National Heart, Lung, and Blood Advisory Council February 2018 Meeting Summary

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 6, 2018

The 276th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) was convened on Tuesday, February 6, 2018, in Building 35A, the Porter Neuroscience Center Conference Center, National Institutes of Health (NIH), Bethesda, Maryland. It was open to the public from 8:42 a.m. until 10:25 a.m. Closed session began at 11:13 p.m. and ended at 12:24 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 Arnett
Dr. Bradford Berk
Dr. Nancy Brown
Dr. James Crapo
Dr. George Daley
Dr. Michael DeBaun
Dr. Serpil Erzurum
Dr. Karen Glanz
Dr. Luisa Iruela-Arispe
Dr. Diane Nugent
Dr. Pilar Ossorio
Dr. Kim M. Smith-Whitley
Dr. Sally Wenzel
Dr. Phyllis Zee

Council Members attending via teleconference

Dr. Richard Schofield (ex officio)

Council Members unable to attend

Dr. Fernando Martinez
Dr. Robert Robbins

Public attending

Ms. Debby Berlyne, IQ Solutions
Dr. Lauren Brodd, American Association of Immunologists(AAI)
Ms. Sonia Pearson-White, Social & Scientific System

NHLBI employees attending

A number of NHLBI staff members were in Dr. Karen Glanz attendance.

Other NIH Institute employees attending

Dr. Margaret Bevans, OD, NIH
Dr. Eugene D. Carstea, CSR, NIH
Dr. Gniesha Y. Dinwiddie, CSR, NIH
Dr. Mary E. Groesch, OD, NIH
Dr. H. Bradley Nuss, CSR, NIH

I. CALL TO ORDER AND OPENING REMARKS

Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI), welcomed members and other attendees and called the 276th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) to order.

II. ADMINISTRATIVE ANNOUNCEMENTS

Dr. Laura K. Moen, Director, Division of Extramural Research Activities (DERA), NHLBI, made the required announcements for the Council meeting, which included: that a notice of the meeting was published in the Federal Register, Council members are required to absent themselves from the room if their presence would constitute a conflict of interest, Council members may not engage in lobbying activities while attending Council meetings or sponsored events, and portions of the meeting are closed to the public in accordance with the provisions set forth in 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.

III. ENHANCING SUPPORT FOR EARLY TRANSLATIONAL RESEARCH AT NHLBI

NHLBI Translational Research Implementation Committee. Dr. Matthew McMahon, Director of the Office of Translational Alliances and coordination at the NHLBI, reported that the Committee formed several working groups focused on product definition, preclinical studies, enabling technologies and transformative platforms, workforce development, the Coordinating Center, and communications. The Committee received guidance from early translational research breakout sessions at the joint NHLBAC and Board of Extramural Experts (BEE) meeting in September 2017, as well as a previous meeting in the fall of 2016. It also receives input from other NIH Institutes and other government and private-sector organizations that support translational research, and investigators who use NHLBI resources.

NHLBI Catalyze Program. This program is designed to reorganize early translational research support at the NHLBI across its entire portfolio of heart, lung, and blood disorders for development of drugs, biologics, devices, and health information technology. Three major areas of the program are: product development, enabling technologies and transformative platforms, and workforce development. The program will also support requests for applications that address specific barriers to early translation.

The program will use the NIH other transaction authority (OTA), a mechanism that is different from the more traditional NIH funding vehicles. The OTA provides more flexibilities and allows engagement of trusted partners to collaboratively define requirements. The Catalyze Program will have the flexibility to alter or terminate projects, reallocate funds among projects, and hire technical and business experts when needed, and it will try novel approaches to research and management.

The next steps are to finalize the Catalyze Program’s governance structure, establish the external oversight board, and launch the Coordinating Center. While the initial focus will be on preclinical research, the program will then move to establishment of assays, tools, models, biomarkers, and transformative platforms. The program will then focus on developing shortterm translational research training, and entrepreneurial education and training. Finally, the product definition component will be launched.

IV. REPORT OF THE DIRECTOR

End-of-Year Budget Summary. Dr. Gary H. Gibbons reported that in fiscal year (FY) 2017, the NHLBI maintained its 15 percent payline for R01 awards, with hopes to sustain this payline in FY 2018. The NHLBI also used the selective pay option to fund several meritorious science programs that address important scientific priorities and scored just above the payline.

The NHLBI is at the vanguard across the NIH in promoting the next generation of researchers. The success rate for early-stage investigators reached 30 percent and the success rate for career (K) awards was 40 percent.

American Heart Month. The NHLBI uses American Heart Month (February) to convey the message that heart disease is the top killer of men and women in the United States. The Institute encourages everyone to take the #MoveWithHeart pledge, and Dr. Gibbons urged NHLBAC members to take this pledge, as Dr. Francis Collins, the NIH director, and many other NIH leaders have already done.

Translational Research. In addition to supporting early translational research efforts, NHLBI supports T4 studies (translation of clinical research to real-world settings), which involves implementation and dissemination science. An example is the use of the NHLBI-sponsored Systolic Blood Pressure Intervention Trial (SPRINT) findings to support 2017 hypertension clinical practice guidelines from the American Heart Association and American College of Cardiology, which now define hypertension as a systolic blood pressure > 130 mm Hg or diastolic blood pressure > 80 mm Hg. In addition, the NHLBI issued 10 new K12 awards to help early-stage investigators expand their skills in moving their scientific discoveries into practice.

Sleep and Circadian Biology. An NHLBI strategic objective is to understand the basic pathways underlying the effects of circadian function, synchronization, and harmonization on heart, lung, blood, and sleep health and resilience across the lifespan. NHLBI efforts in this area include: Trans-Omics for Precision Medicine (TOPMed), research on genetic variants associated with biomedical pathways that influence sleep apnea; the Sleep Disordered Breathing, Obesity and Pregnancy Study, on the effects of continuous positive airway pressure on cardiovascular disease risk in pregnant women with sleep apnea; and a study of treatment for mild sleepdisordered breathing in children to improve behavior and attention.

Sickle Cell Disease Cure Initiative. Because sickle cell disease is rare, the potential market for a cure is not large. Thus, the NHLBI has a critical role in facilitating progress in this area. The NHLBI plans to take many of the lessons learned from its early translational research programs to help find a cure for sickle cell disease. One of the early applications could be the development of gene therapies for monogenic disorders, of which sickle cell disease is a specific opportunity.

NHLBI’s Use of the Other Transaction Authority (OTA). Although the NHLBI has had this authority for years, it has not used it before. This legally binding agreement engages a diverse set of stakeholders and allows the Institute to conduct its business in a more flexible way, enhancing collaboration, supporting unique partnerships, leveraging commercial technology, and permitting matching funds contributed by an external partner. The OTA is particularly well suited to high-risk, high-reward research because it maximizes the flexibility to adapt, work creatively, and negotiate with entities as collaborative partners to develop new requirements and solutions.

The OTA might be useful in the TOPMed Program. TOPMed is at the vanguard of the NIH-wide cloud-based data platform, the NIH Data Commons. The NIH and the NHLBI are using the OTA to create this multidisciplinary open science data space while maintaining controlled access. The rich data in TOPMed are representative of the diverse heart, lung, blood, and sleep phenotypes and populations that can enable multi-omics exploration to define the mediator pathways of heart, lung, blood, and sleep disorders and discover novel therapies.

V. 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 that the council had approved in 2017 for 2018.

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 (5 U.S.C. appendix 2).

VI. 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 2,937 applications requesting $5,916,735,783 in total costs. For the record, it is noted that secondary applications were also considered en bloc. There were applications considered by early concurrence.

ADJOURNMENT

The meeting was adjourned at 12:24 p.m.