2. Remarks of the Director, NIAID

Anthony S. Fauci, M.D.

Dr. Fauci opened the Monday afternoon, May 19, session of Council by welcoming visitors to the 126th meeting. He welcomed the ad hoc Council members: Dr. Paul Allen, Professor of Pathology, Washington University; Dr. Charles Janeway, Jr., Professor of Immunobiology, Yale University; Dr. Marc Jenkins, Associate Professor, Department of Microbiology, University of Minnesota Medical School; Dr. Stanley Lemon, Professor and Chair, Department of Microbiology and Immunology, University of Texas Medical Branch at Galveston; Dr. John Mekalanos, Professor and Chair, Department of Microbiology and Molecular Genetics, Harvard Medical School; and Dr. Kenneth Rock, Professor and Chairman, Department of Pathology, University of Massachusetts Medical Center.

The minutes of the January 23-24, 1997 meeting were considered and approved as written.

September 8-9, 1997; and for 1998, February 2-3, June 1-2 and September 24-25.

Within the Office of the Director, NIAID, Dr. John McGowan has been appointed Deputy Director of the Institute. In this position Dr. McGowan will provide leadership for scientific policy issues, and oversee the Office of Communication, and the Office of Research on Minority and Women’s Health. Mr. Steven Berkowitz has been appointed Associate Director for Management and Operations. In this role he will assist the Institute Director with the overall management and operations of the Institute, and oversee the offices of Administrative Services, Financial Management, Technology Transfer, Human Resources, Policy Analysis, and Technology Information Systems.

Dr. Fauci announced the recruitment process has begun to fill the position of Director, Division of Extramural Programs (DEA). Dr. Lawrence Deyton has served in an outstanding capacity as the Acting Director of DEA and will continue in the position until a new Director is appointed.

Dr. Fauci announced the departure of Dr. Robert Goldstein, who left the Directorship of the Division of Allergy, Immunology and Transplantation (DAIT) to become Vice President for Research at the Juvenile Diabetes Foundation International. Dr. Daniel Rotrosen has been appointed to serve as the Acting Director of DAIT while a national search is conducted for a new Director.

Within the Division of Microbiology and Infectious Diseases (DMID), Ms. Martha Mattheis, Chief of the Clinical and Regulatory Affairs Branch (CRA), has retired after almost 30 years service with NIAID. Dr. George Curlin, Deputy Director, DMID is currently serving as Acting Branch Chief, CRA.

For both this year and next, the NIH budget news is good. This fiscal year, NIAID raised its paylines to the 26.0 percentile for AIDS and 24.0 for non-AIDS. The payline for FIRST grants (R29) is the 32.0 percentile for both AIDS and non-AIDS research. Intramurally, NIAID is benefiting from $5 million in AIDS vaccine money from the Office of AIDS Research.

Though the President requested a 2.6 percent increase for the NIH, Congress is pushing for more money for FY 1998, as much as 7.5 percent over the FY 1997 funding level. If this occurs, NIAID will reduce the level of programmatic reductions and increase the cap on type 2 (recompeting) awards - both good news for grantees. Under this scenario, percentile-based reduction bands would be as low as 5, 7, and 9 percent versus the current 17, 19, and 21 percent. For recompeting applications, NIAID would allow grantees to request as much as 20 percent more money than they received in the last year of their previous grant, up from the current cap of 10 percent.

NIAID participated in a successful round of congressional hearings. At Council, Dr. Fauci described his experience testifying before the House Appropriations Subcommittee in February, "Chairman Porter and the Subcommittee Members have been extremely generous to and supportive of NIAID and NIH research, and it was a pleasure to testify before them."

Members of Congress have shown interest in these NIH-related areas:

• Protease inhibitors
• AIDS vaccine - roles of Congress, NIH and industry
• Malaria research
• Impact of the media on research
• Cloning
• Gulf War syndrome

As announced by President Clinton in May, NIH has begun developing a Vaccine Research Center to focus on AIDS vaccines. The new center will be part of the NIH intramural research program, a joint venture of the National Cancer Institute (NCI) and NIAID. It will stimulate multidisciplinary research from basic and clinical immunology and virology through vaccine design and production.

Resources will be provided by the NCI and the NIAID with FY 1998 funds from the Office of AIDS Research, which has proposed $10 million - $5 million to each Institute. A search committee will conduct a nationwide search for a director.

The Center will begin as a "laboratory without walls" while laboratory space is sought near the NIH Bethesda campus. Later, as scientists are recruited from outside, NIH will consider constructing a building on the campus for the Center.

Malaria

To tackle the increasing urgency of global malaria, NIAID is enlarging its investment in malaria research. Malaria kills two to three million people each year making it the most deadly tropical disease. NIAID has developed a research plan for expanded malaria research, produced by staff scientists with input from the international malaria research community. Focusing on the development of a malaria vaccine, the plan was recently reviewed and endorsed by an NIAID-sponsored blue ribbon panel.

The plan capitalizes on the Institute’s commitment to malaria research and its track record in developing new vaccines. A growing body of research suggests that effective malaria vaccines are feasible. Success relies on applying a better understanding of the biology of malaria parasites and the human immune response to infection to vaccine development.

NIAID spends $19.2 million on malaria research, growing to about $21 million with the addition of the three new projects. Other research related to the plan will be funded as high-quality applications are received. The new malaria projects are to 1) establish a repository of well-characterized malaria reagents to improve access to research materials for investigators worldwide; 2) expand parasite genome sequencing to include the genomes of Plasmodium vivax and Plasmodium falciparum, which cause human malaria, and Plasmodium berghei, which causes malaria in rodents, providing an animal model for studying the disease; and 3) expand malaria vaccine production and evaluation through collaborations between intramural and extramural scientists.

HIV Vaccine Committee

As Dr. Fauci told Council, "The AIDS Vaccine Research Committee is in high gear." The committee, chaired by Dr. David Baltimore, explored prime-boost and live attenuated strategies for vaccine development at its second meeting in May; and in early March, the Committee held its first focus group meeting in Boston.

At the Boston meeting, an interdisciplinary group of experts in HIV and related areas discussed gaps and opportunities, including immune correlates and cell receptors, as well as three vaccine approaches: live attenuated, DNA, and envelope-based.

Together with the Committee, NIAID is trying to jump start the HIV vaccine field with the Innovation Grant Program for Approaches in HIV Vaccine Research. This program announcement (PA) supports high-risk or novel research in vaccine design and evaluation. NIAID will fund about $6 million in grant awards later this year. The first phase focuses on the HIV envelope, animal models, and antigen processing.

The response to the PA was strong. By the May 23 receipt date, NIAID had received over 130 applications. If the program accomplishes its goal of stimulating novel research, it may be extended to include other areas of scientific need related to HIV vaccine development.

Committee Reports

Dr. Glimcher reported on the Office of AIDS Research Advisory Committee meeting held in March. Among the many topics the Committee discussed was the need to improve the regional primate research centers, the need to make repositories and databases more user-friendly, the need for more research into AIDS pathogenesis, the involvement of AIDS patients in real-time studies, the need for more prevention studies, the lack of formulations of antiretrovirals suitable for young children, and the need to integrate clinical trials efforts within NIAID.

NIAID Office of Communications and Public Liaison

The NIAID Office of Communications and Public Liaison provided Council members with several publications and press releases. Dr. Fauci noted one publication in particular entitled "Emerging Infectious Disease Research: Meeting the Challenge." The publication provides a valuable lay language description of the Institute’s emerging diseases research agenda.