Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3 Clinical Trial Required)
Funding Opportunity RFA-HL-23-017 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 (FDA), seek 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. Appl...
Source: NIH Funding Opportunities (Notices, PA, RFA) - July 7, 2022 Category: Research Source Type: funding
Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
Funding Opportunity RFA-NS-22-071 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) - May 12, 2022 Category: Research Source Type: funding
IND-enabling Studies of Somatic Genome Editing Therapeutic Leads (U19, Clinical Trial Not allowed)
Funding Opportunity RFA-RM-22-015 from the NIH Guide for Grants and Contracts. This funding opportunity announcement (FOA) is part of a suite of FOAs of the NIH Common Fund Somatic Cell Genome Editing (SCGE) Phase II Program. The goal of this U19 FOA is to support team-based research Projects to accelerate further optimization and development of genome editing-based therapeutic leads towards IND-enabling studies and an IND (Investigational New Drug) application submission to the U.S. Food and Drug Administration (FDA). The proposed leads should demonstrate strong biological rationale and in vitro and/or in vivo proof of...
Source: NIH Funding Opportunities (Notices, PA, RFA) - April 11, 2022 Category: Research Source Type: funding
PDX Data Commons and Coordinating Center (PDCCC) for the PDX Development and Trial Centers Research Network (PDXNet) (U24 Clinical Trial Not Allowed)
Funding Opportunity RFA-CA-22-013 from the NIH Guide for Grants and Contracts. The purpose of this funding opportunity announcement (FOA) is to establish a PDXNet Data Commons and Coordinating Center (PDCCC). PDCCC will interact with and coordinate with the PDX (Patient-Derived Xenograft) Development and Trial Centers Research Network (PDXNet) comprised of five PDX Development and Trial Centers (PDTCs, to be supported by companion FOA, RFA-CA-22-012) in a collaborative network. The PDXNet is a National Cancer Institute (NCI) program established to coordinate collaborative, large-scale development and pre-clinical testin...
Source: NIH Funding Opportunities (Notices, PA, RFA) - March 25, 2022 Category: Research Source Type: funding
Investigational New Drug (IND)-enabling and Early-Stage Development of Medications to Treat Alcohol Use disorder and Alcohol-Associated Organ Damage (U43/U44 Clinical Trial Optional)
Funding Opportunity PAR-22-102 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) supports Small Business Innovation Research (SBIR) applications from small business concerns (SBCs) that propose the development of therapeutic agents for the treatment of alcohol use disorder (AUD) and/or alcohol associated organ damage (AAOD). As a starting point, eligible applicants must identify a therapeutic candidate with a robust body of background data in the basic science and early discovery phases to be ready for transition to the preclinical and clinical phases of development. Data may inclu...
Source: NIH Funding Opportunities (Notices, PA, RFA) - January 21, 2022 Category: Research Source Type: funding
Investigational New Drug (IND)-enabling and Early-Stage Development of Medications to Treat Alcohol Use disorder and Alcohol-Associated Organ Damage (UT1/UT2 Clinical Trial Optional)
Funding Opportunity PAR-22-103 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) supports Small Business Technology Transfer (STTR) applications from small business concerns (SBCs) that propose the development of therapeutic agents for the treatment of alcohol use disorder (AUD) and/or alcohol associated organ damage (AAOD). As a starting point, eligible applicants must identify a therapeutic candidate with a robust body of background data in the basic science and early discovery phases to be ready for transition to the preclinical and clinical phases of development. Data may inclu...
Source: NIH Funding Opportunities (Notices, PA, RFA) - January 21, 2022 Category: Research Source Type: funding
Translational Efforts to Advance Gene-based Therapies for Ultra-Rare Neurological and Neuromuscular Disorders (U01 - Clinical Trial Optional)
Funding Opportunity PAR-22-030 from the NIH Guide for Grants and Contracts. The Ultra-Rare Gene-Based Therapy (URGenT) network supports Investigational New Drug (IND)-enabling studies and planning activities for First-in-Human (FIH) clinical testing of gene-based or transcript-directed therapeutics, such as oligonucleotides and viral-based gene therapies, for ultra-rare neurological or neuromuscular disorders. The goal of this funding opportunity announcement (FOA) is to accelerate the development of a promising clinical candidate with robust biological rationale and demonstrated proof of concept (POC) data for the inte...
Source: NIH Funding Opportunities (Notices, PA, RFA) - November 9, 2021 Category: Research Source Type: funding
Advancing Validated Drug Targets for Substance Use Disorders (R43/R44 - Clinical Trial Not Allowed)
Funding Opportunity RFA-DA-22-023 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) solicits grant applications from small business concerns (SBCs) to continue research projects with robustly validated targets for Substance Use Disorders (SUDs). This FOA will provide funding for projects entering at either assay development (AD), lead identification (LI), lead optimization (LO), or preclinical development (PCD) stages to allow for the ultimate goal of successfully completing Investigational New Drug-enabling activities. (Source: NIH Funding Opportunities (Notices, PA, RFA))
Source: NIH Funding Opportunities (Notices, PA, RFA) - July 29, 2021 Category: Research Source Type: funding
Advancing Validated Drug Targets for Substance Use Disorders (R41/R42 - Clinical Trial Not Allowed)
Funding Opportunity RFA-DA-22-018 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) solicits grant applications from small business concerns (SBCs) to continue research projects with robustly validated targets for Substance Use Disorders (SUDs). This FOA will provide funding for projects entering at either assay development (AD), lead identification (LI), lead optimization (LO), or preclinical development (PCD) stages to allow for the ultimate goal of successfully completing Investigational New Drug-enabling activities. (Source: NIH Funding Opportunities (Notices, PA, RFA))
Source: NIH Funding Opportunities (Notices, PA, RFA) - July 29, 2021 Category: Research Source Type: funding
Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3 Clinical Trial Required)
Funding Opportunity RFA-HL-22-014 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 (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. App...
Source: NIH Funding Opportunities (Notices, PA, RFA) - July 13, 2021 Category: Research Source Type: funding
New FDA Tools for Investigators and Clinicians
The FDA recently released two new tools that were developed for investigators and clinicians: 1) Research IND Pilot Portal and 2) Expanded Access eRequest.
The Research IND (Investigational New Drug) Pilot Portal is a web-based tool for submission of non-eCTD (electronic Common Technical Document) Research INDs. The submission process is streamlined by using dynamic and intuitive questions with targeted links, resources, and CFR guidance. The tool provides user-friendly capabilities such as auto population of Form FDA 1571, reusable data, and a centralized dashboard to track all submissions. Digitizing non-eCTD Research IN...
Source: NIH Extramural Nexus - June 4, 2021 Category: Research Authors: NIH Staff Tags: New Resources clinical trial FDA Source Type: funding
Notice to Extend the Expiration Date for PAR-18-580 "Investigational New Drug (IND)-enabling Development of Medications to Treat Alcohol Use disorder and Alcohol-related disorders (UT2 Clinical Trial Optional)"
Notice NOT-AA-20-026 from the NIH Guide for Grants and Contracts (Source: NIH Funding Opportunities (Notices, PA, RFA))
Source: NIH Funding Opportunities (Notices, PA, RFA) - January 6, 2021 Category: Research Source Type: funding
Notice of Extension of the Expiration Date for PAR-18-578 "Investigational New Drug (IND)-enabling Development of Medications to Treat Alcohol Use disorder and Alcohol-related disorders (U44 - Clinical Trial Optional)"
Notice NOT-AA-20-025 from the NIH Guide for Grants and Contracts (Source: NIH Funding Opportunities (Notices, PA, RFA))
Source: NIH Funding Opportunities (Notices, PA, RFA) - December 9, 2020 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-21-010 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) - September 16, 2020 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-20-129 from the NIH Guide for Grants and Contracts. The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from small business concerns (SBCs) to the newly re-authorized Commercialization Readiness Pilot (CRP) program. The FOA 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 includ...
Source: NIH Funding Opportunities (Notices, PA, RFA) - July 10, 2020 Category: Research Source Type: funding
