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NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required)

PAR
Friday, July 16, 2021
Heal
Saturday, April 6, 2024
R41/R42
PAR-21-267
Emily Caporello

Funding Opportunity Purpose

(Reissue of PAR-18-617) The purpose of this funding opportunity announcement (FOA) is to provide a vehicle for Small Business Concerns (SBCs) submitting Small Business Technology Transfer (STTR) grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The projects must focus on products related to the mission and goals of the NINDS and may evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral or rehabilitation therapies. Only STTR Phase II and Fast-Track applications are supported under this program. STTR Phase I applications are only accepted as part of a Fast-track application.

NINDS Exploratory Clinical Trials for Small Business (R43/R44 Clinical Trial Required)

PAR
Thursday, July 15, 2021
Saturday, April 6, 2024
R43/R44
PAR-21-266

Funding Opportunity Purpose

(Reissue of PAR-18-618) The purpose of this funding opportunity announcement (FOA) is to provide a vehicle for Small Business Concerns (SBCs) submitting Small Business Innovation Research (SBIR) grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The projects must focus on products related to the mission and goals of the NINDS and may evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral or rehabilitation therapies. Only SBIR Phase II and Fast-Track applications are supported under this program. SBIR Phase I applications are only accepted as part of a Fast-track application.

NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Clinical Trials and Clinical Research (R44 Clinical Trial Optional)

PAR
Thursday, July 15, 2021
Translational Research, Clinical Trials Research, Clinical Research
Saturday, April 6, 2024
R44
PAR-21-265
Emily Caporello

Funding Opportunity Purpose

(Reissue of PAR-18-665) This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) applications from small business concerns (SBCs) that seek additional funding to support clinical trials for projects that were previously funded by NIH SBIR and STTR Phase II awards. The projects must focus on products related to the mission and goals of the National Institute of Neurological Disorders and Stroke (NINDS) and may evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral or rehabilitation therapies. Since conducting the clinical trials needed for commercialization may be capital-intensive, the FOA aims to facilitate the transition of SBIR Phase II projects to the commercialization stage by promoting partnerships between NIH's SBIR/STTR awardees and third-party investors and/or strategic partners. Consistent with the goals of this funding initiative and as required by the SF424 instructions for all SBIR Phase II applications, applicants must submit a Commercialization Plan, which should include details on any independent third-party investor funding that has already been secured or is anticipated during the project period. It is expected that the level of this independent third-party funding will equal or exceed the NINDS funds being requested throughout the SBIR Phase IIB project period.

Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3 Clinical Trial Required)

RFA
Tuesday, July 13, 2021
Saturday, October 9, 2021
UG3/UH3
RFA-HL-22-014

Funding Opportunity Purpose

The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration (FDA), seeks highly meritorious clinical trial applications proposing to explore and enable the development of safe and effective regenerative medicine (RM) interventions 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. Applications submitted in response to this bi-phasic, milestone-driven cooperative agreement FOA are expected to propose highly innovative projects with a focus on solutions to widely-recognized issues in the development of safe and effective RM therapies. Of particular interest are projects using RM products that have undergone appropriate product development and pre-clinical studies and have demonstrated readiness to advance into clinical trials. This FOA seeks Phase I and beyond clinical trial applications that present a strong scientific rationale for the proposed clinical trial and a comprehensive scientific and operational plan. Trials must be relevant to the research mission of one or more participating NIH Institutes and Centers and meet the NIH definition of a clinical trial (see NOT-OD-15-015). Applications are expected to include plans for project management, participant recruitment and retention, performance milestones, conduct of the trial, and dissemination of results. Before the time of award and if applicable, successful applicants must obtain an Investigational New Drug (IND) authorization or Investigational New Device Exemption (IDE) approval to administer the product to humans. Successful applicants proposing the use of adult stem cells as a clinical intervention will be asked to make available representative samples of the source stem cell and clinical-grade stem cell-derived product for in-depth and independ

Blueprint Neurotherapeutics Network (BPN): Biologic-based Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional)

PAR
Friday, April 23, 2021
Saturday, April 6, 2024
U44
PAR-21-233
Ann-Marie Broome

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.

Notice of Special Interest (NOSI): Availability of Funds to defray Childcare Costs for NCI, NHGRI, NIA, NIDCR, NIDDK, and NIH Blueprint Predoctoral to Postdoctoral Fellow Transition Programs F99 Awardees

Notice of Special Interest
Friday, April 23, 2021
Monday, January 8, 2024
333
NOT-CA-21-053

Funding Opportunity Purpose

NIH recognizes that the high cost of childcare impacts graduate students and post-doctoral researchers funded through NIH fellowships, and their ability to successfully complete their training and fully participate in the extramural research workforce. Therefore, this Notice announces that NCI, NHGRI, NIA, NIDCR, NIDDK, and NINDS (on behalf of the NIH Blueprint DSPAN) will defray childcare costs to recipients of Predoctoral to Postdoctoral Fellow Transition Award (F99/K00) programs during the F99 phase of the award.

Notice of Special Interest (NOSI): Availability of Funds to defray Childcare Costs for NCI, NIA, NIDCR, NIDDK, and NIH Blueprint Predoctoral to Postdoctoral Fellow Transition Programs F99 Awardees

Notice of Special Interest
Friday, April 23, 2021
Monday, January 8, 2024
333
NOT-CA-21-053

Funding Opportunity Purpose

NIH recognizes that the high cost of childcare impacts graduate students and post-doctoral researchers funded through NIH fellowships, and their ability to successfully complete their training and fully participate in the extramural research workforce. Therefore, this Notice announces that NCI, NHGRI, NIA, NIDCR, NIDDK, and NINDS (on behalf of the NIH Blueprint DSPAN) will defray childcare costs to recipients of Predoctoral to Postdoctoral Fellow Transition Award (F99/K00) programs during the F99 phase of the award.

RESCINDED - Notice of Special Interest (NOSI): Availability of Funds to defray Childcare Costs for NCI, NHGRI, NIA, NIDCR, NIDDK, and NIH Blueprint Predoctoral to Postdoctoral Fellow Transition Programs F99 Awardees

Notice of Special Interest
Friday, April 23, 2021
Monday, January 8, 2024
333
NOT-CA-21-053

Funding Opportunity Purpose

NIH recognizes that the high cost of childcare impacts graduate students and post-doctoral researchers funded through NIH fellowships, and their ability to successfully complete their training and fully participate in the extramural research workforce. Therefore, this Notice announces that NCI, NHGRI, NIA, NIDCR, NIDDK, and NINDS (on behalf of the NIH Blueprint DSPAN) will defray childcare costs to recipients of Predoctoral to Postdoctoral Fellow Transition Award (F99/K00) programs during the F99 phase of the award.

NIH Blueprint and BRAIN Initiative Diversity Specialized Predoctoral to Postdoctoral Advancement in Neuroscience (D-SPAN) Award (F99/K00 Clinical Trial Not Allowed)

RFA
Wednesday, April 21, 2021
Saturday, December 16, 2023
RFA-NS-21-012

Funding Opportunity Purpose

Reissue of RFA-NS-19-011: The purpose of the NIH Blueprint and BRAIN Initiative Diversity Specialized Predoctoral to Postdoctoral Advancement in Neuroscience (D-SPAN) Award is to support a defined pathway across career stages for outstanding graduate students who are from backgrounds that are nationally underrepresented in neuroscience research. This two-phase award will facilitate completion of the doctoral dissertation and transition of talented graduate students to strong neuroscience research postdoctoral positions, and will provide career development opportunities relevant to their long-term career goal of becoming independent neuroscience researchers.

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.

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