Bethesda, MD
Description
DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL INSTITUTES OF HEALTH
NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL
MEETING SUMMARY OF THE NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL
October 25, 2022
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.