Flexible defenses roundtable meeting: promoting the strategic innovation of medical countermeasures.

271 ON MAY 10, 2007, THE CENTER for Biosecurity of the University of Pittsburgh Medical Center convened an invitational meeting to discuss a national strategy for developing “flexible defenses” against chemical, biological, radiological, and nuclear (CBRN) threats. This was the second of two meetings held by the Center to discuss issues related to those aspects of the Pandemic and All-Hazards Preparedness Act (P.L. 109-417, passed in December 2006) that are intended to improve the development of medical countermeasures for national security threats.1 The Act requires that the Department of Health and Human Services (HHS) deliver to Congress on June 19, 2007, a strategic plan for developing medical countermeasures against CBRN threats. The first Center for Biosecurity meeting, held on March 22, 2007, discussed administrative and implementation issues of Title IV of the Act, including the role of the Biomedical Advanced Research and Development Authority (BARDA), how medical countermeasure procurement processes might be improved, and the essential elements for successful leadership of BARDA.2 In the May meeting, participants focused on the January 2007 Homeland Security Presidential Directive 18 (HSPD-18), which requires HHS to develop a flexible defense strategy— defined as “a rapidly deployable and flexible capability to address both existing and evolving[CBRN] threats”—using the Title IV authorities in the Pandemic and All-Hazards Preparedness Act.3 The concept of a flexible defense is still a term of art. There is limited consensus on what it could or should mean. Meeting attendees and interviewees (“participants”) expressed a range of views on the possible goals of a flexible defense strategy for medical countermeasures and how those goals might be implemented. These diverse views, summarized in this report, will need to be evaluated for their technical feasibility and prioritized, as the nature and proportion of countermeasure investments in a national flexible defense strategy are refined. Meeting attendees (listed in the sidebar) included present and former U.S. government officials, members of the biopharma industry and venture capital community, and academic experts. The daylong discussion addressed the rationale, goals, feasibility, and implementation of a flexible defense. In advance of the meeting, the staff of the Center for Biosecurity interviewed 35 people, including representatives from the biopharma industry, such as the Alliance for Biosecurity;4 present and former government officials from HHS, the Department of Defense (DoD), and the National Institutes of Health (NIH); and academic researchers. The purpose of the interviews was to elicit their conceptions of what a national flexible defense strategy should entail and how it might be implemented. The results of the interviews were distilled and presented to meeting attendees to inform the discussion. Individual comments made during the meeting were not for attribution, and there was no effort to reach consensus within the group.