Carole A. Heilman, Ph.D., Director, DMID
Dr. Heilman chaired the NAAID Microbiology and Infectious Diseases Subcommittee meeting. In her opening remarks, Dr. Heilman reported on recent staff changes. She briefly introduced the 28 staff members who have joined the different DMID offices and branches since the last Subcommittee meeting.
She provided an update on DMID activities over the past few months, beginning with an update on biodefense research activities. She acknowledged the overview NIAID Director Anthony S. Fauci, M.D., provided earlier in the day, and added that DMID had recently developed a research agenda that focuses on NIAID's Category B and C Priority Pathogens. This agenda stems from a NIAID meeting held in October 2002 and will help shape a number of NIAID core research initiatives in the coming years.
Dr. Heilman reported that NIAID developed a total of 52 biodefense initiatives to stimulate research in Fiscal Years 2002 and 2003; 36 are new initiatives and 16 are significant expansions. During this same time period, NIAID has seen a 30 percent increase in the number of grant applications -- the vast majority of these are in response to NIAID's biodefense research initiatives.
In Fiscal Year 2002, several NIAID initiatives encouraged industry partnerships and focused on the development of new diagnostics, vaccines and therapeutics for CDC Category A agents. These types of research initiatives have been well received. As a result, NIAID has expanded and reissued many of these collaborative efforts for Fiscal Year 2003, and plans to do the same in Fiscal Year 2004. In addition, the new initiatives will be broadened to address NIAID's Category B and C Priority Pathogens, as recommended in the Category B and C research agenda.
Dr. Heilman reported that NIAID would make awards in mid February in response to the recent Request for Proposals (RFPs) that will provide resources for the initial development of MVA vaccine candidates. MVA vaccines may be a viable alternative to the current Dryvax smallpox vaccine for individuals at high risk of complications.
Dr. Heilman mentioned that there had been several Congressional briefings and hearings focused on smallpox. She also reported on her attendance at two malaria conferences in Tanzania at the end of 2002 that focused on clinical trial capacity building within Africa and evidence-based decision-making for malaria control and policy, respectively. She also provided an update on NIAID-supported thimerosalresearch studies. Finally, she reported that the 20th anniversary edition of the Jordan Report had been completed and that a copy was provided for each Subcommittee member.
Dr. Heilman then introduced Dr. Dennis M. Dixon, Chief of the Bacteriology and Mycology Branch, who provided a brief update on rules governing select agents. As part of new regulations enacted by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (PL 107-188), researchers are now required to register with the federal government and get approval to possess or use any pathogen or toxin defined as a "select agent." The CDC and the USDA are the agencies tasked with implementing this effort.
Dr. Ernie Takafuji, Director of DMID's Office of Biodefense Research Affairs, presented a brief overview of the Special Immunization Program, which is designed to make vaccines for various Category A-C agents available to laboratory and clinical researchers.
Dr. Heilman informed the Subcommittee that five research concepts for FY 2004 would be presented for their approval. The state of the science in each area would be summarized first in an effort to provide necessary context.
TB Vaccine Testing and Research Materials
The TB Vaccine Testing and Research Materials contract will provide validated, small animal models for testing potential candidates in aerosol challenge protocols, a service provided at no cost to qualified investigators throughout the world. The knowledge gained from the previous contract has brought TB vaccine development into an exciting new phase where promising candidates are beginning to enter human testing. The Subcommittee unanimously approved the initiative.
Partnerships for Vaccine and Diagnostic Development
This initiative is intended to support development of vaccines and point-of-care diagnostics for group A and group B streptococci and vaccines for Helicobacter pylori through partnerships with academia and the private sector. The Subcommittee unanimously approved the initiative.
Hepatitis C Recovery Research Network
This initiative will support mechanistic studies of recovery/persistence and response to therapy. The Subcommittee unanimously approved the initiative.
Sexually Transmitted Diseases and Topical Microbicides Research Centers
This grant initiative will provide a refocus as well as an expansion of the current STD CRCs and Topical Microbicides Program Project grants in order to develop new and improved approaches for the diagnosis, prevention and treatment of STDs. Important studies ancillary to a large Phase III efficacy trial of a vaccine against Herpes simplex virus will also be supported. The Subcommittee unanimously approved the initiative.
STD Clinical Trials Group
Basic research supported by NIAID is producing a pipeline of potential vaccine and microbicide candidates. Renewal of the STD Clinical Trial Unit will provide the structure under which candidates for prevention or treatment of STDs can be evaluated. The Subcommittee unanimously approved the initiative.
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