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HEAL Initiative: Team Research for Initial Translational Efforts in Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] (U19 Clinical Trial Not Allowed)
This funding opportunity announcement (FOA) is part of a suite of FOAs to support the development of safe, effective, and non-addictive therapeutics to treat pain. The goal of this FOA is to support interdisciplinary team-based research projects to develop assays, conduct screening and early optimization work followed by pharmacokinetic, pharmacodynamic, and in vivo efficacy studies to demonstrate that proposed therapeutic agent(s) have sufficient biological activity to warrant further development. Discovery and validation of pharmacodynamic markers as well as development and validation of animal models or outcome measures are also responsive. The result of the project should be to advance a hit or lead to the point where they can meet the entry criteria for RFA-NS-21-010 HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional) within the five years of the award. Applications should propose a plan that will lead to the development of analgesics with a rigorous biological rationale and scientifically sound and well-validated assays. If the data does not currently exist, the application must include a strong plan for developing data linking the putative therapeutic target(s) to the proposed pain indication and supporting the hypothesis that altering the target activity will produce desirable outcomes for the disease.
This FOA is not specific for any one or group of pain conditions. Projects to develop therapeutics for acute pain, chronic pain, painful neuropathy, musculoskeletal pain, headache disorders, osteoarthritis, diabetic neuropathy, chemotherapy-induced neuropathy, eye pain, sickle-cell pain, post-surgical pain, cancer pain, visceral pain, obstetric pain, gynecologic pain, post stroke pain, myofascial pain, painful disorders of the orofacial region and other conditions will be considered. Projects to develop analgesics for a combination of chronic overlapping pain conditions or for specific disease or pathological conditions will also be considered. Projects that seek to identify pain treatment targets in specific populations such as women, children, older adults, and other underrepresented groups will also be responsive to this FOA. Input from patients and caregivers on the therapeutic goals of the project is highly encouraged.
- Letter of Intent Due Date(s): 30 days prior to receipt date.
- Application Due Date(s): June 9, 2022, October 11, 2022, June 9, 2023, and October 10, 2023
RFA-NS-22-052 Expiration Date October 11, 2023
Application budgets are limited to direct costs of $1.5 million per year.
The maximum project period is 5 years.