National Heart, Lung, and Blood Advisory Council February 2016 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 10, 2016

The 266th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) was
convened on Wednesday, February 10, 2016, Building 35A, Room 610/620-630/640 at the
National Institutes of Health (NIH), Bethesda, Maryland. It was open to the public from 8:17 a.m.
until 12:20 p.m. Closed session began at 1:07 p.m. and ended at 1:59 p.m. Dr. Gary H.
Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI), presided as Chair.

Council Members attending
Dr. Nancy J. Brown
Dr. James D. Crapo
Dr. Pamela S. Douglas
Dr. Jonathan A. Epstein
Dr. Ron G. King
Dr. Barbara A. Konkle
Dr. Pilar N. Ossorio
Dr. Bruce M. Psaty
Dr. Véronique Lee Roger
Dr. Anna Maria Siega-Riz
Dr. Phyllis C. Zee

Council Members attending by teleconference
Dr. Bradford C. Berk
Dr. Michael R. DeBaun
Dr. Serpil C. Erzurum
Dr. Jeffrey A. Whitsett

Council Members unable to attend
Dr. George Q. Daley
Dr. Fernando D. Martinez

NIH Center for Scientific Review attending
Dr. Larry Boerboom
Dr. Margaret Chandler

Members of the Public attending
Dr. Amy Brewster, Purdue University
Dr. Perry Kirkham, Purdue University
Dr. Juergen Lernk, Deloitte
Ms. Cassandre Marseille, American Association of Colleges of Osteopathic Medicine
Ms. Tracy Roades, American Society of Hematology
Ms. Taylor Swankie, Research Triangle Institute
Ms. Min Zhang, Purdue University

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

I. WELCOME

Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI),
welcomed members to the 266th meeting of the National Heart, Lung, and Blood Advisory
Council (NHLBAC).

II. ADMINISTRATIVE ANNOUNCEMENTS

Dr. Jodi B. Black, Acting Director, Division of Extramural Research Activities (DERA), NHLBI,
made the standard administrative announcements and outlined the agenda for the Council
meeting. A notice of the meeting was published in the Federal Register. Members were
reminded about conflicts of interest and the need to absent themselves during review of any
application if their presence would constitute or appear to constitute a conflict of interest. They
may not engage in any lobbying activities while attending Council meetings or sponsored
events. Members were reminded to sign and return a conflict of interest form at the end of the
meeting.

III. REPORT OF THE DIRECTOR

Dr. Gibbons began by acknowledging that February is American Heart Month, noting the
research opportunities that exist to improve treatment of the number one cause of death for both
men and women. He then remarked on the following topics:

Congressional Developments: In December 2015, Congress increased the NIH budget by
$2 billion, resulting in a 3.9% budget increase that puts the Institute back on the type of budget
trajectory it was on prior to sequestration. Dr. Gibbons noted that Congress has indicated a
willingness to ensure that the NIH budget will continue to grow each year.

NHLBI Research Funding: Thanks to the increased budget and its multi-year budget modeling
approach, the NHLBI has been able to fund more grants and establish a more forgiving cutoff
score at which grants are funded. Dr. Gibbons expressed optimism that the Institute would be
able to fund 700 new R01 awards in the current fiscal year. R01s are awarded to support a
discrete, specified, circumscribed project in an area representing the grantee's specific interest
and competencies. If the Institute achieves that goal, it would be the first time it had done so in
many years. Dr. Gibbons reiterated that the Institute is moving away from a grant awarding
process that focuses almost exclusively on the peer review score to one that is more flexible
and awards grants based on additional criteria, such as a project’s ability to impact public
health, contribute to portfolio balance, or fill in knowledge gaps. In addition, the new approach
would support emerging scientific opportunities that could significantly impact research or public
health.

Strategic Visioning Update: Noting that the Institute is in the last stage of developing its
research priorities that resulted from the Strategic Visioning process, Dr. Gibbons invited
members of the Council to suggest additions to the draft report that could indicate in a
memorable way the potential impact of the research objectives.

New NIH Research Expectations: Dr. Gibbons apprised Council members of new NIH policies,
including an NIH notice that states the NIH has the expectation that sex as a biological variable
will be factored into research designs, analyses, and reporting in vertebrate animal and human
studies. Dr. Gibbons added that the draft strategic research priorities document echoes this
need for NHLBI research to consider sex as a biological variable.

Dr. Gibbons concluded his remarks by highlighting progress in the TOPMed program and in the
work of an internal group examining how to more effectively identify and manage valuable
clinical trials.

IV. UPDATE FROM THE NHLBAC CLINICAL TRIALS WORKING GROUP

Dr. Amy Patterson, Director of Scientific Research Programs, Policy, and Strategic Initiatives,
and Chief Scientific Advisor at the NHLBI, gave a presentation elaborating on the progress of
the internal group that is examining the NHLBI’s funding of clinical trials and exploring ways to
promote successful clinical studies. She is also serving as the NHLBI staff chair for the
Optimizing the Clinical Trials Enterprise working group.

After highlighting some of the successful clinical trials that the NHLBI has funded, Dr. Patterson
noted there is still room for improvement and that trials often face many challenges, such as an
overestimate of the number of available research subjects and delays in acquiring a drug for the
study. As the internal group works to identify solutions to these problems, they are also
monitoring other groups who likewise are exploring ways to more effectively run clinical trials.

The Institute’s examination of its clinical trials enterprise coincides with the final months of a
program that began in 2007 and funded multi-site clinical trials. It will end in May 2016. The
initial task of the group is to come up with a revised funding opportunity announcement (FOA)
for this program. Then it will seek to institute general reforms in how the NHLBI reviews, selects,
and manages clinical trials.

Potential reforms for the new FOA include new requirements for information in the grant
application that would allow reviewers to more effectively assess the operational feasibility of
proposed clinical trials.

V. STRATEGIC VISIONING UPDATE

Dr. James P. Kiley highlighted the main elements of the draft Strategic Research Priorities
report, which was released for public comment a few days prior to the meeting. Council was
asked to determine if it reflected the various contributions of Council, the NHLBI Board of
External Experts, and the community over time. In essence, the Institute’s four strategic goals
were grouped into eight objectives that then captured the 150 Compelling Questions and Critical
Challenges. Both Dr. Kiley and Dr. Epstein who led the Council discussion stressed that this is
a living document that will evolve as warranted by moving targets of science and clinical
research, Council members then offered various suggestions for the content of the document
and dissemination strategies.

VI. PRECISION MEDICINE INITIATIVE UPDATE

Josephine P. Briggs, Director of the National Center for Complementary and Integrative Health,
gave a presentation on the NIH Precision Medicine Initiative (PMI), providing an overview of its
main elements and noting progress to date. The NHLBI will play a prominent role in the initiative
as the Institute responsible for issuing PMI grants. Dr. Briggs also explained that the projected
million volunteers for the study will reflect the diversity of the U.S. population. In addition, those
collecting data will not start with genetic information but instead will first gather information on
volunteers’ general health and their communities.

VII. SEQUENCE-DRIVEN DISCOVERY OF GENES UNDERLYING CARDIOVASCULAR
AND PULMONARY RISK

Dr. Richard Lifton, Chair of the Department of Genetics at the Yale University School of
Medicine, gave a presentation entitled “Genes, Genomes, and the Future of Medicine” that built
on Dr. Briggs’ discussion of the PMI. After providing an overview of various lines of research in
genetics, he noted that the PMI, with its large number of volunteers, will enable studies that can
reveal the factors, including genetic factors, that predict various diseases. He also suggested
that the PMI may improve our ability to match appropriate drugs and drug doses to patients
based on their genetics.

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).

VIII. 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 1,674 applications requesting $2,155,243,186.

ADJOURNMENT

The meeting was adjourned at 1:59 p.m.