projects whose risks and payoffs are very high—that is, whose successes may provide dramatic advances—and that pursues these projects with both flexibility and speed. There is a real need for NIH, particularly NIAID, to adopt an approach like this for funding the kinds of high-payoff, high-risk projects that might create innovative scientific tools for addressing bioterror threats.
Recommendation 15: Create special research organizations to build expertise in countermeasures to bioterrorism. Federal agencies must build human resources in threat-agent characteristics, pathogenic mechanisms, and responses to bioterrorism-induced disease. Protected environments that foster innovation must be developed to support a cadre of leaders, scientists, engineers, policy experts, and strategic thinkers. These designated research organizations should address both classified and unclassified issues, and special mechanisms for rapid funding should be created to support external research efforts as the needs and opportunities emerge. New mechanisms for funding high-risk, long-term, high-payoff projects should be created in NIH.
Ideally, the new organizations recommended above would be small but have strong interactions with universities and government agencies. They would work in basic and applied science—specifically, to understand pathogenic (virulence) factors at the molecular level and how they affect mammalian systems. And they would also work in product development—specifically, in diagnostics, antiviral and antibacterial drugs, and all stages of vaccine manufacture, from development to pilot production. Clearly, drugs and diagnostics should have dual use, and the range of pathogens studied will inevitably have dual-use spinoffs. As a companion to this initiative, a mechanism for rapid funding should be established for bioterrorism-related research conducted extramurally; this mechanism would select for creative ideas quickly, with a minimum of bureaucracy.
The goals for research on surveillance and clinical diagnostics include rapid diagnostic assays for common pathogens and biological warfare agents. These assays could be used in primary-care settings (point of care) as well as referral laboratories. But standards are needed by which they may be rigorously evaluated and validated, and centralized repositories of standardized reagents and samples are needed as well. Because the development and evaluation of diagnostics require interdisciplinary applied research, however, it is currently difficult to find targeted funding sources and mechanisms.
Recommendation 16: Establish laboratory standards. Set up an oversight standards laboratory to evaluate diagnostic and detection tools; to ensure