Skip to main content

BioShield Stakeholders Workshop

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

Return to BioShield Stakeholders Workshop