Carole A. Heilman, Ph.D., Director, DMID
Dr. Carole Heilman, director of the Division of Microbiology and Infectious Diseases (DMID), chaired the January 26, 2004 NAAID Microbiology and Infectious Diseases Subcommittee meeting. In her opening remarks, Dr. Heilman introduced two new Council members who will serve on the Microbiology and Infectious Diseases Subcommittee: Drs. Stanley Chapman and Gail Wertz. In an effort to provide background information on the role that Council plays for these new members, Dr. Heilman took the opportunity to briefly describe Institute proceedings that fuel the formation of new research plans and initiatives. She then referred to the branch chiefs to introduce new staff members who have joined the different DMID offices and branches since the last subcommittee meeting.
Dr. Heilman provided a brief update on severe acute respiratory syndrome (SARS), noting that DMID has issued a number of initiatives since the initial appearance of SARS to encourage work in this area, and that there are several funding mechanisms in place that are available to this research community. In addition, a number of SARS vaccine projects were recently funded, including: 1) a partnership with Baxter Healthcare and Aventis Pasteur to develop inactivated whole-SARS-CoV vaccines, and 2) a partnership with Protein Sciences Corporation to develop a SARS-CoV Spike protein recombinant vaccine.
Dr. Heilman also updated the subcommittee on DMID’s research on transmissible spongiform encephalopathies (TSEs), or prion diseases. She acknowledged that the National Institute of Neurological Disorders and Stroke, another component of the NIH, had the lead on TSE research, and that NIAID intramural scientists also play a significant role. Many of NIAID’s efforts are focused on a form of TSE disease called chronic wasting disease, which has been detected in U.S. deer and elk populations.
She reported that NIAID held a workshop on September 22-23, 2003, to develop a clinical trial plan for the evaluation of pandemic influenza vaccines. The meeting included representatives of the Federal Government (The Department of Agriculture, HHS and its component agencies – the Food and Drug Administration, and the Centers for Disease Control and Prevention), WHO international influenza collaborating centers, and domestic and foreign influenza vaccine manufacturers.
NIAID also recently co-sponsored a meeting in collaboration with the Food and Drug Administration’s Center for Biologics Evaluation and Research that focused on TB vaccine regulatory issues, particularly those related to the conduct of clinical trials. Finally, Dr. Heilman reported on a number of NIAID biodefense research resources that have recently been established and encouraged the subcommittee to visit the NIAID Web site for details.
Dr. Leslye Johnson, Chief of the Enteric and Hepatic Diseases Branch, then provided a brief overview of DMID’s hepatitis C research efforts. Two hepatitis concepts were presented for approval by the subcommittee:
Hepatitis Animal Models – Ms. Diana Berard, special projects program officer in the Enteric and Hepatic Diseases Branch (EHDB), presented this initiative, which will provide new capabilities for the animal model phase of pre-clinical drug development for hepatitis C virus (HCV) and continue such capabilities for hepatitis B virus (HBV). The emphasis will be on safety and efficacy evaluation of candidate drugs and immunomodulators in small-established animal models. The subcommittee was very enthusiastic about this initiative and it was unanimously approved.
Hepatitis C Cooperative Research Centers – Dr. Rajen Koshy, viral hepatitis program officer in EHDB, presented this initiative, which will continue multidisciplinary research in HCV, spanning basic molecular biology and immunology to natural history and other clinical studies in well-defined patient populations. The subcommittee was very supportive of this initiative and it was unanimously approved.
International Clinical Sciences Support – Dr. Polly Sager, assistant director for international research on infectious diseases, presented this initiative, which will continue support for clinical research that is carried out at international sites through assistance with protocol development, design and implementation, site assessment, and monitoring. The contract also provides training opportunities related to clinical research. The subcommittee unanimously approved the initiative.
Dr. Barbara Mulach of DMID’s Office of Scientific Coordination and Program Operations provided background information on the partnership mechanism utilized in several past and present DMID initiatives. This mechanism facilitates cooperative partnerships between industry, non-profit organizations, or academic institutions and the government for research areas that are priority issues but may not provide adequate incentive for private sector involvement. Several additional concepts were then presented for clearance, all of which will utilize the partnership mechanism:
Early Hospital Diagnostics for Blood Stream Pathogens in Sepsis and Community Acquired Pneumonia – Dr. Jukka Korpela, medical bacteriology program officer in DMID, presented this initiative to the subcommittee, which will serve as a uniform platform for both early recognition of agents capable of spreading in the bloodstream and/or detection of agents not easily differentiated from each other that cause sepsis and pneumonia. The subcommittee was very supportive of this initiative and it was unanimously approved.
Therapeutics for Rare and Emerging Non-biodefense Viral, Parasitic Infections – DMID Virology Program Officer Dr. Patricia Repik presented this initiative, which will support identification and development of products for treatment of infections caused by non-category A, B, and C viral and parasitic pathogens of public health importance considered to be rare or emerging in U.S. and global populations. The subcommittee unanimously approved this initiative.
Partnerships for Topical Microbicide Development – Dr. Carolyn Deal, chief of the Sexually Transmitted Infections Branch, presented this initiative to the subcommittee. The rationale for the encouragement of industry participation in the development of topical microbicides was presented, along with a summary of the current status of the product development pipeline. Committee members commented that this is a topic of public health importance for the control of HIV and STIs. They agreed that the rationale for utilization of the partnership mechanism was clearly presented and could potentially assist in preparing additional topical microbicides for subsequent clinical evaluation. The subcommittee recommended approval of the initiative.
Challenge Grants: Biodefense Product Development – Dr. Michael Kurilla, medical officer in the Respiratory Diseases Branch, presented this initiative. 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.
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