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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

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.

• 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

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

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

Day Two: October 12, 2017

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?

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).

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.

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