Advancing Therapeutic Development for Pain and Opioid Use Disorders through Public-Private Partnerships: A Workshop
October 11, 2017 - October 12, 2017 (1:30 PM Eastern)
Keck Center of the National Academies of Sciences, Engineering, and Medicine (Room 100) • 500 Fifth Street NW, Washington, D.C. 20001
||Biomedical and Health Research, Substance Use and Mental Health, Diseases, Aging, Public Health, Quality and Patient Safety
Forum on Neuroscience and Nervous System Disorders
Board on Health Sciences Policy
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 last decade has been a major factor contributing to the opioid epidemic the country currently faces, with alarming rates of misuse, abuse, and overdose deaths. In the 2011 Institute of Medicine report on Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research, the committee advocated for a multidisciplinary approach for pain research and for public-private partnerships 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.
At the request of Dr. Francis Collins, NIH hosted three small meetings in June and July 2017 focused on creating public-private partnerships 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 to cut 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 will host a public workshop bringing together key stakeholders to advance the discussions that emerged from the three NIH meetings to address the opioid epidemic, and examine potential implementation barriers and opportunities related to the proposed approaches discussed.
- 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.
- Consider regulatory issues related to the approval of pain medications and discuss potential opportunities to address those challenges.
- 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 anti-tampering mechanisms).
- Discuss public-private partnerships that might facilitate and de-risk the development of drugs to treat overdoses and non-opioid therapeutics for pain (e.g., an Accelerating Medicines Partnership [AMP] 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).