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Carole A. Heilman, Ph.D., Director, DMID
Dr. Carole Heilman, Director of the Division of Microbiology and Infectious Diseases (DMID), welcomed the Microbiology and Infectious Diseases Subcommittee of the National Advisory Allergy and Infectious Diseases Council and provided a brief report on Division activities. In her opening remarks, Dr. Heilman introduced Dr. Maria Giovanni, who has joined DMID to oversee division-wide microbial genomics and technology initiatives. Dr. Heilman also reported on two in-house staff changes: Dr. Leigh Sawyer has joined the Enteric and Hepatic Diseases Branch where she will have responsibility for direction and management of the Branch's clinical trials program and serve as the Project Officer for the Enteric Pathogens Research Unit; and Dr. Lee Hall will head the new malaria vaccine development section within the Parisitology and International Programs Branch. Finally, Dr. Heilman reported on DMID's recent decision to split the Clinical and Regulatory Affairs Branch into two separate offices: the Office of Clinical Research Affairs and the Office of Regulatory Affairs. She announced the appointment of Dr. Lydia Falk as the Chief of the Office of Regulatory Affairs; Dr. Falk comes to DMID from the FDA where she served in the Center for Biologics Evaluation and Research Division of Vaccines and Related Products Applications.
Dr. Heilman described recent activities in the area of vaccine safety:
- In collaboration with CDC, NIAID requested that the IOM establish an independent expert committee to review hypotheses regarding associations between specific vaccines and alleged adverse events. In response, the IOM funded an Immunization Safety Review Committee in September 2000. For each concern presented, the committee will assess its plausibility and specific additional actions (e.g., surveillance, research, public policy, risk communication), if any, that should be undertaken. The panel will meet at least three times a year and its findings will be disseminated to the public.
- DMID is involved in two studies that will help provide baseline information about the risks of Thimerosol, a preservative in the form of ethylmercury that is found in many vaccines.
Dr. Heilman reported on DMID's recent half-dose influenza vaccine study in healthy adults and stated that data should be available later this fall. Dr. Heilman then updated the Subcommittee on the status of the General Accounting Office's current review of NIH and CDC Lyme disease research activities. Dr. Heilman provided a brief summary of DMID's West Nile Virus research activities, which include antiviral screening and the funding of a contract to help develop a vaccine for West Nile Virus. She noted that DMID also supports research on related viruses. Finally, Dr. Heilman gave a status report on the newly-funded NIAID Challenge Grants. This recently initiated joint venture with the biotechnology, pharmaceutical and medical device industries involves one-on-one matching of federal dollars for performance-based research and development activities ranging from drug and vaccine development through Phase III clinical trials for TB, malaria, influenza and emerging and resistant infections.
A number of concepts for FY 2002 initiatives were then presented for clearance:
Millennium Vaccine Initiative – Dr. Stephanie James, Chief of the Parasitology and International Programs Branch, presented this concept to the Subcommittee. The objective of this initiative is to entice biotechnology companies to focus on the development of malaria and tuberculosis vaccines. The Subcommittee agreed that this initiative was a good use of NIAID resources and was a good initial effort to jump start research in these areas. The Subcommittee unanimously endorsed this initiative.
Response to the Presidential Vaccine Initiative: Overcoming the Tuberculosis Latency Challenge – Dr. Ann Ginsberg, Acting Chief of the Respiratory Diseases Branch and Tuberculosis Program Officer, presented this concept. The Subcommittee felt that this initiative would be an effective way to increase the number of research groups focused on the problem of tuberculosis latency. The Subcommittee suggested that the RFA be written in a way that encourages investigators from fields other than tuberculosis to respond. The Subcommittee unanimously approved the initiative.
Malaria Vaccine Development: Understanding Malarial Anemia – Dr. James presented this concept for approval. The Subcommittee thought that it was appropriate and important to emphasize the relationship between hematologists and malariologists since malarial anemia plays a major role in malaria related deaths. They were very supportive of this initiative and it was unanimously approved.
Prevention of Group B Streptococcal (GBS) Disease – Dr. Fran Rubin, DMID's Neonatal Pathogens and Maternal Immunization Program Officer, presented this initiative, which is a renewal of the current Streptococcal Initiative with a modified scope of work. The Subcommittee stressed the importance of a multivalent vaccine approach for disease prevention. The initiative was approved unanimously by the Subcommittee.
Infectious Etiology of Chronic Diseases: Novel Approaches to Pathogen Detection – Dr. Maria Giovanni, DMID's Assistant Director for Microbial Genomics and Related Technology Development, presented this concept to the Subcommittee. The Subcommittee felt that this initiative would be useful to encourage the public sector to work in the area of infectious etiology of chronic diseases, an area traditionally centered in the private sector. In addition, they felt it would be important to include a component related to the analysis and interpretation of data forthcoming from the use of genomic technologies. The Subcommittee approved the initiative unanimously.
Leprosy Research Support and Maintenance of an Armadillo Colony in the Post Genome Era – Dr. Ginsberg presented this initiative, which proposes to expand two existing contracts to take advantage of advances in functional genomics and other new technologies. The Subcommittee stated that these contracts are needed in order for leprosy research to continue. This initiative was unanimously approved by the Subcommittee.
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