they may circumvent the problem of rapid emergence of resistance. Second, immunomodulators may expand treatment options for immunocompromised patients, in whom traditional antimicrobials often work poorly. Third, they offer the potential of a broad spectrum of activity against viral and fungal, as well as bacterial, diseases and may provide nonspecific emergency-treatment options in the event of the emergence of a novel pathogen or a biowarfare attack.

The 2-day workshop, held on April 29-30, 2005, was attended by 33 invited participants, who had a wide array of expertise in molecular and cellular biology, chemistry, ecology, microbiology, immunology, and infectious disease. An agenda and a roster of participants and speakers can be found in Appendix E. Six speakers provided the participants with an overview of immune-system function, potential mechanisms of immunomodulation, and possible obstacles to the development of new immunomodulators. At the end of the first day, the participants formed four discussion groups. Each group identified a number of potential therapeutics and defined background research that would be necessary to make their development possible. The workshop concluded with a plenary discussion during which the breakout groups’ conclusions were presented and discussed. This report describes the most interesting insights that came out of the workshop and the most promising avenues for future research on and development of immunomodulators to treat infectious diseases.

An Informed Choice of Goals

The objective of developing a single immunomodulatory agent that is effective against all infectious agents in all patients was generally considered to be unrealistic or even foolhardy. A clear theme emerging from the workshop was that immunomodulatory interventions will probably be most effective in a tailored role: against particular agents, in subsets of patients, at critical points in the course of an infectious disease, or most promisingly as adjuncts to therapeutics—such as antibiotics and antivirals—that target the microorganism directly. Because so many of the potential immunomodulatory therapies discussed at the workshop would have narrow applications, an overarching conclusion of the discussions was the importance of developing rapid and specific diagnostics both to identify the disease-causing agent and to define the patient’s immune status and stage of infection. Improved ability to identify the patients most likely to require or respond to particular immunomodulators will greatly increase the likelihood of suc-

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