The 262nd meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) was held Wednesday, June 10, and Thursday, June 11, 2015, in Building 35A, Conference Room 610/620-630/640, National Institutes of Health (NIH), Bethesda, Maryland. It was open to the public from 1:40 p.m. until adjournment on June 10 at 4:30 p.m., and from 8:00 a.m. until 11:45 a.m. on June 11. The closed session began at 12:35 p.m. and adjourned at 1:45 p.m. Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI) presided as chair
DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL INSTITUTES OF HEALTH
NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL
June 10–11, 2015
The 262nd meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) was held Wednesday, June 10, and Thursday, June 11, 2015, in Building 35A, Conference Room 610/620-630/640, National Institutes of Health (NIH), Bethesda, Maryland. It was open to the public from 1:40 p.m. until adjournment on June 10 at 4:30 p.m., and from 8:00 a.m. until 11:45 a.m. on June 11. The closed session began at 12:35 p.m. and adjourned at 1:45 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 (ad hoc)
Dr. James D. Crapo
Dr. George Q. Daley
Dr. Pamela S. Douglas
Dr. Jonathan A. Epstein
Dr. Robert Jesse (ex officio)
Dr. Ron G. King
Dr. Barbara A. Konkle
Dr. Fernando D. Martinez
Dr. Bruce M. Psaty
Dr. Véronique Lee Roger
Dr. Anna Maria Siega-Riz
Dr. Jeffrey A. Whitsett
Dr. Phyllis Zee (ad hoc)
Council Member attending via videoconference
Dr. Bradford C. Berk
Board of External Experts attending
Dr. Edward J. Benz
Dr. Eric Boerwinkle
Dr. Aravinda Chakravarti
Dr. Barry S. Coller
Dr. Allen W. Cowley
Dr. Ronald G. Crystal
Dr. Karina W. Davidson
Dr. Geoffrey S. Ginsburg
Dr. Christopher B. Granger
Dr. Philip Greenland
Dr. Judith S. Hochman
Dr. Deborah Nickerson
Dr. Douglas Rader
Dr. Paul M Ridker
Dr. David Scadden
Dr. James T. Willerson
Dr. Stacey Adam, Deloitte
Mr. Dane Christiansen, Health & Medical Counsel of Washington
Ms. Alia Knaban, American Society of Hematology
Mr. Chandon Karnik, Deloitte
Ms. Claudia Louis, American Heart Association
Ms. Nuala Moore, ATS
Dr. Karen Mowrer, Lewis-Burke Associates
Dr. Alison Denton, Decision Lens
Ms. Michelle Rodrigues, SRI
Dr. Sarah Ronnebaum, Deloitte
Ms. S.B. Sepelak, Social & Scientific Systems
Ms. Phyanka Sirio, SRS
Mr. Daryl Sng, Deloitte
Dr. Jill Stevens, Social & Scientific Systems
Ms. Katelin Young, Decision Lens
NIH Center for Scientific Review attending
Dr. John Firrell
NHLBI Staff attending
A number of NHLBI staff were in attendance.
I. CALL TO ORDER
Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI), welcomed members to the 262nd meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC).
II. REPORT OF THE STRATEGIC VISION GOAL GROUPS
Four different working groups, each focusing on one of the four goals of the under-development strategic vision, reported on the outcomes of their efforts to select compelling questions and critical challenges that should be considered for inclusion in an upcoming public report. The working groups also noted the high priority topic areas into which the questions and challenges fell.
III. FIRST DAY’S CLOSING REMARKS BY DR. JAMES P. KILEY
Dr. Kiley, Director of the Division of Lung Diseases, gave closing remarks on the meeting’s first day, thanking the working groups for their hard work and identifying cross-cutting themes in the topics that the groups had selected. He also outlined the next steps the Institute will take in developing a strategic vision, including determining whether any research topics identified as compelling questions or critical challenges are already being funded in some way by the NHLBI.
IV. ADMINISTRATIVE ANNOUNCEMENTS
On the second day of the meeting, Dr. Stephen C. Mockrin, Director of the Division of Extramural Research Activities, made the standard administrative announcements and outlined the day’s agenda.
V. REPORT OF THE DIRECTOR
Dr. Gibbons began by welcoming Dr. Amy Patterson to the leadership team; Dr. Patterson is the Director of the Scientific Research Program, Policy, and Strategic Initiatives. He then remarked on the following topics:
NIH Strategic Plan: The recent Congressional funding law requires NIH to develop a strategic plan.
Portfolio Analysis: Dr. Gibbons described the findings from an internal analysis of the NHLBI research portfolio and noted that the Institute is considering whether changes are needed in the distribution of funds to certain programs.
Precision Medicine Initiative: Dr. Gibbons also highlighted recent preliminary steps NIH is taking to carry out President Obama’s Precision Medicine Initiative as well as steps the NHLBI is taking to align its efforts with the initiative. For example, the NHLBI is funding the sequencing of the genomes of patients who are part of various NHLBI-funded cohort studies.
R35 Funding Mechanism: Dr. Gibbons stated that the Institute is evaluating the experience of the National Cancer Institute and the National Institute of General Medical Sciences with a new funding mechanism, the R35 grant that invests in a particular scientist rather than in a particular project. The NHLBI is weighing the advantages and disadvantages of this approach and considering whether to adopt the funding mechanism.
Management of Clinical Trials: Dr. Gibbons informed the Council that a task force is examining ways to achieve better selection of clinical trials to fund and more effective management of those trials once they begin. The task force has made 42 recommendations.
VI. OBSERVATIONS ON CLINICAL RESEARCH: SOME IDEAS FOR NHLBAC
Oregon Health & Science University management professor David Dilts made a presentation on his research into the processes for managing clinical trials and how adjusting those processes can improve the efficiency and value of clinical trials. To illustrate the importance of studying management processes, he described his work in mapping out the processes for opening clinical trials and his discovery that a third of the steps could be eliminated. He also discussed his finding that if a trial does not open quickly enough it will not achieve sufficient patient enrollment to be effective. Moreover, his research has shown that establishing deadlines for opening a trial has proven to be an effective means of ensuring clinical trials open on time. In reviewing these findings and others, Dr. Dilts emphasized that in striving to be a learning organization, NHLBI should study the outcomes of its management processes and make continual refinements to improve its funding and oversight of research.
VII. NHLBI INITIATIVE CONCEPTS
The initiatives were presented by NHLBI staff and Council engaged in detailed discussions. While generally supportive, members had a number of questions and recommendations for consideration prior to their approval. The NHLBI will consider the recommendations of the BEE and the Council, as well as other budgetary and programmatic issues in determining which of the proposed initiatives, if any, to implement.
Title: The Role of the Human Virome in Heart, Lung, and Blood Health and Resilience (R21/33)
Objectives: The goal of this initiative is to support studies that evaluate how the human virome interacts with its host and the molecular and physiological mechanisms by which the virome may affect heart, lung, and blood (HLB) health and resilience.
Title: New Technologies for the Heart, Lung, and Blood Virome (R41/R42, R43/R44)
Objectives: The goal of this solicitation is to facilitate the development of new technologies to harvest, detect, and sequence viruses that relate to heart, lung, and blood health.
Title: Onsite Tools and Technologies for Heart, Lung, Blood, and Sleep Clinical Research at the Point-of-Care (R41/42, R43/44)
Objectives: The objective of this renewal is to support the development and practical application of novel, innovative point-of-care (POC) technologies to guide diagnostic and therapeutic efforts in heart, lung, blood, and sleep disorders.
Title: Pediatric Heart Network Renewal (U10)
Objectives: The objective of this initiative is to improve patient outcomes through clinical trials and other clinical studies of pediatric acquired heart disease and congenital heart disease.
Title: Progenitor Cell Translational Consortium (U01)
Objectives: The objective of the initiative is to translate advances in progenitor cell biology into clinical applications.
Title: The National Health and Nutrition Examination Survey (NHANES), Cardiovascular, Pulmonary, and Sleep Component (Y01)
Objectives: The objective of the initiative is to gather nationally representative data on the prevalence of heart, lung, blood, and sleep disorders and disease and their risk factors.
Title: Action to Reduce the Risk of Gestational Hypertension (MOU/TBD)
Objectives: The objective of this initiative is to determine through a clinical trial whether treating maternal sleep apnea in women reduces their risk of developing gestational hypertension.
Title: Clinical Trial Pilot Studies (R34)
Objectives: The objective of this initiative is to support studies that are critical for investigators to make decisions about the designs of important clinical trials in the prevention and treatment of heart, lung, blood, and sleep disorders.
Title: Identification of Gene Variants for HLB-Related Complex Diseases by Using Whole Genome Sequencing Approach (UM1, X01)
Objectives: The objective of this initiative is to identify gene variants underlying complex heart, lung, and blood (HLB) disease phenotypes by applying whole genome sequencing (WGS) to tens of thousands of well-phenotyped subjects and creating the NHLBI’s largest medical genomic dataset.
Title: Impact of Age on Currently Employed Animal Models of Disease, Conditions, and Environmental Exposures: Demonstration Projects (UH2/UH3)
Objectives: The goal of this program is to test whether or not the age of an animal model is an important consideration in disease pathology or response to therapy, intervention, or environmental exposure.
Title: Mechanisms of Inhaled Nicotine Action in Lung and Heart Health and Disease (R01)
Objectives: The purpose of this initiative is to stimulate mechanistic research on the pathophysiological effects of inhaled nicotine on the pulmonary and cardiovascular system in the context of non-cancerous diseases.
Title: Open-Source Idiopathic Pulmonary Fibrosis (IPF) Laboratory (UH2/UH3, U01)
Objectives: This new initiative is intended to support clinical research and enable precision medicine in idiopathic pulmonary fibrosis.
Title: T4 Translation REsearch Capacity Building INitiative in Low-Income Countries (TREIN) (U24)
Objectives: The goal of T4 Translation TREIN is to catalyze in-country T4 research network development linked with a high-quality heart, lung, and blood diseases and sleep disorders (HLBS) research platform.
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 approved 1,748 applications requesting $3,839,472,309 in total direct costs.
The meeting was adjourned at 1:45 p.m.