Biomedical Advanced Research and Development Authority (BARDA) roundtable.

ON MARCH 22, 2007, the Center for Biosecurity of the University of Pittsburgh Medical Center (UPMC) convened an invitational meeting to discuss the implementation of Title IV of the Pandemic and All-Hazards Preparedness Act (P.L. 109-417, passed in December 2006), which seeks to improve the development of medical countermeasures for national security threats. The Act requires the Department of Health and Human Services (HHS) to develop a strategic plan, and deliver it to Congress on June 19, 2007, to integrate biodefense and emerging infectious disease requirements with advanced research and development, strategic initiatives for innovation, and the procurement of qualified countermeasures. The goals for the meeting were to provide ideas for improving the research, development, and procurement of countermeasures; to provide concrete suggestions for building an effective partnership between HHS and the biopharmaceutical industry for developing countermeasures; and to facilitate communication among HHS, industry, Congress, and all other parties interested in the development of medical countermeasures for the nation. The Center for Biosecurity will offer, in a separate report, suggestions for how HHS might develop strategic, flexible defense initiatives in BARDA. The meeting participants included present and former U.S. government officials, members of the biopharma industry, and academic experts (participants are listed in the sidebar). Participants were not asked to reach consensus on the topics discussed; rather, the intention was to spur an open discussion of key issues related to medical countermeasure development and to seek proposals for constructive actions. Individual comments made during the meeting were not for attribution. In advance of the meeting, the Center for Biosecurity interviewed more than 40 people from the biopharma industry, including the members of the Alliance for Biosecurity;1 current and former officials from HHS, the Department of Defense (DoD), the National Institutes of Health (NIH), and Congress; and academics with knowledge and experience in this area. The results of the interviews were distilled and presented during the meeting. The meeting agenda roughly followed the provisions of Title IV of the Pandemic and All-Hazards Preparedness Act, as well as the obligations that HHS has under the Act. It included the following topics: