6. Report of the DMID Council Subcommittee

Carole A. Heilman, Ph.D., Director, DMID

Dr. Carole Heilman, Director, DMID, chaired the subcommittee meeting. In her opening remarks, Dr. Heilman reported on staff changes since the last meeting, introducing new individuals in each of the different DMID offices and branches. She noted the addition of Dr. Polly Sager, who will serve as the Assistant Director for International Research and Infectious Diseases in the Office of the Director. She also introduced two new members of the Office of Scientific Coordination and Program Operations (OSCPO) - Ms. Katrina Gross, who will focus on operations, and Ms. Sarah Miers, who will assist with legislative affairs. In addition, Ms. Sarah Landry, who currently serves as a communications expert in the OSCPO recently assumed the position of Deputy Director for this office.

Dr. Heilman reported on the creation of the Office of Biodefense Research Affairs within DMID's Office of the Director and introduced the first two staff additions to this office: Dr. Ed Nuzum, who will focus on vaccine development, and Dr. Rona Hirschberg, who will be the Team Leader of the Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research Program. In the Enteric and Hepatic Diseases Branch, Dr. Heilman noted the addition of Drs. Clare Schmitt and Robert Hall, who will both work on food and water-borne diseases.

Dr. Heilman also introduced new staff in the Parasitology and International Programs Branch: Dr. John Rogers, who will serve as the parasite biology program officer, and Dr. Abdollah (Abdi) Naficy, who will serve as the clinical vaccine development program officer responsible for awards dealing with the clinical testing and evaluation of parasite candidate vaccine antigens. Dr. Heilman also introduced the new Chief of the Sexually Transmitted Diseases (STD) Branch, Dr. Carolyn Deal, as well as the new STD branch secretary, Mr. Dwight Foreman.

Finally, Dr. Heilman introduced new staff in the Virology Branch, including Dr. Mark Challberg, who will oversee the poxvirus portfolio, and Dr. Pat Repik, who will be working on special RNA pathogens.

Dr. Heilman then provided an update on DMID activities over the past few months. She reported on biodefense anthrax and smallpox clinical research activities. She noted that NIAID recently produced a clinical lot of a recombinant protective antigen (rPA), a new generation anthrax vaccine, and that the Division is currently planning clinical trials of the candidate for early fall.

Dr. Heilman also summarized recent smallpox vaccine activities. This includes clinical trials to evaluate the effectiveness of different strengths of the current Dryvax vaccine and the recent "pilot" study to examine the effect of re-vaccinating individuals who were previously vaccinated more than 30 years ago to determine the spectrum of reactions (vaccine "takes") and safety.

Dr. Heilman then provided an update on NIAID-supported biodefense and non-biodefense genomic sequencing efforts. This includes the comprehensive genomic analysis of B.anthracis, which will provide the sequencing of 14 strains of B.anthracis, related species and clinical isolates. This work is being done through the Institute's Pathogen Functional Genomics Resource Center based at The Institute for Genomics Research. Dr. Heilman also reported on non-biodefense sequencing activities, notably the ongoing sequencing efforts for both plasmodium falciparum and anopheles gambiae.

Dr. Heilman informed the Subcommittee that NIAID would soon announce the outcome of the recent recompetition of the Vaccine and Treatment Evaluation Units. These sites have been a cornerstone of DMID's overall clinical research effort and have played a key role in rapidly responding to recent biodefense research needs during the past several months.

Dr. Heilman provided a status update on several vaccine research initiatives that focus on three of the most deadly infectious diseases: HIV/AIDS, malaria and TB. These initiatives, all of which will be funded during this fiscal year, include:

1. Malaria Vaccine Development: Understanding Malarial Anemia;
2. Response to the Presidential Vaccine Initiative - Overcoming the Tuberculosis Latency Challenge; and
3. Millennium Vaccine Initiative - Novel Vaccines for Malaria and Tuberculosis. The last two initiatives stem from a May 2000 NIAID workshop entitled "Addressing the Presidential Challenge," which was held in response to former President Clinton's earlier effort to enhance national efforts to address these major global health priorities.

Dr. Heilman then updated the Subcommittee on influenza vaccine supply and planning issues. She noted that because of vaccine distribution delays during the past 2 years, the CDC's Advisory Committee on Immunization Practices (ACIP) recommends that vaccination efforts in October focus on persons at greatest risk for influenza-related complications and health-care workers, and that vaccination of other groups begin in November. In addition, she reported that NIAID has been actively engaged in the development of an HHS Pandemic Influenza Action Plan, which has been bolstered by recent bioterrorism concerns. Dr. Heilman noted that the 4th World TB Congress would be held June 3-5 and she shared a copy of the meeting agenda with the Subcommittee.

In follow-up to the last Council meeting, Dr. Heilman returned to the question of whether the Subcommittee should approve a concept to renew the Chronic Fatigue Syndrome Cooperative Research Centers;
Dr. David Morens, NIAID's CFS Program Officer, led this part of the discussion. At the January Council meeting, discussions had focused on the need to bring scientific expertise, in addition to that of infectious diseases, to CFS research due to the multifaceted nature of the illness. NIAID had set aside funds for this effort and had attempted to secure co-funding from other Institutes or Centers to fully fund this effort. In January, the Subcommittee asked Dr. Morens to make further attempts to solicit co-funding from other NIH entities to help support the Centers before a decision was made on the concept. He reported back at the current Subcommittee meeting that such efforts were unsuccessful. He then presented options to the subcommittee. After careful consideration and a lengthy discussion of all the options, the Subcommittee ultimately voted not to renew the Centers. Instead, they unanimously voted to give the money that NIAID had set aside for this concept to the NIH Office for Research on Women's Health, which coordinates CFS research for the entire NIH, to work with all relevant NIH Institutes and Centers to develop a new, trans-NIH CFS research effort.

Dr. Heilman summarized FY 2002 biodefense research activities. She noted that DMID rapidly modified several planned FY 2002 research initiatives to include biodefense research , as well as developed several new biodefense research initiatives, which were implemented in an expeditious manner. She also outlined biodefense research plans for FY 2003. In particular, staff presented further details on two proposed FY 2003 biodefense initiatives: Dr. John McGowan, Director of NIAID's Division of Extramural Activities, summarized the Regional Biocontainment Laboratories concept and Dr. Carl Dieffenbach, who is with NIAID's Division of AIDS, summarized the concept for the Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research.

Finally, Dr. Michael Osterholm, Director of the Center for Infectious Diseases Research and Policy at the University of Minnesota, who is also currently serving as one of the Acting Directors of the Centers for Disease Control and Prevention, presented an overview of biodefense research in the current environment and his perspective on its role in the future.