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.
This FOA will support research programs with up to five research components (listed below) focused on target validation and early development of a new therapeutic asset. An Administrative Core and a Data Management Core are also required components. Applicants may also propose up to three Resource Cores; however, these are optional. All proposed components and cores are expected to be integrated and work together as part of a whole project to develop a single asset. The following research components are necessary for a successful project.
- Validation of Therapeutic Target and Underlying Biology
- Development and Validation of Animal Models and/or Outcome Measures
- Assay Development, Screening, and Early Optimization
- Discovery and/or Validation of Pharmacodynamic Markers
- Pharmacokinetic/Pharmacodynamic (PK/PD) and Efficacy Studies
The individual research components must be part of a cohesive whole where the success or failure of each component is tightly linked to that of all the other components. Additional details on the scope and activities of these research components are described below. At least three of these five components must be proposed within an application. Teams can only propose to omit a component if it can be demonstrated that the necessary activity has already been reasonably completed.
It is anticipated that at the end of the application, successful programs will meet the entry criteria for RFA-NS-21-010 HEAL Initiative FOA: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional), which is a promising hit or lead small molecule or biologic starting point for optimization that has a rigorous biological rationale for the intended approach and scientifically sound assays to test the agent. Applicants must propose to get to the entry point of RFA-NS-21-010 within the five-year grant period. There will be no opportunities for renewal of this award.
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