Technologies to Enable Autonomous Detection for BioWatch: Ensuring Timely and Accurate Information for Public Health Officials: Workshop Summary (2014)

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C Workshop Agenda Strategies for Cost-Effective and Flexible Biodetection Systems That Ensure Timely and Accurate Information for Public Health Officials: A Workshop AGENDA National Academy of Sciences Building, Room 125 2101 Constitution Avenue, NW • Washington, DC 20001 The Institute of Medicine and the National Research Council will host a 2-day workshop that will explore alternative cost-effective sys- tems that would meet requirements for BioWatch as an automated detec- tion system for aerosolized agents (alternative technologies for auto- nomous detection). Systems identified need to be capable of being de- ployed by the Department of Homeland Security (DHS) by 2018 and enabling day-to-day environmental surveillance that would be of value to the public health and medical community. Workshop Objectives:  Develop an understanding of the nature of the biothreat and the role of biodetection. 123 

124 TECHNOLOGIES TO ENABLE AUTONOMOUS DETECTION FOR BIOWATCH  Discuss the history of the BioWatch program and the draft re- quest for proposals (RFP) released by DHS for alternative tech- nologies for autonomous detection.  Discuss the role of public health officials and laboratorians in the interpretation of BioWatch data and the information that is need- ed from a system for effective decision making.  Review the current state of the art and explore the potential use of four families of biodetection technology for the BioWatch program.  Explore how the technologies discussed might be strategically combined or deployed to optimize their contributions to an effec- tive environmental detection capability. DAY ONE 8:00 a.m. Breakfast available for planning committee and speakers 8:30 a.m. Welcome, Introductions, and Meeting Objectives WILLIAM RAUB, Chair, Workshop Planning Committee Science Advisor to the Secretary (Retired) Department of Health and Human Services SALLY PHILLIPS Principal Deputy Assistant Secretary (Acting) Office of Health Affairs Department of Homeland Security SESSION I: OVERVIEW OF THE BIOWATCH PROGRAM Session Objectives: Develop an understanding of the nature of the biothreat and the role of biodetection. Discuss the history of the BioWatch Program and the draft RFP released by the Department of Homeland Security regarding alternative technologies for autonomous detection. 8:45 a.m. Nature of the Biothreat 

APPENDIX C 125 Moderator: WILLIAM RAUB Science Advisor to the Secretary (Retired) Department of Health and Human Services ROBERT KADLEC Consultant RPK Consulting LLC Former Special Assistant to the President for Homeland Security Former Senior Director for Biological Defense Policy White House Homeland Security Council 5 Minutes for Questions 9:05 a.m. BioWatch Program History JEFFREY RUNGE Principal The Chertoff Group Assistant Secretary for Health Affairs and Chief Medical Officer (2005–2008) Department of Homeland Security 5 Minutes for Questions 9:25 a.m. Current BioWatch Program, Technology, and Autonomous Detection MICHAEL V. WALTER Detection Branch Chief BioWatch Program Manager Office of Health Affairs Department of Homeland Security 20 Minutes for Discussion (specific to the BioWatch Program and alternative technologies for autonomous detection) 10:05 a.m. Break SESSION II: PUBLIC HEALTH AND DECISION MAKERS 

126 TECHNOLOGIES TO ENABLE AUTONOMOUS DETECTION FOR BIOWATCH Session Objectives: Discuss role of public health officials and labora- torians in the interpretation of BioWatch results. What information is needed to call a BioWatch Actionable Result (BAR) (i.e., a positive re- sult, not necessarily a threat to public health) in the current system? What information would be needed for confidence in a BAR determined using an automated detection system? Once a BAR is determined, what data are needed for analysis and to help determine if there is a threat to public health (i.e., what decisions or actions may be taken as result of a BAR)? 10:20 a.m. Panel Discussion: BioWatch—Information for Decision Making Moderator: SUZET M. MCKINNEY Deputy Commissioner Bureau of Public Health Preparedness and Emergency Response Division of Women & Children’s Health Chicago Department of Public Health Rapporteur: BETH MALDIN MORGENTHAU Assistant Commissioner Bureau of Policy, Community Resilience and Response Office of Emergency Preparedness and Response New York City Department of Health and Mental Hygiene Commissioned Paper Writer: SANDRA SMOLE Director Division of Molecular Diagnostics and Virology Bureau of Laboratory Sciences Massachusetts Department of Public Health Panel: UMAIR A. SHAH Executive Director Local Health Authority Harris County Public Health and Environmental Services 

APPENDIX C 127 DAVID PERSSE Emergency Medical Services Physician Director Public Health Authority City of Houston ERICA PAN Deputy Health Officer and Director Division of Communicable Disease Control & Prevention Alameda County Public Health Department COLIN STIMMLER Director of the BioWatch Program New York Department of Health and Mental Hygiene JOHN PLANTE Senior Manager of Emergency Preparedness Chicago Transit Authority 12:15 p.m. Break for Lunch (lunch available for planning committee and speakers) SESSION III: REVIEW OF POTENTIAL TECHNOLOGIES FOR THE BIOWATCH PROGRAM Session Objectives: Explore the potential use of four families of technol- ogy for the BioWatch Program: (1) nucleic acid signatures, (2) immuno- assays and protein signatures, (3) genomic sequencing, and (4) mass spectrometry. 1:00 p.m. Panel: State of the Art for Autonomous Detection Systems Using Nucleic Acid Signatures Moderator: JOHN VITKO Rector St. Luke Church Director of Biological and Chemical Countermeasures for Science and Technology Directorate (Retired) Department of Homeland Security 

128 TECHNOLOGIES TO ENABLE AUTONOMOUS DETECTION FOR BIOWATCH Rapporteur: WILLIAM O’NEILL Development Program Manager and Project Engineer Biohazard Detection System U.S. Postal Service Commissioned Paper Writer: RAYMOND P. MARIELLA, JR. Senior Scientist Lawrence Livermore National Laboratory Panel: DAVID TILLES Vice President CBRNE Defense Northrop Grumman M. ALLEN NORTHRUP Chief Executive Officer Northrup Consulting Group STEVAN JOVANOVICH Co-Founder and Chief Technology Officer IntegenX, Inc. IVOR KNIGHT Senior Vice President and Chief Technology Officer Canon U.S. Life Sciences, Inc. 3:00 p.m. Break 3:15 p.m. Panel: State of the Art for Autonomous Detection Systems Using Immunoassays and Protein Signatures Moderator: WILLIAM RAUB, Chair, Workshop Planning Committee Science Advisor to the Secretary (Retired) Department of Health and Human Services 

APPENDIX C 129 Rapporteur: THOMAS SLEZAK Associate Program Leader Informatics for the Global Security Program Lawrence Livermore National Laboratory Commissioned Paper Writer: R. PAUL SCHAUDIES Chief Executive Officer GenArraytion, Inc. Panel: AMY ALTMAN Vice President Biodefense and Food Safety Luminex Corporation TED OLSEN Chief Executive Officer and President PathSensors, Inc. ANDREW BARTKO Principal Scientist Battelle Memorial Institute DAVID HANLON Director Business Development and Strategic Collaborations Quanterix 5:00 p.m. Concluding Remarks WILLIAM RAUB, Chair, Workshop Planning Committee Science Advisor to the Secretary (Retired) Department of Health and Human Services 5:30 p.m. Adjurn Room will be open until 6:30 and participants are en- couraged to continue conversations. 

130 TECHNOLOGIES TO ENABLE AUTONOMOUS DETECTION FOR BIOWATCH DAY TWO 8:15 a.m. Breakfast available for planning committee and speakers 8:45 a.m. Welcome and Overview WILLIAM RAUB, Chair, Workshop Planning Committee Science Advisor to the Secretary (Retired) Department of Health and Human Services SESSION III (CONT.): REVIEW OF POTENTIAL TECHNOLOGIES FOR THE BIOWATCH PROGRAM Session Objectives (cont.): Explore the potential use of four families of technology for the BioWatch Program: (1) nucleic acid signatures, (2) immunoassays and protein signatures, (3) genomic sequencing, and (4) mass spectrometry. 9:00 a.m. Panel: State of the Art for Autonomous Detection Systems Using Genomic Sequencing Moderator: RITA COLWELL Distinguished University Professor University of Maryland Johns Hopkins University School of Public Health Rapporteur: ERIC EISENSTADT Independent Technical Consultant Commissioned Paper Writers: CHRIS DETTER Bio-Threat/Bio-Defense Program Director Emerging Threats Program Office Global Security and Bioscience Division Los Alamos National Laboratory 

APPENDIX C 131 GARY RESNICK Independent Consultant Guest Scientist Los Alamos National Laboratory Panel: JEFFREY SCHLOSS Director, Division of Genome Sciences Program Director, Technology Development and Coordination Extramural Research Program National Human Genome Research Institute National Institutes of Health THOMAS CEBULA Chief Technical Officer CosmosID™ Visiting Professor Johns Hopkins University BRIAN YOUNG Program Manager Battelle Memorial Institute 10:30 a.m. Break 10:45 a.m. Panel: State of the Art for Autonomous Detection Systems Using Mass Spectrometry Moderator: DONALD PROSNITZ Independent Consultant Rapporteur: CHARLES KOLB President and Chief Executive Officer Aerodyne Research, Inc. Commissioned Paper Writers: A. PETER SNYDER Private Citizen 

132 TECHNOLOGIES TO ENABLE AUTONOMOUS DETECTION FOR BIOWATCH RABIH JABBOUR Private Citizen Panel: RUDOLPH JOHNSON Acting Manager Emergency Response Branch Division of Laboratory Sciences National Center for Environmental Health Centers for Disease Control and Prevention ERIC E. GARD Scientist Defense Biology Division Lawrence Livermore National Laboratory ZHENG OUYANG Associate Professor Weldon School of Biomedical Engineering Purdue University SESSION IV: TECHNOLOGIES AS PART OF COMPLETE ENVIRONMENTAL DETECTION CAPABILITY Session Objectives: Review the themes and key points from previous panel discussions. Explore how the technologies discussed might be stra- tegically combined or deployed to optimize their contributions to an ef- fective environmental detection capability. Additional consideration of technologies and how they might fit together as whole system (e.g., mod- ular, hybrid, etc.). 1:30 p.m. Panel of Rapporteurs Moderator: WILLIAM RAUB, Chair, Workshop Planning Committee Science Advisor to the Secretary (Retired) Department of Health and Human Services 

APPENDIX C 133 Panel: BETH MALDIN MORGENTHAU Assistant Commissioner Bureau of Policy, Community Resilience and Response Office of Emergency Preparedness and Response New York City Department of Health and Mental Hygiene SANDRA SMOLE Director Division of Molecular Diagnostics and Virology Bureau of Laboratory Sciences Massachusetts Department of Public Health WILLIAM O’NEILL Development Program Manager and Project Engineer Biohazard Detection System U.S. Postal Service THOMAS SLEZAK Associate Program Leader Informatics for the Global Security Program Lawrence Livermore National Laboratory CHARLES KOLB President and Chief Executive Officer Aerodyne Research, Inc. ERIC EISENSTADT Independent Technical Consultant 3:00 p.m. Concluding Remarks WILLIAM RAUB, Chair, Workshop Planning Committee Science Advisor to the Secretary (Retired) Department of Health and Human Services 3:30 p.m. Adjourn