Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)
Funding Opportunity RFA-TR-24-023 from the NIH Guide for Grants and Contracts. This notice of funding opportunity (NOFO) provides funding to conduct efficacy studies in an established rare disease preclinical model to demonstrate that a proposed therapeutic agent warrants further development. In addition to preclinical efficacy, accompanying pharmacodynamic and pharmacokinetic studies would be supported. Therapeutic agents include small molecules, biologics or biotechnology-derived products. The goal of this NOFO is to spur therapeutic development for a variety of rare diseases by advancing projects to the point where t...
Source: NIH Funding Opportunities (Notices, PA, RFA) - April 3, 2024 Category: Research Source Type: funding

Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
Funding Opportunity RFA-NS-24-029 from the NIH Guide for Grants and Contracts. The National Institute of Neurological Disorders and Stroke (NINDS) and the Office of the Director, National Institutes of Health (OD), intend to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for the conduct of scientific research utilizing data from expanded access (EA) to investigational drugs or biological products. These applications will target intermediate size populations of patients living with amyotrophic lateral sclerosis (ALS) who are not otherwise eligible for clinical tria...
Source: NIH Funding Opportunities (Notices, PA, RFA) - November 21, 2023 Category: Research Source Type: funding

Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development of Disorders of the Nervous System (UG3/UH3 Clinical Trial Optional)
Funding Opportunity PAR-24-043 from the NIH Guide for Grants and Contracts. Reissue of PAR-18-546. The Blueprint Neurotherapeutics Network (BPN) invites applications from neuroscience investigators seeking support to advance their small molecule drug discovery and development projects into the clinic. Participants in the BPN are responsible for conducting all studies that involve disease- or target-specific assays, models, and other research tools and receive funding for all activities to be conducted in their own laboratories. In addition, applicants will collaborate with NIH-funded consultants and can augment their pr...
Source: NIH Funding Opportunities (Notices, PA, RFA) - November 2, 2023 Category: Research Source Type: funding

Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional)
Funding Opportunity PAR-24-063 from the NIH Guide for Grants and Contracts. Reissue of PAR-18-541. The Blueprint Neurotherapeutics Network (BPN) encourages applications from small businesses seeking support to advance their small molecule drug discovery and development projects into the clinic. Participants in the BPN are responsible for conducting all studies that involve disease- or target-specific assays, models, and other research tools and receive funding for all activities to be conducted in their own laboratories. In addition, applicants will collaborate with NIH-funded consultants and can augment their project w...
Source: NIH Funding Opportunities (Notices, PA, RFA) - November 1, 2023 Category: Research Source Type: funding

HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)
Funding Opportunity RFA-NS-24-019 from the NIH Guide for Grants and Contracts. Reissue of RFA-NS-20-010: The purpose of this funding opportunity announcement (FOA) is to support preclinical optimization and development of safe, effective, and non-addictive small molecule and biologic therapeutics to treat pain. The goal of the program is to accelerate the optimization and development of promising small molecule and biologic hits/leads towards clinical trials. Applicants must have a promising hit/lead, robust biological rationale for the intended approach, and identified assays for optimization of the agent. The scope of...
Source: NIH Funding Opportunities (Notices, PA, RFA) - October 31, 2023 Category: Research Source Type: funding

Planning for Product Development Strategy (R34 Clinical Trial Not Allowed)
Funding Opportunity PAR-24-029 from the NIH Guide for Grants and Contracts. The purpose of this Notice of Funding Opportunity (NOFO) is to support the development of a comprehensive and well-defined product development strategy for next-generation treatments for HIV and HIV-associated comorbidities, coinfections and complication and preventive strategies for HIV, as well as facilitating the translation of research findings into drug products that enables submission of an Investigational New Drug (IND) application to the FDA. (Source: NIH Funding Opportunities (Notices, PA, RFA))
Source: NIH Funding Opportunities (Notices, PA, RFA) - August 14, 2023 Category: Research Source Type: funding

SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1 Clinical Trial Required)
Funding Opportunity PAR-23-220 from the NIH Guide for Grants and Contracts. The purpose of this Notice of Funding Opportunity (NOFO) is to encourage applications from small business concerns (SBCs) to the newly re-authorized Commercialization Readiness Pilot (CRP) program. The NOFO aims to facilitate the transition of previously or currently funded SBIR and STTR Phase II and Phase IIB projects to the commercialization stage by providing additional support for technical assistance and later stage research and development (R and D) not typically supported through Phase II or Phase IIB grants or contracts. This may include...
Source: NIH Funding Opportunities (Notices, PA, RFA) - July 12, 2023 Category: Research Source Type: funding

SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1, Clinical Trial Not Allowed)
Funding Opportunity PAR-23-219 from the NIH Guide for Grants and Contracts. The purpose of this Notice of Funding Opportunity (NOFO) is to encourage applications from small business concerns (SBCs) to the newly re-authorized Commercialization Readiness Pilot (CRP) program. The NOFO aims to facilitate the transition of previously or currently funded SBIR and STTR Phase II and Phase IIB projects to the commercialization stage by providing additional support for technical assistance and later stage research and development (R and D) not typically supported through Phase II or Phase IIB grants or contracts. This may include...
Source: NIH Funding Opportunities (Notices, PA, RFA) - July 12, 2023 Category: Research Source Type: funding

Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)
Funding Opportunity RFA-TR-23-016 from the NIH Guide for Grants and Contracts. This notice of funding opportunity (NOFO) provides funding to conduct efficacy studies in an established rare disease preclinical model to demonstrate that a proposed therapeutic agent warrants further development. In addition to preclinical efficacy, accompanying pharmacodynamic and pharmacokinetic studies would be supported. Therapeutic agents include small molecules, biologics or biotechnology-derived products. The goal of this NOFO is to spur therapeutic development for rare diseases by advancing projects to the point where they would at...
Source: NIH Funding Opportunities (Notices, PA, RFA) - July 5, 2023 Category: Research Source Type: funding

NEI Translational Research Program for Therapeutics (R61/R33 Clinical Trial Not Allowed)
Funding Opportunity PAR-23-200 from the NIH Guide for Grants and Contracts. The purpose of this Notice of Funding Opportunity (NOFO) is the rapid and efficient translation of innovative laboratory research findings into therapeutics for use by clinicians to treat visual system diseases or disorders. Multidisciplinary teams of scientists and clinicians must focus on generating preclinical data that will lead to the development of biological, pharmacological, medical device and/or combination product interventions. The ultimate goal of this program is to make new technological, biological and pharmacological resources ava...
Source: NIH Funding Opportunities (Notices, PA, RFA) - June 27, 2023 Category: Research Source Type: funding

NEI Translational Research Program for Therapeutics (R33 Clinical Trial Not Allowed)
Funding Opportunity PAR-23-205 from the NIH Guide for Grants and Contracts. The purpose of this NOFO is the rapid and efficient translation of innovative laboratory research findings into therapeutics for use by clinicians to treat visual system diseases or disorders. Multidisciplinary teams of scientists and clinicians must focus on generating preclinical data that will lead to the development of biological, pharmacological, medical device and/or combination product interventions. The ultimate goal of this program is to make new technological, biological and pharmacological resources available to clinicians and their p...
Source: NIH Funding Opportunities (Notices, PA, RFA) - June 27, 2023 Category: Research Source Type: funding

Chemical Screening and Optimization Facility (X01 Clinical Trial Not Allowed)
Funding Opportunity PAR-23-193 from the NIH Guide for Grants and Contracts. The NICHD has a state-of-the-art Chemical Synthesis and Optimization Facility for advancing both non-hormonal contraceptive and reproductive health related product development. This facility has the capabilities and capacity for preclinical services including Investigational Device Exemption (IDE) or Investigational New Drug (IND)-enabling studies (e.g., protein generation, X-ray crystallography, high throughput screening, structure activity relationships, hit-to-lead generation, drug metabolism). The long-term objective is to enable a preclinic...
Source: NIH Funding Opportunities (Notices, PA, RFA) - May 19, 2023 Category: Research Source Type: funding

Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
Funding Opportunity RFA-NS-23-012 from the NIH Guide for Grants and Contracts. The National Institute of Neurological Disorders and Stroke (NINDS) and the Office of the Director, National Institutes of Health (OD), intend to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for the conduct of scientific research utilizing data from expanded access (EA) to investigational drugs or biological products. These applications will target intermediate size populations of patients living with amyotrophic lateral sclerosis (ALS) who are not otherwise eligible for clinical tria...
Source: NIH Funding Opportunities (Notices, PA, RFA) - January 9, 2023 Category: Research Source Type: funding

Integrated Preclinical / Clinical AIDS Vaccine Development Program (IPCAVD) (U19 Clinical Trial Not Allowed)
Funding Opportunity PAR-23-033 from the NIH Guide for Grants and Contracts. The purpose of this Funding Opportunity Announcement (FOA) is to support translation of advanced HIV-1 vaccine candidates from pre-clinical studies through different phases of process and product development, Current Good Manufacturing Practice (CGMP) manufacturing and regulatory filing to the point of clinical testing. The FOA will support technology transfer, preclinical immunogenicity and optimization studies, process development, analytical assay development, qualification, validation, testing, small scale pilot or engineering runs, CGMP man...
Source: NIH Funding Opportunities (Notices, PA, RFA) - October 31, 2022 Category: Research Source Type: funding

Regenerative Medicine Innovation Projects (RMIP) Investigator- Initiated Studies (Collaborative U01 Clinical Trial Not Allowed)
Funding Opportunity RFA-HL-23-019 from the NIH Guide for Grants and Contracts. The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration, invite cooperative agreement (U01) applications to support investigator- initiated clinical research studies aimed at furthering the field of regenerative medicine (RM) using adult stem cells. This Funding Opportunity Announcement (FOA), issued as part of the Regenerative Medicine Innovation Project (RMIP), represents one step in fulfilling a statutory provision set forth in the 21st Century Cures Act. Appl...
Source: NIH Funding Opportunities (Notices, PA, RFA) - July 7, 2022 Category: Research Source Type: funding