National Academies Press: OpenBook
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×

GLOBAL HEALTH RISK FRAMEWORK

Research and Development of
Medical Products


WORKSHOP SUMMARY

Theresa Wizemann, Michelle A. Mancher, and Anne B. Claiborne,
Rapporteurs

Board on Health Sciences Policy

Institute of Medicine

Image

THE NATIONAL ACADEMIES PRESS

Washington, DC

www.nap.edu

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×

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

This activity was supported by Sponsor Award No. 11849 from the Paul G. Allen Family Foundation, Grant No. 0150-0653 from the Ford Foundation, Investment ID OPP1130763 from The Bill & Melinda Gates Foundation, Dr. Ming Wai Lau, Grant No. 4829 from the Gordon and Betty Moore Foundation, Grant No. 2015 EBO 308 from The Rockefeller Foundation, Award No. GHN-G-00-07-00001-00 from the U.S. Agency for International Development, and the Wellcome Trust. 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: 978-0-309-38099-7
International Standard Book Number-10: 0-309-38099-5
Digit Object Identifier: 10.17226/21853

Additional copies of this report 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. Global health risk framework: Research and development of medical products: Workshop summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×

Image

The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Ralph J. Cicerone is president.

The National Academy of Engineering was established in 1964 under the charter of the National Academy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary contributions to engineering. Dr. C. D. Mote, Jr., is president.

The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president.

The three Academies work together as the National Academies of Sciences, Engineering, and Medicine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine.

Learn more about the National Academies of Sciences, Engineering, and Medicine at www.national-academies.org.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×

This page intentionally left blank.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×

PLANNING COMMITTEE ON GLOBAL HEALTH RISK
FRAMEWORK: A WORKSHOP ON RESEARCH AND
DEVELOPMENT OF MEDICAL PRODUCTS1

MARIA FREIRE (Co-Chair), Foundation for the National Institutes of Health, Bethesda, MD

TADATAKA “TACHI” YAMADA (Co-Chair), Frazier Life Sciences, Seattle, WA

LUCIANA BORIO, U.S. Food and Drug Administration, Bethesda, MD

RAYMOND CHUA, Health Products Regulation Group, Health Sciences Authority, Singapore

NEIL FERGUSON, Department of Mathematical Biology, Imperial College London, London, United Kingdom

GLENDA GRAY, South African Medical Research Council, Cape Town, South Africa

MARGARET “PEGGY” HAMBURG, National Academy of Medicine, Washington, DC

DAVID KASLOW, PATH, Seattle, WA

PATRICK LUKULAY, U.S. Pharmacopeia, Rockville, MD

ADEL MAHMOUD, Princeton University, Princeton, NJ

MARGARETH NDOMONDO-SIGONDA, African Union—New Partnership for Africa’s Development Planning and Coordinating Agency, Johannesburg, South Africa

JOHN REX, AstraZeneca, Waltham, MA

JUDIT RIUS, Médecins Sans Frontiéres Access Campaign, New York, NY

PETER SMITH, London School of Hygiene & Tropical Medicine, London, United Kingdom

PATRICK VALLANCE, GlaxoSmithKline, London, United Kingdom

IOM Staff

ANNE B. CLAIBORNE, Project Director

MICHELLE A. MANCHER, Program Officer

KATHRYN HOWELL, Research Assistant (until November 2015)

BENJAMIN KAHN, Senior Program Assistant

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

__________________

1 The National Academies of Sciences, Engineering, and Medicine’s 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." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×

This page intentionally left blank.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×

BOARD ON HEALTH SCIENCES POLICY1

JEFFREY KAHN (Chair), Johns Hopkins University, Baltimore, MD

ELI Y. ADASHI, Brown University, Providence, RI

WYLIE BURKE, University of Washington, Seattle

R. ALTA CHARO, University of Wisconsin–Madison

LINDA H. CLEVER, California Pacific Medical Center, RENEW, Mill Valley, CA

BARRY S. COLLER, The Rockefeller University, New York, NY

LEWIS R. GOLDFRANK, New York University School of Medicine, New York

BERNARD A. HARRIS, JR., Vesalius Ventures, Houston, TX

MARTHA N. HILL, Johns Hopkins University School of Nursing, Baltimore, MD

STEVEN E. HYMAN, Stanley Center, The Broad Institute, Cambridge, MA

ALAN M. JETTE, Boston University School of Public Health, Boston, MA

PATRICIA A. KING, Georgetown University Law Center, Washington, DC

STORY C. LANDIS, National Institute of Neurological Disorders and Stroke, Bethesda, MD

HARRY T. ORR, University of Minnesota, Minneapolis

UMAIR SHAH, Harris County Public Health & Environmental Services, Houston, TX

ROBYN STONE, Leading Age, Washington, DC

SHARON TERRY, Genetic Alliance, Washington, DC

REED V. TUCKSON, Tuckson Health Connections, LLC, Edina, MN

IOM Staff

HILARY BRAGG, Program Coordinator

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

__________________

1 The National Academies of Sciences, Engineering, and Medicine’s boards do not review or approve individual products. The responsibility for the content of the workshop summary rests with the workshop rapporteurs and the institution.

Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×

This page intentionally left blank.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×

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:

GARY NABEL, Sanofi

BERNARD PECOUL, Drugs for Neglected Diseases Initiative

BT SLINGSBY, Global Health Innovative Technology Fund

SAMBA SOW, Center for Vaccine Development–Mali

RAJEEV VENKAYYA, Takeda Pharmaceuticals

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 ROBERT LAWRENCE, Johns Hopkins University. 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.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×

This page intentionally left blank.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×

Acknowledgments

The National Academies of Sciences, Engineering, and Medicine staff and planning committee thank Dr. Gabriel Leung and his staff, including particularly Mr. Keith Tin, for graciously hosting and supporting Global Health Risk Framework: A Workshop on Research and Development of Medical Products at The University of Hong Kong in August 2015. The meeting support provided by the firm Weber Shandwick is also gratefully acknowledged.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×

This page intentionally left blank.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×

Acronyms and Abbreviations

AAV

adeno-associated viruses

AVAREF

African Vaccine Regulatory Forum

BARDA

Biomedical Advanced Research and Development Authority

BMGF

The Bill & Melinda Gates Foundation

BPO

Biopreparedness Organization

CDC

Centers for Disease Control and Prevention (U.S.)

CHAI

Clinton Health Access Initiative

DNDi

Drugs for Neglected Diseases initiative

DoD

U.S. Department of Defense

EMA

European Medicines Agency

EU

European Union

EUA

emergency use authorization

FDA

U.S. Food and Drug Administration

GAAS

Ghana Academy of Arts and Sciences

GDP

good distribution practice

GHIT

Global Health Innovative Technology Fund

GHRF

Global Health Risk Framework

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
GSK

GlaxoSmithKline

HHS

U.S. Department of Health and Human Services

HIV

human immunodeficiency virus

ICMRA

International Coalition of Medicines Regulatory Authorities

IHR

International Health Regulations

IOM

Institute of Medicine

IP

intellectual property

IRB

institutional review board

MCM

medical countermeasure

MERS

Middle East respiratory syndrome

MMV

Medicines for Malaria Venture

MSF

Médecins Sans Frontières (Doctors Without Borders)

MTA

Material Transfer Agreement

NAM

National Academy of Medicine (U.S.)

NGO

nongovernmental organization

NIH

National Institutes of Health (U.S.)

PCR

polymerase chain reaction

PHEMCE

Public Health Emergency Medical Countermeasures Enterprise

PPE

personal protective equipment

PREP

Public Readiness and Emergency Preparedness

RCT

randomized controlled trial

SAMRC

South African Medical Research Council

SARS

severe acute respiratory syndrome

SNS

Strategic National Stockpile (U.S.)

TB

tuberculosis

UBMTA

Uniform Biological Materials Transfer Agreement

UN

United Nations

UNICEF

United Nations Children’s Fund

WHO

World Health Organization

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
Page R1
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
Page R2
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
Page R3
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
Page R4
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
Page R5
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
Page R6
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
Page R7
Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
Page R8
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
Page R9
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
Page R10
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
Page R11
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
Page R12
Page xiii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
Page R13
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
Page R14
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
Page R15
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
Page R16
Next: 1 Introduction »
Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary Get This Book
×
Buy Paperback | $45.00 Buy Ebook | $35.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

Since the 2014 Ebola outbreak many public- and private-sector leaders have seen a need for improved management of global public health emergencies. The effects of the Ebola epidemic go well beyond the three hardest-hit countries and beyond the health sector. Education, child protection, commerce, transportation, and human rights have all suffered. The consequences and lethality of Ebola have increased interest in coordinated global response to infectious threats, many of which could disrupt global health and commerce far more than the recent outbreak.

In order to explore the potential for improving international management and response to outbreaks the National Academy of Medicine agreed to manage an international, independent, evidence-based, authoritative, multistakeholder expert commission. As part of this effort, the Institute of Medicine convened four workshops in summer of 2015 to inform the commission report. The presentations and discussions from the Workshop on Research and Development of Medical Products are summarized in this report.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!