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Suggested Citation:"Appendix B Workshop Agenda." 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: 10.17226/25060.
×

B

Workshop Agenda

Advancing Therapeutic Development for Pain and Opioid Use Disorders Through Public–Private Partnerships: A Workshop

October 11–12, 2017
Keck Center | Room 100
500 Fifth Street, NW | Washington, DC

Background: Pain is a leading cause of disability in the United States, affecting more people than cancer, diabetes, and heart disease combined. Many physicians have come to prescribe opioids to their pain patients, and pain patients have come to expect such prescriptions. The resulting dramatic increase in opioid prescriptions within the past decade has been a major factor contributing to the opioid epidemic that the country currently faces, with alarming rates of misuse, abuse, and overdose deaths. The dramatic increase in the cost of Naloxone—the only Food and Drug Administration–approved opioid overdose reversal medication—has made it more challenging to gain access to the live-saving medication. In the 2011 Institute of Medicine report Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research, the committee advocated a multidisciplinary approach for pain research and public–private partnerships (PPPs) to improve the process for developing new pain medications. While several initiatives are underway to enhance pain research and improve care in the country, including the National Institutes of Health (NIH) Pain Consortium and Interagency Pain Research Coordinating Committee’s National Pain Strategy, additional efforts are needed to foster collaborations between the public and private sectors in

Suggested Citation:"Appendix B Workshop Agenda." 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: 10.17226/25060.
×

order to reduce the adverse risks of prescribed opioids and to accelerate the development of non-opioid medications.

In June and July 2017 NIH hosted three small meetings focused on creating PPPs to address the urgent public health need associated with opioids. NIH is joining with private partners in the pharmaceutical industry and the research community to launch an opioid research initiative with the goal of cutting in half the amount of time required to develop new therapies for (1) safe, more effective strategies for pain management; (2) new and innovative opioid addiction treatments; and (3) overdose reversal interventions. The Forum on Neuroscience and Nervous System Disorders proposes to host a public workshop bringing together key stakeholders to (1) advance the discussions that emerged from the three NIH meetings held in June and July 2017 to address the opioid epidemic, and (2) examine potential implementation barriers and opportunities related to the proposed approaches discussed.

Workshop Objectives:

  • Review the state of the science for opioid and non-addictive pain treatments.
    • Provide an overview of emerging pain models, including those in the peripheral nervous system (e.g., induced pluripotent stem cells and human experimental biology).
    • Discuss the progress on the identification and validation of targets and biomarkers (neuroinflammation, genetic, proteomics, etc.). Explore whether there is a systematic methodology to validating biomarkers to determine their usefulness.
    • Examine approaches to testing new formulations and drugs, and discuss the patient populations needed for those clinical trials.
    • Consider the formulation of promising pain medications—beyond opioid analgesics—that may have been shelved by companies.
  • Explore opportunities and challenges to changing the formulation of marketed prescription opioids to decrease misuse, addiction, and potential overdoses (e.g., different delivery systems and antitampering mechanisms).
  • Consider regulatory issues related to the approval of pain medications and discuss potential opportunities to address those challenges.
Suggested Citation:"Appendix B Workshop Agenda." 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: 10.17226/25060.
×
  • Discuss public–private partnerships that might facilitate and de-risk the development of drugs to treat opioid overdoses and non-addictive therapeutics for pain (e.g., an Accelerating Medicines Partnership for pain). Highlight lessons learned from industry and opportunities to advance the development of these drugs (e.g., a designated clinical trial network for pain).

Day One: October 11, 2017

1:30 p.m. Welcome and Overview of the Workshop

STORY LANDIS, Vice Chair, Forum on Neuroscience and Nervous System Disorders, National Academies of Sciences, Engineering, and Medicine (Co-Chair)

WALTER KOROSHETZ, National Institute of Neurological Disorders and Stroke (Co-Chair)

1:45 p.m. The Opioid Epidemic and State of the Science on Therapeutic Development for Pain

NORA VOLKOW, National Institute on Drug Abuse (Co-Chair)

2:05 p.m. Living with Pain: A Patient’s Perspective

CHRISTIN VEASLEY, Chronic Pain Research Alliance

2:20 p.m. The Federal Pain Research Strategy: An Overview

LINDA PORTER, National Institute of Neurological Disorders and Stroke

2:40 p.m. Discussion Among Speakers and Workshop Participants
3:10 p.m. BREAK

Objectives: Discuss potential methods for developing extended-release formulations of marketed medicines for opioid use disorders and overdose prevention and reversal. Consider lessons learned for drug

Suggested Citation:"Appendix B Workshop Agenda." 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: 10.17226/25060.
×

development for opioid use disorders and explore the utility of shelved compounds as potential therapeutics.

3:25 p.m. Session Overview

NORA VOLKOW, National Institute on Drug Abuse (Moderator)

3:35 p.m. Patient Advocate

JESSICA HULSEY NICKEL, Addiction Policy Forum

Case Studies
3:45 p.m. Extended-Release Formulations for Opioid Use Disorders

CHRISTIAN HEIDBREDER, Indivior, Inc.

4:05 p.m. Overdose Reversal

ROGER CRYSTAL, Opiant Pharmaceuticals, Inc.

Drug Development
4:25 p.m. Facilitating Therapeutic Development for Opioid Use Disorders: An Academic Perspective

SHARON WALSH, University of Kentucky

4:45 p.m. Discussion Among Speakers and Workshop Participants
5:45 p.m. Day One Wrap-Up
Workshop Co-Chairs
6:00 p.m. Adjourn Day One
Suggested Citation:"Appendix B Workshop Agenda." 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: 10.17226/25060.
×

Day Two: October 12, 2017

8:30 a.m. Day Two Opening Remarks

Workshop Co-Chairs

Objectives: Innovative public–private partnerships are needed for the development of safe, effective, and non-addictive pain treatments. Incentives will be necessary to encourage pharmaceutical and biotechnology company investment in this space. What new targets exist and what would be required to accelerate the process of moving toward therapeutics for non-addictive pain medicines?

8:35 a.m. Session Overview

JOHN DUNLOP, Amgen (Moderator)

Novel Methods for Identifying Targets for Pain
8:45 a.m. Genomic/Genetic Approaches

LUDA DIATCHENKO, McGill University

9:00 a.m. Identifying Potential Targets for Pain Management Using Human Cells/Organoids, Tissue

CLIFFORD WOOLF, Harvard Medical School

9:15 a.m. Monitoring and Modulating Circuit Activity in Pain Promise of the BRAIN Initiative

ROBERT GEREAU, Washington University in St. Louis

9:30 a.m. Discussion Among Speakers and Workshop Participants
Suggested Citation:"Appendix B Workshop Agenda." 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: 10.17226/25060.
×
What Can Be Done to Improve Target Validation in Developing Non-Addictive Pain Medicines?
10:00 a.m. What Has Worked and What Hasn’t Worked in the Preclinical Space to Predict Success

TONY YAKSH, University of California, San Diego

10:15 a.m. What New Preclinical Efforts Are Needed to Improve the Process of Therapy Development (e.g., Companion Animals)?

DOROTHY CIMINO BROWN, Elanco Animal Health

10:30 a.m. Can a Public–Private Partnership Engineer Preclinical Testing Platforms with Better Predictive Validity?

JOHN KEHNE, National Institute of Neurological Disorders and Stroke

10:45 a.m. Discussion Among Speakers and Workshop Participants: Launching Public–Private Partnerships to Accelerate the Development of Therapeutics for Non-Addictive Pain Medicines
11:15 a.m. BREAK

Objectives: Discuss challenges and opportunities to identifying and validating objective biomarkers of pain, including approaches focusing on homogenous populations. Consider mechanisms that might block the acute-to-chronic pain transition. Explore the role of a public–private partnership to advance therapeutic development for pain (e.g., a designated clinical trial network for pain).

11:30 a.m. Session Overview

WALTER KOROSHETZ, National Institute of Neurological Disorders and Stroke (Moderator)

Suggested Citation:"Appendix B Workshop Agenda." 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: 10.17226/25060.
×
Developing Biomarkers to Aid Phase II Studies of Target Engagement and/or Proof of Principle
11:40 a.m. An Industry Perspective on Biomarker-Based Drug Discovery

ANDREW AHN, Eli Lilly and Company

11:55 a.m. Imaging

TOR WAGER (via WebEx), University of Colorado Boulder

12:10 p.m. miRNA Biomarkers

SEENA AJIT, Drexel University

12:25 p.m. Discussion Among Speakers and Workshop Participants
12:40 p.m. PANEL: How to implement a targeted approach to therapy development by focusing on homogenous populations; dissecting pain mechanisms and clinical research in specific pain conditions—natural history biomarkers, clinical trial readiness.

KATHERINE DAWSON, Biogen

SHARON HERTZ, Food and Drug Administration

SEAN MACKEY, Stanford University

WILLIAM MAIXNER, Duke University

KEN VERBURG (via WebEx), Pfizer Inc.

1:20 p.m. LUNCH
Process to Developing Therapies to Prevent the Acute-to-Chronic Pain Transition— What Is Needed?
2:00 p.m. Preclinical Perspective

THEODORE PRICE, The University of Texas at Dallas

2:15 p.m. Clinical Perspective

ROBERT DWORKIN, University of Rochester Medical Center

Suggested Citation:"Appendix B Workshop Agenda." 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: 10.17226/25060.
×
2:30 p.m. Discussion Among Speakers and Workshop Participants
2:45 p.m. PANEL: A U.S. Network for Pain Research (Including Pediatric Research). Where’s the Value?

ROBERT DWORKIN, University of Rochester Medical Center

PETRA KAUFMANN, National Center for Advancing Translational Sciences

SCOTT POWERS, Cincinnati Children’s Hospital

3:15 p.m. Discussion Among Speakers and Workshop Participants: Launching Public–Private Partnerships to Advance Clinical Work in Understanding and Treating the Transition from Acute to Chronic Pain
3:45 p.m. BREAK

Objectives: Synthesize and discuss key highlights from the workshop presentations and discussions and, most importantly, identify next steps and promising areas for future action and research.

4:00 p.m. Workshop Synopsis and Potential Next Steps
Moderator: STORY LANDIS, Vice Chair, Forum on Neuroscience and Nervous System Disorders, National Academies of Sciences, Engineering, and Medicine (Co-Chair)

Session I: NORA VOLKOW, National Institute on Drug Abuse

Session II: JOHN DUNLOP, Amgen

Session III: WALTER KOROSHETZ, National Institute of Neurological Disorders and Stroke

Discussants: DAVID SHURTLEFF, National Center for Complimentary and Integrative Health

Suggested Citation:"Appendix B Workshop Agenda." 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: 10.17226/25060.
×

SHARI LING, Centers for Medicare & Medicaid Services
ANDREY OSTROVSKY, Center for Medicaid and CHIP Services

4:25 p.m. Discussion Among Moderators and Workshop Participants
4:55 p.m. Final Comments
5:00 p.m. Adjourn
Suggested Citation:"Appendix B Workshop Agenda." 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: 10.17226/25060.
×

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Suggested Citation:"Appendix B Workshop Agenda." 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: 10.17226/25060.
×
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Suggested Citation:"Appendix B Workshop Agenda." 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: 10.17226/25060.
×
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Suggested Citation:"Appendix B Workshop Agenda." 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: 10.17226/25060.
×
Page 79
Suggested Citation:"Appendix B Workshop Agenda." 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: 10.17226/25060.
×
Page 80
Suggested Citation:"Appendix B Workshop Agenda." 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: 10.17226/25060.
×
Page 81
Suggested Citation:"Appendix B Workshop Agenda." 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: 10.17226/25060.
×
Page 82
Suggested Citation:"Appendix B Workshop Agenda." 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: 10.17226/25060.
×
Page 83
Suggested Citation:"Appendix B Workshop Agenda." 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: 10.17226/25060.
×
Page 84
Suggested Citation:"Appendix B Workshop Agenda." 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: 10.17226/25060.
×
Page 85
Suggested Citation:"Appendix B Workshop Agenda." 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: 10.17226/25060.
×
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Chronic pain is one of the most prevalent, costly, and disabling health conditions in the United States. Estimates show that more than 11 percent of the American population suffer from chronic pain, yet the federal pain research investment has been minimal. In parallel with a gradual increased recognition of the problems of treating chronic pain, the opioid epidemic has emerged as a growing public health emergency. The intersection of these two crises lies in the fact that an unintended consequence of treating pain has been an increasing number of opioid prescriptions and diversion of drugs for illicit purposes.

In May 2017, the National Institutes of Health (NIH), and the National Institute on Drug Abuse announced a public–private partnership to develop solutions to the opioid crisis and cut in half the time it takes to develop non-addictive analgesics. To advance the planning of NIH’s anticipated public–private partnerships, the National Academies’ Forum on Neuroscience and Nervous Systems Disorders hosted a public workshop that brought together a diverse group of stakeholders from academia, federal agencies, advocacy organizations and companies developing therapeutics for pain and opioid use disorders. Participants discussed potential strategies to accelerate development of non-addictive pain medications and treatments for opioid use disorders. This publication summarizes the presentations and discussions from the workshop.

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