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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×

Innovation in Drug Research
and Development for
Prevalent Chronic Diseases

PROCEEDINGS OF A WORKSHOP

Andrew March, Amanda Wagner Gee, Robert Pool, and Carolyn Shore,
Rapporteurs

Forum on Drug Discovery, Development, and Translation

Board on Health Sciences Policy

Health and Medicine Division

images

THE NATIONAL ACADEMIES PRESS
Washington, DC
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×

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

This activity was supported by contracts between the National Academy of Sciences and Amgen Inc.; Association of American Medical Colleges; AstraZeneca; Biogen; Biomedical Advanced Research and Development Authority; Burroughs Wellcome Fund (Contract No. 1021334); Critical Path Institute; Eli Lilly and Company (Contract No. 4900709231); FasterCures, Milken Institute; Foundation for the National Institutes of Health; Friends of Cancer Research; Johnson & Johnson; Medable, Inc.; Merck & Co., Inc. (Contract No. MRLCPO-21-138769); National Institutes of Health (Contract No. HHSN263201800029I; Task Order No. HHSN26300007): National Cancer Institute, National Institute of Allergy and Infectious Diseases, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, Office of Science Policy; New England Journal of Medicine; Sanofi (Contract No. 65873711); Takeda Pharmaceuticals; U.S. Food and Drug Administration (Grant No. 1R13FD007302-01). 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: 978-0-309-09214-2
International Standard Book Number-10: 0-309-09214-0
Digital Object Identifier: https://doi.org/10.17226/26291

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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in drug research and development for prevalent chronic diseases: Proceedings of a workshop. Washington, DC: The National Academies Press. https://doi.org/10.17226/26291.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×

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. Marcia McNutt 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. John L. Anderson 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.

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

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×

Image

Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based consensus on the study’s statement of task by an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independent peer-review process and it represents the position of the National Academies on the statement of task.

Proceedings published by the National Academies of Sciences, Engineering, and Medicine chronicle the presentations and discussions at a workshop, symposium, or other event convened by the National Academies. The statements and opinions contained in proceedings are those of the participants and are not endorsed by other participants, the planning committee, or the National Academies.

For information about other products and activities of the National Academies, please visit www.nationalacademies.org/about/whatwedo.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×

PLANNING COMMITTEE ON INNOVATION IN DRUG RESEARCH AND DEVELOPMENT FOR PREVALENT CHRONIC DISEASES1

CARLOS O. GARNER (Co-Chair), Eli Lilly and Company

ANANTHA SHEKHAR (Co-Chair), University of Pittsburgh

MELINDA BUNTIN, Vanderbilt University School of Medicine

GRACE COLÓN, InCarda Therapeutics

BETTINA DRAKE, Washington University School of Medicine and Alvin J. Siteman Cancer Center

ALYSON KARESH, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

CHRONIS MANOLIS, UPMC Health Plan

PHYLLIS PETTIT NASSI, Huntsman Cancer Institute, The University of Utah

HOWARD ROSEN, BonVelo Ventures and Stanford University

SUSAN SCHAEFFER, Patients’ Academy for Research Advocacy

AMIR TAMIZ, National Institute of Neurological Disorders and Stroke, National Institutes of Health

Health and Medicine Division Staff

CAROLYN SHORE, Director, Forum on Drug Discovery, Development, and Translation

AMANDA WAGNER GEE, Program Officer

LEAH CAIRNS, Program Officer

ANDREW MARCH, Associate Program Officer

MELVIN JOPPY, Senior Program Assistant

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

Consultant

ROBERT POOL, Science Writer

___________________

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 Proceedings of a Workshop rests with the workshop rapporteurs and the institution.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×

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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×

FORUM ON DRUG DISCOVERY, DEVELOPMENT, AND TRANSLATION1

ROBERT M. CALIFF (Co-Chair), Duke University and Verily Life Sciences and Google Health

GREGORY SIMON (Co-Chair), Kaiser Permanente Washington Health Research Institute

AMY ABERNETHY, Office of the Commissioner, U.S. Food and Drug Administration

CHRISTOPHER P. AUSTIN, National Center for Advancing Translational Sciences, National Institutes of Health

LINDA BRADY, National Institute of Mental Health, National Institutes of Health

JOHN BUSE, University of North Carolina School of Medicine

BARRY S. COLLER, The Rockefeller University

THOMAS CURRAN, Children’s Mercy, Kansas City

RICHARD DAVEY, National Institute of Allergy and Infectious Diseases, National Institutes of Health

KATHERINE DAWSON, Biogen

JAMES H. DOROSHOW, National Cancer Institute, National Institutes of Health

JEFFREY M. DRAZEN, New England Journal of Medicine

STEVEN K. GALSON, Amgen Inc.

CARLOS O. GARNER, Eli Lilly and Company

JULIE L. GERBERDING, Merck & Co., Inc.

DEBORAH HUNG, Broad Institute of Massachusetts Institute of Technology and Harvard Medical School

ESTHER KROFAH, FasterCures, Milken Institute

LISA M. LAVANGE, University of North Carolina

ROSS McKINNEY, JR., Association of American Medical Colleges

JOSEPH P. MENETSKI, Foundation for the National Institutes of Health

ARTI RAI, Duke University School of Law

MARK ROGGE, Takeda Pharmaceuticals

KELLY ROSE, Burroughs Wellcome Fund

SUSAN SCHAEFFER, Patients’ Academy for Research Advocacy

JOSEPH SCHEEREN, Critical Path Institute

ANANTHA SHEKHAR, University of Pittsburgh

JAY SIEGEL, Retired

ELLEN V. SIGAL, Friends of Cancer Research

___________________

1 The National Academies of Sciences, Engineering, and Medicine’s forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.

Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×

LANA R. SKIRBOLL, Sanofi

AMIR TAMIZ, National Institute of Neurological Disorders and Stroke, National Institutes of Health

ANN TAYLOR, AstraZeneca

PAMELA TENAERTS, Clinical Trials Transformation Initiative

JOANNE WALDSTREICHER, Johnson & Johnson

ROBERT WALKER, Biomedical Advanced Research and Development Authority

JONATHAN WATANABE, University of California, Irvine, School of Pharmacy and Pharmaceutical Sciences

CARRIE WOLINETZ, Office of Science Policy, National Institutes of Health

ALASTAIR WOOD, Vanderbilt University

JANET WOODCOCK, U.S. Food and Drug Administration

Forum Staff

CAROLYN K. SHORE, Forum Director

AMANDA WAGNER GEE, Program Officer

ANDREW MARCH, Associate Program Officer

MELVIN JOPPY, Senior Program Assistant

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

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×

Reviewers

This Proceedings of a Workshop was 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 National Academies of Sciences, Engineering, and Medicine in making each published proceedings as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the charge. The review comments and draft manuscript remain confidential to protect the integrity of the process.

We thank the following individuals for their review of this proceedings:

Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the content of the proceedings nor did they see the final draft before its release. The review of this proceedings was overseen by BRADFORD GRAY, Urban Institute (retired). He was responsible for making certain that an independent examination of this proceedings was carried out in accordance with standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the rapporteurs and the National Academies.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×

Acknowledgments

Support from the sponsors of the Forum on Drug Discovery, Development, and Translation is crucial to support this and other work of the National Academies.

The National Academies’ staff wish to express their gratitude to the speakers whose presentations helped inform workshop discussions on the challenges and opportunities for spurring drug research and development for prevalent chronic diseases; to the members of the planning committee for their work in developing the workshop agenda and shaping the discussions; and to additional National Academies staff, without whom this workshop and the accounting thereof would not have been possible: Christie Bell, Robert Day, Sadaf Faraz, Devona Overton, Esther Pak, Marguerite Romatelli, Bettina Seliber, Lauren Shern, and Taryn Young.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
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Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
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Page xiii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
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Investment and innovation in drug research and development (R&D) for highly prevalent chronic diseases has stalled in recent decades, despite half of all Americans living with at least one chronic disease. As a result, prevalent chronic diseases are producing immense health care costs as well as preventable suffering and death. On February 22, March 2, and March 8, 2021, the National Academies of Sciences, Engineering, and Medicine, convened a workshop to discuss barriers to innovation in this space and examine strategies and incentives to support equitable, person-centered drug R&D for prevalent chronic diseases.

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