Rapid Medical
Countermeasure
Response to
Infectious Diseases
Enabling Sustainable Capabilities
Through Ongoing Public- and
Private-Sector Partnerships
Workshop Summary
Theresa Wizemann, Megan Reeve Snair, and Jack Herrmann,
Rapporteurs
Forum on Medical and Public Health Preparedness
for Catastrophic Events
Forum on Drug Discovery, Development, and Translation
Forum on Microbial Threats
Board on Health Sciences Policy
Board on Global Health
Institute of Medicine
THE NATIONAL ACADEMIES PRESS
Washington, DC
THE NATIONAL ACADEMIES PRESS • 500 Fifth Street, NW • Washington, DC 20001
This activity was supported by contracts between the National Academy of Sciences and the American College of Emergency Physicians; American Hospital Association; Association of State and Territorial Health Officials; Centers for Disease Control and Prevention (Contract No. 200-2011-38807, TO #30); Department of Defense (Contract No. HT0011-11-P-0186); Department of Defense, Uniformed Services University of the Health Sciences (Contract No. HT9404-12-1-0022); Department of Health and Human Services’ Administration for Children and Families (Contract No. HHSP2332014001533P); Department of Health and Human Services’ National Institutes of Health: National Institute of Allergy and Infectious Diseases, National Institute of Environmental Sciences, National Library of Medicine (Contract No. HHSN26300007 [Under Base 1 #HHSN263201200074I]); Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (Contract No. HHSO100201000021P); Department of Homeland Security, Office of Health Affairs (Contract No. HSHQDC-13-J-00384 [Under Base 1 #HSHQDC-11-D-00009]); Department of Transportation’s National Highway Traffic Safety Administration (Contract No. DTNH22-10-H-00287); Department of Veterans Affairs (Contract No. 101-G09041); Food and Drug Administration (Contract No. HHSF22301027T [Under Base Contract DHHS-8598]); Infectious Diseases Society of America; Martin, Blanck & Associates; Merck Research Laboratories (Contract No. APA-2014-1666); National Association of Chain Drug Stores; National Association of County and City Health Officials; National Association of Emergency Medical Technicians; Novartis Vaccines and Diagnostics, Inc.; Pharmaceutical Research and Manufacturers of America; Robert Wood Johnson Foundation; Target Corporation; and Trauma Center Association of America. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.
International Standard Book Number-13: 978-0-309-37861-1
International Standard Book Number-10: 0-309-37861-3
DOI: 10.17226/21809
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.
Copyright 2016 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America
Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2016. Rapid medical countermeasure response to infectious diseases: Enabling sustainable capabilities through ongoing public and private-sector partnerships: Workshop summary. Washington, DC: The National Academies Press.
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WORKSHOP PLANNING COMMITTEE1
RICHARD HATCHETT (Co-Chair), Biomedical Advanced Research and Development Authority, Department of Health and Human Services, Washington, DC
MONIQUE MANSOURA (Co-Chair), Novartis Vaccines and Diagnostics, Cambridge, MA
PHYLLIS ARTHUR, Biotechnology Industry Organization, Washington, DC
MARK FEINBERG, Merck & Co., Inc., West Point, PA
THOMAS INGLESBY, UPMC Center for Health Security, Baltimore, MD
ALI KHAN, College of Public Health, University of Nebraska Medical Center, Omaha, NE
MICHAEL KURILLA, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD
JOSEPH LARSEN, Biomedical Advanced Research Development Authority, Department of Health and Human Services, Washington, DC
CARMEN MAHER, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, Silver Spring, MD
MICHAEL OSTERHOLM, Center for Infectious Disease Research and Policy, University of Minnesota, Minneapolis, MN
TARA O’TOOLE, In-Q-Tel, Inc., Arlington, VA
GERALD PARKER, Center for Innovation in Advanced Development & Manufacturing, Texas A&M University Health Science Center, Bryan, TX
ANDREW PAVIA, Infectious Disease Society of America, Salt Lake City, UT
JOHN REX, AstraZeneca, Waltham, MA
IOM Staff
BRUCE M. ALTEVOGT, Forum Director (until May 2015)
JACK HERRMANN, Forum Director (since May 2015)
___________________
1Institute of Medicine 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.
FORUM ON MEDICAL AND PUBLIC HEALTH
PREPAREDNESS FOR CATASTROPHIC EVENTS1
DAN HANFLING (Co-Chair), UPMC Center for Biosecurity, Bethesda, MD
SUZET M. MCKINNEY (Co-Chair), Illinois Medical District Commission, Chicago, IL
ROY L. ALSON, American College of Emergency Physicians, Winston-Salem, NC
KATHRYN BRINSFIELD, Office of Health Affairs, Department of Homeland Security, Washington, DC
SUSAN COOPER, Regional Medical Center, Memphis, TN
BROOKE COURTNEY, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, Washington, DC
DAVID T. DYJACK, National Association of County and City Health Officials, Washington, DC
BRUCE EVANS, National Association of Emergency Medical Technicians, Upper Pine River Fire Protection District, Bayfield, CO
JULIE L. GERBERDING, Merck Vaccines, Merck & Co., Inc., West Point, PA
LEWIS R. GOLDFRANK, New York University School of Medicine, New York
JOHN L. HICK, Hennepin County Medical Center, Minneapolis, MN
PAUL E. JARRIS, Association of State and Territorial Health Officials, Arlington, VA
LISA G. KAPLOWITZ, Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services, Washington, DC
MICHAEL G. KURILLA, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD
EMILY LORD, Healthcare Ready, Washington, DC
DONALD M. LUMPKINS, Federal Emergency Management Agency, Department of Homeland Security, Washington, DC
JAYNE LUX, National Business Group on Health, Washington, DC
LINDA M. MACINTYRE, American Red Cross, San Rafael, CA
___________________
1Institute of Medicine forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.
MONIQUE K. MANSOURA, Novartis Vaccines and Diagnostics, Inc., Cambridge, MA
NICOLE MCKOIN, Target Corporation, Furlong, PA
AUBREY K. MILLER, National Institute of Environmental Health Sciences, Bethesda, MD
MATTHEW MINSON, Texas A&M University, College Station
JOHN OSBORN, Mayo Clinic, Rochester, MN
TARA O’TOOLE, In-Q-Tel, Arlington, VA
ANDREW T. PAVIA, Infectious Diseases Society of America, Salt Lake City, UT
STEVEN J. PHILLIPS, National Library of Medicine, Bethesda, MD
ALONZO PLOUGH, Robert Wood Johnson Foundation, Princeton, NJ
LEWIS J. RADONOVICH, Department of Veterans Affairs, Washington, DC
STEPHEN C. REDD, Centers for Disease Control and Prevention, Atlanta, GA
MARY J. RILEY, Administration for Children and Families, U.S. Department of Health and Human Services, Washington, DC
SARA ROSZAK, National Association of Chain Drug Stores, Arlington, VA
KENNETH W. SCHOR, Uniformed Services University of the Health Sciences, Bethesda, MD
ROSLYNE SCHULMAN, American Hospital Association, Washington, DC
RICHARD SERINO, Harvard School of Public Health, Boston, MA
DAVID J. SMITH, Department of Defense, Washington, DC
MARGARET VANAMRINGE, The Joint Commission, Washington, DC
W. CRAIG VANDERWAGEN, Martin, Blanck & Associates, Alexandria, VA
JENNIFER WARD, Trauma Center Association of America, Las Cruces, NM
JOHN M. WIESMAN, Washington State Department of Health, Tumwater, WA
GAMUNU WIJETUNGE, National Highway Traffic Safety Administration, Washington, DC
MATTHEW K. WYNIA, Center for Bioethics and Humanities, University of Colorado Denver, Aurora, CO
FORUM ON DRUG DISCOVERY, DEVELOPMENT, AND
TRANSLATION1
RUSS ALTMAN (Co-Chair), Stanford University, CA
STEVEN GALSON (Co-Chair), Amgen Inc., Thousand Oaks, CA
MARGARET ANDERSON, FasterCures, Washington, DC
HUGH AUCHINCLOSS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD
CHRISTOPHER AUSTIN, National Center for Advancing Translational Sciences, Bethesda, MD
ANN BONHAM, Association of American Medical Colleges, Washington, DC
LINDA BRADY, National Institute of Mental Health, National Institutes of Health, Bethesda, MD
GAIL CASSELL, Harvard Medical School Department of Social and Global Medicine (Visiting), Carmel, IN
ANDREW DAHLEM, Eli Lilly & Co., Indianapolis, IN
JAMES DOROSHOW, National Cancer Institute, Bethesda, MD
JEFFREY DRAZEN, New England Journal of Medicine, Boston, MA
HARRY GREENBERG, Stanford University School of Medicine, CA
LYNN HUDSON, Critical Path Institute, Tucson, AZ
S. CLAIBORNE JOHNSTON, Dell Medical School at the University of Texas, Austin
JACK KEENE, Duke University Medical Center, Durham, NC
RUSTY KELLEY, Burroughs Wellcome Fund, Research Triangle Park, NC
RONALD KRALL, University of Pittsburgh, Steamboat Springs, CO
FREDA LEWIS-HALL, Pfizer, Inc., New York, NY
BRIGGS MORRISON, AstraZeneca, Summit, NJ
BERNARD MUNOS, InnoThink Center for Research in Biomedical Innovation, Indianapolis, IN
ELIZABETH (BETSY) MYERS, Doris Duke Charitable Foundation, New York, NY
JOHN ORLOFF, Baxter BioScience, Deerfield, IL
RAJESH RANGANATHAN, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD
___________________
1Institute of Medicine forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.
ROBERT RATNER, American Diabetes Association, Alexandria, VA
MICHAEL ROSENBLATT, Merck & Co., Inc., Kenilworth, NJ
MICHAEL SEVERINO, AbbVie Inc., North Chicago, IL
ELLEN SIGAL, Friends of Cancer Research, Washington, DC
LANA SKIRBOLL, Sanofi, Washington, DC
MURRAY STEWART, GlaxoSmithKline, Collegeville, PA
BRIAN STROM, Rutgers, the State University of New Jersey, Newark
JANET TOBIAS, Ikana Media, New York, NY
JOHN WAGNER, Takeda Pharmaceuticals, Cambridge, MA
JOANNE WALDSTREICHER, Johnson & Johnson, New Brunswick, NJ
CARRIE WOLINETZ, National Institutes of Health, Bethesda, MD
JANET WOODCOCK, Food and Drug Administration, Silver Spring, MD
IOM Staff
ANNE CLAIBORNE, Forum Director
CHRISTOPHER J. DEFEO, Program Officer
REBECCA ENGLISH, Program Officer
EMILY BUSTA, Associate Program Officer
KATHRYN HOWELL, Senior Program Assistant
ANDREW M. POPE, Director, Board on Health Sciences Policy
BOARD ON GLOBAL HEALTH1
THOMAS C. QUINN (Chair), National Institute of Allergy and Infectious Disease and Johns Hopkins University School of Medicine
JO IVEY BOUFFORD, New York Academy of Medicine
GARY DARMSTADT, Stanford School of Medicine
JACOB A. GAYLE, Medtronic Foundation
GLENDA E. GRAY, South African Medical Research Council
MARGARET A. HAMBURG, National Academy of Medicine
STEPHEN W. HARGARTEN, Medical College of Wisconsin
CLARION JOHNSON, ExxonMobil
ALAN I. LESHNER, American Association for the Advancement of Science (Emeritus)
GUY H. PALMER, Washington State University
ANNE C. PETERSEN, University of Michigan
DAVID VLAHOV, University of California, San Francisco, Schools of Nursing and Medicine
IOM Staff
PATRICK KELLEY, Board Director
___________________
1Institute of Medicine boards do not review or approve individual reports and are not asked to endorse conclusions and recommendations. The responsibility for the content of the reports rests with the workshop rapporteurs and the institution.
Reviewers
This workshop summary has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. 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:
PHYLLIS A. ARTHUR, Biotechnology Industry Organization
KENNETH W. BERNARD, (Retired) World Health Organization
THOMAS J. BOLLYKY, Council on Foreign Relations
MANON COX, Protein Sciences Corporation
JULIE GERBERDING, Merck & Co., Inc.
TARA O’TOOLE, In-Q-Tel, Inc.
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 LESLIE Z. BENET, University of California, San Francisco. He 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.
Contents
Achieving Rapid and Nimble MCM Capability
Overview of Topics Highlighted During Presentations and Discussion
2 A WAKE-UP CALL: THE 2014 EBOLA OUTBREAK RESPONSE
3 PREPAREDNESS AS AN ISSUE OF NATIONAL SECURITY
Leveraging the Department of Defense Mission
Capitalizing on the Current Momentum
4 RAPID DEVELOPMENT OF EBOLA VACCINES
Values of Multistakeholder Partnerships: Large Company Perspective
Engaging the Innovators: Small Biotechnology Company Perspective
Pre-Positioned EUA for Diagnostics
5 INFLUENZA RISK ASSESSMENT AND PANDEMIC PREPAREDNESS
Influenza Risk Assessment Tool
Industry Partners in Pandemic Preparedness and Rapid Response
Developing and Sustaining New Vaccine Platforms
Funding a Better Influenza Vaccine
6 DEVELOPING MCMs FOR CORONAVIRUSES
Response to the 2003 SARS Outbreak
Sustaining Product Development
7 SUSTAINABLE BUSINESS MODELS TO ENSURE RAPID AND NIMBLE RESPONSES
Addressing “Market Failures” in Global Health and Biodefense
What Motivates Companies?: Lessons from Antibacterial Drug Development
U.S. Government Models for Incentivizing Development
Viral Hemorrhagic Fever Consortium: A University-Based Model
Critical Path to Tuberculosis Drug Regimens: A Public–Private Partnership Model
Creating Shared Value for Social Change
A Discussion of Priorities Moving Forward
8 SUPPORTING MCM DEVELOPMENT ACROSS THREATS AND FUNDING CYCLES