Carole A. Heilman, Ph.D., Director, DMID
Dr. Carole Heilman, Director of the Division of Microbiology and Infectious Diseases (DMID), chaired the Subcommittee meeting. In her opening remarks, she reported on staff changes since the last Subcommittee meeting, introducing new individuals in each of the different DMID offices and branches. Dr. Heilman announced that the Institute established a new Office of Biodefense Research Affairs (OBRA) within DMID's Office of the Director and that Dr. Ernest Takafuji would serve as its first director.
Dr. Heilman then provided an update on DMID's research activities. She discussed DMID's top ten science advances during the past year, focusing on four priority areas: tuberculosis, sexually transmitted diseases, malaria/genomics, and West Nile virus. Dr. Heilman noted that 1) DMID-supported TB researchers are poised to conduct clinical evaluations of the first new candidate vaccines in eighty years;
2) DMID is preparing to launch an efficacy trial of GlaxoSmithKline's glycoprotein D herpes vaccine to prevent genital herpes disease in women; 3) DMID provided partial support for the now completed sequencing of the Anopheles gambiae and Plasmodium falciparum genomes; and 4) DMID supported the development of the hamster model of West Nile virus, which will help accelerate the development and testing of vaccines as well as antiviral therapies.
Dr. Heilman informed the Subcommittee that, during the past year, NIAID has markedly expanded, intensified and accelerated its ongoing research programs in biodefense. Specifically, NIAID has launched or expanded 35 research initiatives in areas ranging from the basic biology of microbes and their interactions with the human immune system to preclinical and clinical evaluation of new therapeutics and vaccines. She summarized biodefense activities and goals for Fiscal Years 2002, 2003 and 2004, reporting on science advances and the development of new research initiatives.
Dr. Heilman updated the Subcommittee on smallpox vaccine clinical trials activities, including the recent Request for Proposals (RFP) for the development and testing of a MVA vaccine with the goal of providing resources for the initial development of MVA vaccine candidates (MVA may be a viable alternative smallpox vaccine). She also reported on the recent RFP designed to spur development of a new anthrax vaccine; awards would be made within the next few weeks. She noted that the Institute was convening a Blue Ribbon Panel to provide advice and expertise regarding the NIAID Category B and C priority pathogens. The goals will be similar to the Institute-sponsored meeting held last February for the NIAID Category A priority pathogens.
Dr. Heilman then introduced Dr. Takafuji who, following brief remarks, presented a number of FY 2004 biodefense research concepts for the Subcommittee's approval (see below for details on presented biodefense concepts). Following Dr. Takafuji's presentation, Dr. Dennis Dixon, Chief of the Bacteriology and Mycology Branch, summarized ongoing Department of Health and Human Services efforts to implement new legislative requirements regarding the possession, use and transfer of select agents. Finally, other DMID staff members presented several non-biodefense concepts for approval.
A summary of the all concepts presented and the Subcommittee's assessment follows:
Biocontainment Laboratories: These regional biocontainment laboratories will provide the research community with the appropriate certified facilities for conducting research on potential agents of bioterrorism. The Subcommittee unanimously approved the initiative.
Biodefense and Emerging Infectious Diseases Research Resources Program: This program will facilitate efforts to acquire, authenticate, store, and distribute state of the art research and reference reagents to the scientific community and to provide current information to facilitate research and product development for biodefense and emerging infectious diseases This program will collect and disseminate information; laboratory protocols, and methods; enhance technology transfer; and facilitate commercialization. The Resources Program will also provide technical assistance in the handling and shipping of infectious materials. The Subcommittee unanimously approved the initiative.
Collaborative Research for Vaccines, Adjuvants, Therapeutics, Immunotherapeutics and Diagnostics: This program will help translate research from the target identification stage through target validation to early product development. Collaborations between researchers from different disciplines and from industrial laboratories are strongly encouraged in order to establish multiple focal points for the development of new biodefense products. The Subcommittee unanimously approved the initiative.
Development, Testing, and Evaluation of Candidate Vaccines Against Plague: This effort is designed to support the rapid development of a plague vaccine through enhanced testing of promising candidates. The Subcommittee unanimously approved the initiative.
In Vitro and Animal Models for Emerging Infectious Diseases and Biodefense: This program will provide targeted screening of potential therapeutic and prevention modalities for emerging infectious agents and bioterrorism pathogens using in vitro, small animal, and non-human primate models to test safety and efficacy. The Subcommittee unanimously approved the initiative.
Malaria Clinical Research and Trial Preparation Sites: Under this initiative, a network of field sites will be established in Africa for the study of malaria transmission and pathogenesis. The Subcommittee unanimously approved the initiative.
Mycology Research Unit: This effort will support multidisciplinary research units focused on the identification and validation of targets for the development of diagnostics, vaccines, or therapies for systemic fungal infections. The Subcommittee unanimously approved the initiative.
Next Generation Smallpox Vaccines: Designed to develop a next generation of smallpox vaccine that 1) is safer and can be used in vulnerable populations and 2)will be effective against genetically-engineered poxviruses. The Subcommittee unanimously approved the initiative.
Novel Therapeutic Strategies for Botulinum Toxin: Botulism can result from ingestion or inhalation of one of seven different serotypes of neurotoxin produced by Clostridium botulinum. This initiative will support development of products to neutralize these toxins. The Subcommittee unanimously approved the initiative.
Partnerships for Biodefense Research: This effort will facilitate collaborative partnerships between government, academia, and the private sector to develop novel biodefense products. The Subcommittee unanimously approved the initiative.
Partnerships for Vaccine and Diagnostic Development: Designed to stimulate industry participation in the clinical development of GAS, GBS, and H. pylori vaccines and bring new point of care diagnostics for GAS and GBS to market. The Subcommittee unanimously approved the initiative.
Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases: The overall goal of the RCE Program is to develop and maintain strong infrastructure and multifaceted research and development activities that will provide the scientific information and translational research capacity to make the next generation of therapeutics, vaccines and diagnostics against the NIAID Category A, B,and C priority pathogens,with particular emphasis on Category A. The Subcommittee unanimously approved the initiative.
Tools for Detection of Adventitious Agents: To develop tools to assess safety issues associated with the use of primary cell cultures and continuous cell lines used in the manufacturing of vaccines and other biologics, particularly vaccines against potential agents of bioterrorism. The Subcommittee unanimously approved the initiative.
Tropical Diseases Translational Research Program: This effort will support translational research leading to the discovery and preclinical development of new drugs or vector control methods to reduce or eliminate morbidity and mortality resulting from parasitic infection. The Subcommittee unanimously approved the initiative.
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