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HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R41/R42 Clinical Trial Required)

RFA
Friday, October 4, 2019
Heal, Translational Research, Clinical Trials Research
Friday, September 9, 2022
R41/R42
RFA-NS-20-008

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) aims to speed scientific solutions to stem the national opioid public health crisis by supporting the development of therapies and technologies directed at enhanced pain management through the Small Business Technology Transfer (STTR) program. This FOA is focused on applications directed at improving pain treatment, including the development of new non-addictive medications and devices and objective pain measurement. In addition, NIH is interested in new screening tools and models focused specifically on pain and development of pain therapies.

HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Required)

RFA
Friday, October 4, 2019
Heal, Translational Research, Clinical Trials Research
Friday, September 9, 2022
R43/R44
RFA-NS-20-010

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) aims to speed scientific solutions to stem the national opioid public health crisis by supporting the development of therapies and technologies directed at enhanced pain management through the Small Business Innovation Research (SBIR) program. This FOA is focused on applications directed at improving pain treatment, including the development of new non-addictive medications and devices and objective pain measurement. In addition, NIH is interested in new screening tools and models focused specifically on pain and development of pain therapies.

Advancing Research on Alzheimer's Disease (AD) and Alzheimer's-Disease-Related Dementias (ADRD) (R41/R42 Clinical Trial Optional)

PAS
Thursday, July 18, 2019
Translational Research, Clinical Trials Research
Wednesday, September 7, 2022
R41/R42
PAS-19-317

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites applications to NIA's Small Business Technology Transfer Research (STTR) program to conduct research leading to the development of innovative products and/or services that may advance progress in preventing and treating Alzheimer's disease (AD) and Alzheimer's-disease-related dementias (ADRD) and/or caring for and treating AD/ADRD patients.

Advancing Research on Alzheimer's Disease (AD) and Alzheimer's-Disease-Related Dementias (ADRD) (R43/R44 Clinical Trial Optional)

PAS
Thursday, July 18, 2019
Translational Research, Clinical Trials Research
Wednesday, September 7, 2022
R43/R44
PAS-19-316

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites applications to NIA's Small Business Innovation Research (SBIR) program to conduct research leading to the development of innovative products and/or services that may advance progress in preventing and treating Alzheimer's disease (AD) and Alzheimer's-disease-related dementias (ADRD) and/or caring for and treating AD/ADRD patients.

Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Development and Validation of Model Systems and/or Pharmacodynamic Markers to Facilitate Neurotherapeutic Discovery (R61/R33 Clinical Trial Not Allowed)

PAR
Thursday, April 19, 2018
Translational Research
Saturday, May 8, 2021
R61/R33
PAR-18-763

Funding Opportunity Purpose

This funding opportunity announcement (FOA) encourages the development and validation of: 1) animal models and human tissue ex vivo systems that recapitulate the phenotypic and physiologic characteristics of a defined neurological disorder and/or 2) clinically feasible pharmacodynamic markers for therapeutics designed to treat neurological disease. The goal of this FOA is to promote a significant improvement in the translational relevance of animal models, ex vivo systems, and pharmacodynamic markers that will be utilized to facilitate the development of neurotherapeutics. Ideally, models, model systems and pharmacodynamic markers proposed in applications for this FOA would have the potential to provide feasible and meaningful assessments of efficacy following therapeutic intervention that would be applicable in both preclinical and clinical settings. This FOA is part of a suite of Innovation Grants to Nurture Initial Translational Efforts (IGNITE) focused on enabling the exploratory and early stages of drug discovery.

Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Assay Development and Neurotherapeutic Agent Identification (R61/R33 Clinical Trial Not Allowed)

PAR
Thursday, April 19, 2018
Translational Research
Saturday, May 8, 2021
R61/R33
PAR-18-762

Funding Opportunity Purpose

This funding opportunity announcement (FOA) encourages research grant applications to develop in vitro and/or ex vivo assays and conduct iterative screening efforts to identify and characterize potential therapeutic agents for neurological disorders. 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 NINDS Cooperative Research to Enable and Advance Translational Enterprises for Biologics (CREATE Bio) program for biologics, biotechnology products, the Blueprint Neurotherapeutics Network (BPN) for small molecules, or other translational programs.

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

PAR
Thursday, April 19, 2018
Translational Research
Saturday, May 8, 2021
R61/R33
PAR-18-761

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 disorders that fall under the NINDS mission. Therapeutic agents may include but are not limited to 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 NINDS Cooperative Research to Enable and Advance Translational Enterprises for Biologics program (CREATE Bio) program for biologics, biotechnology products, Blueprint Neurotherapeutics Network for small molecules, or other translational programs.

SBIR Technology Transfer (R43/R44 Clinical Trial Not Allowed)

PA
Tuesday, March 6, 2018
Translational Research
Tuesday, April 6, 2021
R43/R44
PA-18-705

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) for projects to transfer technology out of the NIH intramural research labs into the private sector. If selected for SBIR funding, the SBC will be granted a royalty-free, non-exclusive patent license agreement for internal research use for the term of and within the field of use of the SBIR award to technologies held by NIH with the intent that the SBC will develop the invention into a commercial product to benefit the public.

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

PAR
Thursday, February 15, 2018
Translational Research, Clinical Trials Research, Clinical Research
Tuesday, April 6, 2021
R44
PAR-18-665

Funding Opportunity Purpose

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 NIHs 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.

BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 - Clinical Trial Required)

RFA
Thursday, December 21, 2017
Translational Research
Tuesday, February 23, 2021
UG3/UH3
RFA-NS-18-021

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue translational and clinical studies for recording and/or stimulating devices to treat nervous system disorders and better understand the human brain. The program will utilize a cooperative agreement mechanism to support the submission of an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or obtain Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, and a subsequent small clinical trial (e.g., Early Feasibility Study). 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 nonclinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. 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. As part of the BRAIN Initiative, NIH has initiated a Public-Private Partnership Program (BRAIN PPP) that includes agreements (Memoranda of Understanding, MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research. In general, it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without need for significant additional non-clinical data. For more information on the BRAIN PPP, see http://braininitiative.nih.gov/BRAIN_PPP/.

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