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Suggested Citation:"Front Matter." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×

ADVANCING REGULATORY SCIENCE
FOR MEDICAL COUNTERMEASURE
DEVELOPMENT

Workshop Summary

Theresa Wizemann, Bruce M. Altevogt, and
Anne B. Claiborne, Rapporteurs

Forum on Drug Discovery, Development, and Translation

Forum on Medical and Public Health Preparedness
for Catastrophic Events

Board on Health Sciences Policy

INSTITUTE OF MEDICINE

                OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×

THE NATIONAL ACADEMIES PRESS   500 Fifth Street, N.W.   Washington, DC 20001

NOTICE: The project that is the subject of this report 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 project was supported by contracts between the National Academy of Sciences and Department of Health and Human Services (Contract Nos. N01-OD-4-2139 TO #158, HHSF223001003T, HHSF22301022T TO #24, N01-OD-4-2139 TO #198, HHSP233200900680P, HH5P23320042509X1, and HHSP233200800498P), the American Diabetes Association, the American Society for Microbiology, Amgen Inc., the Association of American Medical Colleges, Bristol-Myers Squibb, the Burroughs Wellcome Fund, Celtic Therapeutics, LLLP, the Critical Path Institute, the Doris Duke Charitable Foundation, Eli Lilly & Co., FasterCures, the Foundation for the NIH, Friends of Cancer Research, GlaxoSmithKline, Howard Hughes Medical Institute, Johnson & Johnson, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Pfizer, Inc, the American College of Emergency Physicians, the American Hospital Association, the American Medical Association, the American Nurses Association, the Association of State and Territorial Health Officials, the Centers for Disease Control and Prevention (Contract No. 200-2005-13434 TO #6), the Department of the Army (Contract No. W81XWH-08-P-0934), the Department of Homeland Security’s Office of Health Affairs (Contract No. HSHQDC-07-C-00097), the Department of Homeland Security, Federal Emergency Management Agency (Contract No. HSFEHQ-08-P-1800), the Department of Transportation’s National Highway Traffic Safety Administration (DTNH22-10-H-00287) the Department of Veterans Affairs (Contract No. V101(93)P-2136 TO #10), the Emergency Nurses Association, the National Association of Chain Drug Stores, the National Association of County and City Health Officials, the National Association of Emergency Medical Technicians, the Pharmaceutical Research and Manufacturers of America, The Robert Wood Johnson Foundation, and the United Health Foundation. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the view of the organizations or agencies that provided support for this project.

International Standard Book Number-13: 978-0-309-21490-2
International Standard Book Number-10: 0-309-21490-4

Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu.

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

Copyright 2011 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America

The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

Suggested citation: IOM (Institute of Medicine). 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press.

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×

“Knowing is not enough; we must apply.
Willing is not enough; we must do.”

                                                                  —Goethe

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INSTITUTE OF MEDICINE
        OF THE NATIONAL ACADEMIES

Advising the Nation. Improving Health.

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×

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. Charles M. Vest 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. Charles M. Vest are chair and vice chair, respectively, of the National Research Council.

www.national-academies.org

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×

PLANNING COMMITTEE FOR THE WORKSHOP ON ADVANCING REGULATORY SCIENCE FOR MEDICAL COUNTERMEASURE DEVELOPMENT1

LESLIE Z. BENET (Co-Chair), University of California-San Francisco

JOHN REX, (Co-Chair), AstraZeneca, Waltham, MA

MARGARET ANDERSON, FasterCures, Washington, DC

PHYLLIS ARTHUR, Biotechnology Industry Organization, Washington, DC

ANTHONY BAHINSKI, Wyss Institute for Biologically Inspired Engineering at Harvard University, Boston, MA

LUCIANA BORIO, Food and Drug Administration, Silver Spring, MD

GAIL H. CASSELL, Harvard Medical School (visiting), Carmel, IN

GARRET A. FITZGERALD, University of Pennsylvania School of Medicine, Philadelphia

STEVEN K. GALSON, Amgen Inc., Thousand Oaks, CA

JOHN GRABENSTEIN, Merck & Co., Inc., West Point, PA

ROBERT KADLEC, PRTM Management Consultants, Washington, DC

MICHAEL KATZE, University of Washington, Seattle, WA

GEORGE KORCH, Department of Health and Human Services, Washington, DC

MICHAEL KURILLA, National Institute of Allergy and Infectious Diseases, Bethesda, MD

BERNARD MUNOS, InnoThink, Indianapolis, IN

GERALD PARKER, Department of Defense, Washington, DC

MARY PENDERGAST, Pendergast Consulting, Washington, DC

NICKI PESIK, Centers for Disease Control and Prevention, Atlanta, GA

ERIC TONER, Center for Biosecurity of the UPMC, Baltimore, MD

IOM Staff

ANNE B. CLAIBORNE, Director, Forum on Drug Discovery, Development, and Translation

BRUCE M. ALTEVOGT, Director, Forum on Medical and Public Health Preparedness for Catastrophic Events

ELIZABETH F. C. TYSON, Research Associate

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

DONNA L. RANDALL, Administrative Assistant

ROBIN GUYSE, Senior Program Assistant

ALEX REPACE, Senior Program Assistant

_____________

1 Institute 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.

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×

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Suggested Citation:"Front Matter." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×

FORUM ON DRUG DISCOVERY, DEVELOPMENT, AND TRANSLATION1

GAIL H. CASSELL (Co-Chair), Harvard Medical School (visiting), Carmel, IN

JEFFREY M. DRAZEN (Co-Chair), New England Journal of Medicine, Boston, MA

BARBARA ALVING, National Center for Research Resources, Bethesda, MD

MARGARET ANDERSON, FasterCures, Washington, DC

LESLIE Z. BENET, University of California-San Francisco

ANN BONHAM, Association of American Medical Colleges, Washington, DC

LINDA BRADY, National Institute of Mental Health, Bethesda, MD

ROBERT CALIFF, Duke University Medical Center, Durham, NC

SCOTT CAMPBELL, Foundation for the National Institutes of Health, Bethesda, MD

C. THOMAS CASKEY, University of Texas-Houston Health Science Center

PETER B. CORR, Celtic Therapeutics, LLLP, New York, NY

ANDREW M. DAHLEM, Eli Lilly and Company, Indianapolis, IN

JAMES H. DOROSHOW, National Cancer Institute, Bethesda, MD

GARY L. FILERMAN, ATLAS Research, McLean, VA

GARRET A. FITZGERALD, University of Pennsylvania School of Medicine, Philadelphia

ELAINE K. GALLIN, QE Philanthropic Advisors, Potomac, MD

STEVEN K. GALSON, Amgen Inc., Thousand Oaks, CA

HARRY B. GREENBERG, Stanford University School of Medicine, Stanford, CA

STEPHEN GROFT, National Institutes of Health, Bethesda, MD

ANNALISA JENKINS, Bristol-Myers Squibb, Plainsboro, NJ

MICHAEL KATZ, March of Dimes Foundation, White Plains, NY

PETRA KAUFMANN, National Institute of Neurological Disorders and Stroke, Bethesda, MD

JACK D. KEENE, Duke University Medical Center, Durham, NC

RONALD L. KRALL, University of Pennsylvania, Center for Bioethics, Steamboat Springs, CO

FREDA LEWIS-HALL, Pfizer, New York, NY

MARK B. McCLELLAN, The Brookings Institution, Washington, DC

CAROL MIMURA, University of California-Berkeley

_____________

1 Institute 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.

Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×

ELIZABETH (BETSY) MYERS, Doris Duke Charitable Foundation, New York, NY

JOHN ORLOFF, Novartis Pharmaceuticals Corporation, East Hanover, NJ

AMY PATTERSON, National Institutes of Health, Bethesda, MD

MICHAEL ROSENBLATT, Merck & Co., Inc., Whitehouse Station, NJ

JANET SHOEMAKER, American Society for Microbiology, Washington, DC

ELLEN SIGAL, Friends of Cancer Research, Arlington, VA

ELLEN STRAHLMAN, GlaxoSmithKline, Research Triangle Park, NC

NANCY SUNG, Burroughs Wellcome Fund, Research Triangle Park, NC

JORGE A. TAVEL, National Institute of Allergy and Infectious Diseases, Bethesda, MD

JANET TOBIAS, Mt. Sinai School of Medicine, New York, NY

JOANNE WALDSTREICHER, Johnson & Johnson, Raritan, NJ

JANET WOODCOCK, Food and Drug Administration, White Oak, MD

RAYMOND L. WOOSLEY, The Critical Path Institute, Tucson, AZ

IOM Staff

ANNE B. CLAIBORNE, Forum Director

REBECCA A. ENGLISH, Associate Program Officer

ELIZABETH F. C. TYSON, Research Associate

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

ROBIN GUYSE, Senior Program Assistant

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×

FORUM ON MEDICAL AND PUBLIC HEALTH PREPAREDNESS FOR CATASTROPHIC EVENTS1

ROBERT KADLEC (Co-Chair), PRTM Management Consultants, Washington, DC

LYNNE KIDDER (Co-Chair), Center for Excellence in Disaster Management and Humanitarian Assistance, Tripler AMC, Hawaii

ALEX ADAMS, National Association of Chain Drug Stores Foundation, Alexandria, VA

DAMON ARNOLD, Association of State and Territorial Health Officials, Arlington, VA

GEORGES BENJAMIN, American Public Health Association, Washington, DC

VICTORIA DAVEY, Department of Veterans Affairs, Washington, DC

JEFFREY DUCHIN, Seattle & King County and University of Washington, Seattle

ALEXANDER GARZA, Department of Homeland Security, Washington, DC

JULIE GERBERDING, Merck Vaccines, West Point, PA

LEWIS GOLDFRANK, New York University Medical Center, New York

DAN HANFLING, Inova Health System, Falls Church, VA

JACK HERRMANN, National Association of County and City Health Officials, Washington, DC

JAMES JAMES, American Medical Association, Chicago, IL

JERRY JOHNSTON, National Association of Emergency Medical Technicians, Mt. Pleasant, IA

BRIAN KAMOIE, The White House, Washington, DC

LISA KAPLOWITZ, HHS Office of the Assistant Secretary for Preparedness and Response, Washington, DC

ALI KHAN, Centers for Disease Control and Prevention, Atlanta, GA

MICHAEL KURILLA, National Institute of Allergy and Infectious Diseases, Bethesda, MD

JAYNE LUX, National Business Group on Health, Washington, DC

ANTHONY MACINTYRE, American College of Emergency Physicians, Washington, DC

ANGELA McGOWAN, Robert Wood Johnson Foundation, Princeton, NJ

MARGARET McMAHON, Emergency Nurses Association,

Williamstown, NJ

MATTHEW MINSON, Texas A&M University, College Station, TX

_____________

1 Institute 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.

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×

ERIN MULLEN, Pharmaceutical Research and Manufacturers of America, Washington, DC

CHERYL PETERSON, American Nurses Association, Silver Spring, MD

STEVEN PHILLIPS, National Library of Medicine, Bethesda, MD

ROSLYNE SCHULMAN, American Hospital Association, Washington, DC

RICHARD SERINO, Federal Emergency Management Agency, Washington, DC

MICHAEL SKIDMORE, Office of Assistant Secretary of Defense for Health Affairs, Department of Defense, Washington, DC

SHARON STANLEY, American Red Cross, Washington, DC

ERIC TONER, University of Pittsburgh Medical Center, Pittsburgh, PA

REED TUCKSON, UnitedHealth Group, Minneapolis, MN

MARGARET VANAMRINGE, The Joint Commission, Washington, DC

GAMUNU WIEJETUNGE, National Highway Traffic Safety Administration, Washington, DC

IOM Staff

BRUCE M. ALTEVOGT, Forum Director

CLARE STROUD, Program Officer

KRISTIN VISWANATHAN, Research Associate

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

ALEX REPACE, Senior Program Assistant

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×

Reviewers

This report 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 Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report 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 report:

Gigi Kwik Gronvall, Center for Biosecurity of UPMC

Richard Jaffe, ANSER/Analytic Services Inc.

Jon Mogford, Defense Sciences Office, DARPA

Raymond L. Woosley, The Critical Path Institute

Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the final draft of the report before its release. The review of this report was overseen by Peter Honig, AstraZeneca. Appointed by the Institute of Medicine, he was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authors and the institution.

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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Acronyms

ASPR

HHS Assistant Secretary for Preparedness and Response

 
BARDA

Biomedical Advanced Research and Development Authority

BUN

blood urea nitrogen

 
CBER

FDA Center for Biologics Evaluation and Research

CBRN

chemical, biological, radiological, nuclear

CDC

Centers for Disease Control and Prevention

CDER

FDA Center for Drug Evaluation and Research

CDISC

Clinical Data Interchange Standards Consortium

CDRH

FDA Center for Devices and Radiological Health

CNS

central nervous system

C-Path

Critical Path Institute

 
DARPA

Defense Advanced Research Projects Agency

DoD

Department of Defense

 
EUA

emergency use authorization

 
FDA

U.S. Food and Drug Administration

 
GLP

good laboratory practice

GMP

good manufacturing practice

Page xviii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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HHS

U.S. Department of Health and Human Services

HL7

Health Level Seven International

 
IND

investigational new drug

IOM

Institute of Medicine

IRB

institutional review board

 
LRN

CDC Laboratory Response Network

 
MBF

mobile bioprocessing facility

MCM

medical countermeasure

MIMIC

Modular IMmune In Vitro Constructs

MRSA

methicillin-resistant Staphylococcus aureus

 
NBSB

National Biodefense Science Board

NCTR

FDA National Center for Toxicological Research

NIAID

National Institute of Allergy and Infectious Diseases

NIH

National Institutes of Health

NRC

National Research Council

 
PCAST

President’s Council of Advisors on Science and Technology

PCR

polymerase chain reaction

PHEMCE

Public Health Emergency Medical Countermeasures Enterprise

PK/PD

pharmacokinetic/pharmacodynamic

PSTC

Predictive Safety Testing Consortium

 
RNA

ribonucleic acid

 
SNS

Strategic National Stockpile

 
VAERS

Vaccine Adverse Event Reporting System

VXDS

Voluntary Exploratory Data Submission program

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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Whether or not the United States has safe and effective medical countermeasures--such as vaccines, drugs, and diagnostic tools--available for use during a disaster can mean the difference between life and death for many Americans. The Food and Drug Administration (FDA) and the scientific community at large could benefit from improved scientific tools and analytic techniques to undertake the complex scientific evaluation and decision making needed to make essential medical countermeasures available. At the request of FDA, the Institute of Medicine (IOM) held a workshop to examine methods to improve the development, evaluation, approval, and regulation of medical countermeasures.

During public health emergencies such as influenza or chemical, biological, radiological/nuclear (CBRN) attacks, safe and effective vaccines, treatments, and other medical countermeasures are essential to protecting national security and the well being of the public. Advancing Regulatory Science for Medical Countermeasure Development examines current medical countermeasures, and investigates the future of research and development in this area. Convened on March 29-30, 2011, this workshop identified regulatory science tools and methods that are available or under development, as well as major gaps in currently available regulatory science tools.

Advancing Regulatory Science for Medical Countermeasure Development is a valuable resource for federal agencies including the Food and Drug Administration (FDA), the Department of Health and Human Services (HHS), the Department of Defense (DoD), as well as health professionals, and public and private health organizations.

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