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Strategic Plan 2000
NIAID: Planning for the 21st Century


Introduction

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NIAID

NIAID conducts and supports research that strives to understand, treat, and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives.

The National Institute of Allergy and Infectious Diseases (NIAID) is the component of the National Institutes of Health (NIH) charged with conducting and supporting research on diseases of the immune system and infectious diseases. With a FY 2000 budget of more than $1.8 billion, NIAID is the third largest institute at NIH. During the past 15 years, three factors have prompted NIAID to grow significantly. First, the emergence of HIV/AIDS in the early 1980s shattered the notion that successful new vaccines and therapies had brought an end to infectious diseases. Second, results from basic research are now driving new approaches to solving clinical and public health problems. Third, is the realization that infectious diseases will continue to emerge unpredictably and at times explosively.

Today, there are more research avenues to invest in and opportunities to capitalize on than there were even 5 years ago. Consequently, planning has become a more critical element of the Institute's day-to-day operation. The need to prioritize opportunities to maximize potential advances is among the primary motivations driving our strategic plan. This plan also stems from the 1998 Institute of Medicine (IOM) Report, Scientific Opportunities and Public Health Needs: Improving Priority Setting at the National Institutes of Health, which recommended that the NIH Director receive a forward-looking strategic plan, developed with public input, from each Institute and Center (IC). Because unforeseeable circumstances may shift the Institute's priorities, the plan is necessarily a dynamic document that will require reexamination over time.

NIAID's stewardship of this mission is driven by two convictions: strong commitment to basic research and the understanding that the fields of immunology, microbiology, and infectious disease are related and complementary. Although the plan framework centers on four cornerstones - immune-mediated diseases (and immune tolerance), AIDS, emerging infectious diseases, and vaccines - considerable synergy exists within that framework.

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Planning and Priority Setting

NIAID planning and priority setting occurs in a larger programmatic and resource allocation context. This context includes areas of emphasis determined by Congress, the Department, and NIH; a highly refined peer review process; the annual congressional appropriation; and other factors. Within that setting, NIAID supports both extramural and intramural research.

NIAID supports extramural studies initiated by individual investigators as well as those solicited by the Institute to address specific scientific opportunities, fill scientific gaps, and respond to insufficiently met public health needs. To ensure scientific quality and public health merit, all extramural research applications undergo an extensive, two-tiered review process. At the first tier, scientific review groups evaluate applications. At the second tier, the National Advisory Allergy and Infectious Disease (NAAID) Council gives the final approval to fund the applications. The quality and merit of intramural research is assured through the laboratory review process. Support of intramural laboratory projects is based on budget resources, the outcome of review by the Board of Scientific Counselors, the relevance of the work to NIH and NIAID areas of emphasis, and other considerations, such as congressional mandates.

Public Input

 

DNA studies
DNA studies on the varicella-zoster virus responsible for chicken pox (varicella) and shingles (zoster).
Public input is achieved in many ways. Representatives of voluntary health organizations and individuals based in health care are active

on the NAAID Council.

Also, NIAID's Executive Secretariat in the Office of Policy Analysis and its Office of Communications and Public Liaison establish and maintain strong links between the Institute and the public. These units respond to public inquiries, communicate NIAID news to the public, and funnel public concerns to appropriate NIAID divisions. Moreover, lay organizations actively participate in NIAID planning meetings. For example:

  • The Directors of NIAID and its divisions frequently meet with lay organizations.
  • On behalf of NIH, the Division of Allergy, Immunology and Transplantation (DAIT) chairs the Autoimmune Diseases Coordinating Committee, of which the Ad Hoc Coalition for Autoimmune Patient Groups is a member.
  • PARA (Patient Advocates for Crohn's and Mycobacterium paratuberculosis) attended a workshop held, in part, to decide whether controlled antibiotic treatment trials are needed.
  • Representatives of two patient advocacy groups are on the Advisory Panel for Clinical Studies in Chronic Lyme Disease and have made presentations to that group.
  • The Division of AIDS (DAIDS) has been at the forefront in involving the community in all aspects of the research process. Community representatives sit on the AIDS Research Advisory Committee, which provides broad oversight and input and advises the Director on programmatic plans and priorities. Each of the prevention, vaccine, therapeutic, and epidemiological research networks supported by DAIDS has a national and/or local Community Advisory Board (CAB). CABs are composed of representatives from the volunteer research populations, such as the parents of children with AIDS, individuals infected with HIV, and people at high risk for contracting HIV. The national CABs work with network leadership to develop a scientific agenda and set priorities. At the local level, CABs work with principal investigators to exchange information with the broader community and to assist with recruitment and retention of research subjects.

Development of the Draft Strategic Plan

Strategic plan development began in January 1999 with division staff outlining recommendations from the range of planning and consultative events NIAID has participated in and sponsored during recent years.

strategic plan framework diagramThe Institute developed a strategic planning framework organized around four cornerstones, or broad areas, that encompass the NIAID research portfolio, including immune-mediated diseases, AIDS, emerging infectious diseases, and vaccines. In July 1999, the Institute convened a Strategic Planning Task Force composed of scientist and non-scientist members and comprising a panel for each cornerstone (see Appendix A). The panels deliberated the priority areas and suggested revisions to the draft plan. The next iteration of the plan was discussed during the September 1999 NAAID Council meeting. Following further revisions, the document was posted on the World Wide Web for public comment during November 1999. The subsequent draft, which reflected those comments, was submitted to the Director, NIH, and was discussed at the NAAID Council meeting in February 2000. (See Appendix B for NAAID Council membership.) Most recently, the plan was updated to reflect development of a separate NIAID strategic plan addressing health disparities.

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Scientific Opportunity

Years of investment in basic research have generated remarkable opportunities to understand immune-mediated and infectious diseases. As biomedical research moves into the post-genomic era, DNA technologies are profoundly altering the health research landscape, including the study of immunology and infectious diseases. Those technologies and others are revolutionizing approaches to understanding pathogenesis, microbial physiology, and epidemiology of infectious diseases; radically advancing the understanding of immune activation and regulation; uncovering the genetic bases of disease susceptibility; and accelerating the development of new diagnostic, treatment, and intervention strategies.

Recent advances in computer modeling, x-ray crystallography, combinatorial chemistry, and robotics are being harnessed for rational drug design and high-throughput drug screening. These advances will provide faster and cheaper drug discovery, more precise and effective pharmaceuticals, and new drugs for diseases that have eluded previous treatment solutions.

Basic research has opened remarkable opportunities in other areas of immunology and infectious disease research. One of the most exciting, selectively blocking the immune response, might be used to treat many im-mune-mediated diseases. In addition, this approach may help achieve long-term, durable graft survival after transplantation.

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Public Health Need

The Impact of Immunologic Diseases

Immunologic diseases, such as asthma and allergy, autoimmune diseases, and primary immunodeficiencies, afflict millions of Americans and result in considerable illness, death, and medical costs. In addition, graft rejection and the critical shortage of donated organs are the two major barriers to success in transplantation.

  • Allergic Diseases and Asthma
    Allergies and asthma are major causes of illness and disability in the United States. More than 50 million Americans (1 out of every 5) suffer from allergies and/or asthma. Although asthma is a disease with low mortality, its economic costs are enormous, with an estimated cost in the United States in 1996 of $14 billion.
  • Autoimmune Diseases
    Autoimmune diseases are illnesses in which the immune system attacks the body's own tissues. Examples include insulin-dependent diabetes mellitus, systemic lupus erythematosus, rheumatoid arthritis, and multiple sclerosis. While many autoimmune diseases are rare, collectively these diseases afflict millions of people in the United States, especially women. The chronic nature of these diseases leads to high medical costs.
  • Insulin-Dependent Diabetes Mellitus
    Also called Type 1 diabetes, this disease is caused by the immune destruction of pancreatic cells responsible for insulin production.
  • Systemic Lupus Erythematosus (SLE)
    SLE damages multiple tissues and organs. Muscles, skin, joints, and kidney, as well as the brain and nerves, may be affected.
  • Rheumatoid Arthritis (RA)
    RA usually begins as pain, swelling, and tenderness of the small joints of the hands and feet. The mechanisms that trigger the inflammatory process, which may cause destruction and deformity of the affected joints, are not completely understood.
  • Multiple Sclerosis (MS)
    A chronic, inflammatory disease of the central nervous system, MS is the second most likely cause of more than 30 percent limitation in physical and outdoor activities. The disease frequently results in permanent disability.
  • Graft Rejection
    For many victims of kidney failure, diabetes, leukemia, and heart and liver disease, the ultimate treatment must be transplantation of an organ, tissue, or cells. Yet, transplants often fail. Graft rejection and the critical shortage of donated organs are major barriers to success in transplantation.

In addition to carrying the burden of the primary illness, people with immunologic diseases, and those taking immunosuppressive drugs to enhance graft acceptance, are at high risk for infections because of their compro-mised immune systems.

The Impact of Infectious Diseases

Adult female and male ticks
Adult female and male ticks (Ixodes scapularis), the most common vector for Lyme disease.

A Story of Discovery: Transplant Tolerance

In the past decade, discoveries made by NIAID-supported scientists about mechanisms that activate and regulate the immune response have yielded a new approach to preventing transplant rejection. Rather than suppressing the entire immune system, a targeted strategy has been designed to induce tolerance (the lack of an immune response) by turning off the specific immune cells that attack the transplant. Although more research is needed to develop therapies, NIAID-supported research on immune tolerance is contributing to the eventual development of ways to improve transplant success and of new treatments for a wide range of immunologic disorders.

Infectious diseases are the second largest cause of death worldwide. The economic impact of infectious diseases is also great, with an estimated annual cost in excess of $120 billion.

  • Acquired Immunodeficiency Syndrome (AIDS)
    In the United States, an estimated 271,000 people are living with HIV, and the rate of new HIV infections, approximately 40,000 per year, continues at an unaccept-ably high level. Effective, low-cost tools for HIV prevention, such as a vaccine, are needed urgently to bring the HIV epidemic under control.
  • Tuberculosis (TB)
    TB is the eighth leading cause of death worldwide. One-third of the world's population has latent TB, constituting a huge reservoir from which active TB can surface. Moreover, multidrug-resistant TB is an increasing problem.
  • Malaria
    Malaria has been undergoing a global resurgence in recent years with 275 million cases occurring annually, and a death toll estimated at 1.1 million.
  • Influenza
    Pneumonia and influenza are the sixth leading cause of death in the United States, killing 10,000 to 40,000 people in an average flu season. Since 1918, at least three major influenza pandemics have occurred. The worst of these, the pandemic of 1918-1919, caused about 500,000 deaths in the United States, and 20 million worldwide.
  • Hepatitis
    Hepatitis (liver inflammation) can be caused by a variety of viruses. The most common include hepatitis A virus (HAV), which causes acute liver inflammation and is generally transmitted from contaminated food or water; hepatitis B virus (HBV), which is an easily transmitted, bloodborne disease that leads to chronic infections, especially in newborn children infected at birth (chronic HBV infection is also a leading cause of liver cancer); and hepatitis C virus (HCV), which also is bloodborne and has infected almost 4 million people in the United States (2.7 million are chronically infected). Although HCV may not cause symptoms for 20 or more years, about 85 percent of infected individuals eventually develop chronic liver disease, 20 percent develop cirrhosis, and a smaller percentage develop liver cancer. About 9,000 people die annually from HCV. A good vaccine candidate is still needed.
  • Emerging Infections
    There are numerous emerging infectious agents among the viruses, bacteria, protozoa, and fungi that make up the microbial world. Because the frequency of world travel makes the United States part of a global community, diseases that emerge in foreign countries are also health threats in the United States.
  • Bioterrorism
    Terrorist incidents involving biological agents are uniquely complicated because of the large number of potential agents, their long incubation periods and possible delayed onset of disease, and their potential for communicable spread. Unlike naturally occurring pathogens, agents used by bioterrorists may be genetically engineered to resist current therapies and evade vaccine-induced immunity.

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A Story of Discovery: Nevirapine – A Global Weapon to Battle Maternal-to-infant HIV Transmission

HIV/AIDS is a truly global health threat affecting all nations and all population subgroups. Now, for the first time, there is a potent and inexpensive means of reducing the incidence of HIV/AIDS infection in one of the most vulnerable populations of all – newborn babies of HIV-infected mothers. In a collaborative effort involving research scientists at the Johns Hopkins University in Baltimore, the University of Washington in Seattle, and the Makerere University in Kampala, Uganda, investigators supported by NIAID’s HIV Prevention Trials Network (HIVNET) have achieved a stunning breakthrough – a practical means of significantly reducing the rate of maternal-to-infant HIV transmission. A single does of nevirapine, to mother and child, reduced the rate of maternal-infant transmission by half when compared to a similar short course of zidovudine (AZT). In developing countries, this approach may prevent 300,000 to 400,000 newborns from suffering the effects of HIV infection. The nevirapine regimen also has the potential to provide last-minute HIV prevention for the babies of pregnant women who do not know their HIV status until they are admitted to a health care facility for delivery. Nevirapine has significant implications for HIV-infected mothers in the United States as well, especially in minority populations that have been particularly stricken by the AIDS epidemic and that have limited access to prenatal care or to health care in general.

A Story of Discovery: Protease Inhibitors-A New Class
of Anti-HIV Drugs

Institute-supported basic research was pivotal to the discovery and definition of the importance of the HIV protease enzyme, which is used by the virus to produce infectious HIV particles. Institute-supported scientists also helped determine the precise, three-dimensional structure of HIV protease, a crucial step in designing drugs that block the action of the enzyme. In addition, NIAID-supported researchers helped drug-screening efforts by developing simple, rapid tests to measure the inhibition of protease activity. These NIAID accomplishments set the stage for the institute’s successful collaboration with the pharmaceutical industry in developing the new class of anti-HIV drugs known as protease inhibitors.

A Story of Discovery: Haemophilus Influenzae Type b (Hib) Vaccine

As recently as 20 years ago, children worldwide frequently died of bacterial meningitis and 1 in 200 children in the United States contracted Haemophilus influenzae type B (Hib), the primary cause of bacterial meningitis. A quarter of those who survived had brain damage or hearing loss. Today, thanks to the Hib vaccine developed by NIAID-supported researchers, Hib is a rarity. Introduced in 1985, the Hib vaccine boosts immunity in infants (who have a poorly developed immune system) by linking the bacterium’s polysaccharide coat to a protein (thus creating a conjugate vaccine). The spinoffs of this breakthrough still reverberate. The conjugate vaccine technology developed for Hib, now a proven approach to the development of vaccines for the very young, is being applied to other diseases as well.

Accomplishments

The outstanding contributions of NIAID-supported investigators extend from basic discoveries in microbiology and immunology to the development of vaccines, drugs, and diagnostic tools.

Immune-Mediated Diseases

The NIAID investment in research on the processes of immune activation and regulation, and on the genetic basis of disease susceptibility, has elevated our conceptual understanding of the human immune system.

Some key discoveries in basic immunology research include discovering mechanisms of antibody diversity; defining humoral and cell-mediated immunity; discovering immune response genes and the genetic bases for many immune-mediated diseases; and developing ways to prevent and treat these diseases.

Research on allergies and asthma defined the role of inflammation and viral infections in asthma and delineated the molecular mechanisms of the allergic response, including the role of IgE antibodies, the characterization of the IgE receptor, and the discovery of leukotrienes.

Acquired Immunodeficiency Syndrome

In the United States and other parts of the industrialized world, the number of new AIDS cases and AIDS-related deaths has dropped dramatically. This has largely been the result of powerful new antiviral drug treatments that have prolonged and improved the quality of life for many HIV-infected people. NIAID-supported basic research identified the HIV protease enzyme as a target for antiviral drugs, which led to the development of very potent protease inhibitors. Later clinical studies demonstrated the effectiveness of triple-drug treatments (combinations of protease inhibitors and reverse transcriptase inhibitors), often called "highly active antiretroviral therapy," or HAART, over one- or two-drug treatments. NIAID research also led to better ways to prevent perinatal transmission of HIV, first by treating infected pregnant women and their infants with AZT, and more recently, by a single dose each to mother and child of the highy cost-effective drug nevirapine.

Emerging Infectious Diseases

NIAID research strives to understand microbes, how they cause disease, and how they develop drug resistance, and to apply that knowledge to develop new diagnostic tools and interventions. Toward that goal, NIAID research has identified infectious agents for several human diseases, including Lyme disease, bronchopneumonia, hemorrhagic fevers, and diarrheal illness. The sequenced genomes of Treponema pallidum (syphilis), Escherichia coli strain K 12, Chlamydia trachomatis, Plasmodium falciparum chromosome 2 (malaria), and Mycobacterium tuberculosis will lead to more specific targets for diagnosis and antibiotic and vaccine development. Finally, NIAID-supported clinical trials have led to new therapies for influenza, Lyme disease, hantavirus pulmonary syndrome, and fungal infections.

Vaccine Development Development of new vaccines provides safe, cost-effective, and efficient means of preventing disease, illness, disability, and death from infectious diseases. Just four of the many vaccines developed recently by NIAID and its collaborators (hepatitis B, Haemophilus influenzae type b conjugate, pneumococcus, and acellular pertussis) have the potential to save millions of lives annually. Other vaccines developed with substantial support from NIAID include hepatitis A, adenovirus, typhoid, meningococcus, and influenza.

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Last Updated December 19, 2011