.

V. NHLBI CONCEPT CLEARANCE
NHLBI staff presented 21 concepts for clearance. Members of the Advisory Council were asked to rate the concepts on six criteria using Decision Lens.

Titles: The Pediatric Heart Network Renewal (UM1); The Pediatric Heart Network Renewal (U24)

Description: These two concepts support the renewal of the Pediatric Heart Network (PHN), funding a Coordinating Cluster and multiple clinical centers. PHN’s objective is to
improve patient outcomes through clinical trials and studies of congenital heart disease (CHD) and other pediatric heart diseases across the lifespan. The renewal will build on PHN’s initial strengths, focus on precision medicine, explore disparities in outcomes, and apply big data science.

Title: Renewal of the Sudden Death in the Young Initiative 2024-2028 (R01, N01, IAA)

Description: This concept renews support for a collaborative initiative with the National Institute of Neurological Disorders and Stroke and the Centers for Disease Control and Prevention. It is designed to address critical knowledge gaps in the epidemiology and causes of sudden death in the young and to inform prevention efforts. Key changes to enhance the program are surveillance of disparities, collection of biospecimens, and engagement in strategies to support diversity of data in the registry.

Titles: Programs to Increase Diversity among Individuals Engaged in Health Related Research (PRIDE) Renewal - Coordination Center (U24 Clinical Trial Not Allowed); Programs to Increase Diversity among Individuals Engaged in Health Related Research (PRIDE) Renewal - Summer Institutes (R25 Clinical Trial Not Allowed); Programs to Increase Diversity among Individuals Engaged in Health Related Research (PRIDE) Renewal - Notice of Special Interest (NOSI): Administrative Supplements for Small Research Program (SRP) Pilot Awards (U24)

Description: These three concepts renew support for the trans-NIH PRIDE program. PRIDE focuses on the recruitment of a cohort of summer scholars, mentor-mentee matching, assistance in grantsmanship, administration of small research program pilot grants, and evaluation of the program’s impact. Continuation of this program will stimulate the entry of new research investigators from historically excluded and underrepresented groups into the pipeline across existing and emerging areas of science relevant to NHLBI’s mission.

Title: Limited Competition: Small Grant Program for NHLBI K01/K08/K23/K25 Recipients (R03 Clinical Trial Optional)

Description: This concept renews support for a small grant program designed to expand the research objectives and help the transition to research independence of current and recent NHLBI K award grantees. This program has proven successful in increasing the application and success of rate of grantees in obtaining R01-equivalent grants and helping them achieve their stated goals. Minor changes that will benefit awardees include an increase in direct costs and addition of the K25 grant mechanism.

Title: Secondary participation in Catalyst Award for Early-Stage Investigators (ESIs) Pursuing Research on HIV Comorbidities, Coinfections, and Complications (DP1- Clinical Trial Optional)

Description: This concept supports participation in a trans-NIH initiative that falls under NHLBI’s HIV/AIDS program. Its goal is to fund creative, early-stage research on HIV comorbidities, coinfections, and complications to support the next generation of researchers. It arose from a portfolio analysis that revealed a critical decline in junior investigators involved in HIV research.

Title: (Renewal/Secondary Participation) ORWH SCORE Program Specialized Centers of Research Excellence on Sex Differences (U54 Clinical Trial Optional)

Description: This concept supports the Specialized Centers of Research Excellence on Sex Differences (SCORE) program, a trans-NIH initiative led by the Office of Research on Women’s Health. The Centers have research projects and an administrative core. This program funds translational research on sex differences and applies across all NHLBI mission areas.

Title: Dissemination and Implementation Research in Health (R01 Clinical Trial Optional)

Description: This concept supports a trans-NIH funding opportunity for dissemination and implementation research focusing on underserved populations in the United States and abroad. This funding opportunity bridges the gap between research and policy by building a knowledge base about integrating health information, effective innovations, and new clinical practice guidelines and tools into a broad range of healthcare settings.

Titles: Secondary Participation in FIC International Research Training Award (NCD-LIFESPAN) Program (D43 – Clinical Trial Optional); Secondary Participation in FIC Emerging Global Leader Award (K43 Independent Clinical Trial Required); Secondary Participation in FIC Emerging Global Leader Award (K43 Clinical Trial Not Allowed)

Description: These three concepts support trans-NIH global health research capacity building. These funding announcements, issued by the Fogarty International Center (FIC), support collaborative research training between U.S. and low- and middle-income country institutions. The goal of this program is to develop evidence-based interventions relevant to a given country’s setting for noncommunicable diseases across the lifespan.

Title: Secondary Participation to Implementation Research to Reduce Non-communicable Disease (NCD) Burden in Low- and Middle-Income Countries and Tribal Nations During Critical Life Stages and Key Transitions (R01 Clinical Trial Optional)

Description: This concept relates to the GACD Multimorbidity Program. This global program with trans-NIH participation supports implementation and multimorbidity research to reduce the noncommunicable disease burden in low- and middle-income countries, as well as for the first time in Native American and Alaska Native populations. High-income partner countries also will focus on their indigenous populations. This program seeks to overcome barriers to implementing evidence-based innovations, tools, policies, strategies, and guidelines. This concept focuses on critical life stages and key transitions.

Titles: Secondary Participation to Implementation Research to Reduce Non-communicable Disease (NCD) Burden in Low- and Middle-Income Countries and Tribal Nations in Urban Environments (R01 Clinical Trial Optional); Secondary Participation to Implementation Research to Reduce Non-communicable Disease (NCD) Burden in Low- and Middle-Income Countries and Tribal Nations in Urban Environments (R61/R33 Clinical Trial Required)

Description: These two concepts relate to the GACD Multimorbidity Program, emphasizing risks and exposures linked to urbanization and related health inequities. They seek to develop environmentally sustainable innovations.

Titles: Secondary Sign-on to GACD Multimorbidity Research: Chronic Disease Prevention Across the Lifespan (R01 Clinical Trial Optional); Secondary Participation to Leveraging Implementation Research for Chronic Disease Prevention Across the Lifespan (R61/R33 Clinical Trial Required)

Description: These two concepts focus on multimorbidity research conducted by the GACD program. They support implementation research that aims to improve integrated care for patients with noncommunicable disease multimorbidities in low- and middle-income countries and underserved communities in high-income countries across the lifespan.

Title: Build UP Trust Prize Challenge (N01)

Description: This concept’s objective is to increase research participation and adoption of existing and new tools and strategies by improving engagement with underserved populations. This trans-NIH funding initiative engages directly with nontraditional innovators, including underserved community members who do not traditionally apply for NIH grants. Its two phases are first to solicit new ideas and second to implement proposed solutions.

Titles: Secondary Sign On: SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late-Stage Development (SB1 Clinical Trial Not Allowed, R42, R44); Secondary Sign On: SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late-Stage Development (SB1 Clinical Trial Required, R42, R44)

Description: These two concepts support reauthorization of a trans-NIH program to expand commercialization readiness. They support late-stage technical assistance and research and development activities. Positive outcomes from these funding opportunities have included the development of cellular therapies, an ultrasound system, and SARS-CoV-2 diagnostics.

CLOSING REMARKS

Dr. Gibbons adjourned the meeting at 3:16 p.m.

The 296th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) convened virtually on Tuesday, February 8, 2022. The Council meeting began with a closed session that started at 10:02 a.m. and ended at 11:15 a.m. The open session convened at 11:31 a.m. and ended at to 1:28 p.m. Dr. Gary H. Gibbons, Director of NHLBI, presided as chair.

NHLBAC Members Attending
Victoria L. Bautch, Ph.D.
Kirsten Bibbins-Domingo, M.D., Ph.D.
Mercedes R. Carnethon, Ph.D.
Jennifer E. DeVoe, D.Phil., M.D.
Grace Anne Dorney Koppel, J.D.
Martha U. Gillette, Ph.D.
Garth Graham, M.D., M.P.H.
Tina V. Hartert, M.D., Ph.D.
David H. Ingbar, M.D.
Monica Kraft, M.D.
Edward E. Morrisey, Ph.D.
Kiran Musunuru, M.D., Ph.D.
Mohandas Narla, D.Sc.
Richard S Schofield, M.D. (Ex Officio)
Dean Sheppard, M.D.
Kevin L. Thomas, M.D.
Andrew S. Weyrich, Ph.D.
Zachariah P. Zachariah, M.D.

Members of the Public Attending
The total number watching online was reported by NIH Videocast to 252.

NHLBI Employees Attending
Several NHLBI staff members were in attendance 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 3,489 applications requesting $8,315,941,244 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 11:31 A.M. He welcomed Council members, NHLBI staff, and public attendees to the Open Session of the meeting.

II. ADMINISTRATIVE ANNOUNCEMENTS
Dr. Laura K. Moen (Director, Division of Extramural Research Activities, NHLBI) noted that the meeting will be publicly broadcast and archived on videocast. She reviewed the agenda.

III. REPORT OF THE DIRECTOR
Dr. Gibbons began by updating the Council on leadership transitions within NHLBI. Drs. Robert

S. Balaban (Scientific Director, NHLBI Division of Intramural Research) and Catherine Stoney (Deputy Director, NHLBI Center for Translation Research and Implementation Science ) are stepping down from their positions. Dr. Gibbons expressed his deep appreciation for the contributions to the Institute and its mission. He noted that searches for both positions are open. Dr. Gibbons also bid farewell to Dr. W. Keith Hoots (Division Director, NHLBI Division of Blood Diseases and Resources) and thanked him for his superb service. Dr. Julie Panepinto has been recruited by Dr. Hoots to step in as a highly qualified Acting Director.

Dr. Gibbons observed that this month is American Heart Month, the theme of which is “Taking the Stress Out of Heart Health.” He invited all members to participate in the spirit of the initiative and join in the social media campaign to raise awareness of America’s number-one killer and to trigger action to move toward healthier lifestyles.

Accountable Stewardship: Dr. Gibbons updated the NHLBAC on NHLBI’s funding prospects for fiscal year (FY) 2022. Under the current continuing resolution, NHLBI’s appropriations are aligned with those of FY 2021. In preliminary budget negotiations, indications are that NHLBI’s budget in FY 2022 will increase relative to FY 2021. Future budget models project that NHLBI will be able to optimize its clinical research enterprise by increasing investment as appropriations allow. This trend recognizes the great opportunities and importance of NHLBI’s clinical trial portfolio to impact patient care, provide mechanistic insights, and develop treatments.

NHLBI is actively promoting diversity and inclusive excellence in biomedicine. From FY 2018 to FY 2021, the proportion of female investigators receiving awards under R01, R01 ESI, K, and F award mechanisms have increased. Awards to members of underrepresented minorities also give an indication of NHLBI’s support of diversity and inclusion.

Advancing Scientific Priorities: Dr. Gibbons highlighted the relevance to the NHLBI mission of addressing the impact of climate change on health disparities. Rising temperatures, extreme weather, rising sea levels, and increasing drought affect populations made vulnerable by increased sensitivity, increased exposure, and impaired adaptive capacity. Climate change affects acute and chronic cardiovascular and respiratory illnesses by altering exposure pathways. Communities of color and low-income communities are disproportionately affected. For example, climate impacts surface heat from urban heat islands. The NIH Climate Change and Health Initiative, led by the National Institute of Environmental Health Sciences (NIEHS), supports research to decrease health threats from, and increase resilience to, climate change.

Asthma provides an example of the need to address health disparities in climate change impacts. Racial disparities in the burden of asthma persist and are exacerbated by climate drivers such as wildfires. Children in communities of color have higher exposures to air pollution, affecting lung development. Exposure to wildfire smoke has had health implications across the U.S. However, improving air quality has been shown to improve lung health in children.

Health conditions that fall within NHLBI’s mission cause many heat-related deaths. Urban heat islands are an example of how the built environment drives health inequities. Historic redlining has contributed to health inequities. For example, in Washington, D.C., Blacks disproportionately live in disinvested urban areas with greater urban heat island effects.

However, climate change creates an opportunity to measure the mitigating effects of interventions on public health in underserved communities. Leveraging community-engaged research will promote participation in, and adherence to, these interventions.

Expanding data resources will better inform public interventions. Leveraging partnerships will facilitate data integration, harmonization, and the sharing of a variety of data sources and types. Harnessing big data, and using resources such as NHLBI’s BioData Catalyst, will foster connecting data types and cohorts and promote cross-disciplinary teams. An all-hands approach will engage diverse communities, foster diverse partnerships, expand cohort study indicators, leverage existing data, and develop a multidisciplinary workforce.

In responding to new initiatives like NIH’s Climate Change and Health, NHLBAC has played a critical role in its strategic guidance of NHLBI.

IV. CLIMATE CHANGE AND HEALTH EQUITY: A STRATEGIC FRAMEWORK TO ENHANCE SOLUTIONS-DRIVEN SCIENCE ACROSS NIH
Dr. Richard Woychik (Director, NIEHS and the National Toxicology Program) reported on NIH’s strategic framework on climate change and health equity. The federal government has renewed federal actions on climate change, impelled by Executive Orders 13990, Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis; and 14008, Tackling the Climate Crisis at Home and Abroad; and allocating $100 million in funding to NIH for climate change and health (CCH) research. The U.N. Secretary General has declared a Code Red for humanity because of climate change. From a global view, the impacts of climate change are felt most by under resourced and marginalized communities. The United States has experienced increases in weather-related disasters that need to be understood.

Climate change’s effects on health include both direct and indirect impacts, and their complexity requires a transdisciplinary approach. Accordingly, the governance structure for NIH’s Climate Change and Health Initiative, led by NIEHS, includes the heads of six NIH Institutes and Centers (ICs). Governance is provided by the Executive Committee, Steering Committee, and CCH Working Group. The working group conducted a portfolio analysis of current CCH research across NIH, finding that a strong majority of the more than 350 unique CCH awards are administered by NIEHS. The analysis also described the research focus of NIH’s portfolio across a range of weather-related effects and health outcomes. The working group then issued a request for information about priority areas for CCH research, the top three responses being innovative research, translation and dissemination, and scientific infrastructure.

Climate change affects people unequally. The most vulnerable populations are those with health disparities, disabilities, and chronic medical conditions, as well as those in vulnerable life stages, exposed workers, and populations in low- and middle-income countries. The CCH Working Group brainstormed research project examples, ranging from predictive exposures of extreme weather events to laboratory studies of how heat exposure affects cellular systems.

NIH’s CCH initiative goals are to reduce health threats, especially among those at highest risk. Its objectives are to identify risks and optimize health benefits, develop the needed infrastructure and workforce, leverage partnerships, and translate findings. NIH’s strategic framework on climate change and health equity calls for transformative, transdisciplinary efforts in health equity research, training and capacity building, intervention science, and health effects research. The proposed appropriation would serve as a catalyst to implement this NIH-wide initiative.

Dr. Woychik concluded by acknowledging the Executive Committee and Steering Committee members, as well as other critical contributors, cochairs, and advisors.

V. THE TRIENNIAL INCLUSION REPORT FY2019–2021
Dr. Gail Pearson (Associate Director, Division of Cardiovascular Sciences; and Director, Office of Clinical Research, NHLBI) and Ms. Katie Kavounis (Office of Clinical Research, NHLBI) presented an overview of the Triennial Inclusion Report, the NIH inclusion policy, NHLBI inclusion data, and NIH and NHLBI inclusion initiatives. The Council’s awareness and discussion of the report constitute certification that NHLBI complies with the NIH policy.

Under the NIH Revitalization Act of 1993, women and minorities must be included in all clinical research studies unless a reason for their exclusion exists; Phase III clinical trials must analyze data by sex/gender, race, and ethnicity; and advisory councils must discuss inclusion efforts.

NIH policy is to include women, minorities, children, and older adults in research unless there is a reason not to. NIH policy on inclusion across the lifespan was revised in 2019 to expand reporting, clarify reasons for exclusion, and require annual reporting of trial participants’ ages at enrollment.

NHLBI’s approach to inclusion is multifaceted, including investigating factors that account for differences in health among populations. To evaluate whether a study meets inclusion standards, NHLBI examines the study’s enrollment plan, the match between proposed enrollment and prevalence, and annual progress toward inclusion. These data are included in the Triennial Report to Congress.

This report’s data were collected in FY 2019, FY 2020, and FY 2021. Total enrollment has been consistent across all 3 years. Phase III trial enrollment also has been consistent, except for a large all-woman trial that ended in FY 2019. Total female enrollment was somewhat lower in FY 2021 relative to the 2 earlier years because of the all-woman trial ending and the COVID-19 pandemic. The proportion of female enrollment in Phase III trials also was highest in FY 2019 because of the all-woman trial. Total enrollment by race increased for Blacks and Asians from FY 2019 to FY 2021 as underrepresented populations were targeted. In Phase III trials, Black and Asian enrollment almost doubled from FY 2019 to FY 2021. By ethnicity, total enrollment of Hispanic/Latinos was greatest in FY 2020. In Phase III trials, Hispanic/Latino representation increased from FY 2019 to FY 2021, reflecting trial topics and dissemination efforts. NHLBI’s investments in diverse trial participation have fostered inclusivity by sex/gender, race, and ethnicity.

Enrollment data by age group is only available for FY 2021. Enrollment was greatest in those over 65, as is consistent with NHLBI’s focus on chronic conditions. A majority of enrolled children were school age. Most enrolled older adults were in the 75 to 79 and 80 to 84 age groups. NIH’s interest in diversity extends to institutions’ student and faculty populations.

NIH policy is that studying sex as a biological variable strengthens science. NIH developed a strategic plan to advance research on sexual and gender minorities and to foster a diverse workforce in such research. One approach taken is that of NIH’s Brain Research Through Advancing Innovative Neurotechnologies® (BRAIN) Initiative, which requires and scores workforce diversity plans in all of its grant proposals. NIH established a grass-roots strategy to share best practices and review innovative recruitment methods for increasing inclusion in NIH research.

NHLBI is actively carrying out NIH’s policy. NHLBI’s Women’s Health Working Group has sponsored workshops and other activities on maternal and sex/gender-specific health. In addition, the NHLBAC/Board of External Experts Working Group on Trials met in 2021 with a charge that included considering ways to optimize inclusion in NHLBI clinical trials, and developed sets of recommendations for investigators and participants.

VI. 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 delegated authorities presented, with no changes.

VII. OPEN DISCUSSION
Dr. Gibbons asked Council members whether they had any issues or matters of concern to raise. Retiring members voiced their appreciation for their time on Council.

CLOSING REMARKS

Dr. Gibbons adjourned the meeting at 1:28 p.m.

The 295th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) convened virtually on Tuesday, October 26, 2021. The Council meeting began with a closed session that started at 10:05 a.m. and ended at 11:32 a.m. The open session reconvened from 11:52 a.m. and ended at to 2:32 p.m. Dr. Gary H. Gibbons, Director of NHLBI, presided as chair.

NHLBAC Members Attending

Victoria L. Bautch, Ph.D.
Kirsten Bibbins-Domingo, M.D., Ph.D.
Mercedes R. Carnethon, Ph.D.
Jennifer E. DeVoe, D.Phil., M.D.
Grace Anne Dorney Koppel, J.D.
Martha U. Gillette, Ph.D.
Garth Graham, M.D., M.P.H.
Tina V. Hartert, M.D., Ph.D.
David H. Ingbar, M.D.
Monica Kraft, M.D.
Kiran Musunuru, M.D., Ph.D.
Edward E. Morrisey, Ph.D.
Mohandas Narla, D.Sc.
Richard S Schofield, M.D. (Ex Officio)
Dean Sheppard, M.D.
Kevin L. Thomas, M.D.
Andrew S. Weyrich, Ph.D.
Zachariah P. Zachariah, M.D.

Members of the Public Attending

The total number watching online was reported by NIH Videocast to 301.

NHLBI Employees Attending

Several NHLBI staff members were in attendance 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 3,261 applications requesting $7,686,955,970.00 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 11:52 A.M. He welcomed Council members, NHLBI staff, and public attendees to the Open Session of the meeting.

II. ADMINISTRATIVE ANNOUNCEMENTS
Dr. Laura K. Moen (Director, Division of Extramural Research Activities, NHLBI) noted that the meeting will be publicly broadcast and archived on videocast. She reviewed the agenda.

III. REPORT OF THE DIRECTOR
Dr. Gibbons began by expressing his gratitude to the Council members whose terms were ending: Drs. Graham, Koppel, Kraft, Sheppard, and Weyrich. He highlighted each of their unique strengths and perspectives that they had provided to the Council. Dr. Gibbons then welcomed the new Council members: Drs. Bautch, Bibbins-Domingo, Carnethon, Hartert, and Morrisey—saying that he looks forward to their active engagement and thanking them for sharing their time and talent.

Accountable Stewardship. Dr. Gibbons updated the NHLBAC on NHLBI’s investments for fiscal year (FY) 2021 and funding prospects for FY 2022. Under the current continuing resolution, NHLBI’s appropriations are aligned with those of FY 2021. Early indications are that NHLBI’s FY 2022 budget may expand at a rate above inflation through both increased direct funding and participation in trans-NIH initiatives on maternal health, health disparities, the Advanced Research Projects Agency for Health (ARPA-H), and climate change health.

Despite fiscal challenges in FY 2021, NHLBI was able to align spending with its priorities. Overall funding success rates in FY 2021 were slightly lower than in FY 2020, but NHLBI was able to maintain its funding commitments to early-stage investigators, including cost extensions to K awardees in response to COVID-19. An outcome of the combined NHLBAC meeting with invited external experts in September 2021 was Council support and consequent rededication of NHLBI efforts to provide new opportunities for the next generation of investigators. Closing the funding gap between the K award and first R01 award is a key priority that the K-R03 mechanism appears to address. Also, the R56 bridge award is facilitating success in the transition of early-stage investigators to their first R01 award.

Advancing Scientific Priorities. Dr. Gibbons highlighted a specific area of the NHLBI mission which has been the subject of recent focused efforts. The initiative to improve maternal health through a multipronged approach intersects with NHLBI’s mission and prioritization of health disparities. Racial and ethnic disparities in morbidity and mortality among pregnant women persist. Morbidity and mortality also have increased as a result of increased maternal age. These statistics are highly relevant to NHLBI because of the high prevalence of hypertension, thrombotic, and bleeding orders in pregnancy, as well as peripartum cardiomyopathy. These adverse outcomes lead to increased cardiovascular risk to women that extends past their reproductive years, making pregnancy an important point for intervention. He noted that:

• Racial/ethnic disparities in women’s health must be addressed. Differences in maternal age, obesity, and family diabetes history manifest as heterogeneity among subgroups in gestational diabetes. Racial/ethnic disparities in sleep disorders also exist in pregnancy and are drivers of cardiovascular disease. NHLBI is committed to the challenge of characterizing heterogeneity in heart, lung, blood, and sleep disorders across racial/ethnic groups and subgroups.
• Pregnancy is equivalent to a stress test that reveals the long-term risk of heart disease. Common risk factors for adverse pregnancy outcomes and heart disease overlap. Rates of comorbidities in pregnancy are increasing. Current data show that up to 10 percent of pregnancies are complicated by hypertension.
• NHLBI is testing novel interventions on sleep-disordered breathing to reduce adverse pregnancy outcomes and cardiovascular disease risk. Recruitment is underway for a clinical trial to characterize sleep apnea during pregnancy and evaluate the interventions of sleep counseling and continuous positive airway pressure (CPAP) machines. The trial will examine the effects of these interventions on hypertension in pregnancy.

Dr. Gibbons explained that NHLBI is committed to a community-centered, multilevel approach to reducing health disparities in maternal mortality. Drivers of health disparities relate to individual characteristics and social determinants of health. Environmental and social factors are critical determinants of health in pregnancy and across diseases and conditions.

He pointed out that a key result of the Community Engagement Alliance (CEAL) against COVID-19 disparities was the critical importance of community engagement. CEAL established partnerships with the community, empowered them with information, and accelerated community benefits and uptakes. To sustain this lesson in maternal health, the Maternal Health Community Implementation Project (CIP) has formed multilevel partnerships on several high-risk communities to improve maternal health outcomes and advance health equity.

IV. THE NATIONAL CENTER ON SLEEP DISORDERS RESEARCH: FOSTERING SLEEP AND CIRCADIAN RESEARCH TO ADVANCE MEDICINE AND PUBLIC HEALTH FOR ALL
Dr. Marishka K. Brown (Director, NCSDR, NHLBI) provided an overview of NCSDR’s legislative origin, its charge, and the NIH Sleep Research Plan revision. The formation of NCSDR was congressionally mandated in 1993, and authorizing legislation outlined its charge, which includes conducting research, coordinating activities with other government agencies, and developing a research plan.

Dr. Brown noted that sleep and circadian research is supported across NIH, and funding has been increasing steadily. The exponential growth in the field of sleep disorders over the past few years has made it critical to reassess and update research opportunities and recommendations in a new Sleep Research Plan. NCSDR research has three broad mission areas: (1) regulation of sleep and sleep disorders, (2) sleep-disordered breathing, and (3) how the brain controls breathing. The Center’s coordinating activities extend across NIH and the federal government. Ideas are exchanged across NIH at meetings of the Sleep Disorders Research Advisory Board (SDRAB). Since NCSDR’s inception, three research plans were developed and implemented in 1996, 2003, and 2011. A highlight in sleep research was the awarding of the 2017 Nobel Prize in Physiology or Medicine for discoveries in the molecular mechanisms controlling circadian rhythms.

She explained the process for developing the plan and subsequent approval. Publication is expected in November or December of 2021. The plan focuses on trans-NIH activities over the next 5 years, serving as guidance rather than limiting activities. Dr. Brown then reviewed the five strategic goals of the plan, with the underlying goal being fostering the development of a strong and diverse workforce for sleep and circadian research. Each goal aligns with a cross-cutting theme of the NIH-wide strategic plan.

Dr. Brown closed by outlining the steps planned to ensure that the revised NIH Sleep Research Plan reaches the community, has its yearly progress tracked, and achieves sustainability.

V. NHLBI CONCEPT CLEARANCE
NHLBI staff presented 18 concepts for clearance. Members of the NHLBAC were asked to rate the concepts on six criteria using Decision Lens.

Titles: New Epidemiological Cohort Study among Asian Americans, Native Hawaiians, and Pacific Islanders (AsA-NHPI-CS): Clinical/Community Field Centers (UG3/UH3); New Epidemiological Cohort Study among Asian Americans, Native Hawaiians, and Pacific Islanders (AsA-NHPI-CS): Coordinating Center (U24)

Description: These concepts support clinical, community, and coordinating centers for a new epidemiological cohort study among Asian Americans, Native Hawaiians, and Pacific Islanders. This population is one of the fastest growing in the United States and is extremely understudied. This research will meet the urgent need for robust prospective studies with the ability for data disaggregation among subgroups of these ethnic groups.

Title: Coronary Artery Risk Development in Young Adults (CARDIA) Study Renewal (N01)

Description: This concept proposes renewal of contract support for the infrastructure component of the CARDIA study. CARDIA has evolved into an adult life course study of cardiovascular lung and brain aging with outstanding cohort retention and scientific productivity. Renewal of contract support would allow NHLBI to build on its 40-year investment in this unique and productive study.

Title: NHLBI Secondary Participation in RFA-DK-21-503 “Limited Competition of Epidemiology of Diabetes Interventions and Complications (EDIC) Study Clinical Research Center” (Collaborative U01)

Description: This concept requests secondary participation in a long-term clinical trial, led by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), of intensive glycemic control in patients with Type 1 diabetes. The cohorts are aging into the early geriatric age group, a population whose continued survival has been made possible by the current era of intensive therapy. This rich phenotype resource would allow evaluation of cardiovascular and sleep health in a unique population.

Title: Renewal of Co-funding (FY2023-FY2026) for the Adolescent Brain Cognitive Development (ABCD) Study (U24)

Description: This concept would renew NHLBI participation via co-funding of the trans-NIH ABCD study, which emphasizes understanding of brain cognitive, social, and emotional development during a key transformational period of human life. It will support the collection of heart, lung, blood, and sleep data as part of a deep dive into human development.

Title: Renewal of Secondary Support for NIDDK’s Chronic Kidney Disease in Children (CKiD) Cohort Study (U01)

Description: This concept requests renewal of secondary support for NIDDK’s CKiD study. CKiD is a prospective, multicenter, longitudinal study that follows children with impaired kidney function to assess the impact of chronic kidney disease progression on quality of life, cardiovascular disease, and other health outcomes. Many of these children are now entering early adulthood, a critical period of change in cardiovascular health.

Title: 2022 Renewal of Mortality Disparities in American Communities Study NHLBI Inter-Agency Agreement with the Census Bureau, Funding Cycle: August 2022 through July 2026 (Y01)

Description: This concept would renew the NHLBI interagency agreement with the U.S. Census Bureau to support the study of mortality disparities in American communities. This study enables research on individual- and societal-level characteristics for a broad range of diseases and mortality outcomes. Census records have been linked with death and healthcare utilization records to allow studies of longitudinal health disparity trends. NHLBI stimulation can make this study an even more valuable population science resource.

Title: Secondary participation in the NIBIB Point-of-Care Technology Research Network (U54)

Description: This concept is a renewal of funding for an NHLBI research center in the trans-NIH Point-of Care Technology Research Network. This center would fill a critical gap in clinical validation and adoption studies for technologies with an intended use in low resource settings. NHLBI’s continued participation would facilitate late-stage translational research and accelerate the diffusion of technologies to the communities that need them most.

Title: Secondary sign-on: Senator Paul D. Wellstone Muscular Dystrophy Specialized Research Centers (MDSRC) (P50 Clinical Trial Optional)

Description: This concept would fund secondary support for the trans-NIH Center program that was established as part of NIH’s enhancement of muscular dystrophy research. These centers promote collaborative basic translational and clinical research and provide important resources that can be used by the national muscular dystrophy research community. New to the program are adding young investigators to the leadership teams and having part of the study include understudied areas that are relevant to NHLBI’s mission.

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

Description: The goals proposed in this concept are to stimulate use of existing datasets and support early-stage investigators’ career development. Future availability of BioData Catalyst data and COVID-19 open access data will increase research opportunities and demand for secondary analysis funding. This program has been cost effective and extremely productive across heart, lung, blood, and sleep domains, and NHLBI believes that that will continue to be the case.

Titles: Optimizing Investigator-initiated Multi-site Clinical Trial FOAs—Clinical Coordinating Center (UG3, UH3); Optimizing Investigator-initiated Single-site Clinical Trial FOA (R33, R61); Optimizing Investigator-initiated Multi-site Clinical Trial FOAs – Data Coordinating Center (U24)

Description: This group of concepts would allow renewal of the program announcements that allow investigators to apply to NHLBI for funds to support multisite or single-site clinical trials. These program announcements pertain to investigator-initiated applications to conduct efficacy, comparative effectiveness, pragmatic, or implementation research clinical trials. To foster trial completion, NHLBI reviews applications for operational feasibility as well as scientific merit, and multisite trials are funded through phased and milestone-based cooperative agreements. NHLBI is considering modifying funding opportunity announcements to encourage applications that address the need for increased diversity in both participants and investigators, as well as those that foster community engagement.

Title: CIBMTR Renewal: Data Resource for Analyzing Blood and Marrow Transplants (Limited Competition U24)

Description: This concept supports renewal of secondary participation in a National Cancer Institute-led resource program, the Center for International Blood and Marrow Transplant Research (CIBMTR), which is an unparalleled resource for research in blood stem cell transplantation and cell therapies. The CIBMTR database is high quality, contemporary, longitudinal, and designed for research. The purpose of NHLBI co-funding is to facilitate observational research for mission-relevant diseases.

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

Description: The aims of this concept are to maximize the scientific value of NHLBI’s biospecimens repository and promote the use of this resource by early-stage investigators. The NHLBI established the biorepository as an open resource comprising biospecimens and data from completed clinical trials in heart, lung, and blood diseases; transfusion medicine; and cellular therapies. In the past, numerous requests were not fulfilled because the investigators were not able to procure their own funding. This concept will leverage two NHLBI-wide resources, one for BioLink, and the other for the biorepository.

Titles: Support for Research Excellence (SuRE) Award (R16 - Clinical Trial Not Allowed); Support for Research Excellence - First Independent Research Support & Transition (SuRE-First) (R16 - Clinical Trial Not Allowed)

Description: These concepts are requests for secondary participation in the NIH-wide SuRE program. SuRE-eligible institutions enroll significant numbers of students from backgrounds that are nationally underrepresented in biomedical research, as well as institutions that award undergraduate or graduate degrees in biomedical sciences and receive limited NIH research grant support. These funding announcements, which replace the Support of Competitive Research (SCORE) awards, represent opportunities to help diversify the scientific workforce by enhancing the participation of individuals from groups identified as underrepresented in biomedicine and are a very important part of NHLBI’s program to advance diversity as part of overall inclusive excellence. The first concept provides research grant support for faculty investigators who have prior research experience in leading externally funded independent research but are not currently funded by any NIH research project grant, except for a previous SCORE award. The purpose of the second concept is to support research grants for faculty investigators who have not had any prior independent external research grants, including no previous SCORE awards.

Title: Secondary Sign-On: Innovations for Healthy Living - Improving Minority Health and Eliminating Health Disparities (R43/R44 - Clinical Trial Optional)

Description: This concept aims to support NHLBI’s participation in the National Institute of Minority Health and Health Disparities’ small-business grant program. This program funds the development of new home diagnostic and monitoring devices which target the needs of underserved populations. Although advances in digital health, telemedicine, and point-of-care technologies improve the ability of patients to manage their health, several issues prevent these technologies from being widely used among underserved populations. This funding announcement focuses on developing technologies that will assist in overcoming social determinants of health and barriers that include physical knowledge, infrastructure, and economic and cultural barriers.

CLOSING REMARKS

Dr. Moen adjourned the meeting at 2:32 p.m.

The 294th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) convened virtually on Tuesday, August 31, 2021, and continued on Wednesday, September 1, 2021. In addition to NHLBAC members, the meeting included an ad hoc Board of External Experts (BEE), scientists with research expertise in National Heart, Lung, and Blood Institute (NHLBI) mission areas, who were recruited for this meeting as a special NHLBAC working group. On Day 1, the Council meeting began at 12:02 p.m. and ended at 5:35 p.m., EDT. The meeting was open to the public between 12:02 and 3:15 p.m. Working groups of the NHLBI Council convened between 3:15 and 4:30 p.m. On Day 2, the Council met in open session from 10:00 a.m. to 12:00 p.m., EDT. The working groups met briefly between 12:00 to 1:30 p.m. The open session reconvened from 1:30 to 2:42 p.m. to hear reports and recommendations from each working group. Dr. Gary H. Gibbons, Director of NHLBI, presided as chair.

NHLBAC Members Attending
Jennifer E. DeVoe, D.Phil., M.D.
Grace Ann Dorney Koppel, J.D.
Martha U. Gillette, Ph.D.
Garth Graham, M.D., M.P.H.
David H. Ingbar, M.D.
Monica Kraft, M.D.
Kiran Musunuru, M.D., Ph.D.
Mohandas Narla, D.Sc.
Dean Sheppard, M.D.
Kevin L. Thomas, M.D.
Andrew S. Weyrich, Ph.D.
Zachariah P. Zachariah, M.D.

Ad Hoc BEE Attendees
Michelle A. Albert, M.D., M.P.H.
Judy L. Aschner, M.D.
Timothy S. Blackwell, M.D.
Annetine C. Gelijns, Ph.D., J.D.
Nadia N. Hansel, M.D., M.P.H.
Bertha Hidalgo, Ph.D., M.P.H.
Darrell N. Kotton, M.D.
Elizabeth McNally, M.D., Ph.D.
Brian S. Mittman, Ph.D.
Matthias Nahrendorf, M.D., Ph.D.
Ellis J. Neufeld, M.D., Ph.D.
Laura Kristin Newby, M.D.
Bruce M. Psaty, Ph.D., M.D., M.P.H.
Susan Redline, M.D., M.P.H.
M. Celeste Simon, Ph.D.
Herman A. Taylor, Jr., M.D.
Griffin M. Weber, M.D.

Members of the Public Attending
Some 200 members of the public were present.

NHLBI Employees Attending
Several NHLBI staff members were present.

I. CALL TO ORDER

Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI), called the meeting to order at 12:02 p.m. He welcomed members of the National Heart, Lung, and Blood Advisory Council (NHLBAC) and other attendees to this joint meeting.

II. ADMINISTRATIVE ANNOUNCEMENTS

Dr. Laura K. Moen, Director of the Division of Extramural Research Activities at NHLBI, introduced the session, stating that the main topic is optimizing clinical trials and noting that presentations will be web-cast live for the public.

III. DIRECTORS REMARKS

Dr. Gibbons explained that as part of NHLBI’s integrative approach to strategic visioning, this annual meeting was an opportunity to reflect and brainstorm to keep that vision evergreen and shape Institute-initiated priorities. This meeting responds, in part, to the National Institute of Medicine’s assessment of the clinical trial enterprise—namely, that there are long delays from research ideas to proposals to research outcomes; suboptimal participant accrual and retention; and regulatory and risk management challenges. Dr. Gibbons encouraged attendees to challenge the NHLBI in identifying new ways to think about its clinical research enterprise, and how its  investments could be more effective in supporting the NHLBI strategic vision. The overarching charge for this meeting was to consider innovative ways to optimize the clinical research enterprise and enhance efficiency, collaboration, inclusion, and impact.

IV. PCORnet: ENHANCING & EVOLVING COMPARITIVE EFFECTIVENESS RESEARCH

Ms. Penny Mohr, Acting Director of the Patient-Centered Outcomes Research Institute (PCORI), and Dr. Adrian Hernandez, Vice Dean and Executive Director of the Duke University Clinical Research Institute, and Co-Principal Investigator of the PCORnet Coordinating Center, described how PCORnet advances PCORI’s goal of improving decision-making to advance health outcomes while reducing costs. PCORnet is not a repository of data, but a health community of systems and investigators (e.g., people, infrastructure, aggregated data, trust), enabling investigators to avoid having to rebuild infrastructure at the start each new study. PCORnet aims to bring people together and engage patients.

This national research network, comprising more than 70 research organizations in diverse settings, geography and scale, provides the flexibility needed to address particular needs irrespective of disease type. Additionally, the network builds trust by leveraging the distributive data model, which minimizes transfer of individual-level data outside of the network.

Key findings for research infrastructure include: use of templates, hybrid approaches, and a standing community of sites to speed site activation, cohort identification, and outcomes ascertainment; collaborative governance to help build trust; patient and community engagement  early and often; as well as recognizing the critical role of health system leadership. PCORI anticipates hosting webinars to find ways to build out the data network, evaluate social determinants of health (SDOH) and patient-reported outcomes, and enhance access to public claims.

Comments from NHLBAC and attendees were as follows:

• Understanding patient preferences could improve the participation rate, which averages about 2% of those eligible. PCORnet creates teams from that community.
• Investigators should not reach back to people who contributed to their last study, but engage new partners.
• PCORnet’s breadth enables it to funnel tens of millions of people to a study, making it a great resource for research on rare diseases.
• To attract participants, rural or urban, investigators must be able to make the case to the patient that researchers have their best interest in mind.
• The frequently reported data breaches and misinformation campaigns have eroded trust.
• Federally Qualified Health Centers are very under-resourced, and their involvement depends on their priorities in serving their communities.
• A variety of electronic health records (EHRs) are required. A local site must be able to load and transform their data in the common data model. This depends on using local tools, which must be customized.
• One aid to advancing young investigators is having them partner with successful investigators.

V. THE MAKING OF NCI-MATCH

Dr. Alice Chen, Director of the National Cancer Institute (NCI), explained how leveraging the centralized functions in the National Clinical Trials Network supports NCI-Molecular Analysis for Therapy Choice (MATCH), a precision medical trial exploring treatment of patients based on the molecular profile of their tumors. MATCH opened in August 2015 and  is currently evaluating 694 patients, with representation from all ethnic groups, in some 1,100 participating sites throughout the United States, including 30 lead academic sites participating in phase 2 and phase 3 trials.

MATCH’s success relies on involving young investigators as principal investigators (PIs); levels of evidence for drug variants; planned interim analysis; constant oversight (e.g., weekly meetings); biopsy and lab analyses flexibilities; and the ability to close arms as the landscape changes. Correlative studies are ongoing with multiple projects having been developed using the data from this trial.

NHLBAC and attendee comments during the discussion included the following:

• MATCH treated patients individually according to their tumor features, whereas the
  I-SPY network sequentially tested a class of agents as they became available.
• The MATCH arms were designed so that if a drug was approved to treat a particular cancer, it was excluded; if a higher-priority trial was opening, histology was used to determine the trial a patient would join.
• MATCH launched in a time of single-cell sequencing and adapted as technology evolved.

VI. CHARGE FOR THE WORKING GROUPS

Council and expert attendees were asked to consider innovative ways to optimizing clinical trials with the goal of enhancing efficiency, collaboration, inclusion, and impact. Overall, the working groups were charged to weigh in on the structures of clinical trial models and to:

• advise the NHLBI on opportunities to advance and build upon the Strategic Vision in the rapidly evolving and cross-cutting area of the design of clinical trial models 
• engage the NHLBAC and others as representatives of the NHLBI research community in breakout sessions to tackle challenging topics
• develop a series of breakout group report-outs to be presented to the plenary group, which includes a final summary of the forum discussion and anticipated next steps

VII. LESSONS LEARNED FROM THE NHLBI: CONNECTS/ENDEVOR

Dr. Amy Patterson, Deputy Director of Clinical Research and Strategic Initiatives at NHLBI, moderated this panel discussion. Panelists were Dr. Yves Rosenberg, Branch Chief of the NHLBI; Dr. Antonello Punturieri, Program Officer in the Division of Lung Diseases at NHLBI; Dr. Clyde Yancy, Chief of the Division of Cardiology at Northwestern University Feinberg School of Medicine; and Dr. Robert Harrington, Chair of the Department of Medicine at Stanford University.

Prior to the COVID-19 pandemic, NHLBI initiated Enhancing the Design, Evidence Base, and Monitoring of NHLBI Clinical Trials (ENDEVOR), an integrated set of management tools controlling and monitoring the mainframe software development lifecycle. During the COVID-19 pandemic, the Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies (CONNECTS) was created in an effort to halt virus progression and speed patients’ recovery. The two are complementary approaches relevant to all NHLBI trials.

CONNECTS succeeded in: accelerating site activation and recruitment; enabling networks capable of site expansion; developing an adaptive platform design that permitted adding and removing potential therapies; supporting a multi-platform approach for analysis of shared therapeutics; real time collaborative interaction with the U.S. Food and Drug Administration; sufficient capitation to expedite study set-up; as well as an infrastructure and methodology that promoted diversity and inclusion.

CONNECTS engaged over 6,000 patients via it’s more than 700 sites, including 20% from underrepresented populations. Human capital made it possible to bring a network of networks together. In effect, the spirit of the investigators for collaboration and cooperation changed the practice of medicine in a single year.

In 2016, NHLBI initially reengineered its clinical trial FOAs to adopt a milestone-driven, biphasic approach to its awards.  In 2019, the FOAs were further revised to emphasize the Institute’s expectations regarding a systemic review of current clinical practices; ample scientific evidence base for trial hypothesis; and justification for proposed clinical trial designs, including equipoise.

VIII. WORK GROUP REPORT-OUTS AND DISCUSSION

Each working group addressed the charge with respect to its given area of focus.

Group A: Optimizing Inclusion in Clinical Trials

Dr. Laura Newby summarized the responses to the key questions for Group A.

• How should the NHLBI think about different clinical trial models to make them more relevant to public health?
  • Facilitate partnering with institutions to share resources, which will also provide investigators early in their careers with opportunities for experience beyond what is available through their home institutions.
  • Use opportunities for nesting clinical trials and participating outside the structure.
• How can the NHLBI promote and support equity in clinical trials for participants; how can infrastructure support rather than impede participants’ ability to participate?
  • Network at both the institution and investigator level, perhaps leveraging Clinical and Translational Science Awards.
  • Partner with less-experienced investigators and make smaller institutions the prime.
  • Use investigators’ medical and research institutions to disseminate knowledge.
  • Provide additional funding to integrate early-stage investigators (ESIs) into clinical trials, as is done with P-grants.
  • Create an infrastructure that minimizes participants’ burden by including indirect costs, such as for centralized resources for administrative support, transportation, and staff to handle recruitment and community engagement.
  • Train investigators in administrative and other management matters.
• How can we access populations and institutions not traditionally included in clinical trials?
  • Recruit from existing epidemiologic cohorts, including older populations.
  • Provide adequate funding to support inclusiveness at all levels.
  • Use personalized behavioral approaches (e.g., a MATCH template).
• How can we address hesitancy and mistrust about clinical trial participation, particularly among underrepresented groups?
  • Establish trust and expand reach through education and information.
  • Increase the budget for community engagement.
  • Reach populations not involved through investigator engagement and commitment.
  • Be prescriptive in application requirements, such as adding a separate criterion score asking that ages of participants reflect the actual epidemiology of the condition.

Group B: Optimizing Clinical Trial Adaptiveness, Efficiency, and Translational Advances

Dr. Ellis Neufeld summarized the responses to the key questions for Group B.

• What are ways to provide support for important changes to increase efficiency and flexibility in trials?
  • Maintain flexibility to study heart, lung, blood, and sleep (HLBS) research questions across diverse populations.
  • Encourage use of master protocols, such as PrecISE.
  • Make technological strategies that have been successful in one area available across the NHLBI.
  • Link clinical trial participants to administrative networks, as important clinical outcomes be 5 to 10 years in the future, so.
  • Apply the same considerations to prevention trials as to treatment trials.
  • Include patients as members of the team designing a trial.
• Are there new infrastructures and technologies that would make each stage of the clinical trial process (recruitment, retention, study visits, virtual assessments, outcome ascertainment, etc.) faster, more efficient, and less burdensome?
  • Include non-technological means because not everyone has access to technology.
  • Use Implementation Science methods in trial designs.
  • Use technology as a conduit for referrals of clinical patients to research.
  • Use master protocols in the outpatient arena.
  • Use remote follow-up for patients.
• Are there lessons learned from the COVID-19 pandemic on opportunities to innovate how clinical trials are conducted?
  • Ensure that development and approval are rapid.
  • Use technology for remote studies.
  • Identify, review, assess, and repurpose existing infrastructure to meet emerging needs.
  • Keep some of this infrastructure ready for future emergencies.
• Can we leverage practice networks, private practices, health systems, EHR, health clinics, and traditional healers to answer important questions?
  • Consider initiatives to investigate innovative ways to use EHRs for research purposes.
  • Leverage large cohorts, such as All of Us.
  • Be sure site leadership reflects the populations of interest.
  • Use practice settings to better reveal SDOH.
  • Engage private practices with networks and leadership from the beginning.
• How can we integrate and/or adapt existing clinical research networks to enhance efficiency and impact?
  • Incorporate lessons and methods of Implementation Science.
  • Improve data access and other network resources for non-network participants.
  • Communicate research goals and outcomes to the community early and often.
• What are the barriers to successful uptake of potential technologies, infrastructure changes, and efficiencies to optimize clinical trials, and what strategies can be implemented by the NHLBI to address those barriers?
  • Invest in capacity-building.
  • Involve patients more.
  • Use infrastructure that includes home visits.
  • Educate and clarify objectives and outcomes to facilitate understanding the process.
  • Streamline contracting needs.
  • Consider funding Implementation Science.
  • Consider having experienced sites serve as mentor sites for investigators and leaders. Develop templates for research agreements, data sharing, bio-specimen collection and sharing, and regulatory cooperation.

Group C: Fostering the Next Generation of HLBS Clinical Trialists

Dr. Bertha Hidalgo summarized the responses to the key questions for Group C.

• How can the NHLBI attract clinical trialists representative of the U.S. demographics?
  • Use virtual technology for mentorship, training, and collaboration.
  • Leverage existing models and partnerships, such as with PCORI.
• How can the NHLBI support the investment and training for a diverse group of investigators to learn how to conduct HLBS clinical trials, and provide them opportunities to do so?
  • Promote stable funding for junior faculty through capitation-independent funding.
  • Use foundation grants, such as from the American Heart Association and the Doris Duke Foundation, or National Institutes of Health mechanisms that do not require U.S. citizenship.
• How should the NHLBI support training of non-traditional staff (e.g. community members) to participate in the conduct of clinical trials?
  • Explicitly state and offer incentives in FOAs to include ESIs and community members.
  • Include funding for community partners.
  • Partner with patient advocacy groups for clinical trials.
• How can the NHLBI support training investigators in approaches to enhance diversity and community engagement in HLBS clinical research?
  • Provide access to experts via national networks to address geographic and racial disparities for training.
  • Bridge the gap between pay and independent grant funding in relation to payment structure.
  • Promote community involvement that provides training opportunities.
  • Fund national networks to include formal plans for training to share expertise.
  • Encourage inclusion of patient advocacy groups in review of FOAs.
• How can we sustain engagement of diverse clinical trial investigators, not only in the early career stages but through mid-career as well?
  • Provide mid-career funding and create mechanisms for trainees to be supported.
  • Create an academic environment that promotes the needed diversity.
  • Recognize support from industry to develop clinical trialists.
• How can the NHLBI nurture the next generation of trialists in developing the skills required to conduct trials across the spectrum of trial types, from early phase, through efficacy, effectiveness, to dissemination and implementation trials?
  • Enhance the flexibility of RO3/R21s and offer mechanisms like K24s or K18s.
  • Offer micro-grants for explicit groups to bolster the science to obtain larger grants.
  • Encourage use of smaller studies or projects so junior investigators can publish manuscripts before the main product is published years later.
  • Include ESIs in larger grants/networks to provide training and experience.

Group D: Optimizing Engagement and Responsiveness to Communities to Enhance the Impact of Clinical Trials

Dr. Garth Graham summarized the responses to the key questions for Group D.

• How can the NHLBI invest in promoting community engagement—including patients, community health centers, and society at large—in all stages of clinical trial design and conduct to enhance understanding and responsiveness to local conditions and community priorities?
  • Identify key phases of the research process, then identify opportunities in each phase and create a framework for ensuring patient and community engagement.
  • Ensure that PIs become advocates.
  • Seek community leadership early and often.
  • Demonstrate and document understanding of and commitment to community needs by taking steps such as establishing advisory boards and holding workshops.
• How and when should the NHLBI seek input from community leadership regarding the research concept, rationale to establish common grounds, and concerns?
  • Engage early and have ongoing relationships with the community.
  • Develop research networks by building on relationships developed during the pandemic.
  • Gain understanding of community needs and existing infrastructures.
  • Ensure that FOAs and the review processes require proof of community input and engagement.
  • Ensure that the NHLBI peer review process is focused on community needs.
• How can the NHLBI support the infrastructure needed to enhance engagement of community members throughout the design and conduct of clinical studies?
  • Establish advisory boards, hold workshops and town halls, expand existing mechanisms, and support community-level bodies.
  • Disseminate FOAs.
• What can the NHLBI do to enhance the understanding of research (“research literacy”) by participants and community?
  • Take guidance from PCORI when developing new approaches.
  • Focus peer review on community needs and resources.
• How can the NHLBI support developing and sustaining partnerships beyond traditional healthcare or public health and its infrastructure?
  • Ensure that those who need funding the most get it.
  • Employ community members.
  • Enhance understanding of the research and create infrastructure to bring the benefits of the research back to the community.
  • Develop and sustain partnerships.
  • Create partnerships to reach people.

DISCUSSION

Several common themes for all four groups include: early and frequent community engagement; importance of establishing trusting relationships; fostering research network transparency; and exploring opportunities to nurture and sustain a well-trained clinical research workforce..

CLOSING REMARKS AND ADJOURNMENT

Dr. Gibbons thanked everyone for the rich dialogue and discussion to expand and enhance the clinical trials research enterprise.  Dr. Moen thanked everyone and adjourned the meeting at 2:42 p.m.

The 293rd meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) was convened on Tuesday, August 24, 2021 at 1:05 p.m. as a virtual Zoom Event. The meeting was closed to the public from 1:05 p.m. until adjournment at 1:51 p.m. Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI), presided as Chair.

Council Members attending via teleconference
Dr. Jennifer DeVoe
Ms. Grace A. Dorney Koppel
Dr. Martha Gillette
Dr. Garth Graham
Dr. David Ingbar
Dr. Monica Kraft
Dr. Kiran Musunuru
Dr. Mohandas Narla
Dr. Dean Sheppard
Dr. Kevin Thomas
Dr. Andrew Weyrich
Dr. Zachariah Zachariah

Council Members unable to attend
Dr. Richard S. Schofield (ex officio)

NHLBI employees attending
A number of NHLBI staff members were in attendance

I. CALL TO ORDER AND OPENING REMARKS
Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI), welcomed members and called the 293rd meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) to order at 1:05 p.m. The meeting was held via video conference for the members.

II. ADMINISTRATIVE ANNOUNCEMENTS
Dr. Laura K. Moen, Director, Division of Extramural Research Activities, NHLBI, 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. 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 967 applications requesting $862,472,949 in total costs. For the record, it is noted that secondary applications were also considered en bloc.

ADJOURNMENT
The meeting was adjourned at 1:51 p.m.

The 292nd meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) convened virtually on Tuesday, June 8, 2021. The meeting began in closed session at 10:03 a.m. and was open to the public between 12:13 p.m. until adjournment at 3:45 p.m. Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI), presided as chair.

NHLBAC Members Attending

Jennifer DeVoe, D.Phil., M.D.
Grace Anne Dorney Koppel, J.D.
Martha U. Gillette, Ph.D.
Garth Graham, M.D., M.P.H.
David H. Ingbar, M.D.
Monica Kraft, M.D.
Kiran Musunuru, M.D., Ph.D.
Mohandas Narla, D.Sc.
Richard S. Schofield, M.D. (Ex Officio)
Dean Sheppard, M.D.
Kevin L. Thomas, M.D.
Andrew S. Weyrich, Ph.D.
Zachariah P. Zachariah, M.D.

NHLBI Employees Attending

A number of NHLBI staff members were in attendance via Zoom.

NIH Employees and Public Attending

The total number watching/participating online was reported by NIH Videocast to be 267.

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 3,559 applications requesting $7,746,820,630 in total costs. For the record, it is noted that secondary applications were also considered en bloc.

REVIEW OF INTRAMURAL RESEARCH
A report prepared by the Board of Scientific Counselors (BSC), NHLBI, on the NHLBI staff and intramural laboratories was presented to the Council by Dr. Donald M. Bers, BSC Chair.

OPEN SESSION
I. CALL TO ORDER
Dr. Gibbons reconvened the NHLBAC meeting at 12:13 p.m. in Open Session. He welcomed Council members, NHLBI staff and public attendees to the Open Session of the meeting.

II. ADMINISTRATIVE ANNOUNCEMENTS
Dr. Laura K. Moen (Director, Division of Extramural Research Activities, NHLBI) provided guidance on participating, reminding Council members of conflict of interest requirements. She noted that the meeting would be publicly broadcast and archived on videocast.

III. REPORT OF THE DIRECTOR
Dr. Gibbons announced the recent appointment of Julie Panepinto, M.D., MSPH, as Deputy Director of the Division of Blood Diseases and Disorders.

Accountable Stewardship. Dr. Gibbons updated NHLBAC on NHLBI’s investments for fiscal year (FY) 2021 and early FY 22 funding prospects. He explained that the budget increase of $103 million dollars relative to FY 20 equated to just a 1% increase overall. However, NHLBI also received supplemental funds under the Coronavirus Aid, Relief, and Economic Security (CARES) Act. Current spending is aligned with NHLBI priorities:

• maintaining research project grants (RPGs) and investing in the future and continued commitment to investigator-initiated science in FY 21, particularly maintaining high success rates in the face of the challenge of the rising award costs of R01 (Research Project) funding over the past 5 years.
• continued commitment to nurturing the next generation of researchers by supporting career development (K) and fellowship awardees adversely affected by COVID-19.
  NHLBI was invited to participate in the congressional hearings on FY 22 budget appropriations. Many of the congressional health care priorities for the upcoming year are aligned with the NHLBI mission.

NHLBI is actively fostering diversity, equity, and inclusion. The Institute has a policy of accountable stewardship. The Institute is aware that women and underrepresented minorities comprise a lower proportion of established researchers, although recipients of early career awards are more diverse. NHLBI is actively participating in the National Institutes of Health’s (NIH) UNITE Initiative, which addresses structural racism and reflects NIH’s commitment to diversity, equity, and inclusion.

Advancing Scientific Priorities. Dr. Gibbons highlighted specific areas of the mission upon which NHLBI has focused recent efforts:

• Advances in discovering novel therapeutics to cure sickle cell disease: The guiding principle of this initiative is that it is patient centered. In preliminary work, gene-based therapies are being assessed for safety and efficacy. Dr. Gibbons reported that genetic cell therapy trials are resuming after two cases of hematological cancers were found to be unrelated or misdiagnosed. A related effort is underway to investigate the background risk for hematological cancers in sickle cell disease, given the stress the disease places on bone marrow. This effort will require ancestrally diverse resources.
• Addressing the long-term public health impact of COVID-19: Goals of this undertaking include reducing severity, speeding recovery, and addressing health inequities. NHLBI has joined a trans-NIH research response that features adaptive clinical trials involving a variety of patient populations with a range of therapeutic goals.
• Disparate impact of COVID-19 on communities of color: It is recognized that this will require a multidimensional approach to address. The NIH Community Engagement Alliance (CEAL) is combating disparities by addressing mistrust and misinformation. Trends suggest that early disparities in vaccination are shrinking, but work is still needed in high-risk communities.
• Post-Acute Sequelae of COVID-19 (PASC): Initiative The NHLBI is at the forefront of this $1.1B effort. The challenges are to learn who is at risk and which therapeutic interventions prevent sequelae. PASC is characterizing infections with a meta-cohort that includes cohort studies and electronic health record interrogations.
• Catalyzing the transition from translational research to commercialization: NHLBI is committed to supporting the cycle of discovery and innovation that translates discoveries to precision prevention and new therapies. A major component of the overall effort is the NHLBI’s Catalyze program which provides flexible funding and key resources to bridge the gap in the translational pipeline.
• Understanding the molecular basis of heart failure and uncovering new therapeutic targets: To this end, researchers are leveraging genomic technologies for target discovery using diverse and inclusive genotype/phenotype resources. They are exploring heart failure at the level of the single cell to discover types of heart failure with different biological signatures. NHLBI’s Heart Share Initiative will promote discovery by leveraging NHLBI’s Trans-Omics for Precision Medicine (TOPMed) program and public-private partnerships.

IV. THE NIH UNITE INITIATIVE TO STRENGTHEN DIVERSITY, EQUITY, AND INCLUSION: TOGETHER, WE’RE STRONGER
Dr. Marie A. Bernard (Chief Officer for Scientific Workforce Diversity, NIH) provided NHLBAC with an overview of the NIH UNITE Initiative. She noted that the past year’s events have brought ongoing racial injustice in our country into sharp relief. In June 2020, Institute and Center (IC) directors met to identify initial issues related to structural racism and diversity, equity, and inclusion at NIH. Two self-assembled affinity groups also met with NIH leadership. Together, these groups and NIH leadership arrived at a shared commitment to address structural racism, recognizing that we must not let this pivotal moment pass. The UNITE Initiative was unveiled at the February 26, 2021, meeting of the Advisory Committee to the Director.

The UNITE Initiative identified initial issues to address. Biomedical research and its supporting administrative system must be devoid of hostility grounded in race, sex, and other federally protected characteristics. NIH must look within to delineate elements that perpetuate structural racism in biomedical research. All ideas must be given an equal and fair review regardless of who presents them, and regardless of the current dogma. Fundamental causes of health disparities and inequities must be redressed.

The UNITE Initiative comprises five intersecting committees:

• The U Committee’s charge is to evaluate elements that perpetuate structural racism and lead to a lack of diversity, equity, and inclusion within NIH and the external scientific community.
• The N Committee’s charge is to ensure NIH-wide transparency, accountability, and sustainability in marshaling resources for health equity research.
• The charge of the I Committee is to change NIH organizational culture and structure to promote diversity, equity, and inclusion throughout the NIH workforce.
• The charge of the T Committee is to ensure the transparency, accountability, and sustainability of all UNITE efforts.
• The E committee’s charge is to identify and change NIH extramural policies and processes that perpetuate a lack of inclusivity and diversity.

Dr. Bernard pointed out that NIH has made substantial progress toward initiating and implementing the initiative’s recommendations under UNITE. Actions taken include:

• Dr. Francis S. Collins’ (Director, NIH) apology to those disadvantaged by structural racism. In his statement, he affirmed NIH’s commitment to supporting diversity, equity, and inclusion through dismantling structurally racist policies and practices.
• NIH has launched a Common Fund initiative addressing health disparities and advancing health equity with a commitment of up to $24M. A request for applications (RFA) on understanding the impact of structural racism and discrimination on minority health and health disparities has been issued with a $30.8M commitment from 25 Institutes, Centers, and Offices.
• NIH workforce data by race/ethnicity and disability status is now available online.
• NIH has convened an Anti-Racism Steering Committee open to all members of the NIH workforce.

Dr. Bernard also described two other Institute-sponsored actions of potential interest to the Council. The National Institute of General Medical Sciences issued a Notice of Special Interest (NOSI) on understanding structural racism’s effects on biomedical careers and research. The BRAIN Initiative is the first NIH funding opportunity announcement that will be using a plan to enhance diverse perspectives as a consideration for scoring. She concluded with a quotation from Dr. Martin Luther King, “Injustice anywhere is a threat to justice everywhere.”

V. DIR SCIENTIFIC PRESENTATION: “OPPORTUNITIES IN CARDIOPULMONARY IMAGING USING A HIGH-PERFORMANCE 0.55T MRI SYSTEM”
Dr. Adrienne E. Campbell-Washburn (Stadtman Tenure Track Investigator, NHLBI) told the Council about new translational opportunities offered by a high-performance 0.55T MRI 6 system. This system allows more accessible cardiac MRI, comprehensive lung MRI, and safer MRI-guided cardiac procedures.

Current MRI clinical technologies primarily are used for imaging the brain, spine, and joints. These systems have a large magnetic field (1.5T or 3T)—50,000 times stronger than the earth’s magnetic field. Magnetic field strength has increased since the 1990s to improve the image resolution and signal-to-noise ratio, but these higher-field systems have disadvantages, including higher costs.

The innovation of the 0.55T system is that it combines low-field strength with high-performance hardware and technology. The image acquisition and reconstruction methods shift the financial burden of enhanced technology from expensive magnets to cheap computing. The system has advanced data sampling that uses efficient spiral sampling. The image-reconstruction algorithms take advantage of the power of cloud computing. Clinical cardiac MRI allows imaging of anatomy, function, and physiology. Cardiac MRI has been underutilized because of system cost and complexity, but lower-field systems could increase accessibility. Savings are derived from decreased magnet strength, a lighter system, less shielding, and less helium. Other benefits of 0.55T are increased patient safety and comfort. A 0.55T system potentially could provide a lower-cost radiology system capable of meeting 90 percent of radiology needs.

Dr. Campbell then demonstrated the capabilities of the lower-field system for heart and lung imaging. Comparing 0.55T and 1.5T systems for imaging the heart, she showed that measurement concordance is high, and interpretation is consistent. Dr. Campbell noted that MRI of the lung presents challenges. The lung has low water content, and the air-tissue interfaces distort the magnetic field. At 0.55T, however, distortions are reduced at the air-tissue interface. Low-field MRI can also use oxygen as a contrast agent which works well in determining lung function. Dr. Campbell showed the Council how oxygen signal enhancement maps were able to accurately contrast healthy volunteers with patients with lymphangioleiomyomatosis (LAM).

Dr. Campbell also presented imaging data for patients with acute COVID-19 infection. Although resolution is lower than CT, the lack of radiation exposure allows longer follow-up. Results from oxygen mapping in COVID-19 reveal reduced oxygen regions in recovered patients, suggesting that continued monitoring is needed. Quantitative lung perfusion shows perfusion deficits in patients with COVID-19, and low perfusion persists even in recovery.

Low-field MRI can be used to guide cardiovascular procedures. In a video, Dr. Campbell showed an MRI-guided cardiac catheterization. Comparing an X-ray to MRI, the device is easier to see with an X-ray, but the tissue being biopsied is clearer with MRI. Regarding the potential for human MRI catheterization, MRI produces accurate measurement of pulmonary vascular resistance. Low-field MRI has overcome previous issues with device safety which hampered clinical translation, since radiofrequency-induced heating of metallic devices is greatly reduced. Dr. Campbell also noted that use of MRI in cardiac ablation allows the clinician to see the effect on tissue and heart function in real time.

VI. NHLBI CONCEPT CLEARANCE
The NHLBI staff presented 17 concepts for clearance. Members expressed support for these concepts during discussions. They also asked for clarification on certain details and offered recommendations.

Title: Strategies to Innovate EmeRgENcy Care Clinical Trials (SIREN) Trans-NIH Network Renewal (U24)

Description: The overarching goal of this concept is to improve the outcomes of patients with neurologic, cardiac, respiratory, hematologic, and trauma emergencies. It renews NHLBI’s investment in a trans-NIH multidisciplinary network for emergency-care clinical trials to identify effective treatments given in the earliest stages of care.

Title: Secondary Participation in Renewal of PAR-17-255 Limited Competition: National Swine Resource and Research Center (U42)

Description: This concept proposes an initiative to support the use of a large animal model, the pig, as a useful model of diseases relevant to NHLBI’s mission. It provides an additional 5 years of support for the trans-NIH National Swine Resource and Research Center, thereby increasing the understanding of human health and disease through the support of swine models for biomedical research.

Title: Renewal of NOT-HL-20-769: Bold New Bioengineering Research for Heart, Lung, Blood and Sleep Disorders and Diseases (R21)

Description: This concept fosters discovery-driven bioengineering ideas relevant across NHLBI’s mission. It provides a cost-effective way to support proof-of-concept efforts transitioning to R01 and other follow-up funding, targeting ideas that advance NHLBI’s mission.

Title: NHLBI Career Transition Award for Intramural Postdoctoral Fellows and Research Trainees (K22)

Description: This concept supports talented NHLBI intramural postdoctoral fellows to prepare them for extramural research. It supports awardees through a mentored intramural phase (1–2 years) and a second extramural phase, which requires that awardees secure a faculty appointment at an extramural institution.

Title: Secondary Participation Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (U54, U24)

Description: This concept proposes a competitive renewal initiative, in collaboration with the National Institute of Neurological Disorders and Stroke, to support multidisciplinary ME/CFS research across a network of academic institutions. It further builds on the successes of the current network, helps develop the capacity to collect biospecimens, and fosters career development.

Title: Opportunities for Collaborative Research at the NIH Clinical Center (U01)

Description: This concept would create research opportunities not available elsewhere through supporting extramural and intramural collaborative research at the NIH Clinical Center. It would provide access to state-of-the-art equipment and expertise, platforms for translational research, and rare disease cohorts.

Title: Notice of Special Interest: Resilience and Vulnerability following Acute Heart, Lung, Blood, and Sleep Insults in People with HIV (R01, Clinical Trial Not Allowed)

Description: This NOSI concept stimulates research on resilience and vulnerability following acute heart, lung, blood, and sleep (HLBS) diseases and disorders in people with HIV as compared with people who are not HIV-positive. It investigates factors—including HIV infection, antiviral treatment, age, sex, gender, and social determinants of health—related to the transition from acute insult to complete recovery, partial recovery, or persistent residual dysfunction. Proposals will be considered across the spectrum of basic science to population science.

Title: Notice of Special Interest (NOSI): Examining Effects of HIV Pre-Exposure Prophylaxis (PrEP) on Heart, Lung, Blood, and Sleep Function (NOSI linked to PA-20-185 and PA-20-183) (R01)

Description: This NOSI concept seeks to stimulate research focused on the impact of PrEP on HLBS function. PrEP is the cornerstone of efforts to prevent HIV transmission. Positive or negative effects of PrEP on HLBS diseases, however, remain relatively unstudied.

Title: Stimulating Access to Research in Residency (StARR) Program Renewal (R38)

Description: As part of a cross-NIH initiative concept, the StARR program provides clinicians with research experiences early in their careers to recruit, retain, and accelerate independence in research. The R38 program supports institutional applications with novel approaches to timing, duration, faculty engagement, and administrative oversight.

Title: Secondary Participation in RFA-OD-22-001: Research Resource for Human Organs and Tissues (Limited Competition U42)

Description: This concept would renew support for the trans-NIH initiative for the Research Resource for Human Organs and Tissues (HTORR). The research resource facilitates the procurement, preservation, and distribution of fresh, fixed, and frozen tissues and organs for basic and clinical research. Cofunding by NHLBI will support tissue and specimen collection, storage, and distribution for HLBS research. The resource provides specimens to study a multitude of HLBS disorders. HTORR also has a specific focus on LAM research, working closely with NHLBI and The LAM Foundation on tissue procurement. In addition, the resource will provide specimens for new research, focusing on sarcoidosis and heart failure.

Titles: Catalyze Product Definition: Devices, Diagnostics and Tools (R61/R33, R33); Small Molecules and Biologics (R61/R33, R33); Catalyze Enabling Technologies and Transformative Platforms (R33)

Description: The NHLBI Catalyze Program provides a comprehensive suite of support and services to help transition basic scientific discoveries into viable diagnostic and therapeutic candidates ready for human testing. It also develops translational researchers fluent in product development and entrepreneurship. The above five initiatives are a suite of renewal RFAs addressing product development, as well as enabling technologies and transformative platforms. Of the product development initiatives, the first two focus on devices and diagnostics, and the second two focus on therapeutics. The enabling technologies and transformative platforms initiative support development of a new generation of diagnostic and therapeutic products.

Title: NHLBI SBIR Phase IIB Competing Renewals for Heart, Lung, Blood, and Sleep Technologies with Small Commercial Markets (R44)

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

Description: The two concepts above facilitate the capital-intensive steps of involved in transitioning from completed Phase IIB projects to the commercialization stage. Both initiatives incentivize partnerships between successful Phase IIB awardees and third-party investors and/or strategic partners. The first initiative focuses on the validation of NHLBI mission-focused technologies that address rare diseases or pediatric indications. The second initiative focuses on validation of technologies for all HLBS indications.

CLOSING REMARKS
Dr. Moen adjourned the meeting at 3:35 p.m.

The 291st meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) convened virtually on Tuesday, February 2, 2021. The meeting began in closed session at 10:05 a.m. and was open to the public between 2:04 p.m. until adjournment at 5:10 p.m. Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI), presided as chair.

NHLBAC Members Attending

E. Dale Abel, M.D., Ph.D.
Donna K. Arnett, Ph.D., M.S.P.H.
Jennifer DeVoe, D.Phil., M.D.
Grace Anne Dorney Koppel, J.D.
Martha U. Gillette, Ph.D.
Karen Glanz, Ph.D., M.P.H.
Garth Graham, M.D., M.P.H.
David H. Ingbar, M.D.
M. Luisa Iruela-Arispe, Ph.D.
Monica Kraft, M.D.
Kiran Musunuru, M.D., Ph.D.
Mohandas Narla, D.Sc.
Julie A. Panepinto, M.D., M.S.P.H.
Richard S. Schofield, M.D. (Ex Officio)
Dean Sheppard, M.D.
Kevin L. Thomas, M.D.
Sally E. Wenzel, M.D.
Andrew S. Weyrich, Ph.D.
Zachariah P. Zachariah, M.D.

NHLBI Employees Attending

A number of NHLBI staff members were in attendance via Zoom.

NIH Employees and Public Attending

The total number watching/participating online was reported by NIH Videocast to be 218.

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 3,520 applications requesting $7,612,609,871 in total costs. For the record, it is noted that secondary applications were also considered en bloc.

OPEN SESSION
I. CALL TO ORDER
Dr. Gibbons reconvened the NHLBAC meeting at 2:04 p.m. in Open Session. He welcomed Council members, NHLBI staff and public attendees to the Open Session of the meeting.

II. ADMINISTRATIVE ANNOUNCEMENTS
Dr. Laura K. Moen (Director, Division of Extramural Research Activities, NHLBI) provided guidance on participating, reminding Council members of conflict of interest requirements. She noted that the meeting would be publicly broadcast and archived on videocast.

III. REPORT OF THE DIRECTOR
Dr. Gibbons announced the recent appointments of Amy Patterson, M.D., as Deputy Director for Clinical Research and Strategic Initiatives in the NHLBI Office of the Director; and Marishka Brown, Ph.D., as Director of the National Center on Sleep Disorders Research (NCSDR).

Accountable Stewardship. Dr. Gibbons provided an update on NHLBI’s appropriations . The FY 2021 budget is 1.09 percent higher than the budget allocated in FY 2020, not including the additional FY 2020 allocation to respond to COVID-19. Investigator-initiated studies remain NHLBI’s highest priority, along with the strategic opportunities embarked upon with the advice of the Council. Dr. Gibbons noted that the rising average costs of investigator-initiated R01s create challenges in maintaining the number of R01 (Research Project) grants , but NHLBI is committed to predictable success rates for R01 grants and high success rates for grants to early-stage investigators and those eligible for career development (K awards).

NHLBI strives to maintain inclusive excellence in biomedicine and tracks sex/gender and race/ethnicity distributions in its awards. Dr. Gibbons highlighted two recent programs at the National Institutes of Health (NIH) level that promote diversity—the Maximizing Opportunities for Scientific and Academic Independent Careers (MOSAIC) program and NIH Faculty Institutional Recruitment for Sustainable Transformation (NIH FIRST) program. The FIRST program is a Common Fund initiative which supports the creation of cultures of inclusive excellence at the institutional level.

Dr. Gibbons acknowledged the challenges posed by the COVID-19 pandemic for the next generation of researchers. He noted that the Institute has been working with the NIH Office of the Director and other NIH Institutes and Centers (ICs) to develop NIH-wide guidance to mitigate the effects of the pandemic on researchers.

Public Health. NHLBI has long supported research that changes clinical practice and recently revised procedures for developing trustworthy clinical practice guidelines. The revised procedures emphasize transparency, systematic review, and communication. In the past, the Council recommended that the Institute develop guidelines on asthma within the framework of the National Asthma Education and Prevention Program (NAEPP), and work on updated guidelines would be presented later in the meeting.

A high-priority area for the Institute is addressing health inequities. Dr. Gibbons described some of the NIH programs that are addressing equity. He stated this effort is particularly timely in the context of the COVID-19 pandemic, which has disproportionately affected communities of color, particularly in the African-American communities, who have also had relatively low rates of vaccine uptake.

A trans-NIH effort has been under way to develop treatments for COVID-19 across its clinical course. NHLBI is supporting a wide range of studies to address both the near and long-term impacts of COVID-19. NHBLI-funded research recently found definitive evidence supporting the use of anticoagulation treatment in those with moderate COVID. Studies have found that monoclonal antibody treatment had no benefit to patients whose disease had progressed, that hydroxychloroquine has no benefit, and that colchicine reduces the risk of complications. Some patients have long-term effects of COVID-19 after viral clearance. This condition is still being defined and clarified, and it is not yet clear who is most at risk. The NIH Director has charged NHLBI, among others, to lead a trans-NIH effort to understand and treat post-acute COVID-19 sequelae.

IV. UPDATE OF THE ASTHMA GUIDELINES
Dr. James P. Kiley (Director, Division of Lung Diseases, NHLBI) provided the background for an overview subsequently presented by Dr. Michelle Cloutier, professor emerita of the University of Connecticut School of Medicine. He noted that the publication of the December 2020 NHLBI update to asthma guidelines began with a recommendation from the NHLBAC in 2014. After an assessment of which areas of asthma management in particular needed systematic review, an NAEPP Coordinating Committee (NAEPPCC) expert panel working group led by Dr. Cloutier was convened in 2018. In a highly inclusive process, more than 650 members of the asthma community provided input. Dr. Kiley pointed out that the 2020 update is a focused update, not a complete revision, as done in 2007. Instead, the update provides new guidance in six key areas and offers 19 recommendations.

In her overview, Dr. Cloutier indicated that the update addressed the four cornerstones of asthma care: assessment and monitoring, therapy, environmental factors, and education. For each new recommendation, the 2020 update provides a section on implementation guidance, providing clinicians with practical suggestions on when they should implement each recommendation and how. Each recommendation is specific for an age group and level of asthma severity. The expert panel included people with diverse expertise—including primary care providers, health policy experts, and those with experience in information dissemination. Focus groups included patients and caregivers. The panel used a transparent method for integrating data so that anyone who disagrees with recommendations can see exactly how they were developed. The panel applied rigorous conflict-of-interest policies. Dr. Cloutier concluded that she believes the end result is a set of “guidelines we can trust.”

Among the recommendations is to use a single inhaler both for daily prevention and acute relief of symptoms for people with moderate, persistent asthma. Preferred and alternative treatments were offered in different contexts. In several cases, the preferred therapies are new recommendations. Fractional exhaled nitric oxide was recommended for use as an adjunct test for asthma diagnosis and management. The panel recommended against using fractional exhaled nitric oxide to assess control, exacerbation severity, or to predict the future development of asthma. Immunotherapy was recommended as an add-on to standard therapy. Allergen mitigation can have small benefits, and the panel did not recommend allergen mitigation as part of routine asthma care, but it did recommend multicomponent mitigation strategies targeted to specific allergens for individuals who are sensitive to specific exposures.

For future directions, the expert panel recommended developing a mechanism for making ongoing guideline updates in a way that is efficient, adheres to the highest standards, and engages a broad range of stakeholders. Moving forward, the panel expects better identification of subpopulations based on their biological characteristics, which will help personalize the management of asthma. The panel would like to encourage researchers to use standardized and validated outcome measures with minimally important differences. One of the challenges the panel faced was the variety of measures used in studies. The panel recommended considering patient preferences in recommending sustainable treatments; for example, many patients say they prefer therapies they can use daily.

Dr. Kiley said that NHLBI will disseminate the guidelines on its own and with partners, including other NIH ICs, other federal agencies, and with representatives from scientific, professional, and voluntary health organizations. NHLBI has prepared materials that are available on its website, including the panel’s full report, a clinicians’ guide, and an at-a-glance guide. In addition, the working group’s report was published in the December 2020 issue of the Journal of Allergy and Clinical Immunology.

V. LOAN REPAYMENT PROGRAM
Dr. Kiley provided an update on NIH’s Loan Repayment Programs (LRPs), which are intended to help individuals pursue research careers. LRPs repay up to $100,000 of researchers’ educational loan debt over 2 years. The 2-year contracts can be competitively renewed. NIH funds approximately 1,300 researchers through LRPs each year. NHLBI is a leading funder of loan repayment recipients among NIH ICs.

Dr. Kiley noted that the LRP was expanded under the 21st Century Cures Act, which gave the NIH Director the authority to increase the maximum repayment amount and to expand eligibility based on workforce and scientific priorities. A working group was convened in the spring of 2018 to make recommendations for revising the program, which led to increasing the maximum loan repayment amount from $35,000 to $50,000 per year. Greater support is also being provided to underrepresented groups. Across NIH, the success rate for applicants to the program has increased from 21 percent to 36 percent.

A new LRP is in development that will focus on emerging and gap areas of research, with awards scheduled to begin in FY 2022. Dr. Kiley welcomed feedback from the Council on how to structure the new LRP. NHLBI also welcomes feedback on benchmarks to use to track the success of the new program and LRPs in general.

Dr. Kiley presented data on the numbers of applications, awards, and success rates of NHLBI LRPs over the last decade. Overall, about 43 percent of all applicants and awardees for the program were female over FY 2011-2019. Success rates for female researchers were initially lower than for male researchers but have recently been higher. About 11 percent of both applicants and awardees to LRPs over FY 11-19 have been underrepresented minorities (URMs). The success rates for URMs have increased in recent years.

The program was originally intended to target graduates of medical school programs in order to encourage physicians to pursue careers in academic medicine rather than careers in private practice. Future directions have discussed the possibility of expanding the programs to include more support for research which does not involve direct patient contact. Some members of the Council agreed that expanding program access could be beneficial to the NHLBI mission.

VI. OPTIMIZING STEWARDSHIP OF EMERGENCY CARE RESEARCH CONDUCTED UNDER EXCEPTION FROM INFORMED CONSENT
Dr. Patterson, and two investigators from the Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) (Dr. Robert Silbergleit, Department of Emergency Medicine, University of Michigan Medical School, and Dr. Neal Dickert, Division of Cardiology, Emory University) reported their findings about Exception from Informed Consent (EFIC) studies as part of an NIH response to a query from a member of Congress. Dr. Patterson noted that EFIC studies are intended to address major gaps in knowledge in how to administer emergency care. She explained that EFIC studies are restricted to settings where time constraints and the condition of the patient preclude obtaining informed consent for a medical trial and where subjects have life-threatening conditions. EFIC trials have helped improve the care of patients in critical condition. Dr. Patterson welcomed Council suggestions as these findings are shared with a broader research community.

Dr. Silbergleit explained that the work organized through the SIREN network was intended to contribute to NIH’s stewardship of emergency medicine research conducted under EFIC or in prehospital settings. Input was sought from stakeholder focus groups, as well as semi-structured telephone interviews, followed by a thematic analysis of the information gathered. More than half of the stakeholders were paramedics. Ultimately, agreement emerged in the themes:

• Paramedics would like to have more input in trial design
• Stakeholders agreed on the importance of engaging nonmedical leaders in striving to improve patient care
• Generational culture differences were observed, with rising professional standards among younger paramedics
• In-person training was considered important for paramedics

The investigators also undertook a robust review of policies, practices, and training related to EFIC studies, with the goal of delivering a thorough review and model operating procedures for NIH-sponsored multicenter clinical trials that use EFIC for emergency research.

Dr. Dickert noted that EFIC regulations are the only federal regulations that require formal community engagement, with community consultation (CC) required before studies are approved, and public disclosure (PD) required before studies are conducted and after they are finished. Heterogeneous practices have emerged for both CC and PD, but both CC and PD remain unfamiliar to many investigators and Institutional Review Boards (IRBs).

Much of the literature has focused on feedback from the general public through surveys. A number of surveys have asked if people who participate in CC would accept being enrolled in the discussed study. For public disclosure, a variety of methods were used: traditionally, print media, and more recently, internet-based approaches. Institution-based notifications such as flyers in hospitals were also common. Awareness among the public has tended to be low. Dr. Dickert said that it is difficult to know the right metrics for public disclosure beyond making a good-faith effort.

The group identified a consensus in the literature that community consultation should be a two-way process. It is common for researchers to use a combination of methods. Areas of debate are whether to aim for depth versus breadth of feedback, whether to focus on those with a connection to the condition as opposed to representing the geographic community, and how best to assess community acceptance.

For public disclosure, the literature showed consensus around needing a good-faith effort, but no ideal benchmarks were proposed on what a good-faith effort is. There is less focus in the literature on PD than on CC. Open questions include:

• the proper role of social media in the PD process,
• the importance of broad surveys versus targeting people with a stake in the condition,
• the role of central IRBs.

A manuscript about this work is currently under review, and a draft was circulated to the Council. Dr. Silbergleit pointed out that every trial has to be tailored to its particular context. The manuscript he and his colleagues developed is intended to be a useful tool and serve as peer-to-peer guidance rather than as regulatory guidance or a policy requirement of NIH.

Dr. Silbergleit ended the presentation by discussing the insights obtained in a workshop involving family members of patients with cardiac arrest or severe neurotrauma.

• Family members were involved after recovered patients noted that they had little insight to share about their experiences since they were often comatose. Four workshop cochairs decided to invite a small enough group to allow everyone to share their experiences while representing a diversity of experience. In the workshop, 58 themes emerged across five domains: information needs, communication needs, emotional needs, sociocultural needs, and physical needs.
  • As an information need, family members said they often were not sure whether they did not know what was happening with their family member because the information was not known or they were not told. For communication, family members would like clear, consistent, compassionate communication and appreciated when information was repeated since they were often overwhelmed. Many family members wanted to be able to communicate via text or social media.
  • Families expected to be respected no matter their sociocultural differences, and language-interpretation services when needed. Physical needs included wanting space to be close to the patient and care teams, as well as having basic needs met, such as access to toothbrushes and razors. Many family members wished to be able to touch the patient in critical care but refrained from doing so because of the tubing and equipment surrounding the patient and the fear of disturbing the apparatus or breaking rules. Cases where a provider encouraged family members to touch a patient can be very meaningful.

Dr. Silbergleit closed with the suggestion that perhaps there are ways to break the bubble of physical isolation around patients.

VII. DELEGATION OF AUTHORITY
Dr. Moen asked the Council to consider and confirm the delegated authorities for the Institute for 2021. No questions were raised, and delegated authorities were approved.

CLOSING REMARKS
Dr. Moen adjourned the meeting at 5:10 p.m.