India Hook-Barnard, Sheena M. Posey Norris,
and Joe Alper, Rapporteurs

Board on Health Sciences Policy

Board on Life Sciences

      INSTITUTE OF MEDICINE AND    
NATIONAL RESEARCH COUNCIL
              OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.

www.nap.edu

THE NATIONAL ACADEMIES PRESS • 500 Fifth Street, NW • Washington, DC 20001

NOTICE: The workshop that is the subject of this workshop summary was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.

This activity was supported by Contract No. HSHQDC-12-J-00188 between the National Academy of Sciences and the Department of Homeland Security, Office of Health Affairs. The views presented in this publication do not necessarily reflect the views of the organizations or agencies that provided support for the activity.

International Standard Book Number-13: 978-0-309-29251-1
International Standard Book Number-10: 0-309-29251-4

Additional copies of this workshop summary are available for sale from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu.

For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu.

Copyright 2014 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America

Suggested citation: IOM (Institute of Medicine) and NRC (National Research Council). 2014. Technologies to enable autonomous detection for BioWatch: Ensuring timely and accurate information for public health officials: Workshop summary. Washington, DC: The National Academies Press.

THE NATIONAL ACADEMIES

Advisers to the Nation on Science, Engineering, and Medicine

The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences.

The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. C. D. Mote, Jr., is president of the National Academy of Engineering.

The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine.

The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. C. D. Mote, Jr., are chair and vice chair, respectively, of the National Research Council.

www.national-academies.org

This page intentionally left blank.

PLANNING COMMITTEE FOR A WORKSHOP ON STRATEGIES FOR COST-EFFECTIVE AND FLEXIBLE BIODETECTION SYSTEMS THAT ENSURE TIMELY AND ACCURATE INFORMATION FOR PUBLIC HEALTH OFFICIALS¹

WILLIAM RAUB (Chair), Science Advisor to the Secretary, Department of Health and Human Services (Retired)

RITA COLWELL, Distinguished University Professor, University of Maryland; Professor, Johns Hopkins University Bloomberg School of Public Health

JEFFREY DUCHIN, Chief, Communicable Disease Epidemiology and Immunization Section, Public Health–Seattle & King County; Professor in Medicine, Division of Allergy and Infectious Diseases, University of Washington School of Medicine

SUZET M. MCKINNEY, Deputy Commissioner, Bureau of Public Health Preparedness and Emergency Response; Division of Women and Children’s Health, Chicago Department of Public Health

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

DONALD PROSNITZ, Independent Consultant

JOHN VITKO, Rector, St. Luke Church, Department of Homeland Security (Retired)

IOM/NRC Staff

INDIA HOOK-BARNARD, Senior Program Officer

BRUCE M. ALTEVOGT, Senior Program Officer

SHEENA M. POSEY NORRIS, Research Associate

RACHEL KIRKLAND, Senior Program Assistant

ANDREW M. POPE, Director, Board on Health Sciences Policy

FRANCES E. SHARPLES, Director, Board on Life Sciences

____________

¹Institute of Medicine/National Research Council planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.

This page intentionally left blank.

BOARD ON LIFE SCIENCES¹

JO HANDELSMAN (Chair), Yale University

SEAN EDDY, Howard Hughes Medical Institute, Janelia Farm Research Campus

SARAH C. R. ELGIN, Washington University

DAVID R. FRANZ, Former Commander, U.S. Army Medical Research Institute for Infection Diseases, Consultant

LOUIS J. GROSS, University of Tennessee

RICHARD A. JOHNSON, Arnold & Porter, LLC

JUDITH KIMBLE, University of Wisconsin–Madison

CATO T. LAURENCIN, University of Connecticut Health Center

ALAN I. LESHNER, American Association for the Advancement of Science

KAREN E. NELSON, J. Craig Venter Institute

ROBERT M. NEREM, Georgia Institute of Technology

CAMILLE PARMESAN, University of Texas

ALISON G. POWER, Cornell University

MARGARET RILEY, University of Massachusetts, Amherst

JANIS C. WEEKS, University of Oregon

MARY WOOLLEY, Research!America

NRC Staff

JO L. HUSBANDS, Scholar/Senior Project Director

JAY B. LABOV, Senior Scientist and Program Director for Biology Education

KATHERINE W. BOWMAN, Senior Program Officer

INDIA HOOK-BARNARD, Senior Program Officer

MARILEE K. SHELTON-DAVENPORT, Senior Program Officer

KEEGAN SAWYER, Program Officer

BETHELHEM M. BANJAW, Financial Associate

CARL G. ANDERSON, Program Associate

SAYYEDA AYESHA AHMED, Senior Program Assistant

FRANCES E. SHARPLES, Director

____________

¹Institute of Medicine boards do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.

This page intentionally left blank.

BOARD ON HEALTH SCIENCES POLICY¹

C. THOMAS CASKEY (Chair), Baylor College of Medicine

ELI Y. ADASHI, Brown University

WYLIE BURKE, University of Washington

ROBERT M. CALIFF, Duke University Medical Center

DENNIS CHOI, Stony Brook University

KATHLEEN A. DRACUP, University of California, San Francisco

MICHAEL EHLERS, Pfizer Inc.

NAOMI L. GERBER, George Mason University

LEWIS R. GOLDFRANK, Bellevue Hospital Center and New York University Langone Medical Center

STEVEN E. HYMAN, Broad Institute of Harvard University and Massachusetts Institute of Technology

PAUL E. JARRIS, Association of State and Territorial Health Officials

JEFFREY KAHN, Johns Hopkins University

HARRY T. ORR, University of Minnesota

SHARON TERRY, Genetic Alliance

REED V. TUCKSON, Tuckson Health Connections, LLC

KEITH A. WAILOO, Princeton University

CLYDE YANCY, Feinberg School of Medicine and Northwestern Memorial Hospital

IOM Staff

ANDREW M. POPE, Director

DONNA RANDALL, Administrative Assistant

____________

¹National Research Council boards do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.

This page intentionally left blank.

Reviewers

This workshop summary has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committees. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published workshop summary as sound as possible and to ensure that the workshop summary meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the process. We wish to thank the following individuals for their review of this workshop summary:

Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the workshop summary before its release. The review of this workshop summary was overseen by Enriqueta C. Bond, Burroughs Wellcome Fund. Appointed by the Institute of Medicine, she was responsible for making certain that an independent examination of this workshop summary was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this workshop summary rests entirely with the rapporteurs and the institution.

This page intentionally left blank.

Contents

ACRONYMS AND ABBREVIATIONS

1   INTRODUCTION

2   OVERVIEW OF THE BIOWATCH PROGRAM

3   PUBLIC HEALTH’S PERSPECTIVE ON THE ROLE OF BIOWATCH IN THE DECISION-MAKING PROCESS

4   POTENTIAL TECHNOLOGIES FOR THE BIOWATCH PROGRAM

5   FINAL THOUGHTS

APPENDIXES

A   References

B   Biographical Sketches of Workshop Participants

C   Workshop Agenda

D   Registered Attendees

E   Technology Readiness Levels in the Department of Defense

F   White Paper 1: The BioWatch Program: What Information Is Needed to Inform Decision Making?

G   White Paper 2: Nucleic-Acid Signatures at Three Levels of Readiness for BioWatch

H   White Paper 3: State of the Art for Autonomous Detection Systems Using Immunoassays and Protein Signatures

I    White Paper 4: State of the Art for Autonomous Detection Systems Using Genomic Sequencing

J   White Paper 5: State of the Art for Autonomous Detection Systems Using Mass Spectrometry

Acronyms and Abbreviations