National Heart, Lung, and Blood Advisory Council June 2020 Meeting Summary

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

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

June 9, 2020

The 287th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) was convened on Tuesday, June 9, 2020, with online attendance via Webex. The closed session began at 10:00 a.m. The meeting was open to the public from 12:30 p.m. until adjournment at 3:50 p.m. Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI), presided as Chair.

Council Members attending

Dr. E. Dale Abel
Dr. Donna K. Arnett
Dr. Jennifer Devoe
Dr. Martha U. Gillette
Dr. Karen Glanz
Dr. Garth Graham
Dr. David Ingram
Dr. M. Luisa lruela-Arispe
Ms. Grace Anne Dorney Koppel
Dr. Monica Kraft
Dr. Kiran Musunuru
Dr. Mohandas Narla
Dr. Julie Panepinto
Dr. Richard S. Schofield (Ex Officio)
Dr. Dean Sheppard
Dr. Kevin L. Thomas
Dr. Sally E. Wenzel
Dr. Andrew S. Weyrich
Dr. Zachariah P. Zachariah

NHLBI Employees Attending

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

NIH Employees and Public Attending

The total number watching/participating online was reported by NIH Videocast to be 340.

Closed Portion

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 3,398 applications requesting $7,348,645,192 in total costs. For the record, it is noted that secondary applications were also considered en bloc.

Open Session

I. Welcome

Dr. Gibbons called the open session of the 287th meeting of the NHLBAC to order and welcomed Council members and other attendees.

Dr. Gibbons welcomed four new Council members: Dr. David Ingbar, Dr. Kiran Musunuru, Dr. Julie Panepinto, and Dr. Zachariah Zachariah.

Dr. Gibbons also introduced two new assistant directors in the NHLBI Office of the Director: Dr. Jessica Chertow and Dr. Dina Paltoo. In addition, he introduced the new deputy director for the NHLBI Center for Translation Research and Implementation Science, Dr. Catherine Stoney.

II. Administrative Announcements

Dr. Laura K. Moen (Director, Division of Extramural Research Activities, NHLBI) provided guidance on participating virtually. She noted that the video of the open session would be posted publicly.

III. Report of the Director

Dr. Gibbons provided an update on the fiscal year (FY) 2020 budget, which at $3.63 billion was 4.1 percent higher than the FY 2019 budget. He noted that a record of sustained increases in the NHLBI budget over the last few years reflects recognition of the significant burden of the chronic diseases in NHLBI’s portfolio. Dr. Gibbons explained that emergency supplemental appropriation from the Coronavirus Aid, Relief, and Economic Security (CARES) Act has provided NHLBI with $130 million to respond to the COVID-19 pandemic.

Dr. Gibbons affirmed his commitment to maintaining high success rates for applications and promoting diversity and inclusive excellence in the biomedical workforce as he presented summaries of NHLBI activities:

• Response to COVID-19. Dr. Gibbons described NHLBI’s role in responding to the historic COVID-19 pandemic. NHLBI is addressing the heart, lung, blood, and sleep dimensions of the disease. The novel coronavirus affects a wide range of organs, including the heart, lungs, and vascular system. Many people who are particularly at risk from COVID-19 have chronic conditions in the NHLBI portfolio.
  
  National Institutes of Health (NIH) leadership has charged NHLBI and the National Institute of Child Health and Human Development to lead the NIH effort to understand the multisystem inflammatory syndrome associated with COVID-19 that affects children and adolescents.
  
  NHBLI staff convened a series of meetings in March to address the emerging COVID-19 pandemic. Proposal ideas were developed within a few weeks, and the first NHLBI clinical study relating to COVID-19 launched on April 9. Now, several clinical studies are underway. NHLBI-supported studies are investigating interventions such as blood- derived immune boosts, antithrombotic care, anti-inflammatory therapies, and antiviral therapies.

• Other Public Health Crises. Vaping: Dr. Gibbons noted that NHLBI is continuing to push research to understand the health risks of vaping and the lung syndrome that frequently afflicts young people as a consequence of vaping. Recent research using a mouse model has found that vitamin E acetate exposure is a key cause of lung injury.

• HIV/AIDS. Dr. Gibbons noted that the AIDS pandemic has evolved into a chronic disease with comorbidities. NHLBI continues to address HIV/AIDS by supporting basic research, community-based cohorts, and research on interventions to cure this disease.

• Additional Areas of Focus. Dr. Gibbons described a few other priority areas: The NHLBI Catalyze program is intended to facilitate rapid clinical translation of basic scientific discoveries. The Cure Sickle Cell Initiative supports the development of gene therapy strategies that could be used in resource-limited settings. BioData Catalyst (BDC) is an important platform for providing access to biomedical data, tools, and workflows.

IV. BioData Catalyst Overview

Dr. Ingrid Borecki, Chair, Steering Committee, NHLBI BioData Catalyst (BDC), described the overall vision for the platform and provided context for the demonstration which followed her introduction. She explained that BDC is intended to be a community-driven ecosystem implementing data solutions. BDC connects to the Trans-Omics for Precision Medicine (TOPMed) genotype imputation server, which provides access to genome data for approximately 100,000 multiethnic samples representing more than 300 million genomic variants. The cloud-based environment collects clinical, epidemiological, genomic, and image data and provides a variety of tools and workflows, as well as space where investigators can work and collaborate. BDC users must have their identities authenticated and are permitted access to specific datasets in secure workspaces.

The first cohort of users are members of the NHLBI BDC fellows program. The 16 fellows who were selected proposed compelling scientific questions to answer using BDC and are a computationally savvy group that is able to collaborate with NHLBI to test and improve the BDC ecosystem. Two more BDC fellow cohorts are expected to begin work in the next year. Dr. Borecki encouraged meeting participants to share information about the fellows program.

Dr. Kira Bradford, Co-PI, Team Helium, NHLBI BDC, provided a demonstration of the BDC ecosystem from the perspective of a hypothetical researcher studying COVID-19. For a portion of the datasets available in BDC, harmonized variables allow users to conduct combined analyses across datasets without additional processing of data. Dr. Bradford demonstrated how a user might create a cohort, pull associated data, and import the data into an environment where further analyses can be done.

Dr. Borecki outlined additional BDC release targets for 2020. She noted that BDC is ready to make COVID-19 clinical data rapidly available.

V. NHLBI Initiatives

NHLBI staff presented 11 concepts for clearance. Members of the Advisory Council were asked to rate the concepts. In discussions, members expressed their support for , asked for clarification on certain details and offered recommendations for some of these concepts.

Title: Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) (UG3/UH3) with Coordinating Center (U24)

Description: This concept plans to test the effectiveness of early intervention to promote cardiovascular health in at-risk mothers and their young children. The United States ranks last in maternal cardiovascular morbidity and mortality among wealthy countries. This program supports a multisite intervention to test whether a home visit program can improve maternal and early childhood cardiovascular health. Other institutes are expected to join in with increasing funding in the future for this initiative.

Title: Summer Institute for Research Education in Biostatistics and Data Science (R25).

Description: This program is intended to introduce advanced undergraduates and recent college graduates to the field of data science and encourage them to pursue careers in biostatistics. The program has been successful in recruiting underrepresented minorities. Program staff are seeking cofunding with other institutes to increase the number of students supported.

Title: Using Syndemics to Understand HLBS Disease Emergence and Progression in People with HIV (PWH) (R01)

Description: Syndemics studies how two or more health problems act in synergy. This concept fosters research into factors that affect clustering of morbidities affecting the heart, lung, blood, and sleep (HLBS) in people with HIV in order to identify useful approaches for integrated care.

Title: Understanding and Reducing Cardiovascular Disease in Type 1 Diabetes Mellitus (R01- Clinical Trial Optional)

Description: This concept is proposed in collaboration with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). If developed, this program will support a breadth of studies to discover more effective cardiovascular disease prevention and treatment strategies for people with type 1 diabetes mellitus. This program requires NHLBI staff involvement but no additional funding from NHLBI. Funding decisions will be made in collaboration with NIDDK.

Title: The O2 Challenge Prize (N01)

Description: The goal of the oxygen challenge prize is to encourage the development of more portable supplemental oxygen therapy technology for outpatients. The competition format is intended to reach a wide pool of innovators.

Title: ARDS, Pneumonia, and Sepsis Phenotyping Consortium (U01)

Description: This concept proposes to study acute respiratory distress syndrome (ARDS), community-acquired pneumonia, and sepsis in coordination with each other. An important partner in this effort is the National Institute of General Medical Sciences (NIGMS), which has deep experience in studying sepsis. NIGMS has already approved the concept and committed to supporting the program. . Recent investment in ARDS research has led to interventions that have worked and others that have not, and mortality for the condition remains high. This concept proposes an initiative that plans to explore heterogeneity and mechanisms in critical illness syndromes and recovery.

Title: Maintenance of the NHLBI Biologic Specimen Repository (N01)

Description: The NHLBI biorepository has more than 4 million well-phenotyped specimens, including from unique populations, linked to clinical study data. The effectiveness of repository storage is regularly evaluated. Excess aliquots are not maintained if a specimen is not actively used. As new specimens are added to the repository, their use is evaluated. DNA is either available for specimens or can be harvested from stored white blood cells. For several cohorts, images are linked to the specimens. Publications based on biorepository use are being tracked. Typically, 100 to 200 papers per year use samples from the biorepository.

Title: Multidisciplinary Approaches to HIV-Associated Comorbidities and Prioritizing Intervention Targets (R01)

Description: This concept aims to fund 4 grants per year, 12 overall, researching approaches to mitigate comorbidities associated with HIV. The program will use HIV/AIDS-specific funding.

Title: Limited Competition: International epidemiology Databases to Evaluate AIDS (IeDEA) (U01 Clinical Trial not Allowed)

Description: This concept is led by the National Institute of Allergies and Infectious Diseases. The program recruits sites from around the world to collaborate to collect and define key variables and implement methods to effectively analyze data to address high-priority HIV/AIDS questions. The program will use Office of AIDS Research funds. This is the first time NHLBI has asked to formally participate in the program.

Title: Secondary Participation in FIC International Research Training Award (NCD-LIFESPAN) Program (D43 Clinical Trial Optional)

Description: The NHLBI would join the Fogarty International Center (FIC) to support research programs in low- and middle-income countries focusing on noncommunicable diseases. The program will also foster training.

Title: Secondary Participation in FIC Emerging Global Leader Award (K43 Independent Clinical Trial Required and K43 Independent Clinical Trial Not Allowed)

Description: This program provides awards to investigators involved in the previous program, with the expectation of supporting an intensive, mentored research career development experience. If approved, the NHLBI hopes to support up to 3 new meritorious applicants per year for the next 5 years.

Adjournment

The meeting was adjourned at 3:50 p.m.