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This FOA provides funding to conduct pharmacodynamic, pharmacokinetic, and in vivo efficacy studies to demonstrate that proposed therapeutic agent(s) have sufficient biological activity to warrant further development to treat neurological or neuromuscular disorders that fall under the NINDS mission. Therapeutic agents include small molecules, biologics or biotechnology-derived products. This FOA is part of a suite of Innovation Grants to Nurture Initial Translational Efforts (IGNITE) to advance projects to the point where they can meet the entry criteria for the Blueprint Neurotherapeutics Network or other translational programs.

This funding opportunity announcement (FOA) encourages the development and validation of animal models and human/animal tissue ex vivo systems that recapitulate the phenotypic and physiologic characteristics of a defined neurological or neuromuscular disorder. The goal of this FOA is to promote a significant improvement in the translational relevance of animal models or ex vivo systems that will be utilized to facilitate future development of neurotherapeutics. Ideally, models proposed for this FOA would have the potential to provide feasible and meaningful assessments of efficacy following therapeutic intervention that would be applicable in both preclinical and clinical settings. This FOA is part of a suite of Innovation Grants to Nurture Initial Translational Efforts (IGNITE) Program focused on enabling the exploratory and early stages of drug discovery.

This funding opportunity announcement (FOA) encourages research grant applications to develop in vitro and/or ex vivo assays and conduct iterative screening efforts to identify and characterize potential therapeutic agents for neurological or neuromuscular disorders. This FOA is part of a suite of Innovation Grants to Nurture Initial Translational Efforts (IGNITE) to advance projects to the point where they can meet the entry criteria for the Blueprint Neurotherapeutics Network (BPN) or other translational programs.

The goal of this funding opportunity announcement (FOA) is to solicit Initial Analgesic Development R34 applications that propose 2-year exploratory/planning awards that are expected to enable a future application for RFA-NS-21-015 HEAL Initiative: Team Research - for Initial Translational Efforts in Non-addictive Analgesic Development [Small Molecules and Biologics] (U19 Clinical Trial Not Allowed). Thus, the limited scope of aims and approach of these applications are expected to establish a strong research team, feasibility, validity, or other technically qualifying results that support, enable, and/or lay the groundwork for a subsequent Team Research U19 application. These R34 awards will support the building of a research team to collect initial data and recruit additional collaborators. The proposal must include a plan for developing a strong research team, as well as a strategy to collect preliminary data linking putative therapeutic targets to the proposed pain indication and supporting the hypothesis that altering target activity will produce desirable outcomes for the disease.

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 team-based research projects to develop assays, screening and early optimization work to develop a non-addictive therapeutic to treat pain. Discovery and validation of pharmacodynamic markers efficacy and pharmacokinetic/pharmacodynamic (PK/PD) studies 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 5 years of the award, there is no opportunity for renewal of this award. Applications should propose a plan that will lead to the development of analgesics with a rigorous biological rationale and scientifically sound assays. If the data does not currently exist, the proposal 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, post stroke pain, myofascial pain, painful disorders of the orofacial region and other conditions will be considered.

The Blueprint Neurotherapeutics Network for Biologics (BPN-Biologics) provides support for biologic-based therapeutic discovery and development, from lead optimization through phase I clinical testing. This Funding Opportunity Announcement (FOA) supports preclinical discovery and development of potential therapeutic Biotechnology Products and Biologics including, but not limited to, large biologic macromolecules, (e.g., proteins, antibodies, and peptides), gene-based therapies (i.e., oligonucleotide- and viral-based), cell therapies, and novel emerging therapies (e.g., microbial and microbiome therapies). Applicants will collaborate with NIH-funded consultants and can augment their project with NIH contract research organizations (CROs) that specialize in manufacturing, scaling, pharmacokinetics, toxicology, and Phase I clinical testing. BPN-Biologics awardee institutions retain their assignment of IP rights and gain assignment of IP rights from the BPN-Biologics contractors (and thereby control the patent prosecution and licensing negotiations) for biotherapeutic candidates developed in this program.

This is a reissue of RFA-MH-20-120. This FOA invites applications that will conduct secondary analysis or data mining of existing data relevant to the BRAIN Initiative goal of understanding brain circuits. The FOA also invites applications that seek to prepare and submit existing data that are highly relevant to the BRAIN Initiative into one of the BRAIN Initiative data archives. Applications can propose to generate or test new hypotheses which would not be possible in studies of single experiments, single technologies or single laboratories, or were beyond the scope of the original studies. Applications that propose to reanalyze existing data sets using new tools or approaches are also welcome. The proposed research may involve innovative analyses of existing data or novel combination or integration of existing data sets to address new aims or explore new questions.

This is a reissue of RFA-MH-19-147. This FOA supports the development of software to visualize and analyze the data as part of programs of building the informatics infrastructure for the BRAIN Initiative. Other informatics programs include developing data standards that are needed to describe the new experiments that are being created by or used in the BRAIN Initiative ( RFA-MH-19-146 ), and creating the data infrastructures that will house the data from multiple experimental groups ( RFA-MH-19-145 ). Each of the programs is aimed at building an infrastructure that is used by a particular sub-domain of experimentalists rather than building a single all-encompassing informatics infrastructure now. Building the infrastructure one experimental area at a time will ensure that the infrastructure is immediately useful to components of the research community. As our understanding of the brain improves, it may be possible to create linkages between these various sub-domain specific informatics programs. Investigators of the informatics programs should keep that goal in mind and build for the future even though the current efforts are more limited in scope.

This Limited Competition Funding Opportunity Announcement (FOA) invites applications to continue the activities of the National NeuroAIDS Tissue Repository (NNTC), a data coordination center for the CHARTER cohort (a cohort of individuals living with HIV on Antiretroviral therapy). CHARTER research sites and DCC will continue to collect and provide research data as well as research specimens to interested investigators to address high priority research areas in NeuroHIV.

This Notice of Special Interest (NOSI) provides an opportunity for clinical trials funded by the Helping to End Addiction Long-term (HEAL) initiative to address challenges of recruiting and engaging the diverse populations suffering from pain and opioid use disorder. NIH will support supplements to current HEAL awards that would either enhance their patient, community, and other stakeholder engagement efforts; improve diversity and inclusion among participants; or both, as appropriate for a particular study. The NIH HEAL Initiative is a trans-agency effort to speed scientific solutions to stem the national opioid public health crisis through understanding, managing, and treating pain and improving treatment for opioid use disorder and overdose. This supplement program is not intended to support research on basic processes but rather to implement strategies to enhance stakeholder engagement and diversity of patient inclusion in HEAL clinical studies.