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Translational Neural Devices (U44 - Clinical Trial Required)

RFA
Wednesday, November 8, 2017
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.

NeuroNEXT Small Business Innovation in Clinical Trials (U44)

PAR
Monday, June 5, 2017
Saturday, January 6, 2018
U44
PAR-17-300

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages small business applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) that may contribute to the justification for and provide the data required for designing clinical studies. Diseases chosen for study should be based on the NINDS' strategic plan and clinical research interests (www.ninds.nih.gov/funding/areas/index.htm ).

NIH StrokeNet Small Business Innovation Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U44)

PAR
Wednesday, May 10, 2017
Clinical Research
Saturday, January 6, 2018
U44
PAR-17-275

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose exploratory and confirmatory clinical trials focused on promising interventions, as well as biomarker-or outcome measure validation studies that are immediately preparatory to trials in stroke prevention, treatment, and recovery. The program will utilize the cooperative agreement mechanism to enable milestone-drive projects.

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

PAR
Thursday, March 9, 2017
Translational Research
Friday, May 8, 2020
U44
PAR-17-201
Charles Cywin

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.