NIAID Council Minutes: June 4, 2018

The 189th meeting of the National Advisory Allergy and Infectious Diseases Council (NAAIDC) convened at 10:30 a.m. on Monday, June 4, 2018, in Conference Rooms E1/E2, Building 45, National Institutes of Health. Dr. Anthony S. Fauci, director, National Institute of Allergy and Infectious Diseases (NIAID) presided as chair.

In accordance with the provisions of Public Law 92-463, the meeting was open to the public from 10:30 a.m. to 11:45 a.m. and from 1:00 p.m. to 3:15 p.m. The meeting was closed to the public from 8:30 a.m. to 9:45 a.m. and from 11:45 a.m. to 12:00 noon for review and consideration of individual grant applications. Notice of the meeting was published in the Federal Register.

Meeting Attendees

Council Members Present:

Dr. Aftab Ansari
Dr. Wendy Book
Dr. Amanda Castel
Dr. Stephen Galli
Dr. John Guatelli
Dr. Sally Hodder
Dr. Gurjit Khurana Hershey
Dr. Karen Nelson
Dr. Robin Patel
Dr. Cara Wilson

Ex Officio Members Present:

Dr. Victoria Davey
Dr. Anthony Fauci

Ad Hoc Members Present:

Dr. Carlos Camargo
Dr. Ana Fernandez-Sesma
Dr. Tina Hartert

Council Members Absent:

Dr. Raul Andino
Dr. Mark Feinberg
Dr. Stanley Lemon

Ex Officio Members Absent:

Dr. Rima Khabbaz

NIAID Senior Staff Present:

Dr. Hugh Auchincloss
Dr. Carl Dieffenbach
Dr. Emily Erbelding
Dr. Jill Harper
Dr. Cliff Lane
Dr. Susan Old
Dr. Daniel Rotrosen

Table of Contents

I. Review of Grant Applications
II. Remarks of the Director, NIAID—Anthony S. Fauci, M.D.
III. Guest Speaker
IV. Report of the Allergy, Immunology, and Transplantation Subcommittee—Daniel Rotrosen, M.D., director, DAIT
V. Report of the Microbiology and Infectious Diseases Subcommittee–Emily Erbelding, M.D., M.P.H., director, DMID
VI. Joint Meeting of the AIDS Subcommittee and AIDS Research Advisory Committee (ARAC)–Carl Dieffenbach, Ph.D., director, DAIDS
VII. Adjournment

I. Review of Grant Applications

The National Advisory Allergy and Infectious Diseases Council convened in closed session to consider applications in allergy and immunology, microbiology and infectious diseases, and AIDS.

Funding Actions: The Council reviewed 4,450 research and training applications with primary assignment to NIAID for a requested amount of $1,605,672,380 in first-year direct costs and recommended approval of 2,147 applications with $657,110,675 in first-year direct costs.

II. Remarks of the Director, NIAID—Anthony S. Fauci, M.D.

Dr. Fauci opened the Council session by welcoming visitors to the meeting and noting that two Council members—Drs. Cara Wilson and Wendy Book—were joining the meeting by telephone. He introduced two ad hoc members: Dr. Carlos Camargo, professor of emergency medicine and epidemiology at Harvard, and Dr. Tina Hartert, professor of medicine and director of the Center for Asthma Research and vice president for translational sciences at Vanderbilt. One pending Council member also attended as an ad hoc, Dr. Ana Fernandez-Sesma, professor in the Department of Microbiology at Mount Sinai.

Council members Drs. Raul Andino, Stanley Lemon, and Mark Feinberg, and ex officio member Dr. Rima Khabbaz were unable to attend the meeting.

Consideration of Minutes of Previous Meeting

Council considered the minutes of the January 29, 2018 meeting and approved them as written.

Staff and Organizational Changes

In late March, Dr. Robert Redfield was named director of the Centers for Disease Control and Prevention. He co-founded the University of Maryland’s Institute of Human Virology and has served as chief of infectious diseases and vice chair of medicine at the University of Maryland School of Medicine.

Dr. Fauci announced several new appointments to leadership positions in the Division of AIDS (DAIDS). Dr. Sarah Read is the new deputy director. She previously served as the director of the Therapeutics Research Program (TRP) in DAIDS. Dr. Peter Kim has been selected as the new director of TRP, which funds the development of evaluation of therapeutic strategies for HIV and related co-infections and comorbidities. Dr. Elizabeth Church will serve alongside Dr. Kim as the new deputy director of TRP. Dr. Patrick Jean-Philippe is the new chief of the Maternal, Adolescent, and Pediatric Research Branch in the Prevention Sciences Program (PSP). Dr. Sheryl Zwerski has been chosen as PSP’s new director.

In the Division of Microbiology and Infectious Diseases (DMID), Dr. John Beigel has been named associate director for clinical research, and Dr. Alan Embry is the new chief of the Respiratory Diseases Branch.

Dr. Dana Scott has been selected as chief of the Rocky Mountain Veterinary Branch.

Tributes and Awards

Dr. Helen Su, chief of the Human Immunological Diseases Section in the Laboratory of Clinical Immunology and Microbiology, received the Society of Pediatric Research E. Mead Johnson Award for her research defining molecular mechanisms of inherited human immunological diseases, understanding the function of the DOCK8 gene in health and human disease, and elucidating innate immunoregulatory mechanisms for control of respiratory virus infections in humans.

Dr. Barney Graham, deputy director of the Vaccine Research Center (VRC) and chief of the Viral Pathogenesis Laboratory and Translational Science Core, and Dr. Ted Pierson, chief of the Laboratory of Viral Diseases, have been named finalists for the 2018 Samuel J. Heyman Service to America Medals for their work in rapidly developing a DNA vaccine against Zika virus.

Dr. Fauci paid tribute to three eminent researchers who recently passed away: Dr. Stanley Falkow, who discovered the molecular nature of antibiotic resistance and revolutionized our thinking about how bacteria cause disease; Dr. Fred Gordin, who was the founding principal investigator of the NIH-funded Community Programs for Clinical Research on AIDS; and Dr. David Cooper, a global pioneer of HIV research.

Meetings and Events

In early February, Dr. Fauci and Major Garrett, CBS News chief White House correspondent, recorded a podcast about influenza and developing a universal influenza vaccine.

Dr. Fauci joined HHS Secretary Alex Azar and other HHS officials on February 15 to provide an update for the media on the influenza season in the United States.

On March 2, Dr. Fauci discussed NIAID’s research programs, including pandemic preparedness efforts and developing a universal influenza vaccine, with the Public and Scientific Affairs Board of the American Society of Microbiology.

On March 6, Dr. Fauci met with Assistant Directors-General from the World Health Organization (WHO) to discuss opportunities for NIAID and WHO cooperation and shared interests, particularly antimicrobial resistance. After the meeting, Dr. Fauci and Dr. Cliff Lane gave the group a tour of the Clinical Center.

HHS Secretary Alex Azar visited NIH on March 20 and led a town hall meeting in Masur Auditorium. Afterwards he met with NIH leaders and toured the Clinical Center.

On March 29, Dr. Fauci participated in a breakfast for health and medical journalists, which was broadcast on C-Span, to provide a briefing on pandemic preparedness.

Dr. David Morens presented the John LaMontagne Memorial Lecture on April 10. He discussed how research on the 1918 flu virus and pandemic is informing current efforts to understand how and why new flu viruses with pandemic potential emerge.

WHO Director-General Dr. Tedros Adhanom Ghebreyesus met with NIH leaders at the Stone House on April 20. Dr. Fauci and Dr. Adhanom Ghebreyesus signed a WHO-NIAID Memorandum of Understanding to enhance future collaborations on research activities conducted in response to emerging infectious disease outbreaks and public health emergencies.

On May 1, Dr. Fauci participated in a symposium honoring the 50-year anniversary of the Fogarty International Center. He gave a talk on the challenges of conducting research in infectious disease outbreak settings and led a panel on the prospect of ending AIDS as a global health problem.

DMID convened the annual meeting of the Vaccine and Treatment Evaluation Units (VTEUs) on May 2. Investigators from all nine VTEUs gave scientific presentations of their work.

As part of his visit to NIH on May 3, Admiral Brett Giroir, who oversees 11 core public health offices, toured VRC and discussed the work being done there to develop a universal influenza vaccine.

On May 6, NIH officially launched the All of Us Research Program. The Program aims to enroll at least one million people across the United States and obtain biomedical data that will help gain unprecedented insights into biological, environmental, and behavioral influences of disease.

On May 9, Dr. Fauci participated in an event to mark the 15th anniversary of the President’s Emergency Plan for AIDS Relief (PEPFAR).

Barbara Streisand delivered the Rall Cultural Lecture on May 15 in Masur Auditorium. She spoke about women’s heart health and the importance of including women in biomedical research studies. During her visit, NIH Director Dr. Francis Collins and Dr. Fauci gave her a tour of the Clinical Center.

On May 18, “Outbreak: Epidemics in a Connected World,” opened at the Smithsonian National Museum of Natural History. The exhibit features case studies of many of the outbreaks with which NIAID has been involved, such as HIV, Ebola, and influenza. NIAID supported the project and provided scientific guidance.

In the last several months, international delegations from France, Poland, and Mali have visited NIAID to discuss areas of mutual interest.

Budget Update

For FY 2018, NIH and most institutes received an increase of about 5.4 percent. NIAID received a 7.5 percent increase over FY 2017, which included an additional $40 million for developing a universal influenza vaccine and an additional $50 million for antibiotic resistance research to continue activities related to the President’s National Strategy for Combating Antibiotic-Resistant Bacteria.

Dr. Fauci summarized NIAID’s financial management plan for FY 2018. The Institute’s R01 payline is the 13 percentile for established investigators and the 17 percentile for new investigators. NIAID will not make programmatic adjustments to competing, unsolicited awards; noncompeting grants; and research and development awards. Competing program initiatives have been cut by up to 10 percent in order to sustain investigator-initiated awards. NIAID’s estimated success rate will be between 21 and 23 percent.

On February 12, the President released his FY 2019 budget request to Congress, which includes an overall decrease to NIH of 4.8 percent or $2.5 billion below the FY 2018 operating level. Dr. Fauci noted that most institutes received reductions exceeding 7 percent. However, Congress will be deliberating the FY 2019 budget soon, and ultimately, it is responsible for authorizing appropriations.

Legislative Update

On February 16, Senator Maggie Hassan, a member of the Senate Committee on Health, Education, Labor and Pensions, visited NIH. Dr. Fauci met with her to discuss our high-priority research to develop a universal influenza vaccine. He also briefed majority and minority clerks for the Senate Appropriations Labor-HHS Subcommittee on May 11 about our strategic plan for developing a universal influenza vaccine and our progress on combating antibiotic resistance.

Dr. Fauci spoke about antimicrobial resistance research at a congressional briefing sponsored by the Pew Charitable Trusts and the Infectious Diseases Society of America on March 1.

On April 11, Dr. Collins, Dr. Fauci, Dr. Lawrence Tabak, and Dr. Nora Volkow participated in a congressional meet and greet event hosted by Representative Pete Sessions, where they had the opportunity to discuss important topics in biomedical research. Dr. Fauci updated the representatives on NIAID’s efforts to implement the NIAID strategic plan for a universal influenza vaccine.

On May 23, Dr. Fauci briefed the Senate NIH Caucus on what it will take to develop a universal influenza vaccine.

On March 8, Dr. Fauci testified before the House Energy and Commerce Subcommittee on Oversight and Investigations about the U.S. public health preparedness and response to seasonal influenza. He also testified about HHS biodefense activities before the House Labor-HHS Appropriations Subcommittee on April 18.

Dr. Collins testified before the House Labor-HHS Appropriations Subcommittee on April 11 and the Senate Labor-HHS Appropriations Subcommittee on May 17 regarding the President’s FY 2019 NIH Budget. Dr. Fauci accompanied him to both hearings.

Other Information Items

Dr. Fauci began by providing an update on the recent outbreak of Ebola in the Democratic Republic of the Congo (DR Congo). A vaccine tested at the NIH Clinical Center is being used in a ring vaccination program being conducted in DR Congo. He briefly outlined selected NIAID activities that are informing the Ebola outbreak response in DR Congo. Dr. Fauci also gave an update on the outbreak of Nipah virus in the Kerala State of India.

Dr. Fauci presented statistics from the recent influenza season, showing weekly reporting charts as the 2017-2018 season progressed and comparing influenza-like illness reporting for this season to previous ones. This was the worst influenza season we’ve had in the last 15 years with a high number of influenza-associated pediatric deaths. He emphasized the need for a universal influenza vaccine and summarized current studies underway to test candidates.

Finally, Dr. Fauci concluded by giving brief updates on Chikungunya vaccine research; malaria; diseases spread by mosquitoes, ticks, and fleas; tuberculosis; HIV; islet transplantation trial in Type 1 diabetes; food allergy; and multidrug-resistant Klebsiella pneumoniae.

III. Guest Speaker—John R. Mascola, M.D., director, Vaccine Research Center

Dr. John Mascola began by noting that VRC was founded as an HIV vaccine research center. However, over the last 15 years, VRC has developed major programs in respiratory syncytial virus (RSV), influenza, filoviruses, Ebola, Marburg, malaria, and tuberculosis.

Dr. Mascola gave an overview of VRC’s vaccine development pathway, which starts with basic research and has the capability to move a product through the pipeline to do first-in-human studies.

He highlighted two of VRC’s major areas of focus, RSV and influenza vaccine research programs.

First, he focused on RSV, giving some background about RSV and approaches to RSV vaccine development that have been tried and been unsuccessful. With continued research and a better understanding of the virus structure in the last seven to eight years, VRC established a new program on RSV vaccines. Dr. Mascola presented some early Phase I data from an RSV clinical trial and described two of the target populations for RSV prevention.

He continued by giving an update on VRC’s influenza vaccine program, highlighting some of the current research being done. For influenza, there is a major focus on numerous universal vaccine approaches, including structure-based, gene-based, and nanoparticle formats.

IV. Report of the Allergy, Immunology, and Transplantation Subcommittee—Daniel Rotrosen, M.D., director, DAIT

Dr. Rotrosen welcomed the subcommittee members to the 189th meeting of the National Advisory Allergy and Infectious Diseases Subcommittee meeting:

Dr. Rotrosen presented the following scientific and Division activities:

Staff and Organizational Changes

Zulmarie Perez Horta, Ph.D. Dr. Perez Horta joined the Radiation and Nuclear Countermeasure Program (RNCP) in August 2017, under an American Association for the Advancement of Science (AAAS) Science and Technology Policy fellowship. In her role, she will facilitate collaborative relationships with private industry and government partners. She will also serve as program officer for Radiation/Nuclear Research and Development grants and contracts. Dr. Perez Horta earned a dual B.S. in chemistry/biology from the University of Puerto Rico, Rio Piedras Campus. After conducting undergraduate research in organic chemistry and molecular biology, she became interested in translational science and completed her Ph.D. in cellular and molecular pathology at the University of Wisconsin in Madison. There she worked in the laboratory of Dr. Paul Sondel evaluating new immunotherapies for the treatment of pediatric cancer.

Selected Funding Opportunities

Autoimmunity Centers of Excellence (RFA-AI-18-002 and RFA-AI-18-003). The purpose of these funding opportunity announcements (FOAs) is to solicit applications to participate in the NIAID Autoimmunity Centers of Excellence (ACE), a cooperative network intended to improve the understanding, prevention, and treatment of autoimmune diseases (www.autoimmunitycenters.org). The ACE was founded on the premise that collaborations among basic and clinical scientists can accelerate both fundamental and applied research. The ACE combines basic (U19) and clinical (UM1) research programs. Members of the research programs will work together to conduct clinical trials with integrated mechanistic studies, including autoimmune disease pathogenesis and mechanisms of action of immune-modulating agents.

Investigations on Primary Immunodeficiency Diseases/Inborn Errors of Immunity (R01) (PAR-18-712). The purpose of this FOA is to advance the discovery and characterization of primary immunodeficiency diseases, also referred to as inborn errors of immunity, to understand the causes and mechanisms of disease, to enable early detection and molecular diagnosis, and to support the development of strategies to treat and eventually cure these disorders. This FOA is a re-issue of PAR-15-130.

Division Activities

Allergy, Asthma, and Airway Biology Branch

Immunology Assays for Allergy & Asthma Research and Allergy Network Summit. On February 1 and 2, 2018, NIAID organized a workshop in Rockville, Maryland. The goal was to discuss state-of-the-art laboratory assays/tests that could be used across DAIT-funded allergy-associated networks for harmonization between and within network studies. The meeting included a variety of invited experts as well as the leadership of the Atopic Dermatitis Research Network, Consortium for Food Allergy Research, Immune Tolerance Network, and Inner City Asthma Consortium networks. The first day discussed mechanistic tests and assays in the following areas: 1) B-cells and antibodies, 2) T-cells, 3) epithelium, ILCs, and APCs, 4) mast cells/basophils and eosinophils, and 5) “-Omics” research including transcriptomics, metabolomics, proteomics, and lipidomics. On the second day, network leadership and NIH staff met to discuss strategies for implementing the suggested technologies into the current and future network studies.

Early Events in the Development of Asthma. On March 2, 2018, NIAID organized a symposium as part of the annual meeting of the American Academy of Allergy and Immunology in Orlando, Florida. Five experts in the field presented lectures on topics including in utero events affecting development of asthma, early allergen sensitization and its consequences, early viral infections and early microbial exposures and effects on asthma, and lung function in infants with early wheezing.

Mast Cell Biology on the March: Lessons from the Asthma and Allergic Diseases Cooperative Research Centers (AADCRC). On March 3, 2018, NIAID organized a workshop as part of the annual meeting of the American Academy of Allergy, Asthma, and Immunology in Orlando, Florida. Three experts in the field presented lectures on topics including mast cell activation by MrgprX2/B2 receptors and regulation and function of type-2 mucosal mast cells in allergic disorders, and targeting mast cells as a treatment for asthma from the KIT in Asthma study.

The Epithelium as Boss: Lessons from the AADCRC. On March 4, 2018, NIAID organized a symposium as part of the annual meeting of the American Academy of Allergy, Asthma, and Immunology in Orlando, Florida. Three experts in the field presented lectures on topics including airway epithelium reprogramming and regulation of IL-13 by surfactant protein A2 in asthma, and SPINK7 in allergic inflammation.

Early Life Exposures Regulate Host Allergic Immune Responses: Lessons learned from the AADCRC. On March 5, 2018, NIAID held a symposium at the annual meeting of the American Academy of Allergy, Asthma, and Immunology in Orlando, Florida. Three experts in the field presented lectures on topics including the effects of the farming environment on immune development and childhood respiratory illnesses, identifying asthma-causing RSV strains and elucidating the mechanisms of RSV-mediated asthma development, and traffic related air pollution and childhood asthma.

Innate Immunity and Aspirin Exacerbated Respiratory Disease (AERD): Lessons learned from the AADCRC. On March 5, 2018, NIAID organized a symposium at the annual meeting of the American Academy of Allergy, Asthma, and Immunology in Orlando, Florida. Three experts in the field presented lectures on topics including ILC2 regulation of AERD, IL-22 in AERD pathogenesis, and TSLP slips into AERD.

Basic Immunology Branch

Human Immunology Project Consortium II (HIPC II) Annual Meeting. On March 12 and 13, 2018, the annual meeting of this renewed cooperative agreement research program was held in Rockville, Maryland. The HIPC II program (http://www.immuneprofiling.org/) is composed of nine U19 cooperative agreement awardees and is designed to characterize molecular profiles of human immune responses to infection or vaccination using systems immunology approaches. All of the data generated by the HIPC investigators are being made available to the broader research community through ImmPort (http://www.immport.org) and ImmuneSpace (https://www.immunespace.org/), a powerful data management and analysis engine for the exploration and analysis of HIPC-generated datasets using state-of-the-art computational tools. The HIPC II program is co-administered by the Basic Immunology and Allergy, Asthma, and Airway Biology Branches within DAIT, NIAID, and co-funded by all three NIAID extramural Divisions (DAIDS, DMID and DAIT).

Systems Immunology U19 Program. On April 4 and 5, 2018, the meeting of the Systems Immunology Program was held in Bethesda, Maryland. The goal of the Systems Immunology Program is to use forward genetic screening of mutated or genetically diverse mouse models, along with systems biology analytics, to develop a comprehensive understanding of innate and adaptive immune response triggered either by pathogens, adjuvants, or vaccines. Investigators from the three U19 programs presented their research projects and discussed scientific progress. In addition, they identified their unique mouse resources (Collaborative Cross inbred strains and their derivatives; mutated mice that are generated either by CRISPR/Cas-mediated loss-of-function; or ENU mutagenesis) and research technologies (single-cell analysis, CyTOF, CODEX, etc.) as the basis for future collaborations among the U19 programs. The meeting also featured two guest presentations from ImmPort, a DAIT-funded public data repository through which the U19 awardees are required to disseminate scientific data.

NIAID Blue Ribbon Panel on Adjuvant Research. On April 23 to 25, 2018, NIAID hosted a Blue Ribbon Panel to discuss the Institute’s adjuvant and adjuvanted-vaccine research portfolios. Staff from the three extramural divisions presented summaries of research activities related to adjuvant discovery, adjuvant development, the preclinical and clinical application of adjuvants to vaccines against infectious diseases, and NIAID’s response to the recommendations made by a panel convened in 2010. Panel members were also provided with a draft of the strategic plan for adjuvant research and charged with identifying gaps in NIAID’s approach to discovering and applying novel adjuvants to vaccines of interest to the Institute. The strategic plan, scheduled to be released in mid-2018, will be updated based on the panel’s recommendations.

Maternal Effects on Fetal Immunity. On May 6, 2018, NIAID organized a symposium at the American Association of Immunologists annual meeting in Austin, Texas. This session highlighted recent progress on defining immune mechanisms during pregnancy and reproduction. Investigators presented recent data and discussed immune regulatory mechanisms by the placenta, the role of nonclassical MHC molecules and their interaction with NK receptors, enhanced antiviral activity of CD38-expressing NK cells during pregnancy, and maternal and fetal T cell activation during preterm labor.

Autoimmune and Mucosal Immunology Branch

2018 United States Immunodeficiency Network (USIDNET) Face-to-Face Meeting: On January 26, 2018, the Steering Committee (SC) of the DAIT supported program, Resources to Assist Investigations in Primary Immunodeficiency Diseases (RFA-AI-13-054), met in Rockville, Maryland. The program supports a registry of clinical data from individuals diagnosed with primary immunodeficiency diseases, a repository of cells and other materials, and educational opportunities aiming to provide training and to encourage collaborative research. The USIDNET SC discussed progress, opportunities, and challenges and planned future directions.

Cancer, Autoimmunity, and Immunology Meeting. On March 22 and 23, 2018, the first meeting on Cancer, Autoimmunity, and Immunology was held in Bethesda, Maryland. The meeting was co-organized by the National Cancer Institute (NCI), NIAID, and National Institute of Arthritis and Musculoskeletal and Skin Diseases. The major goal of the meeting was to foster better understanding of the biology of immune-related adverse events which occur in cancer patients after treatment with checkpoint inhibitor immunotherapies. The meeting featured talks from many investigators working on various autoimmune diseases and cancer.

Radiation and Nuclear Countermeasures Program (RNCP)

2017 Annual Medical Countermeasures (MCM) U01 Meeting. On January 17, 2018, the U01 annual meeting was held in Bethesda, Maryland. The primary objective of this meeting was to allow investigators to present research progress made during the entire funding period of their programs. Represented were eight U01 grants funded to develop MCMs to mitigate radiation-induced hematopoietic, pulmonary, and gastrointestinal injuries. The meeting also facilitated continued dialog and collaboration among the U01 investigators and program staff regarding future research and development directions.

NIAID/BARDA/DoD/NASA Inter-Agency Update Meeting. On December 19, 2017 (biodosimetry) and April 19, 2018 (MCM), members of the NIAID RNCP met with program managers responsible for MCM and biodosimetry development within the Biomedical Advanced Research and Development Authority (BARDA). The purpose of the meeting, requested by the HHS Assistant Secretary of Preparedness and Response, was to provide programmatic transparency, and insure that the funded research across HHS and other government agencies continues to be aligned and there is no scientific overlap between the development portfolios.

Humanetics Corporation Kick-Off Meeting for Contract HHSN272201800011C. On April 24, 2018, NIAID held a kick-off meeting in Rockville, Maryland, to initiate the funding of a new contract with Humanetics Corporation in response to the NIAID Omnibus Broad Agency Announcement - Research Area 002: “Development of Radiation/Nuclear Medical Countermeasures.” The award is to further develop BIO 300 as a radiation medical countermeasure to mitigate delayed effects of acute radiation exposure in lungs. Under this contract Humanetics will conduct pharmacokinetic and efficacy studies to be used towards FDA licensure under the Animal Rule. BIO 300 is also being developed to prevent the onset of radiation-induced pneumonitis and pulmonary fibrosis in patients receiving chemoradiotherapy for non-small cell lung cancer through an NCI-funded Phase Ia/IIb clinical trial.

Innovation Pathways Kickoff Meeting for Contract HHSN272201800012C. On May 9, 2018, NIAID held a kick-off meeting in Rockville, Maryland, to initiate the funding of a new contract in response to the NIAID Omnibus Broad Agency Announcement HHS-NIH-NIAID-BAA2017-1, in Research Area 002: “Development of Radiation/Nuclear Medical Countermeasures.” The goal is to test a novel medical countermeasure to treat radiation-induced lung injury, which has shown promise in increasing survival in a rodent model, and to scale-up manufacturing of the drug and carry out large animal model pharmacokinetic, pharmacodynamic, and proof-of-concept efficacy studies. This contract will generate important data that will be used to approach the FDA, in order to seek licensure of the drug for use during a radiation public health emergency.

Concepts Presented for Clearance

FY 2019 Research Concept Clearances

Immune Response to Arthropod Blood Feeding (R21): The scientific objectives of this initiative are to:

  • Understand the immunological events in the vertebrate host, which occur during and after blood feeding by hematophagous arthropods, at the bite site (skin) and systemically.
  • Identify/characterize arthropod salivary components with immune modulatory properties.
  • Understand the immunological events in arthropods following a blood meal.

The subcommittee endorsed and unanimously approved this initiative.

Expanding Extramural Research Opportunities at the NIH Clinical Center: The goal of this FOA is to support extramural investigator-initiated clinical research in collaboration and partnership with intramural investigators at the NIH Clinical Center in Bethesda, Maryland.

The subcommittee endorsed and unanimously approved this initiative.

FY 2020 Research Concept Clearances

Nonhuman Primate (NHP) Radiation Survivor Cohort: This initiative will allow for the preservation of an extremely valuable, large animal resource. The ability to adopt, monitor, and treat NHP survivors of radiation exposure provides information that is critical to understanding the natural history of radiation exposures, to include early and late injuries and disease development.

The subcommittee endorsed and unanimously approved this initiative.

Centers for Medical Countermeasures Against Radiation Consortium (U19): The CMCRCs will operate in a flexible, cooperative, and multidisciplinary manner to provide comprehensive research support to develop medical products for civilian populations that will assess, diagnose, mitigate and/or treat the short- and long-term consequences of radiation exposure after a radiological/nuclear incident.

The subcommittee endorsed and unanimously approved this initiative.

Radiation Biodosimetry Assays and Devices: This initiative will enable both early and mid-stage research to accelerate the development of radiation biodosimetry assays and devices to rapidly assess radiation dose as well as to predict the consequences of immediate (days) and delayed (months to years) radiation effects to major organs in an individual.

The subcommittee endorsed and unanimously approved this initiative.

NIH Tetramer Core Facility: This initiative will support the continuation of the NIH Tetramer Core Facility, a reagent resource that provides custom-made MHC class I, non-classical MHC, and MHC class II tetramers; CD1 ligands; and related products to the research community worldwide.

The subcommittee endorsed and unanimously approved this initiative.

Atopic Dermatitis Research Network: This initiative aims to further improve our understanding of the defense mechanisms of the skin and host defense defects leading to infection susceptibility by focusing on differences in skin structure/function and in immune responses between patients with atopic dermatitis, healthy individuals, or disease controls.

The subcommittee endorsed and unanimously approved this initiative.

V. Report of the Microbiology and Infectious Diseases Subcommittee–Emily Erbelding, M.D., M.P.H., director, DMID

Director’s Report

Dr. Emily Erbelding, director of the Division of Microbiology and Infectious Diseases (DMID), chaired the NIAID Microbiology and Infectious Diseases Council Subcommittee meeting on June 4, 2018. Dr. Erbelding reported on recent personnel changes, including the appointment of Dr. John Beigel as DMID’s associate director for clinical research; the addition of Dr. Alan Embry as chief of DMID’s Respiratory Diseases Branch, and the selection of Dr. Diane Post to serve as the chief for Influenza, SARS, and Other Respiratory Viral Diseases Section within the Respiratory Diseases Branch.

Dr. Erbelding reported on recent evaluation activities related to two of the concepts being presented at the subcommittee meeting, the Leadership Group for an Infectious Diseases Clinical Research Consortium and Vaccine and Treatment Evaluation Units. She noted that surveys were conducted to gather input from current VTEU investigators and NIAID staff, and that an external review panel was assembled to consider the feedback received. She also informed the Subcommittee that she has travelled to most of the current VTEU sites to meet with principal investigators (PIs) and their staff. Dr. Erbelding noted that the results of this extensive evaluation are reflected in the administrative and scientific changes proposed in the concepts. Finally, she informed the Subcommittee of a video posted on the NIAID website describing DMID’s plans to revamp the clinical research enterprise and welcomed feedback from stakeholders about the proposed changes.

Concepts Presented for Clearance - The following concepts were presented to the Subcommittee:

Collaborative Influenza Vaccine Innovation Centers (CIVIC) (FY 2019)

This concept would support a new consortium to develop innovative influenza vaccines that provide robust, durable, broadly protective mucosal and systemic immunity (“universal” influenza vaccines) and improve the immunogenicity and durability of licensed seasonal influenza vaccines. The Subcommittee expressed strong support for this new concept. One Subcommittee member stressed the importance of industry collaboration for success and recommended engaging industry in innovative ways. Another Subcommittee member echoed the importance of bringing in disciplines and expertise from outside of the influenza field. Lastly, a Subcommittee member encouraged NIAID to include training for new investigators under the program. Another Subcommittee member noted the importance of developing improved influenza vaccines but expressed concern that supporting too many types of vaccine approaches may not be effective. Program responded that the intent is to support multiple vaccine approaches, including combination approaches, and perform head-to-head comparisons to identify and advance those that are most promising to clinical trials. The Subcommittee member also advised NIAID to ensure that the CIVICs do not overlap with other influenza vaccine programs. Program responded that DMID is working with other NIAID divisions to minimize overlap and to ensure that the CIVICs collaborate with and leverage existing NIAID resources and programs, both extramural and intramural. Another Subcommittee member questioned how a universal influenza vaccine will be defined. Program indicated that the definition NIAID is using is the one that was agreed upon at the NIAID “Pathway to a Universal Influenza Vaccine” workshop held in June 2017 which is a vaccine that is at least 75 percent effective against symptomatic infection from influenza A viruses, has durable protection that lasts for at least one year and preferably through multiple seasons, and is suitable for all age groups. The concept was unanimously approved by the Subcommittee.

Leadership Group for an Infectious Diseases Clinical Research Consortium and Vaccine and Treatment Evaluation Units (FY 2020) (Note: these concepts are closely aligned and were described in a single presentation).

The Subcommittee voiced support for the creation of a new Leadership Group for an Infectious Diseases Clinical Research Consortium, which would support the planning and implementation of clinical trials and studies that address the scientific priorities of NIAID in evaluating vaccines, biologics, therapeutics, diagnostics, biomarkers, and devices for infectious diseases, and the change in mechanism for the Vaccine and Treatment Evaluation Units program, which would support clinical trial sites to evaluate the aforementioned products. One Subcommittee member requested clarification regarding the involvement of industry partners in the activity of the Leadership Group; Program confirmed that the cooperative agreement mechanism would allow for industry collaboration and that DMID would continue to engage industry partners in the development of new infectious disease interventions. Another Subcommittee member noted that ideation and prioritization will be important concepts for the Leadership Group; Program explained that clinical research concepts could come from the expert working groups formed under the program, the VTEU PIs, DMID, and other outside collaborators, including international partners. The Subcommittee member also stated that the name “VTEU” is perhaps outdated and omits diagnostics in name and emphasis. Dr. Erbelding confirmed that diagnostics would be part of the new initiatives, especially with regards to sexually transmitted infections. One Subcommittee member stated that there would likely be overlap with the proposed Leadership Group for Antibacterial Resistance; Program confirmed that both Leadership Groups would collaborate and coordinate efforts to avoid duplication and to ensure that relevant scientific questions are being addressed. The concept was unanimously approved.

Leadership Group for a Clinical Research Network on Antibacterial Resistance (AR) (FY 2020)

The objective of this program is to address key clinical research questions in antibacterial resistance. The Subcommittee voiced support for the continuation of the Leadership Group for a Clinical Research Network on Antibacterial Resistance. One Subcommittee member asked several questions about the requirement for international components, policies governing authorship on publications, and the minimum level of commitment of the PIs that should be required. Program staff clarified that there is no requirement for an international component, but that the current program has successfully engaged a number of international partners in ongoing studies. Program staff described the publications policy of the current Leadership Group and noted that there is not a level of effort requirement for the PIs, which has not presented issues under the current program iteration. Another Subcommittee member emphasized the importance of the Leadership Group in performing clinical evaluations of non-traditional approaches to combat AR, such as treatment with bacteriophage. A third Subcommittee member who is involved with the currently supported program, the Antibacterial Resistance Leadership Group, clarified certain aspects of the publications policy and noted that the current group has a separate person who oversees clinical operations. The concept was unanimously approved.

VI. Joint Meeting of the AIDS Subcommittee and AIDS Research Advisory Committee (ARAC)–Carl Dieffenbach, Ph.D., director, DAIDS

Director’s Report
Carl Dieffenbach, Ph.D.

Dr. Dieffenbach paid respect to three colleagues, Fred Gordin, M.D.; David Cooper, M.B.B.S., M.D., D.Sc.; and Cherlene Dezzutti, Ph.D., who had passed within the last year. Recent DAIDS staff changes were subsequently described. The budget for NIAID and DAIDS was discussed and the timeline for the Clinical Trials Networks Recompetition was overviewed.

Budget Update

A budget update covering NIAID funding for fiscal year (FY) 2000 to 2019, a specific NIH budget comparison by Institute/Center for FY 2017 and FY 2018, and a financial management plan of specifically how NIAID is funded during FY 2018 were discussed. It was noted that while the Institute is having a budget increase, the AIDS programs at NIH have not had an increase. For FY 2018 NIAID is seeing the paylines for experienced investigators at the 13 percentile and new PIs are at the 17 percentile. There are no adjustments to competing and noncompeting awards and continuing to focus resources on dollars for the payline and taking money away from research initiatives, while maintaining a success rate in the 21 to 23 percent range. A report card for FY 2018 covering the success rate for all the major types of investigator-initiated grants, R01s, R21s, and program project grants will be given closer to the January 2019 ARAC meeting. The FY 2019 budget has not been finalized and awaits approval from Congress.

The NIAID HIV/AIDS Clinical Trials Network Recompetition draft timelines were summarized. The FOAs for leadership, statistical data management center, laboratory centers, and clinical trials units (CTU) are in the process of being drafted. These will be published in January 2019 with the CTU FOA being published in April 2019. The receipt date is in September with a two-month delay for the CTU FOAs. All awards will be made in December 2020. Currently, this process is on schedule.

The FY 2021 to 2023 Trans-NIH Strategic Plan for HIV and HIV-Related Research is in development by the Office of AIDS Research (OAR). In order to have a broad impact, OAR is requesting that the research community provide input and comments through a webpage on the federal registry. The deadline for this request was June 20, 2018.

Discussion

Q: In regard to the observed decreasing AIDS research budget, is this at a cost of moving money out to another category or the increases not matching?
A: The AIDS budget is flat at 3 billion and has stayed there for several years. As the rest of NIH grows over time, our proportion is shrinking. Thus, a shift in funding priorities is required. The problem that we are facing is that without an increase in support, the only way to start new projects is something else must end.

Office of AIDS Research Advisory Committee (OARAC) Update
Richard Chaisson, M.D.

Dr. Chiasson presented highlights of the OARAC meeting in late March. This included the Professional Judgement budget as recommended by OAR to the President. Also, the report of the ART Guidelines revealed new FDA approved drugs: Bictegravir/Tenofovir Alafenamide/Emtricitabine and Ibalizumab.

An unexpected update, released in May 2018, showed the committees’ ability to quickly respond to new data and make appropriate recommendations regarding the use of Dolutegravir in adults or adolescents with HIV who are pregnant or of child-bearing potential. Other updates in the past six months included recommendations regarding HPV and HHV-8 infections, and updates in progress regarding MAC, VZV and HCV. Pediatric guidelines were updated which included viral load measurements every three to four months to monitor ART adherence and that all children should receive ART regardless of symptoms or CD4 count. Recommendations for what to start in antiretroviral naïve children were outlined.

AIDS study section reorganization was described with more emphasis now on basic and translational research. The changes aim to address the uneven use of these study sections over previous years and there will be six sections instead of the nine that currently exists. The new sections will go “live” in September.

The OAR Cost Sharing Task Force framework and final recommendations were summarized. These are critically important to all institutes and comprises a complex cost sharing portfolio. Examples of HIV-relevant activities for cost sharing included basic research on pathogens, cancers and oncogenic viruses, and clinical trials and cohort studies of comorbidities relevant to HIV such as cardiovascular research, chronic inflammation, and neurocognitive disorders.

The FY 2019/2020 Trans-NIH Strategic Plan for HIV and HIV-Related Research identified priorities for HIV research and its timeline was overviewed.

Highlights of the NCI research portfolio for AIDS research was shown, which included the NCI International Consortia in HIV-Associated Cancers involving the U.S. and low- and middle-income countries (LMIC) partnerships. Also, it was emphasized that malignancy research with current OAR priorities have limitations of what HIV/AIDS funds can be used for, and this poses challenges for HIV basic science research. However, opportunities in inflammation research was highlighted.

The National Institute of Mental Health, Division of AIDS Research portfolio was summarized and presented as multiple schema covering areas including their mission and research priority areas. The importance of HIV-related stigma was also discussed.

Discussion
No questions.

Concept Review (Approval Requested)

Basic Sciences Program (BSP)

Genetic Engineering Technologies for HIV CURE Research
Sandra Bridges Gurgo, Ph.D.

The objective of this initiative is to develop gene- and cell-based approaches to achieve long-term remission or elimination of HIV, and these approaches can eventually be evaluated in the clinic, rendered scalable and deliverable. This is a new initiative with a duration of five years. It is estimated that there will be two to four awards and the first-year total cost for the initiative is $4.5 million. There has been an explosion of interest in the field of genetic engineering techniques that include TALE nucleases, Zinc Finger Nucleases, and the CRISPR nucleases. Challenges for the field of genetic engineering were overviewed and included immunogenicity of viral vectors and transgenes, relevant animal models, and resistance development. For HIV in particular, these challenges include the heterogeneity of target HIV sequences, wide distribution of latently-infected cells in the body, and a low frequency of target cells in suppressed animals or human subjects. NIAID sponsored a workshop on April 18, 2018, to evaluate the state of the art in HIV provirus excision and host gene editing to identify research gaps and to foster multidisciplinary collaborations. This workshop confirmed that there are numerous opportunities for CURE research in this field. The scope of research of this initiative includes approaches to eliminate or inactivate integrated HIV provirus using genome or epigenome editing technologies; strategies to produce cells resistant to infection and/or cells with enhanced ability to eliminate HIV-infected cells; development of novel delivery strategies for targeting therapies to HIV-infected cells or tissues where target cells reside; combination studies that include one required cell or gene therapy modality plus a drug, biologic, or other gene therapy modality; novel approaches for improving transplantation and engraftment of modified cells as part of an HIV-targeted transplantation strategy; and proof-of-concept studies in animals. Not supported by this initiative are vaccines, CCR5 as the sole target, and IND-enabling studies. Inclusion of a private sector partner is a requirement and their projects must be well integrated into the grant. Other related DAIDS programs in the genetic engineering area include Beyond HAART, targeted in vivo delivery of gene therapeutics for HIV cure, and the Martin Delaney Collaboratories. The differences between these related programs and this initiative were outlined. Accomplishments of Beyond HAART were then summarized to provide an example of what can be achieved. Reviewers’ comments were presented and addressed and the ARAC committee members cast their votes.

Discussion

Q: Why was CCR5 not included as a sole target under the scope of research?
A: CCR5 is the best target and much is already known about it. A project that only focuses on CCR5 would not add much more to what we already have. In regard to IND-enabling studies which are expensive, our investigators generally find a way of performing these studies with funding from another source.

Ballot Voting Outcome:
8 Approval
0 Approval with modification(s)
0 Deferral for further information
1 Disapproval

Single-Cell Multi-Omics of HIV Persistence
Lillian S. Kuo, Ph.D.

The purpose of this initiative is to leverage advances in single-cell analyses to interrogate HIV persistence with fine-grain resolution and illuminate molecular details that are lost in population-level studies and to characterize pathways, factors, and biomarkers involved in HIV persistence, latency, latency reversal, cell killing, viral rebound, and control of viremia. This is a new initiative with a duration of five years. There will be an estimated three to four awards for a first-year total cost of $2 million. This initiative seeks to address a number of scientific questions including what the detailed molecular mechanisms of HIV persistence and responses to interventions at the single-cell level are; what RNA, DNA, and/or protein signatures are revealed at single-cell resolution; can we generate our HIV/SIV reservoir atlas; and what are the single-cell determinants of CTL and/or NK killing of reservoir cells. The gaps in understanding HIV persistence were highlighted and the major technological problem was identified as the inherent heterogeneity of the latent HIV-1 reservoir. Dissection of single-cell characteristics is required to comprehensively define parameters for latency, reactivation, and elimination. The opportunities in multi-omics that can help address this problem were discussed. The scientific objectives of this initiative are to foster interdisciplinary research among HIV basic scientists, bioinformatics, and bioengineers; interrogate the molecular details of HIV reservoir heterogeneity and spatiotemporal dynamics at the single-cell level as they relate to latency, reactivation, and elimination; define molecular signatures/biomarkers of latency; characterize individual cellular responses to curative interventions; and develop an “atlas” of the persistent HIV reservoir in various hosts. In-scope research would combine state-of-the-art single-cell transcriptomics, genomics, and/or proteomics to characterize persistently infected cells derived from ART-treated individuals, animal models, lymphoid and other tissues, and primary cell models; characterize the roles of intact, uninduced, replication-competent proviruses, “translation-competent” defective proviruses, and clonal expansion; and gain mechanistic insight. Traditional systems biology using bulk cell populations or cell lines would be out-of-scope. Reviewers’ comments were presented and addressed and the ARAC committee members cast their votes.

Discussion
No questions.

Ballot Voting Outcome:
9 Approval
0 Approval with modification(s)
0 Deferral for further information
0 Disapproval

Vaccine Research Program (VRP)

Simian Vaccine Evaluation Units (SVEU)
Nancy Miller, Ph.D.

The objective of this contract is to facilitate the identification of promising candidate AIDS vaccines by evaluating vaccine immunogenicity and efficacy in nonhuman primates (NHP). This contract is a renewal with a duration of seven years. The estimated number of awards is two to three. The Simian Vaccine Evaluation Units (SVEUs) assist in the effort for the discovery and development of an AIDS vaccine, one of the highest priorities for NIAID, by conducting NHP studies to evaluate the immunogenicity and efficacy of candidate AIDS vaccines. The SVEU studies also support the evaluation of a wide variety of candidate AIDS vaccines at all stages of development, in collaboration with multiple investigators. The SVEU contracts acquire and house nonhuman primates, develop protocols and conduct vaccine studies, prepare and titrate virus challenge stocks, and support an NHP breeding colony. The history of the SVEU contract, which was first awarded in 1991, was overviewed. The SVEU contracts are a flexible vaccine resource that are available to all AIDS vaccine researchers and can support all stages of AIDS vaccine research. The SVEUs provide the ability to test vaccine efficacy by conducting virus challenge; the opportunity for evaluation of systemic and mucosal immune responses to identify correlates to reduced risk of virus acquisition; and the ability to test approaches to enhance immunogenicity and efficacy of vaccines. Reviewers’ comments were presented and addressed and the ARAC committee members cast their votes.

Discussion

Q: Do SVEUs have the capacity to look at vaccine responses for maternal-to-infant or pediatric models?
A: It can be done but requires an infant nursery and breeding program. We are not doing this but are providing challenge viruses for those who do. No one has asked us to do this as they can get resources through labs.

Q: Where are current SVEUs and how long have they been SVEUs; what is the turnover?
A: The current SVEUs are at Advanced Bioscience Labs in Rockville, Bethesda, and Kensington and have been an SVEU for about 15 years; BIOQUAL is in the Bethesda area and has been a SVEU for about 8 or 10 years; and the newest is Tulane which was an SVEU back at the beginning before losing to recompetition before returning. Turnover occurs if someone closes down or loses interest in the contract. There have been a couple of times a SVEU has lost the recompetition.

Q: What is the success rate of proposals requesting SVEUs?
A: We are quite liberal in accepting proposals, especially if data could help those applying for a R01 or a P01 grant. Some proposals have been turned down because of the design or the product.

Q: Where have candidates who fed into this system come from (HIVRADs, CHAVIs, R01 investigators, etc.)?
A: Multiple sources, including R01 investigators and companies. This was initially the first place DNA vaccines were tested because they could not get through peer review.

Q: What are the logistics of funding?
A: The IDIQ mechanism is that there is a pot of money to be used among the three units currently. A base administrative core is awarded, and additional funding is only received as contracts are awarded. This pool of money determines what can be done.

Q: Having each individual study competed for seems terribly inefficient and burdensome on the program. What are the advantages? It is contract law?
A: Yes, it’s contract law and the only way that we have.

Q: What is the possibility of the number of units going down to two?
A: It depends on the funding level. It is a possibility, but we would like to keep it at three as you do not want to overload one unit because they have other activities. For example, BIOQUAL concurrently supports grant-funded researchers, so we cannot occupy all of their capacity. It is good to have different units offering different expertise and technology.

Ballot Voting Outcome:
9 Approval
0 Approval with modification(s)
0 Deferral for further information
0 Disapproval

Office of Clinical Site Oversight (OCSO):

Clinical Research Products Management Center (CRPMC)
Thucuma Sise, Pharm.D., BCPS

This contract provides for a Clinical Research Products Management Center (CRPMC) to support clinical trials of NIAID with the core focus of HIV/AIDS and its co-morbidities, to provide investigational medication product management support for a limited number of other NIAID clinical trial activities, and to support clinical site pharmacy oversight responsibilities. This contract is a renewal with a duration of seven years. The CRPMC is a mission-critical component of NIAID’s clinical research enterprise. The centralization of distribution services has allowed DAIDS and NIAID to comply with regulatory responsibilities related to investigational product management in accordance with CFR, ICH E6, and international and in-country regulations. This quality and integrity of clinical trial investigational product provides the foundation for participant safety and quality study data. The renewal of this contract will support five service areas: receipt and storage of investigational products; security and safety accomplished with redundant storage systems and state of the art fire suppression system; inventory management by ensuring adequate supply, expiration date and stability program monitoring, and forecasting and coordinating timely resupply; shipping and distribution; and processing and disposal of returns. Since the last renewal of this contract in June 2013, CRPMC has shipped 22,800 order items domestically and internationally; increased support of wide-scale international vaccine trials; established a mechanism to support site pharmacy evaluation and assessment; and successful staffing and management of a CRPMC site in Johannesburg, South Africa, to provide specialized support. The future directions of CRPMC are to provide a rapid response and increased capacity to support a limited number of clinical trials on other high priority emergent infectious diseases and to explore structures to better predict costs and adapt to unanticipated trial schedules and changes. Reviewers’ comments were presented and addressed and the ARAC committee members cast their votes.

Discussion

Q: When was the last time CRPMC underwent an internal audit or a regulatory inspection?
A: Last year we initiated an audit. All processes were conducted under GMP and all documentation was in order. No corrective and preventive actions are outstanding but maybe some aesthetics need to be worked on.

Ballot Voting Outcome:
9 Approval
0 Approval with modification(s)
0 Deferral for further information
0 Disapproval

Therapeutic Research Program (TRP):

Patient Safety Monitoring in International Laboratories (SMILE)
Daniella Livnat

The objective of this contract is to provide a critical resource to evaluate and enhance the ability of non-U.S. clinical laboratories to participate in NIAID-funded and collaborative trials, by monitoring compliance with Good Clinical Laboratory Practice standards (GCLP) and monitoring the quality of study-specified laboratory testing. This contract is a renewal with a duration of seven years. This contract is aiming to achieve comparability between trial data obtained in licensed U.S. labs and non-U.S. ones; safety of trial participants; safety of those who perform the tests; confidence in the quality of trial laboratory data; accountability to regulatory organizations, such as the FDA and EMA, for IND/registrational studies; and cross-Network/non-network harmonization in laboratory operations and oversight. The key tasks of SMILE are to help laboratories achieve compliance with Good Clinical Laboratory Practice standards; determine the ability of labs to accurately perform protocol-specified tests; provide guidance and training to correct GCLP and proficiency testing deficiencies; maintain a web-based information repository and searchable resource library; and generate reports to labs, networks, and NIAID. The beneficiaries of SMILE include over 170, in 20 countries, “full service” and “clinic” laboratories that support all DAIDS-funded trial networks, collaborators, DAIDS-funded cohorts, and non-network DAIDS studies. Key accomplishments of SMILE include laboratories taking the initiative to improve their quality measures independently; laboratories striving for and achieving CAP, ISO, and SANAs accreditation; laboratories publishing and receiving awards; recognition from local authorities of laboratory quality; improved capability of our TB diagnostic laboratories; and high praise received from a regulatory agency. Reviewers’ comments were presented and addressed and the ARAC committee members cast their votes.

Discussion
No questions.

Ballot Voting Outcome:
9 Approval
0 Approval with modification(s)
0 Deferral for further information
0 Disapproval

Vaccine Research Center (VRC):

Data Management and Data Warehousing
Brenda Larkin, R.N., B.S.N., M.B.A.

The purpose of this contract is to provide a Clinical Data Management System (CDMS) and Data Warehousing and Reporting Tools (DWRT) for clinical studies implemented by the Vaccine Research Center’s Clinical Trials Program and collaborators. The current contract is non-research and development (R&D), but because it has to be transitioned to R&D, the contract needs approval from the committee. This continuation is for a duration of seven years, and it is estimated that there will be one contract. The importance of the CDMS is to be able to use an electronic data management system to collect all clinical trial required information from protocols that are being implemented and to be compliant with our regulatory requirements. The importance of the DWRT is to compile, store, analyze, and report the collected data from these clinical trials; to have the data in a centralized location so it can be accessed when needed; and to be in compliance with FDA requirements. Accomplishments from the current contract include the 51 clinical trials initiated and conducted using a tested and proven CDMS software program and the DWRT pilot project. Future directions of this contract are to continue to maintain compliance and meet the requirements and high standards developed and executed at the VRC for conducting the clinical trials; develop and implement databases and data management plans; and integrate data into the DWRT annually.

Discussion

Q: Is this a way to get funds from another source? Would this contract take funds from the extramural budget?
A: This is an existing entity. Previously, this contract’s mechanism was not from the R&D line, but now needs to be moved over to the R&D line within the VRC budget. No funds will be taken from the extramural budget.

Ballot Voting Outcome:
9 Approval
0 Approval with modification(s)
0 Deferral for further information
0 Disapproval

VII. Adjournment

The meeting of the Council adjourned at 3:15 p.m., on Monday, June 4, 2018.

We do hereby certify that, to the best of our knowledge, the foregoing minutes are accurate and complete.

 

-s-

Anthony S. Fauci, M.D.

Chair, National Advisory Allergy and Infectious Diseases Council

Director, National Institute of Allergy and Infectious Diseases

09/06/2018

Date

 
-s-

Matthew J. Fenton, Ph.D.

Executive Secretary

National Advisory Allergy and Infectious Diseases Council

Director, Division of Extramural Activities

National Institute of Allergy and Infectious Diseases

09/04/2018

Date

 

Council will formally consider these minutes at its next meeting; any corrections or notations will be incorporated in the minutes of that meeting.

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