Carole A. Heilman, Ph.D., Director, DMID
Dr. Carole Heilman, Director, Division of Microbiology and Infectious Diseases (DMID), chaired the meeting. She welcomed all participants, including Dr. Martin Rosenberg, who served as an ad hoc member of the Council.
In her opening remarks, Dr. Heilman reported on issues of importance to DMID, and discussed recent and upcoming meetings. She informed the Subcommittee that the Lyme Disease Advisory Panel Working Group established in l996 to help guide DMID's Lyme disease clinical studies had concluded its work.
Dr. Heilman reminded the group of the existence of the NIH Lyme Disease Coordinating Committee, which continues to provide a forum for Lyme disease communications.
Dr. Heilman also reported on recent progress to further the NIH Transmissible Spongiform Encephalopathies (TSE) Research Agenda, noting that DMID received funds from the NIH Director's Reserve to carry out related research activities, which provided support to expand an ongoing contract for animal model evaluation to include screening of anti TSE compounds.
She noted that the 20th anniversary edition of the Jordan Report is forthcoming. The Report is a compendium of vaccine activities NIAID publishes on a regular basis.
Dr. Heilman informed the Subcommittee that DMID was entering into a Cooperative Research and Development Agreement (CRADA) with Glaxo-Smith-Kline to conduct a pivotal Phase III efficacy trial of Glaxo's recombinant glycoprotein D herpes vaccine to prevent genital herpes disease in women. The trial, which will begin this summer, will be conducted through NIAID's vaccine evaluation units and will enroll approximately 7,000 women. Dr. Heilman also noted that staff was working on the second phase of the NIAID Global Health Research Plan; phase II will focus on diarrheal, respiratory and parasitic diseases.
She informed the Subcommittee of a recent DMID publication entitled "DMID Good Clinical Practices Handbook," which summarizes relevant regulations for the conduct of clinical trials; the handbook was distributed to NIAID principal investigators involved in clinical trials.
Dr. Heilman also noted that the IOM Immunization Safety Review Committee would continue their efforts in 2002 and would hold their first meeting of the year in March, which will focus on Hepatitis B vaccine and neurological disorders.
Dr. Heilman reported on staff changes since the last meeting. These include: the departure of Dr. Stephanie James, who has joined the Ellison Medical Foundation; the appointment of Dr. Michael Gottlieb to the position of Chief of the Parasitology and International Programs vacated by Dr. James; the appointment of Ms. Audrey Hackman and Ms. Carmen Taylor to the Office of Regulatory Affairs to serve as regulatory affairs specialists; the appointment of Dr. Barbara Mulach to the Office of Scientific Coordination and Programs Operation to serve as a communications specialist; the appointment of Dr. Catherine Taylor to the Enteric and Hepatic Diseases Branch to serve as the Immunological Response Program Officer; and the appointment of Ms. Sonnie Kim to the Respiratory Diseases Branch to serve as a Health Specialist. Finally, Dr. Heilman noted the recent retirement of Ms. Thelma Gaither from the Virology Branch; Ms. Gaither was with NIAID for 31 years.
Dr. Heilman began the next segment of the meeting by introducing Dr. Irene Glowinski, who briefly summarized each of the seven NIAID research initiatives unveiled in December 2001 that provide opportunities for the community to apply for grants to address counter-bioterrorism research needs. These include: 1) the Rapid Response Grant Program on Bioterrorism-Related Research; 2) SBIR and STTR Grant Program (focused on bioterrorism) ; 3) Partnerships for Novel Therapeutic, Diagnostic and Vector Control Strategies in Infectious Diseases; 4) Exploratory/Developmental Grants: Technology Applications to NIAID-funded Research; 5) NIAID Investigator-initiated Small Research (R03) Grants; 6) U.S.-Based Collaborations in Emerging Viral and Prion Diseases; and 7) Development and Testing of Vaccines Against Anthrax. Details of each initiatives are available on the NIAID Web site (http://www.niaid.nih.gov/biodefense/).
Dr. Martin Rosenberg then presented an overview of the recent external review of the Collaborative Antiviral Study Group program, which he chaired. Dr. Rosenberg reported that there was unanimous support that DMID continue this program but informed the Subcommittee that the review group suggested that the CASG return to a more focused agenda (until 1995, the primary focus had been on infections caused by members of the herpesvirus family; at that time, a program review recommended that the CASG be expanded to address several other diseases) In addition, the current review group suggested that DMID play a more prominent role in setting the agenda for the CASG. Dr. Catherine Laughlin, Chief of the Virology Branch who serves as the CASG Program Officer, pointed out that there is a CASG advisory body that reports to DMID, satisfying this recommendation. However, Dr. Laughlin acknowledged that the role of the advisory group should be clarified and steps will be taken to address this issue.
Concept Review
Clinical Trials for Antiviral Therapies:
The goal of this initiative is the conduct of clinical trials of therapies for treatment of severe acute and chronic human viral infections of public health importance including those for non-HIV viral diseases that are not a high priority for the pharmaceutical industry and those for rare viral diseases and diseases in special populations. The Subcommittee felt that this initiative was important and they very enthusiastic about it; it was unanimously approved.
New Animal Models for TB and Invasive Aspergillosis (IA) - Post Genomic Research
The goal of this initiative is the development and use of improved animal models for the rapid in vivo validation of potential vaccine, diagnostic and drug targets that are anticipated to emerge from current genomic and post genomic efforts for tuberculosis (TB) and invasive aspergillosis (IA). The Subcommittee unanimously approved the initiative.
Innovative Approaches for Combating Antimicrobial Resistance
The goal of this initiative is to acquire a better understanding of the factors affecting the development of resistant pathogens and spread of resistance genes, in order to direct actions to diagnose, control, and treat antimicrobial resistance.The Subcommittee felt that this initiative would address a critical national and global public health need and provide important scientific information. They felt the timing was excellent and were very enthusiastic in their support. The Subcommittee unanimously approved the initiative.
Impact of Microbial Interactions on Infectious Diseases
The Subcommittee felt that this initiative would help our understanding of microbial interactions involving multiple organisms. It was recommended that the RFA should be written to ensure applications within the mission of DMID. The Subcommittee was very enthusiastic about the initiative and unanimously approved it.
Partnerships for Novel Approaches to Controlling Infectious Diseases
The goal of this initiative is to facilitate collaborative partnerships between government, academia, and the private sector to develop novel approaches for controlling infectious diseases, including tick-borne diseases, hepatitis B, influenza and biological threat agents. This initiative will also facilitate research on vector control products. The Subcommittee felt that this initiative was important and enthusiastically and unanimously approved the initiative.
Chronic Fatigue Syndrome (CFS) Research Centers
Subcommittee members discussed this initiative in detail and had several concerns. After 6 years of support of these Centers, there is still no data that suggests an infectious etiology for CFS. Much of the work that is currently being conducted is largely in fields (e.g. cardiology, neurology, psychology/psychiatry) not in NIAID's area of scientific responsibility. Subcommittee members strongly suggested that other ICs play a major role in defining the agenda for and supporting research on CFS. In addition, while they urged NIAID to collaborate with other ICs, they indicated that NIAID should not be the lead IC in the development of the initiative. Subcommittee members recommended that this initiative be tabled until the May Council meeting. During the interim, they have asked DMID staff to explore the interests of other ICs in supporting these Centers. Subcommittee members also felt it was imperative for the currently-funded Centers to be given adequate time and resources to handle any transition in scientific focus that might occur. back to top |