2. Remarks of the Director, NIAID

Anthony S. Fauci, M.D.

Dr. Fauci opened the Monday afternoon, September 25, session of Council by welcoming visitors to the 136th meeting.

Dr. Fauci welcomed the ad hoc Council members: Dr. Michael Apicella, Professor and Head, Department of Microbiology, University of Iowa; Dr. W. Ripley Ballou, Director, Clinical Department, MedImmune Incorporated (Gaithersburg); Dr. James Hogle, Edward S. Harkness Professor of Biological Chemistry, Harvard Medical School; Dr. Sami Khoury, Associate Professor of Neurology, Brigham and Women's Hospital; Dr. Brian Kotzin, Professor of Medicine and Immunology, Department of Medicine, University of Colorado Health Sciences Center; and Dr. Dorothy Lewis, Associate Professor, Department of Immunology, Baylor College of Medicine.

Dr. Fauci expressed the Institute's gratitude to the following members of Council whose terms end with this meeting: Drs. Robert Couch and Lowell Young; Mr. Stephan Lawton, and Ms. Emily Spitzer.

The minutes of the June 15-16, 2000 meeting were considered and approved as written.

Dr. Fauci announced the appointment of Ms. Karen Santoro as Legal Advisor in the Office of the Director. In addition to serving as the principal advisor rendering expert legal advice and ethics counseling to NIAID, Karen will also assume the responsibility to advise on conflicts of interest issues for advisory committee members, other Government employees, and individuals involved in the conduct of biomedical research.

Two appointments in the Division of Microbiology and Infectious Diseases were announced. Dr. Maria Giovanni joined the division to oversee division-wide microbial genomics and technology initiatives and to serve as the division's primary liaison to the NIAID Genomics Task Force. Dr. Irene Glowinski joined the division as the Chief of the Office of Scientific Coordination and Program Operations. This is a newly-formed office that will handle Council preparations, communications, policy, legislation and planning activities for the division.

Within the Division of Intramural Research (DIR), Dr. Wendy Fibison has been appointed Associate Director for Special Emphasis Programs. She will provide advice and guidance on matters relating to minority and special emphasis programs to effectively increase the diversity of the DIR workforce.

Dr. Fauci said that since that the last Council meeting, the Institute was still waiting for a final appropriations bill for FY 2001. At the previous meeting, Dr. Fauci had noted that the Institute received both House and Senate budget levels for FY 2001. Dr. Fauci noted it was very likely the Institute will begin FY 2001 under a continuing resolution, rather than a finalized appropriations bill. Under the President's budget, NIH received an additional $1 billion, which is a 5.6 percent increase over the FY 2000 level. NIAID received a 6.1 percent increase. Under both House and Senate allocation levels, NIH received an additional $2.7 billion over the FY 2000 budget, which is a 15.2 percent increase. Under the House budget allocation, NIAID received a 14.8 percent increase; whereas under the Senate budget allocation, NIAID received a 15.0 percent increase. The NIAID financial management plan remains tentative, pending a finalized budget resolution. NIAID will begin FY 2001 with the same financial management plan used in FY 2000. Dr. Fauci said he would keep the Council informed about the progress of the FY 2001 budget via the Council newsletter or a special mailing if necessary.

NIAID HIV Vaccine Trials Network (HVTN)

The Institute is advancing several candidate HIV vaccines through the preclinical and clinical pipeline. The most advanced among the candidate vaccines in trials under NIAID support is a combination of a recombinant canarypox vector (vCP1452 from Aventis Pasteur) and a recombinant gp120 subunit candidate vaccine (AIDSVAX from Vaxgen). A series of Phase I and Phase II trials are underway in the HVTN, which includes both domestic and international sites. The HVTN was established in July and is a global program for HIV vaccine research. To address the issue of public support, the NIAID has convened a national HIV vaccine communications steering group. The steering group's mission is to develop and implement a national communications strategy to create a supportive environment to encourage participation in clinical trials. If the Institute maintains its schedule and achieves expected results, it could start an efficacy trial as early as May 2002.

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.