The purpose of this Funding Opportunity Announcement (FOA) is to develop clinical-grade prototypes intended for use as safe, effective, and non-addictive device-based technologies and approaches to treat pain. The goal of the program is to demonstrate treatment using credible neural targets for device-based interventions and/or diagnostics for pain, building upon the latest mechanistic knowledge about the anatomy and physiology of central, spinal, and peripheral pathways involved in pain. Awarded activities will facilitate the translation of new devices up to the stage of readiness for first in human (FIH) clinical trials by overcoming key challenges identified during preliminary proof-of-concept studies. The scope of the program includes technology development and optimization, and studies to prepare for approvals for human use.
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This funding opportunity announcement (FOA) invites research to develop, characterize, and rigorously validate non-rodent mammalian models of pain, associated outcome measures and/or endpoints that enable translational research for effective pain management. These models are expected to recapitulate molecular, cellular, pathological, behavioral, and/or cognitive aspects of human pain disorders and conditions. Research supported under this FOA is expected to provide well-validated models and measures that facilitate the development of non-opioid analgesic therapeutic interventions with little or no addiction liability.
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 in the prescription of opioids for chronic pain despite their poor ability to improve function and high addiction liability. This contributed to a significant and alarming epidemic of opioid overdose deaths and addictions. Innovative scientific solutions to develop alternative pain treatment options are thus critically needed. Through targeted research efforts, the NIH HEAL Initiative aims to support the development of safe and effective devices to treat pain with little or no addiction liability. This funding opportunity announcement (FOA) is designed to support interdisciplinary research teams of multiple PD/PIs to investigate the mechanism of action of pain relief by medical devices with the overall goal of optimizing therapeutic outcomes for FDA-approved or -cleared technologies. Program teams are expected to accomplish goals that require considerable synergy and collaborative interactions. Teams must leverage appropriate multi-disciplinary expertise to develop new principles and methods for experimentation, analysis, and interpretation. Teams are encouraged to consider objectives that will produce major advances in the field of pain relief by medical devices.
This Funding Opportunity Announcement (FOA) solicits applications for the early-stage development of therapeutics to mitigate the adverse health effects resulting from toxic chemical exposure. Chemical threats are toxic compounds that could be used in a terrorist attack or accidentally released from industrial production, storage or shipping. They include specific chemical warfare agents, toxic industrial chemicals, pesticides, and pharmaceutical-based agents. The overall scope of this solicitation includes validation of therapeutic targets and preclinical characterization of lead compounds. The UG3 phase of this FOA supports target validation and characterization of initial lead compound(s); UH3 phase activities include candidate optimization and in vivo demonstration of activity and efficacy in relevant post-exposure models. At the conclusion of the overall UG3/UH3 funding period, projects are expected to deliver at least one well-characterized therapeutic candidate.