2. Remarks of the Director, NIAID

Anthony S. Fauci, M.D.

Dr. Fauci opened the Thursday afternoon, June 15th, session of Council by welcoming visitors to the 135th meeting.

Before moving on to official business, Dr. Fauci paid tribute to Dr. Janis Giorgi who died on May 30th after a long battle with cancer. In his comments Dr. Fauci stated that "throughout the evolution of the AIDS epidemic, Janis dedicated much of her time to NIH through her work on numerous advisory groups. As someone who could walk the line between policy and science, her focused perspective, keen mind, and warm spirit will surely be missed. A professor of medicine at UCLA, Janis made major contributions to HIV immunology, particularly in immune cell function. She pioneered studies on the correlation between the expression of specific T-cell phenotypes and disease progression. Janis was also a leader in the Multicenter AIDS Cohort Study (MACS) and Principal Investigator at one of the two MACS pathogenesis research laboratories. In her honor, UCLA is establishing a Janis V. Giorgi Fellowship and Lecture Series in HIV Immunology. We at NIAID mourn her loss."

Dr. Fauci welcomed ad hoc Council members: Dr. Christian Larsen, Associate Professor, Department of Surgery, Emory University School of Medicine; Dr. Paula Pitha-Rowe, Professor of Oncology, The Johns Hopkins University School of Medicine; and, Dr. Judith Thomas, Director, Division of Immunobiology, Department of Surgery, University of Alabama at Birmingham.

The minutes of the February 17-18, 2000 meeting were considered and approved as written.

Dr. Fauci announced two new appointments that reflect NIAID's ongoing interest in incorporating new technologies into its research program.

The first is Dr. Robert Hohman as the new associate director for development of research technologies and chief of the Research Technologies Branch in the Division of Intramural Research. Dr. Hohman previously held several positions in the biotech industry; most recently, he served as vice president and general manager of Integen Discovery Products.

The second is Dr. Vicki Seyfert as the head of the new Office of Innovative Scientific Research Technologies. Dr. Seyfert comes to the new position from the Division of Allergy, Immunology and Transplantation, where she was instrumental in introducing new technologies into the research programs, including the NIAID Tetramer facility. In her new role she will guide technology initiatives for programs and also serve as NIAID representative on the NIH Biomedical Information Science and Technology Consortium.

In the Division of AIDS, Dr. James Bradac has been appointed chief of the Preclinical Research and Development Branch of the Vaccine and Prevention Research Program. He has worked 10 years in DAIDS spearheading the institute's HIV variation initiative and managing numerous contracts and grants related to HIV vaccine research and development.

Also in DAIDS, Mr. Thomas La Salvia has joined the institute as the associate director for scientific information and program planning. Prior to his arrival, he was the director of research and evaluation at the Fenway Community Health Center in Boston, one of our HIVNET sites; he was the project director of the site.

In the Division of Intramural Research, Dr. Allan Saul has been named the new facility head of the Malaria Vaccine Research Unit. He joins the institute from the Queensland Institute of Medical Research in Brisbane, Australia, where he served most recently as deputy director.

Dr. Lone Simonsen has assumed a position in the Office of the Director, NIAID as a special expert to implement intramural and extramural epidemiology programs. Dr. Simonsen came to the Institute from the World Health Organization, Geneva, where she worked on global issues including tuberculosis drug resistance, transmission of blood-borne diseases, vaccine safety, and AIDS.

Lastly, Dr. John McGowan has been asked by the leadership of NIH to lend his expertise to the design and implementation of a critical component of the NIH infrastructure, the IMPAC II system. He has agreed to take on this additional task while continuing to serve as the director of the Division of Extramural Activities.

Dr. Fauci stated that the President's budget requests a 5.6 percent increase for NIH, and 6.1 percent for NIAID. Each year NIAID has consistently received slightly higher budget increases than have most of the large institutes. Under both House and Senate allocations, the NIH budget would go up $2.7 billion over the 2000 budget, a 15.2 percent increase. However, a clause in the House bill would restrict NIH spending to the same level as proposed by the President. This clause is not present in the Senate version of the NIH allocation. This difference will need to be resolved in Conference Committee.

Following the President's budget, NIAID would spend 68.5 percent of its FY 2001 budget for research project grants a slight drop from FY 2000, whereas research contracts would grow from 11.3 percent to 12.3 percent. This increase is due to a tap that funds the entire cost of the Agency for Health Care Research and Quality through other agencies' contracting budgets. Additionally, intramural research would decrease to 11.1 percent in FY 2001 from 11.3 percent in fiscal year 2000.

Under this budget, NIAID estimates its success rate would be approximately 31 percent compared to 26 percent for NIH as a whole.

Health Disparities Strategic Plan:

At the last Council, Dr. Fauci indicated that NIAID was producing a health disparities strategic plan. He defined health disparities as the differences in the incidence, prevalence, mortality, and burden of diseases and other health conditions in special U.S. population. NIAID's Plan has been incorporated into an NIH Health Disparities Strategic Plan. Dr. Fauci indicated that the health disparities strategic planning process is a component of the Presidential Initiative on Racial and Ethnic Health Disparities. Dr. Fauci co-chairs the Trans-NIH Working Group on Health Disparities and has been intimately involved in developing the NIH Plan. Created out of the Institute and Center plans, the NIH Plan has been forwarded to NIH management for approval. It will be launched October 1, 2001 and will be fully implemented in FY 2002.

The Plan's goals include developing and executing a five-year research agenda, improving recruitment and training of minority investigators, advancing outreach, forming partnerships, evaluating progress, and enhancing public awareness.

Health disparities will be integrated into the NIH budget as an area of emphasis. The President identified six focal areas: infant mortality, cancer screening and management, cardiovascular disease, diabetes, AIDS, and immunization.

The President's Millennium Vaccine Initiative:

In his State of the Union address, President Clinton made a commitment to fight infectious diseases worldwide and unveiled a new initiative to stimulate the development of vaccines for AIDS, malaria, and TB by providing tax credits to private sector developers.

Dr. Fauci indicated that the President's Millennium Vaccine Initiative includes $50 million in the FY 2001 budget as a contribution to the Global Alliance for Vaccines and Immunization for purchasing vaccines, assurance that the World Bank and other multilateral development banks dedicate an additional $400 to $900 million annually in loans for health care services, increases in NIH- and CDC-funded research on diseases that affect developing nations, and a tax credit for the sale of vaccines for infectious disease to accelerate invention and production.

Dr. Fauci characterized recent activities that have taken place in connection with President Clinton's Millennial Vaccine Initiative as unprecedented. He provided a brief overview of a White House meeting on vaccines held March 3, 2000, at which the President tasked DHHS/NIH/NIAID with convening a meeting of experts on the subject. In response, NIAID organized "Vaccines for Malaria, Tuberculosis and HIV/AIDS: Addressing the Presidential Challenge," a two day meeting (held March 22-23, 2000) that brought together experts from industry, government and academia to address impediments to vaccine development in the private sector and strengthen public, private partnerships. All agreed that vaccines for HIV, malaria, and tuberculosis are feasible and should and would be pursued. They developed a global research agenda for each vaccine, including engagement and training of scientists and developing infrastructure in endemic regions.

Announcement of HVTN Sites:

The institute recently announced the funding of nine domestic sites that comprise the new HIV Vaccine Trials Network, a global program for HIV vaccine research. It includes international sites in Sub-Sarahan Africa, Asia, Latin America, and the Caribbean.

The network's Comprehensive HIV Vaccine Agenda represents an evolution of the research previously conducted by the AIDS Vaccine Evaluation Groups and HIVNET. Total funding for the first year of operations will be about $29 million.

Council Materials:

Copies of the Legislative Update, which describes hearings and bills of interest to the Institute, were distributed. The NIAID Office of Communications provided Council members with several publications and press releases.