General Information

  Discovery and Validation of Biomarkers to

Develop Non-Addictive Therapeutics for Pain


November 14-15, 2018
Washington Marriott Wardman Park
Washington, District of Columbia
 

  

Background

More than 25 million Americans suffer from daily chronic pain, a highly debilitating medical condition that is complex and difficult to manage. In recent decades, there has been an overreliance on the prescription of opioids for chronic pain, contributing to an epidemic of opioid overdose deaths and addictions. Innovative scientific solutions to develop alternative treatment options for pain management are thus needed.  NIH recently released a research plan for a broad and aggressive effort to accelerate scientific solutions to address the opioid crisis.  The NIH HEAL (Helping to End Addiction Long-Term) Initiative will advance research to develop safer therapies for people with pain through a multi-pronged approach.  

The challenges facing the development of non-opioid alternative pain medications include: challenging and costly clinical design requirements, poor predictive power of preclinical models, and a paucity of validated targets.  In addition, patient populations are heterogeneous across multiple pain conditions, with broad variability in individual responses to interventions. Another major barrier to advancing new pain treatments is the inability to measure objectively the biological effect of a treatment in these complex patients.

The NIH HEAL Initiative provides funds for research to discover and validate biomarkers for pain that can serve as such objective measures that will help define patient populations for clinical trials. The use of objective biomarkers and endpoints throughout the drug discovery and development process is critical, as it would help to define pathophysiologic subsets of pain, evaluate target engagement of new drugs, and predict analgesic efficacy of new drugs. Nevertheless, such biomarkers and endpoints remain limited and very few have been validated.

Therefore, the overarching purpose of this workshop is: 1) to inform the community about current regulatory standards and guidelines for the development of biomarkers and endpoints, 2) to evaluate the state of the science in pain biomarker development and 3) to explore potential scientific and collaborative approaches that could facilitate the discovery and validation of robust biomarkers and endpoints that would provide the tools necessary for the diagnosis and treatment of pain conditions. 

Goals

  • Inform the community about current regulatory standards and guidelines for the development of biomarkers and endpoints
    Explore the state-of-the-science of different types and modalities of biomarkers for chronic pain and identify the research needed to stimulate their development in a manner that will withstand rigorous validation
  • Identify roadblocks and gaps in the development of strong candidate biomarkers and endpoints for chronic pain indications that will withstand rigorous validation
  • Identify opportunities to address challenges and gaps
  • Convene academic, biopharmaceutical industry, and government scientists working on biomarker identification and discovery to share and discuss progress, successes, challenges, gaps, and potential solutions going forward.

Deliverables 

  • Recommendations/guidelines for best practices in biomarker discovery and validation
  • Publication of a white paper summarizing workshop findings/guidelines
  • Formation of a core working group representing government, academia and industry that regularly convenes to evaluate progress and remaining challenges in the area of pain biomarker and endpoint development

 

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