Advancing Therapeutic
Development for Pain and Opioid
Use Disorders Through Public–Private
Partnerships
PROCEEDINGS OF A WORKSHOP
Lisa Bain, Sheena M. Posey Norris, and Clare Stroud,
Rapporteurs
Forum on Neuroscience and
Nervous System Disorders
Board on Health Sciences Policy
Health and Medicine Division
THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu
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This activity was supported by contracts between the National Academy of Sciences and the Alzheimer’s Association; Brain Canada Foundation; Cohen Veterans Bioscience; Department of Health and Human Services’ Food and Drug Administration (5R13FD005362-02) and National Institutes of Health (NIH) (HHSN26300089 [Under Master Base #DHHS-10002880]) through the National Center for Complementary and Integrative Health, National Eye Institute, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, National Institute on Drug Abuse, and NIH Blueprint for Neuroscience Research; Department of Veterans Affairs (VA240-14-C-0057); Eli Lilly and Company; Foundation for the National Institutes of Health; Gatsby Charitable Foundation; George and Anne Ryan Institute for Neuroscience at The University of Rhode Island; Janssen Research & Development, LLC; Lundbeck Research USA; Merck Research Laboratories; The Michael J. Fox Foundation for Parkinson’s Research; National Multiple Sclerosis Society; National Science Foundation (BCS-1064270); One Mind; Pfizer Inc.; Pharmaceutical Product Development, LLC; Sanofi; Society for Neuroscience; Takeda Pharmaceuticals International, Inc.; and 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 this project.
International Standard Book Number-13: 978-0-309-47399-6
International Standard Book Number-10: 0-309-47399-3
Digital Object Identifier: https://doi.org/10.17226/25060
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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2018. Advancing therapeutic development for pain and opioid use disorders through public–private partnerships: Proceedings of a workshop. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/25060.
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PLANNING COMMITTEE ON ADVANCING THERAPEUTIC DEVELOPMENT FOR PAIN AND OPIOID USE DISORDERS THROUGH PUBLIC–PRIVATE PARTNERSHIPS1
WALTER KOROSHETZ (Co-Chair), National Institute of Neurological Disorders and Stroke
STORY LANDIS (Co-Chair), Director Emeritus, National Institute of Neurological Disorders and Stroke
NORA VOLKOW (Co-Chair), National Institute on Drug Abuse
ANDREW AHN, Eli Lilly and Company
KATJA BROSE, Chan Zuckerberg Initiative
JOHN DUNLOP, Amgen
ROBERT DWORKIN, University of Rochester
SHARON HERTZ, Food and Drug Administration
LINDA PORTER, National Institute of Neurological Disorders and Stroke
TARAK SAMAD, Pfizer Inc.
FRIEDHELM SANDBRINK, Department of Veterans Affairs
ROBERT SHIBUYA, Food and Drug Administration
DAVID SHURTLEFF, National Center for Complementary and Integrative Health
JACK STEIN, National Institute on Drug Abuse
JAMES SULLIVAN, AbbVie Inc.
CHRISTIN VEASLEY, Chronic Pain Research Alliance
TONY YAKSH, University of California, San Diego
Health and Medicine Division Staff
CLARE STROUD, Forum Director
SHEENA M. POSEY NORRIS, Program Officer
NOAM I. KEREN, Associate Program Officer
DANIEL FLYNN, Research 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 Proceedings of a Workshop rests with the workshop rapporteurs and the institution.
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FORUM ON NEUROSCIENCE AND NERVOUS SYSTEM DISORDERS1
STEVEN HYMAN (Chair), Broad Institute of Massachusetts Institute of Technology and Harvard University
STORY LANDIS (Vice Chair), Director Emeritus, National Institute of Neurological Disorders and Stroke
SUSAN AMARA, Society for Neuroscience
RITA BALICE-GORDON, Sanofi
KATJA BROSE, Chan Zuckerberg Initiative
EMERY BROWN, Harvard Medical School and Massachusetts Institute of Technology
JOSEPH BUXBAUM, Icahn School of Medicine at Mount Sinai
SARAH CADDICK, Gatsby Charitable Foundation
ROSA CANET-AVILES, Foundation for the National Institutes of Health
MARIA CARRILLO, Alzheimer’s Association
E. ANTONIO CHIOCCA, Harvard Medical School
TIMOTHY COETZEE, National Multiple Sclerosis Society
JONATHAN COHEN, Princeton University
FAY LOMAX COOK, National Science Foundation
JAMES DESHLER, National Science Foundation
BILLY DUNN, Food and Drug Administration
MICHAEL EGAN, Merck Research Laboratories
JOSHUA GORDON, National Institute of Mental Health
HANK GREELY, Stanford University
RAQUEL GUR, University of Pennsylvania
MAGALI HAAS, Cohen Veterans Bioscience
RAMONA HICKS, One Mind
RICHARD HODES, National Institute on Aging
STUART HOFFMAN, Department of Veterans Affairs
MICHAEL IRIZARRY, Eli Lilly and Company
INEZ JABALPURWALA, Brain Canada Foundation
FRANCES JENSEN, University of Pennsylvania
GEORGE KOOB, National Institute on Alcohol Abuse and Alcoholism
___________________
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.
WALTER KOROSHETZ, National Institute of Neurological Disorders and Stroke
JOHN KRYSTAL, Yale University
ALAN LESHNER, American Association for the Advancement of Science (Emeritus)
HUSSEINI MANJI, Janssen Research & Development, LLC
DAVID MICHELSON, Merck Research Laboratories (until December 2017)
JAMES OLDS, National Science Foundation (until December 2017)
ATUL PANDE, Tal Medical
STEVEN PAUL, Voyager Therapeutics, Inc.
STEPHEN PEROUTKA, Pharmaceutical Product Development, LLC
RODERIC PETTIGREW, National Institute of Biomedical Imaging and Bioengineering (until November 2017)
EMILIANGELO RATTI, Takeda Pharmaceuticals International
TAREK SAMAD, Pfizer Inc. (until December 2017)
DOUGLAS SHEELEY, National Institute of Dental and Craniofacial Research
TODD SHERER, The Michael J. Fox Foundation for Parkinson’s Research
DAVID SHURTLEFF, National Center for Complementary and Integrative Health
PAUL SIEVING, National Eye Institute
NORA VOLKOW, National Institute on Drug Abuse
ANDREW WELCHMAN, Wellcome Trust
DOUG WILLIAMSON, Lundbeck
STEVIN ZORN, MindImmune Therapeutics, Inc.
Health and Medicine Division Staff
CLARE STROUD, Forum Director
SHEENA M. POSEY NORRIS, Program Officer
NOAM I. KEREN, Associate Program Officer
DANIEL FLYNN, Research Assistant
JIM BANIHASHEMI, Financial Officer (until October 2017)
BARDIA MASSOUDKHAN, Financial Associate (from October 2017)
ANDREW M. POPE, Director, Board on Health Sciences Policy
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:
CHAD MICHAEL BRUMMETT, University of Michigan
KATHERINE DAWSON, Biogen
LUDA DIATCHENKO, McGill University
MICHAEL OSHINSKY, National Insitute of Neurological Disorders and Stroke
HOWARD B. ROSEN, Independent Consultant
KENNETH VERBURG, Pfizer Inc.
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 SARA ROSENBAUM, The George Washington University, and BRADFORD H. GRAY, The Urban Institute. They were 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.
Contents
The Public Health Impact of Pain and Opioid Use Disorders
2 EXPLORING CHALLENGES TO DEVELOPING TREATMENTS FOR PAIN AND OPIOID USE DISORDERS
The Complex Experience of Pain
Insufficient Resources to Treat Pain
Insufficient Understanding of Pain Mechanisms
Understanding Challenges in Conducting Clinical Trials
The Pendulum Swing of Care: Understanding Patient Needs
3 EXPLORING THE STATE OF THE SCIENCE AND PRECLINICAL MODELS FOR PAIN THERAPEUTIC DEVELOPMENT
Neural Circuits, Cells, and Molecular Mediators of Pain
Preclinical Efforts to Identify Pain Targets and Treat Pain
A Targeted Approach to Therapy Development in the Clinical Space
Preventing the Acute-to-Chronic Pain Transition
Regulatory Challenges Related to the Approval of Pain Medications
5 THERAPEUTIC DEVELOPMENT FOR OPIOID DISORDERS AND OVERDOSE PREVENTION AND REVERSAL
New Treatments in Development for Opioid Use Disorders
Therapeutic Development to Reverse Overdose
6 PUBLIC–PRIVATE PARTNERSHIPS TO ADVANCE PAIN AND OPIOID USE DISORDERS RESEARCH AND DEVELOPMENT
Public–Private Partnerships to Accelerate Development of Non-Addictive Pain Medications
Partnerships to Address Opioid Use Disorders and Reverse Overdose