NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL

MEETING MINUTES

October 26, 2010

 

 

I. CALL TO ORDER AND OPENING REMARKS - Dr. Susan B. Shurin

Dr. Susan Shurin, Acting Director of the National Heart, Lung, and Blood Institute (NHLBI), welcomed members to the 240th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC). [Top of Page]

Council Updates

Dr. Shurin recognized five Council members who are retiring:

  • Ms. Jeanine Arden Ornt
  • Dr. Shaun Coughlin
  • Dr. Joe Garcia
  • Ms. Paula Polite
  • Dr. Steven Shapiro

Invited Guests:

Dr. Shurin welcomed representatives of three NHLBI Advisory Committees:

  • Dr. C. William Balke, representing the NHLBI Institutional Training Mechanism Review
  • Dr. Charles Czeisler, representing the Sleep Disorder Research Advisory Board
  • Dr. Curt D. Sigmund, representing the Heart, Lung, and Blood Program Project Review Committee

Dr. Edward Benz of the Sickle Cell Disease Advisory Committee and Dr. Julio Panza of the Clinical Trials Review Committee were unable to attend.
Dr. Paul R. McCurdy, former Chief of the NHLBI Bone Marrow Transplantation Branch and Director of the NHLBI Blood Resources Program prior to his retirement, died on September 7, 2010. Dr. McCurdy was instrumental in advancing the field of stem cell transplantation and promoting blood safety.

II. REVIEW OF CONFIDENTIALITY AND CONFLICT OF INTEREST – Dr. Susan B. Shurin

The Council was reminded that under Public Law 92-463, the Federal Advisory Committee Act, a portion of the meeting would be closed to the public, for the consideration of grant applications and review of the intramural program. 
Dr. Shurin also reminded the Council members that they are Special Government Employees and are subject to Departmental conduct regulations.

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III. REPORT OF THE DIRECTOR – Dr. Susan B. Shurin

Budget Update:

The NIH is currently operating under a Continuing Resolution, which means that the NHLBI must operate at its FY 2010 budget level of $3,095,812,000.  Dr. Shurin reviewed the Institute's proposed FY 2011 President's Budget, which totals $3,187,516,000, a 3.0 percent increase over the FY 2010 actual budget.  No substantial changes in the distribution between mechanisms are anticipated for FY 2011.  The budget reflects Congressionally-mandated increases in salary support and stipends for training grants.
Dr. Shurin noted that the NIH is anticipating the resubmission in FY 2011 of a substantial number of applications initially submitted for funding under the American Recovery and Reinvestment Act (ARRA), which will most likely exacerbate recent declines in the success rate.  The NHLBI is planning carefully in order to preserve current levels of investigator-initiated awards.  Dr. Shurin highlighted several large NHLBI ARRA projects, including an exome sequencing project, a translational research implementation program, and efforts toward building the scientific workforce. (See NHLBI and the Recovery Act.)

Institute Update:

The Institute is celebrating the 100th anniversary of the initial description of sickle cell anemia by Dr. James Herrick with the James B. Herrick Symposium - Sickle Cell Disease Care and Research: Past, Present, and Future.

NIH-Level Issues:

Dr. Shurin noted several NIH-level issues:

  • A preliminary injunction issued on August 23, 2010, by the U.S. District Court for the District of Columbia halted the use of federal funds for human embryonic stem cell research.  As of October 25, 2010, NIH-supported stem cell research was allowed to continue pending appeal. (See NIH Stem Cell Information.)

  • The NIH Scientific Management Review Board Sub-Working Group on Substance Use, Abuse and Addiction recommended creation of a new Addiction Institute wherein all relevant addiction research portfolios from the National Institute on Alcohol Abuse and Alcohol (NIAAA), the National Institute on Drug Abuse (NIDA), and other Institutes/Centers (ICs) would be integrated.  The NIH Director has authority to accept or reject the recommendation.

  • The Cures Acceleration Network, part of the Patient Protection and Affordable Care Act signed into law by President Obama on March 23, 2010, will seek to reduce the time it takes to develop new treatments and cures for debilitating and life-threatening diseases by reducing barriers between laboratory discoveries and clinical trials.  The FY 2011 President's Budget identifies $50 million for the Network.

  • The NIH has completed a therapeutics inventory to identify activities (including development of drugs, biologics, and devices) underway at the NIH, with the goal of accelerating translational medicine and advancing therapeutics development.  The NHLBI is carefully considering where in the drug development pipeline to focus its investments.

  • The NIH will be reconfiguring its diversity programs (in light of relevant legal decisions) to focus on populations defined as disadvantaged, rather than on race or ethnicity.  Future Funding Opportunity Announcements will include revised NIH diversity language and state the IC's compelling need.  The NIH Diversity Task Force will assess workforce diversity at the NIH and make recommendations to the NIH Director on diversification of the intramural and extramural workforce.  Dr. Shurin represents the NHLBI on the Task Force.
  • The Patient-Centered Outcomes Research Institute (PCORI), a non-profit, non-governmental body authorized under the Patient Protection and Affordable Care Act, was established to help stakeholders make informed health decisions.  (See article entitled "Patient-Centered Outcomes Research Institute: The Intersection of Science and Health Care" by Drs. Carolyn Clancy and Francis S. Collins in Science Translational Medicine, June 23, 2010).

  • The NIH faces a number of challenges in the area of comparative effectiveness research (CER) including, setting criteria for priorities, supporting next generation CER, and helping researchers use observational data.  (See article entitled "Using Science to Improve the Nation's Health System: NIH's Commitment to Comparative Effectiveness Research" by Drs. Michael S. Lauer and Francis S. Collins in JAMA, June 2, 2010.)

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IV. DIFFERENTIAL PAYLINE ANALYSIS – Dr. Carl Roth

Dr. Carl Roth, Acting Deputy Director and Associate Director for Scientific Program Operation, NHLBI, reviewed the genesis of the Institute's differential payline policy instituted in FY 2010, and summarized initial results.  Review of the NIH peer review system, initiated in June 2007, emphasized the need for new policies to ensure that the largest number of meritorious applications receive funding earlier in order to improve the efficiency of the peer review system and reduce the burden on applicants and reviewers from increased numbers of resubmissions.


In 2008, the NHLBI conducted a thorough analysis of its prior application submission data and presented the results to Council in October 2008.  The data showed that about 80 percent of applications from established investigators (85 percent from new investigators) with an initial (i.e., unamended) application score at the 20th percentile were eventually funded.  The data also showed a marked shift toward funding of second amendments and away from initial applications.  A proposed policy—to rank order applications separately by percentile score within amendment status (i.e., initial application [A0], first amendment [A1], second amendment [A2]) and pay to equivalent success rates within amendment status—was enthusiastically endorsed by Council, and subsequently disseminated to the research community (see Translating NIH Peer Review Changes into Funding Policies.)  Funding guidelines reflecting the new policy were posted in March 2009, and revised funding guidelines (reflecting a less stringent policy regarding maintaining equivalent success rates) were posted in October 2009.  (During the same period, the NIH issued a notification that beginning with the January 2009 application receipt date, all initial applications would be permitted only a single amendment.)


Dr. Roth presented results from a recent analysis of FY 2010 NHLBI submission data, comparing the difference (in number of awards by amendment status for Research Project Grants [R01s]) between the Institute's actual differential payline policy for FY 2010 and a theoretical policy of equal paylines across amendment status.  The data indicate several benefits of the differential payline policy.

For non-Early Stage Investigators:

The differential payline policy eliminated the need for reapplication and re-review for 15 additional outstanding A0 applications.

  • Under the differential payline policy, 160 A0s, 162 A1s, and 78 A2s were awarded within payline (solicited R01s were excluded).  If a policy of equal paylines across amendment status had been used, the corresponding number of awards would have been 145 A0s, 177 A1s, and 88 A2s.
  • The NHLBI FY 2010 paylines were the 16th percentile for A0s, 12th percentile for A1s, and 10th percentile for A2s; a policy of equal paylines across amendment status would have resulted in a payline at the 13th percentile (with additional monies left over to fund projects at the 14th percentile depending on selection criteria).

For Early Stage Investigators (ESIs):

The differential payline policy enabled funding of 15 additional Type 1 ESI projects that were between the 24th and 26th percentiles. It also enabled two additional first renewal ESI awards between the 19th and 21st percentiles.  (Note: NHLBI policy currently stipulates that regardless of amendment status, the paylines for new competing [Type 1] and First Renewal [Type 2] ESI R01 applications will be 5 percentile points beyond the regular R01 payline for unamended applications.  In addition, and also regardless of amendment status, Type 1 ESI R01 applications that are >5 but <=10 percentile points beyond the regular R01 payline for unamended applications typically undergo an expedited review to resolve comments in the summary statements and were usually funded in FY 2010.)

  • Under the differential payline policy, 105 first-ever ESIs (Type 1 A0s) were awarded; if a policy of equal paylines across amendment status had been used, 90 first-ever ESIs would have been awarded.

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V. CRITERION SCORES AND IMPACT SCORES — ANALYSIS – Dr. Carl Roth

Dr. Roth presented results of an analysis of the revised scoring system and enhanced review criteria for competing NIH applications that were instituted beginning with the summer 2009 review cycle (see Enhancing Peer Review at NIH: Improve the Quality & Transparency of Review).         

Dr. Roth explained a regression analysis that related Impact scores assigned to NHLBI R01 applications in the October 2010 Council Round with the respective individual criteria scores for Significance, Innovation, Approach, Investigator(s), and Environment.  Results showed that the Impact score was affected by the Approach score far more than by any other criterion score.  NIH-wide analyses have shown similar results.

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VI.NHLBI RESEARCH IN CARDIOVASCULAR MAGNETIC RESONANCE IMAGING (MRI):
CLINICAL IMPACT, TECHNICAL DEVELOPMENTS, AND FUTURE DIRECTIONS – Dr. Andrew Arai and Dr. Peter Kellman

Dr. Andrew Arai, Chief of the Cardiovascular and Pulmonary Branch, Division of Intramural Research, NHLBI, and Dr. Peter Kellman, Staff Scientist at the Laboratory of Cardiac Energetics, Division of Intramural Research, NHLBI, discussed NHLBI's bench-to-bedside research program in cardiovascular MRI, which includes:

  • Technical developments in cardiovascular MRI. (Dr. Kellman is highly involved in  developing motion-corrected rapid imaging methods.)
  • Use of MRI in acute coronary syndrome.
  • MRI-guided interventions and MRI-guided robot surgery.
  • Diagnostic and interventional research in pediatrics and congenital heart disease.

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VII. REPORT OF THE BOARD OF EXTERNAL EXPERTS AND INITIATIVE CONCEPTS FOR FISCAL YEARS 2011 AND BEYOND – Dr. Susan B. Shurin

NHLBI staff presented 10 new initiatives, 5 renewals, and 2 requests by other ICs for secondary support, all of which had been reviewed in September by the Board of External Experts (BEE). Initiative development at the NHLBI is a two-cycle process.  First, staff within each extramural division develops ideas and potential initiatives, which they present to the trans-NHLBI Idea Forum. Sufficiently developed initiatives are subsequently considered by the BEE, which ranks each and provides accompanying advice.

The Council was mostly supportive of the initiatives presented, but made a number of specific recommendations for consideration prior to their release.  The Acting Director, NHLBI, will consider the recommendations of the BEE and the Council and other budgetary and programmatic issues in determining which of the proposed initiatives, if any, to implement.

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VIII.PRESENTATION OF INITIATIVES

Strategic Plan Goal I: To improve understanding of the molecular and physiological basis of health and disease, and to use that understanding to develop improved approaches to disease diagnosis, treatment, and prevention:

Basic Research in Calcific Aortic Valve Disease (R01), RFA

To improve understanding of the molecular and physiological basis of calcific aortic valve disease, and to use that understanding to improve diagnosis, treatment, and prevention.

Council recommended this initiative.

Discovery of Genetic Basis of Mendelian/Monogenic HLB Disorders (X01), RFA

To determine the genetic basis of Mendelian or monogenic heart, lung, or blood disorders. The NHLBI plans to leverage an initiative currently under development by the National Human Genome Research Institute (NHGRI) to establish a Center for Mendelian Disorders which will use an exome or whole-genome sequencing approach to identify the molecular basis of Mendelian disorders.

Council recommended this initiative.

Omics in Latinos — A 3rd Generation GWAS Resource (N01), RFP

To identify rare and common genetic variants and to measure context-dependent effects among members of the Hispanic Community Health Study/Study of Latinos. Third generation genotyping and next-generation sequencing will be combined with proteomics and metabolomics in a multi-layered analytical approach.

Council recommended this initiative.  

Pulmonary Vascular-Right Ventricular Axis Research Program (R01), RFA

To identify molecular and cellular mechanisms of right ventricular function and dysfunction, and to define human right ventricular disease in the setting of lung vascular pathology.

Council recommended this initiative.  

Towards Maximizing the Scientific Return on the Women's Health Initiative Biological Resource (N01), Broad Agency Announcement

To maximize the scientific yield from the Women’s Health Initiative (WHI) cohort—a large, diverse, and extensively-phenotyped cohort of older women in the United States—by applying new high-throughput technologies to the WHI biologic resource in order to improve understanding of the cardiovascular risk burden of older women in the United States.

Council recommended this initiative.  

Strategic Plan Goal II: To improve understanding of the clinical mechanisms of disease and thereby enable better prevention, diagnosis, and treatment:

Cardiovascular Cell Therapy Research Network (U01; renewal), RFA To extend the Cardiovascular Cell Therapy Research Network for a second project period to continue to create and maintain an environment and infrastructure that promotes promising research in the use of cell-based therapies for treatment of cardiovascular diseases.

Council recommended this initiative.  

Cardiovascular Health Study — Core Support Renewal (N01; renewal), RFP

To extend support for the Cardiovascular Health Study (CHS) infrastructure in order to facilitate continued access to study resources and expertise by investigators new to the CHS; promote scientific productivity, collaboration, and mentorship of junior investigators; and provide analytic support to existing CHS working groups and facilitate establishment of a new health services research working group.

Council recommended this initiative.  

Clinical Trials Planning Experimental Program for Hemostatic and Thrombotic Disorders (U24, U34), RFA

To support development of feasible, well-designed, multicenter clinical trials focused on rare hemostatic and thrombotic disorders via a two-component experimental program comprising clinical trial planning grants (U34 mechanism) and consultative services (U24 mechanism).

Council recommended this initiative.  

Early-Phase Clinical Trials for Blood Cell Therapies (R01/U01), PAR

To enable early-phase (first-in-human, Phase I, or Phase II) clinical trials of innovative cell therapies to treat blood diseases and improve the outcome of hematopoietic stem cell transplantations.

Council recommended this initiative.  

Gene Therapy Resource Program for Heart, Lung, and Blood Diseases (N01; renewal), RFP

To support gene therapy research by providing resources for NHLBI investigators in the areas of preclinical and clinical-grade vector production, pharmacology/toxicology studies, and regulatory documentation, and by providing funding assistance for Phase I/II clinical trials.

Council recommended this initiative.  

Phase II Clinical Trials for Evaluation of Novel Therapies for Lung Diseases and Sleep Disorders (U01; renewal), RFA

To support Phase II clinical treatment trials (and closely related, ancillary mechanistic studies) of innovative, new agents for lung diseases and sleep disorders.

Council recommended this initiative.

Short Term Institutional Training Grant for Clinician Scientists in Pediatric Respiratory, Sleep, and Hematology/Transfusion Medicine (T35), RFA

To increase the pool of medical students interested in an academic career in pediatric respiratory, sleep, or hematology/transfusion medicine.

Council recommended this initiative.  

Strategic Plan Goal III: To generate an improved understanding of the processes involved in translating research into practice and use that understanding to enable improvements in public health and to stimulate further scientific discovery:

Cardiovascular Research Network (U19 or N01; renewal), RFA or RFP

To build on the existing structure and unique strengths of the Cardiovascular Research Network (CVRN), thereby continuing to facilitate CVD research across multiple health plans; expand access to study resources and expertise by external investigators and institutions; conduct enhanced observational studies to support health services research and large-scale epidemiology; assess the feasibility and efficiency of planning and conducting cluster or pragmatic randomized trials in the CVRN; enhance the CVRN Virtual Data Warehouse by incorporating high-priority cardiovascular data elements that are not currently included; support the CVRN’s ability to contribute rapidly to emerging, high-priority cardiovascular issues; and begin expansion of the CVRN to non-HMOs.

Council recommended this initiative.  

Pilot Studies to Develop and Test Novel, Low Cost Methods for the Conduct of Clinical Trials in Common Diseases with Low Event Rates (R01), RFA

To support the development and pilot testing of new, low cost methodologies for conducting clinical trials that test interventions to reduce morbidity and mortality in common diseases with low clinical event rates.

Council recommended this initiative.

Virtual Reality Technologies for Research and Education in Obesity and Diabetes (R01, R33/R21, R43/R44, R41/R42), RFA

To develop the potential of Virtual Reality technologies as research tools for behavioral science-oriented studies in diabetes and obesity, and as practical tools for clinical and public health-level prevention and management of obesity and diabetes. Virtual Reality technology allows users to interact with (rather than simply observe) computer-simulated environments.

Council recommended this initiative.  

Request for Secondary Support Lifestyle Interventions in Overweight and Obese Pregnant Women Consortium and Research Coordinating Unit (U01) [NIDDK], RFA

To support randomized controlled trials testing behavioral/lifestyle interventions in overweight and obese pregnant women that are designed to control gestational weight gain and/or improve metabolic outcomes in both the pregnant women and their offspring.

Transfusion and Short-Term and Long-Term Outcomes in Children Receiving Extracorporeal Membrane Oxygenation (U10) [NICHD], RFA

To compare and evaluate the effects of different transfusion strategies on clinical and neurodevelopmental outcomes in children receiving extracorporeal membrane oxygenation.  

CLOSED PORTION

This portion of the meeting was closed to the public in accordance with the determination that it concerned matters exempt from mandatory disclosure 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).

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IX.Intramural Review

Reports prepared by the Board of Scientific Counselors (BSC), NHLBI, on the NHLBI intramural laboratories reviewed during FY 2009 were presented to the Council by Dr. Robert Balaban, Director, Division of Intramural Research, NHLBI; Dr. Gary Owens (Retired BSC Chair), University of Virginia; and Dr. Michel I. Kotlikoff, (Acting BSC Chair), Cornell University.

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.

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X.Review of Applications

The Council considered 1,239 applications requesting $1,558,462,129 in total direct costs. The Council recommended 1,239 applications with total direct costs of $1,558,462,129.

ADJOURNMENT

The meeting was adjourned at 3:25 p.m. on October 26, 2010.  

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