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Report of the Expert Panel on the Extramural Asthma and Allergy Research Program

Introduction

In February 2000, NIAID convened a panel of internationally recognized scientists to evaluate the Institute's extramural asthma and allergy research program. Panel members reviewed summaries of the current scientific components of the program, an analysis of the allocation of resources among the components, and a draft of the NIAID Plan for Research on Asthma and Allergic Diseases developed by Division of Allergy, Immunology and Transplantation program staff. The panel was asked to make recommendations regarding the scope and timeliness of the NIAID extramural asthma and allergy research program with respect to new scientific opportunities that warrant the commitment of NIAID resources. The panel members were also asked to recommend strategies to accelerate the translation of basic and preclinical research findings into interventions that will improve the treatment and lead to the prevention of asthma and allergic diseases, particularly in disadvantaged populations.

Specific Issues Addressed

  • Does the current portfolio adequately address the important areas of asthma and allergic disease research?
  • Is the distribution of resources within the portfolio appropriate to address these areas adequately?
  • What emerging areas of science represent particularly important research opportunities?
  • How should the research portfolio be configured to take advantage of these opportunities?
  • What strategies best ensure that NIAID resources will be used to attract, train and retain scientists with the expertise required to carry out cutting-edge research?
  • What is the appropriate role of NIAID in the dissemination of new knowledge about the treatment and/or prevention of asthma and allergic diseases and how can NIAID partner with other federal agencies and private sector organizations to accomplish this?
  • The discussion was structured around the following key elements of the draft NIAID Plan for Research on Asthma and Allergic Diseases: therapeutics; developmental immunobiology; primary prevention; pathobiology; patient, provider, and community education; and research resources.

Recommendations of the Expert Panel

Overall

  • The panel emphasized that asthma and allergic diseases represent a serious and growing public health problem, particularly in disadvantaged populations, and that research in these areas must be intensified to deal effectively with this epidemic.
  • Given the heterogeneity of this disease, the panel suggested that NIAID should support comprehensive surveillance studies to define important asthma phenotypes. Subset identification should lead to the characterization of genotype-specific and phenotype-specific risk factors for the development and pathogenesis of asthma and provide a rational basis for improved therapeutic and preventive strategies. In addition, the panel recommended that asthma phenotyping should be addressed by encouraging high quality clinical studies with asthma patients, and through partnering with other government and private sector agencies to establish a comprehensive, centralized national asthma database to systematically catalog genetic, histological, clinical and other relevant data.
  • The panel enthusiastically endorsed the NIAID Plan for Research on Asthma and Allergic Diseases as a template for developing a comprehensive research portfolio with the capacity to address current and emerging scientific opportunities and to efficiently translate discoveries into new therapeutic and preventive strategies.

Therapeutics

  • The panel strongly endorsed NIAID's continuing commitment to developing new approaches to reducing asthma morbidity among inner-city children through the Inner City Asthma Study (ICAS). The panel emphasized that ICAS and the National Cooperative Inner City Asthma Study have contributed significantly to the success of NIAID in addressing health disparities and have provided important new information about asthma risk factors and interventions to reduce morbidity in these populations.
  • The panel enthusiastically recommended that NIAID support the development of an Inner City Asthma Consortium to conduct clinical trials and mechanistic studies of new therapeutic interventions, including immune-based therapeutics and combination therapies that are unlikely to be developed by the private sector.
  • The panel strongly recommended that NIAID utilize the resources of the Immune Tolerance Network to direct clinical trials of tolerogenic approaches for the treatment of asthma and allergic diseases and to develop surrogate markers to monitor disease progression and therapeutic effect.

Developmental Immunobiology

  • The panel strongly endorsed the emphasis on developmental immunobiology in the research plan, citing the need for additional studies to investigate the possible early life origins of asthma and allergy. The panel stressed the need for human studies because of the limitations of animal models. It was suggested, however, that a primate model may be informative and that NIAID should facilitate access to non-human primates on a limited scale.
  • The panel discussed the ethical concerns and technical difficulties associated with clinical research involving infants and young children and suggested that NIAID develop guidelines for conducting asthma and allergy studies in these populations.
  • In order to facilitate investigations of the early life origins of asthma and allergic diseases, the panel strongly recommended that NIAID support research to discover surrogate markers of the onset and progression, and to accelerate the development of non-invasive techniques for evaluating asthma onset and clinical status in children.
  • The panel recommended increased support for longitudinal epidemiological studies of asthma onset and progression, and the design of funding strategies to ensure the availability of long-term resources necessary to follow a cohort from conception through late childhood.
  • The panel suggested that that NIAID support comprehensive chemical and structural characterization of allergens that are associated with the development of asthma and allergic diseases.

Primary Prevention

  • The panel recognized that primary prevention is not adequately addressed in the current research portfolio and that significant opportunities now exist in this area. A number of risk factors for the development of asthma have already been identified and could be used to design potentially informative clinical trials.
  • The panel recommended the initiation of primary prevention trials and surveillance studies that employ funding strategies permitting long-term evaluation. It was also suggested that provisions be made for the centralized banking of DNA and patient information from these studies. The Multi-Center AIDS Cohort Study was considered to be a potentially viable model for such an initiative.
  • The opinion of the panel was divided regarding the timing of the initiation of primary prevention trials. Several panel members recommended that trials be initiated as soon as possible, while others suggested that additional knowledge regarding the origins and pathogenesis of asthma is necessary before meaningful prevention trials can be designed.

Pathobiology

  • The panel recognized the strength of the current NIAID portfolio in the pathobiology of asthma and allergic diseases and acknowledged that major scientific insights have resulted from the support of investigator-initiated basic and clinical research grants as well as from the Asthma and Allergic Diseases Research Centers (AADRC).
  • The panel endorsed the scope and depth of the current pathobiology portfolio and suggested that the NIAID increase the focus on the innate immune system and the role of infectious agents in the pathogenesis of asthma. It was stressed that the portfolio must maintain an appropriate balance between clinical and basic research, including studies of adult-onset asthma and animal models of disease.
  • The panel recommended that the AADRC program be continued with the level of support for individual centers increased to promote high quality clinical research. Several panel members suggested that the AADRC program could be instrumental in attracting a new cadre of investigators to asthma research.

Patient, Provider and Community Education

  • The panel cited the outstanding success of the Inner City Asthma Programs and the AADRC Demonstration and Education projects in advancing our understanding of the risk factors for severe asthma among disadvantaged populations.
  • The panel highlighted the importance of improving physician education so that currently available therapies can be optimally utilized in these populations. The panel suggested that additional research into effective approaches to modify physician behavior might be required to improve asthma management in disadvantaged populations.
  • The panel noted that the intervention developed by the National Cooperative Inner-City Asthma Study has been proven to be effective in reducing asthma morbidity in inner-city children, and strongly recommended that the NIAID create partnerships with other Federal agencies, as well as state and local health departments, to disseminate and implement this intervention.

Research Resources: Bioinformatics

  • The panel unanimously endorsed the application of the latest approaches in bioinformatics and genomics to asthma and allergic diseases research.
  • The panel strongly recommended the creation of a centralized genomics core to facilitate microarray analysis according to standardized protocols, with a governing board to determine access to the facility and to provide quality control oversight. The genomics core should be linked to a national asthma tissue bank and asthma fatality case registry. It was suggested that databases developed by other agencies, including the National Cancer Institute, could be used as models for an NIAID asthma genomics/bioinformatics effort.

Expert Panel Members

Andrew Saxon, M.D. (co-chair)
UCLA School of Medicine

Jack A. Elias, M.D. (co-chair)
Yale University School of Medicine

K. Frank Austen, M.D.
Brigham & Women's Hospital

William W. Busse, M.D.
University of Wisconsin School of Medicine

Robert Coffman, Ph.D.
DNAX Research Institute

Stephen J. Galli, M.D.
Stanford University

Stephen T. Holgate, Bsc, M.D., Dsc, FRCP, FRCPath
University of Southampton David H. Mack, Ph.D.
Eos Biotechnology, Inc.

Floyd Malveaux, M.D., Ph.D.
Howard University College of Medicine

Dean Metcalfe, M.D.
National Institute of Allergy and Infectious Diseases

Wayne J. Morgan, M.D.
University of Arizona College of Medicine

Carole Ober, Ph.D.
University of Chicago

Thomas A.E. Platts-Mills, M.D., Ph.D.
University of Virginia

Jonathan Samet, M.D., M.S.
The Johns Hopkins University
School of Hygiene and Public Health

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Last Updated August 11, 2005