Find Funding Opportunities

Find Funding Opportunities

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Analytical Validation of a Candidate Biomarker for Neurological Disease (U44 - Clinical Trial Optional)

PAR
Friday, December 22, 2017
Translational Research, Clinical Trials Research
Tuesday, September 8, 2020
U44
PAR-18-549

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to support applications from Small Business Concerns (SBCs) to perform rigorous analytical validation of candidate biomarker measures or endpoints in a manner that is consistent with FDA guidelines. Analytical validation establishes that the performance characteristics of the biomarker measurement or endpoint are acceptable for its intended use.

Clinical Validation of a Candidate Biomarker for Neurological Disease (U44 - Clinical Trial Optional)

PAR
Friday, December 22, 2017
Translational Research, Clinical Trials Research
Tuesday, September 8, 2020
U44
PAR-18-548

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is encourage applications from Small Business Concerns (SBCs) to support rigorous clinical validation of a candidate biomarker using retrospective and/or prospective methods in a manner that is consistent with the purpose of the biomarker. This FOA assumes that: 1) a candidate biomarker has already been identified, 2) an analytical method has been developed and validated that is consistent with the purpose of the biomarker and 3) a working hypothesis regarding context of use is in place. The goal of this FOA is to facilitate the advancement of robust and reliable biomarkers of neurological disease for use in multi-site clinical trials and clinical practice.

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

PAR
Thursday, December 21, 2017
Translational Research, Clinical Trials Research
Friday, May 8, 2020
U44
PAR-18-541

Funding Opportunity Purpose

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 with NIH contract research organizations (CROs) that specialize in medicinal chemistry, pharmacokinetics, toxicology, formulations development, chemical synthesis including under Good Manufacturing Practices (GMP), and Phase I clinical testing. Projects can enter either at the Discovery stage, to optimize promising hit compounds through medicinal chemistry, or at the Development stage, to advance a development candidate through Investigational New Drug (IND)-enabling toxicology studies and phase I clinical testing. Projects that enter at the Discovery stage and meet their milestones may continue on through Development. BPN awardee institutions retain their assignment of IP rights and gain assignment of IP rights from the BPN contractors (and thereby control the patent prosecution and licensing negotiations) for drug candidates developed in this program.

BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (U44 Clinical Trial Required)

RFA
Thursday, December 21, 2017
Translational Research, Clinical Trials Research
Thursday, October 22, 2020
U44
RFA-NS-18-022

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage small business concerns (SBCs) to pursue translational non-clinical studies and clinical studies for recording and/or stimulating devices to treat nervous system disorders and thereby better understand the human brain. The program will utilize a cooperative agreement mechanism to support the non-clinical studies necessary for the submission of an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or to obtain Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, and the subsequent small clinical trial (e.g., Early Feasibility Study). Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, and pursuit of regulatory approval for, and implementation of, a single small clinical trial. The small clinical trial should provide data to answer key questions about the function or final design of a device. This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval. The clinical trial is expected to provide information that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use.

CREATE Bio Development Track: Preclinical and Early-Phase Clinical Development for Biologics (U44 SBIR- Clinical Trial Optional)

PAR
Wednesday, December 20, 2017
Translational Research, Clinical Trials Research
Tuesday, September 8, 2020
U44
PAR-18-543
Chris Boshoff

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) supports the development of therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, cell therapies, and novel emerging therapies) for disorders identified under the NINDS mission. An identified clinical candidate with sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application, is required for entry to this CREATE Bio Development Track. Therefore, this FOA supports Investigational New Drug (IND)-enabling studies for a therapeutic candidate and the inclusion of an optional small delayed-onset first in human Phase I clinical trial. At the end of the funding period, a successful project should have at least an IND application submitted to the U.S. Food and Drug Administration (FDA).

Translational Neural Devices (U44 - Clinical Trial Required)

RFA
Wednesday, November 8, 2017
Translational Research, Clinical Trials Research
Thursday, October 22, 2020
U44
RFA-NS-18-012

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from Small Business Concerns (SBCs) to pursue translational activities and small clinical studies to advance the development of therapeutic and diagnostic devices for disorders that affect the nervous or neuromuscular systems. The translational device activities, including translational bench and animal studies, are expected to lead to submission of an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) or Institutional Review Board (IRB) application for a Non-Significant Risk (NSR) study. This cooperative agreement will also support the subsequent small clinical study to collect safety and effectiveness data required to support a marketing application or to inform final device design.

NINDS CREATE Bio Optimization Track for Biologics (U44)

PAR
Monday, August 14, 2017
Translational Research
Tuesday, September 8, 2020
U44
PAR-17-457
Chris Boshoff

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) supports SBIRs in the optimization of potential therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, cell therapies, and novel emerging modalities) for disorders identified under the NINDS mission. This track supports the further characterization and optimization of therapeutic agent(s) that showed promise as evidenced by relevant, rigorous, convincing in vivo studies. Therefore, at the end of this funding period, successful projects will have delivered an optimized therapeutic candidate with demonstrated bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and should be eligible for entry into the CREATE Bio Development track.

Administrative Supplements for the U.S.-Japan Brain Research Cooperative Program (BRCP) - U.S. Entity (Admin Supplement)

PA
Tuesday, July 18, 2017
Thursday, September 19, 2019
333
PA-17-326

Funding Opportunity Purpose

The National Institutes of Health (NIH) announces the continuation of the U.S. entity of the U.S.-Japan Brain Research Cooperative Program (BRCP). This administrative supplement program will provide funds to research projects that are currently supported by the participating NIH Institutes and Centers.

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