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Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Neurotherapeutic Agent Characterization and In vivo Efficacy Studies (R61/R33 Clinical Trial Not Allowed)

PAR
Friday, March 12, 2021
Translational Research
Wednesday, February 21, 2024
R61/R33
PAR-21-122
Rebecca A. Roof

Funding Opportunity Purpose

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.

Notice of Special Interest: Innovative Approaches or Technologies to Investigate Regional, Structural and Functional Heterogeneity of CNS Small Blood and Lymphatic Vessels in AD/ADRD

Notice of Special Interest
Friday, March 12, 2021
Thursday, May 6, 2021
NOT-NS-21-039

Funding Opportunity Purpose

The purpose of this one-year administrative supplement is to expand the scope of the currently active awards supported by the Blueprint RFAs on the Neurobiology of Small Blood and Lymphatic Vessels (RFAs NS-18-003 and NS-18-004) to advance the mechanistic understanding and/or the development of new technologies to investigate changes in brain small vessels that can lead to Alzheimers Disease and Alzheimers Disease Related Dementias (AD/ADRD). Areas of interest include: alterations in the brain (g)lymphatic system, cerebral microinfarcts and microbleeds, post-stroke cognitive impairment, and vascular contributions to cognitive impairment and dementia, with an emphasis on the microvasculature.

Blueprint Neurotherapeutics Network (BPN): Biologic-based Drug Discovery and Development for Disorders of the Nervous System (UG3/UH3 Clinical Trial Optional)

PAR
Thursday, March 11, 2021
Wednesday, May 8, 2024
UG3/UH3
PAR-21-163

Funding Opportunity Purpose

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.

HEAL Initiative: Analgesic Development Initial Translational Efforts [Small Molecules and Biologics] (U19 Clinical Trial Not Allowed)

RFA
Thursday, March 11, 2021
Wednesday, October 11, 2023
U19
RFA-NS-21-015

Funding Opportunity Purpose

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.

HEAL Initiative: Planning Studies for Initial Analgesic Development Initial Translational Efforts [Small Molecules and Biologics] (R34 Clinical Trial Not Allowed)

RFA
Thursday, March 11, 2021
Heal
Wednesday, October 11, 2023
R34
RFA-NS-21-016

Funding Opportunity Purpose

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.

HEAL Initiative: Team Research for Initial Translational Efforts in Non-addictive Analgesic Therapeutics Development (U19 Clinical Trial Not Allowed)

RFA
Thursday, March 11, 2021
Heal
Wednesday, October 11, 2023
U19
RFA-NS-21-015

Funding Opportunity Purpose

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 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, 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 encouraged. The goal of each 5-year U19 application should be to identify candidate therapeutic(s) that will be ready to be submitted to RFA-NS-21-010 for further optimization.

BRAIN Initiative: Integration and Analysis of BRAIN Initiative Data (R01 Clinical Trial Not Allowed)

RFA
Wednesday, March 10, 2021
Saturday, June 8, 2024
R01
RFA-MH-21-135

Funding Opportunity Purpose

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.

BRAIN Initiative: Secondary Analysis and Archiving of BRAIN Initiative Data (R01 Clinical Trial Not Allowed)

RFA
Wednesday, March 10, 2021
Friday, October 8, 2021
R01
RFA-MH-21-130

Funding Opportunity Purpose

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.

Limited Competition to Convert the CNS HIV Antiretroviral Therapy Effects Research (CHARTER) Study Cohort to a Research Resource (R24 - Clinical Trial Not Allowed)

RFA
Monday, March 8, 2021
Tuesday, May 11, 2021
R24
RFA-MH-21-170

Funding Opportunity Purpose

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.

HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies

Notice of Special Interest
Friday, March 5, 2021
Saturday, May 1, 2021
333
NOT-NS-21-025

Funding Opportunity Purpose

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.

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