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
February 8, 2023
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.
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.
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.