BioShield Stakeholders Workshop Agenda

September 25 (Day 1)
8:00 – 8:30am	On-site Registration
8:00am – 5:30pm	“Help Desk” Informational Booths Available
Opening Session
8:30 – 8:35am	Welcome and introduction of ASPHEP: Dr. Carol Linden , Acting Principal Deputy Director, Office of Public Health Emergency Medical Countermeasures, Office of Public Health Emergency Preparedness, Department of Health and Human Services
8:35 – 8:40am	Introduction of Secretary: RADM Craig Vanderwagen , Assistant Secretary for Public Health Emergency Preparedness, Department of Health and Human Services
8:40 – 9:00am	Secretary Michael O. Leavitt , Department of Health and Human Services
9:00 – 9:20am	Dr. Rajeev Venkayya , Special Assistant to the President for Biodefense, Homeland Security Council, Executive Office of the President
9:20 – 9:40am	Ms. Ellen Embrey , Deputy Assistant Secretary of Defense for Force Health Protection and Readiness, Department of Defense
Session I: Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy for Chemical, Biological, Radiological, and Nuclear (CBRN) Threats
9:40 – 10:10am	Introduction to HHS PHEMC Enterprise and the PHEMCE Strategy: RADM Craig Vanderwagen , Assistant Secretary for Public Health Emergency Preparedness, Department of Health and Human Services
10:10 – 10:30am	Dr. Elias A. Zerhouni , Director, National Institutes of Health, Department of Health and Human Services
10:30 – 10:50am	Dr. Andrew C. von Eschenbach , Acting Commissioner, Food and Drug Administration, Department of Health and Human Services
10:50 – 11:10am	Dr. Julie L. Gerberding , Director, Centers for Disease Control and Prevention, Department of Health and Human Services
11:10 – 11:30am	COFFEE
11:30am – 1:15pm	Stakeholder Panels
11:30 – 12:00pm	Panel 1: Industry (Moderator: Dr. Monique K. Mansoura , HHS/OPHEP/ OPHEMC) Chris Colwell , Director, Healthcare Regulatory Affairs, Biotechnology Industry Organization (BIO) Tom McKenna , Chair, Health Emergency Response Work Group, Pharmaceutical Research and Manufacturers of America (PhRMA) Mark Leahey , Executive Director, Medical Device Manufacturers Association Janet Trunzo , Executive Vice President Technology and Regulatory Affairs, AdvaMed
12:00 – 12:30pm	Panel 2: Academia/ Science (Moderator: Dr. Carol Linden , HHS/OPHEP/ OPHEMC) Dr. Tara O’Toole , CEO and Director, the Center for Biosecurity of the University of Pittsburgh Medical Center Dr. Debra Anderson , Associate Director, Great Lakes Biodefense Research Center of Excellence Dr. Paul Okunieff , Centers for Countermeasures against Radiation, Chairman, Department of Radiation Oncology, University of Rochester Medical Center
12:30 – 1:15pm	Panel 3: Medicine and Public Health (Moderator: Dr. Gerald Parker , Principal Deputy Assistant Secretary HHS/OPHEP) Dr. James J. James , Director, Disaster Preparedness, American Medical Association Nancy L. Hughes , Director of the Center for Occupational and Environmental Health, American Nurses Association Dr. Georges Benjamin , Executive Director, American Public Health Association Dr. Paul E. Jarris , Executive Director, Association of State and Territorial Health Officials Dr. Michael Fraser , Deputy Executive Director, National Association of County and City Health Officials
1:15 – 2:45 pm	LUNCH
2:45 – 4:45 pm:	Work Session I: PHEMCE Strategy for CBRN Threats—Stakeholder Response Focus Areas: Relative Hierarchy of CBRN Threat Classes (Biological versus Chemical versus Radiological/Nuclear) Addressing Top Priority versus All Threats Traditional, Enhanced, Emerging, and Advanced Threats Medical versus Non-medical Countermeasures Specific versus Broad Spectrum or Fixed versus Flexible Defenses Prevention/Mitigation versus Treatment Acute versus Chronic Effects First Available versus Next Generation Medical Countermeasures General versus Special Populations Domestic versus International
4:45 – 5:45pm	NETWORKING/SOCIAL HOUR
6:00pm	ADJOURN DAY 1

September 26 (Day 2)
8:00am – 5:00 pm	“Help Desk” Informational Booths Available
Session II: CBRN Threats and Medical/Public Health Consequences
8:00 – 8:10am	Welcome and First Day Review: RADM Craig Vanderwagen , Assistant Secretary for Public Health Emergency Preparedness, Department of Health and Human Services Session Chair: Dr. Carol Linden (HHS/OPHEP/OPHEMC)
8:10 – 8:30am	Chemical, Biological, Radiological, and Nuclear Threat Assessments: Dr. John Vitko , Science and Technology Directorate, Department of Homeland Security
8:30 – 8:50am	Medical/Public Health Consequence Modeling: Dr. Peter Highnam , Modeler, Office of Public Health Emergency Medical Countermeasures, Office of Public Health Emergency Preparedness, Department of Health and Human Services
8:50 – 9:10am	Medical Countermeasures in a Public Health Emergency: Dr. R. Tom Sizemore III , Acting Deputy Director, Office of Preparedness and Emergency Operations, Office of Public Health Emergency Preparedness, Department of Health and Human Services
9:10 – 9:30am	Threat Surveillance/ Detection and Medical Countermeasure Utilization and Deployment: CAPT Dan Sosin , Senior Advisor for Science and Public Health Practice, Coordinating Office for Terrorism, Preparedness and Emergency Response, Centers for Disease Control and Prevention, Department of Health and Human Services
9:30 – 10:00am	Session II Q and A: Panel of plenary speakers will answer written and oral questions from audience
10:00 – 10:20am	BREAK
Session III: Medical Countermeasure Research, Development, and Acquisition
10:20 – 10:30am	Session Chair: Dr. Jerome Donlon (HHS/OPHEP/ OPHEMC)
10:30 – 10:50am	Biodefense Research and Development Priorities/ Programs: Dr. Michael Kurilla, Director, Office of Biodefense Research Activities in the Division of Microbiology and Infectious Diseases, Associate Director for Biodefense Product Development, National Institute of Allergy and Infectious Disease, National Institutes of Health, Department of Health and Human Services
10:50 – 11:10am	FDA Role in Biodefense: RADM Boris Lushniak , Assistant Commissioner, Office of Counterterrorism Policy and Planning, Food and Drug Administration, Department of Health and Human Services
11:10 – 11:30pm	Establishment and Prioritization of Medical Countermeasure Requirements: Dr. Monique K. Mansoura , Acting Deputy Director for Policy, Planning and Requirements, Office of Public Health Emergency Medical Countermeasures, Department of Health and Human Services
11:30 – 11:50pm	Acquisition Process Programs and Policy under Project BioShield: Dr. Carol Linden , Acting Principal Deputy Director, Office of Public Health Emergency Medical Countermeasures, Office of Public Health Emergency Preparedness, Department of Health and Human Services
11:50 – 12:30pm	Session III Q and A: Panel of plenary speakers will answer written and oral questions from audience
12:30 – 2:00pm	LUNCH
2:00 – 4:00pm	Work Session II: Public Health Consequences and Medical Countermeasure Research, Development, and Utilization—Stakeholder Response Focus Areas: Medical Countermeasure Research and Development Pipeline Establishment and Prioritization of Medical Countermeasure Requirements Acquisition Process and Policy under Project BioShield Reciprocal Influences Between Medical Countermeasure Development and USG Utilization Needs Leveraging Experiences in Addressing Pandemic Influenza to Inform CBRN Efforts USG and External Stakeholder Interactions
Closing Session
4:15 – 4:25 pm	Medical Countermeasure Development and Acquisition— Path Forward under the PHEMCE Strategy: Dr. Carol Linden , Acting Principal Deputy Director, Office of Public Health Emergency Medical Countermeasures, Office of Public Health Emergency Preparedness, Department of Health and Human Services
4:25 – 4:30pm	Closing Remarks: Dr. Gerald Parker , Principal Deputy Assistant Secretary, Office of Public Health Emergency Preparedness, Department of Health and Human Services
4:30 pm	WORKSHOP ADJOURNS

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