Catalyze: Product Definition for Small Molecules and Biologics - Preliminary Product/Lead Series Identification (R33 - Clinical Trial Not Allowed)
ID: 337526Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Award Range

$0 - $350K

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Grant

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/337526

Additional Information

http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-23-012.html
Timeline
    Description

    The National Institutes of Health (NIH) has announced a funding opportunity titled "Catalyze: Product Definition for Small Molecules and Biologics - Preliminary Product/Lead Series Identification" under the R33 activity code. This initiative aims to support the early-stage development of therapeutic agents targeting heart, lung, blood, and sleep (HLBS) diseases by facilitating the identification of lead compound series, with a focus on innovative solutions backed by strong biological rationale and preliminary data. The program requires applicants to secure at least a 25% cash match of direct federal costs and to involve an Accelerator Partner for commercialization support, with a maximum funding amount of $350,000 per year for a project period of up to two years. Interested applicants should note that the submission deadline is February 21, 2024, and can reach out to the NIH OER Webmaster at OERWebmaster03@od.nih.gov for further inquiries.

    Point(s) of Contact
    OERWebmaster03@od.nih.gov
    Files
    Title
    Posted
    RFA-HL-23-012-Full-Announcement.html
    RFA-HL-23-012.html
    The Department of Health and Human Services, through the National Institutes of Health (NIH), has issued a funding opportunity titled "Catalyze: Product Definition for Small Molecules and Biologics - Preliminary Product/Lead Series Identification" under the R33 activity code. This initiative seeks to support the early-stage development of therapeutic agents targeting heart, lung, blood, and sleep (HLBS) diseases by identifying lead compound series. The program encourages applications that propose innovative solutions with a strong biological rationale and preliminary data. Key requirements for applicants include securing at least a 25% cash match of direct federal costs and the involvement of an Accelerator Partner for commercialization support. The maximum funding available is $350,000 per year, with a project period of up to two years and a total anticipated budget of $6.2 million annually. Applications will undergo a rigorous merit review process. The deadline for submissions is February 21, 2024, with additional relevant dates outlined for letters of intent and milestone achievements. This FOA reflects NIH’s commitment to advancing therapeutic discoveries and improving health outcomes through collaborative innovation and clear project management strategies, while also emphasizing regulatory and intellectual property considerations.
    Similar Opportunities
    Catalyze: Product Definition for Small Molecules, Biologics and Combination Products - Target Identification and Validation, and Preliminary Product/Lead Series Identification (R61/R33 Clinical Trials Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Catalyze: Product Definition for Small Molecules, Biologics, and Combination Products," aimed at supporting early-stage translational research for heart, lung, blood, and sleep disorders. This initiative employs a phased approach (R61/R33), where the R61 phase focuses on identifying and validating therapeutic candidates, while the R33 phase involves lead series identification for preclinical testing, emphasizing innovation and addressing therapeutic gaps. The total funding commitment is approximately $4.47 million per fiscal year from 2026 to 2028, with a maximum budget of $400,000 per year for each phase, and applications are due by December 23, 2027. Interested applicants can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    Catalyze Product Definition Medical Device prototype design/testing and disease target identification and assay development (R61/R33 - Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Heart, Lung, and Blood Institute (NHLBI), has announced a funding opportunity titled "Catalyze Product Definition," aimed at supporting the development of medical device prototypes, diagnostic targets, and related research tools for heart, lung, blood, and sleep (HLBS) diseases. This initiative adopts a phased approach (R61/R33) to assist early-stage projects, focusing on preliminary prototype testing in the R61 phase and advancing to extensive development activities in the R33 phase, with a requirement for applicants to demonstrate novelty and a strong biological rationale supported by preliminary data. The program anticipates funding approximately $4.4 million annually from FY 2026 to FY 2028, with up to 24 awards available, and requires applicants to engage with an Accelerator Partner to enhance commercialization expertise. Interested parties can find more information and application guidelines at the NIH grants website, with a submission deadline of December 23, 2027.
    Catalyze: Enabling Technologies and Transformative Platforms for HLBS Research (R33 - Clinical Trials Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Heart, Lung, and Blood Institute (NHLBI), is offering a funding opportunity titled "Catalyze: Enabling Technologies and Transformative Platforms for HLBS Research (R33 - Clinical Trials Not Allowed)." This grant aims to support the development and validation of innovative technologies that address significant gaps in heart, lung, blood, and sleep (HLBS) research, focusing on advancing diagnostic and therapeutic solutions with promising preliminary data. Eligible applicants include a wide range of institutions and organizations, with a budget ceiling of $350,000 in direct costs per year, and total funding commitments expected to reach $2,156,000 annually for the next three fiscal years. The application deadline is set for January 11, 2025, and further details can be found on the NIH grants website or by contacting NIH Grants Information at grantsinfo@nih.gov.
    Catalyze: Product Definition Medical Device Prototype Optimization (R33 - Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Catalyze: Product Definition – Medical Device Prototype Optimization" (RFA-HL-26-020) aimed at supporting early-stage translational research for the optimization of prototypes related to heart, lung, blood, and sleep (HLBS) diseases. This initiative seeks to facilitate the transition of basic science discoveries into viable diagnostic and therapeutic candidates, encouraging significant improvements over existing solutions through strong biological rationale and preliminary data. The total anticipated funding is approximately $4.466 million per fiscal year from FY 2026 to FY 2028, with applications due by 5 PM local time on specified dates, and a maximum project duration of two years. Interested applicants can find more information and contact NIH Grants Information at grantsinfo@nih.gov for inquiries.
    NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R33 CT Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for the NHLBI Early Phase Clinical Trials (R33), aimed at supporting investigator-initiated Phase I clinical trials for therapeutic and diagnostic interventions targeting heart, lung, blood, and sleep (HLBS) disorders. Applicants are required to be prepared to initiate their clinical trials within the first quarter of the project period and must demonstrate readiness in obtaining necessary regulatory approvals, including FDA and IRB, prior to the award. This funding is crucial for addressing unmet medical needs through innovative research, with a maximum budget of $1.515 million per year and a project duration of up to three years, contingent upon achieving specific milestones. Interested applicants should note the application deadline of June 4, 2024, and can direct inquiries to NIH Grants Information at grantsinfo@nih.gov for further details.
    NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R33 CT Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a funding opportunity aimed at supporting Phase I clinical trials for therapeutic and diagnostic interventions related to heart, lung, blood, and sleep (HLBS) disorders. This initiative seeks to accelerate the development of clinical interventions by funding investigator-initiated studies that demonstrate potential advancements in HLBS health, with a focus on ensuring that applicants are prepared to initiate trials promptly after receiving funding. The funding is capped at $1.5 million per year for a project period of up to three years, contingent on satisfactory progress and milestone completion, with applications opening on January 3, 2025, and the first due date set for February 3, 2025. Interested applicants can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries and are encouraged to review the full announcement available at https://grants.nih.gov/grants/guide/pa-files/PAR-25-025.html.
    NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R61/R33 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders," aimed at supporting investigator-initiated Phase I clinical trials for heart, lung, blood, and sleep (HLBS) disorders in both adults and children. This grant (R61/R33) facilitates funding for essential preclinical activities and the execution of clinical trials, structured in two phases: the R61 phase focuses on preparatory tasks, while the R33 phase involves the actual trial conduct, guided by specific milestones. This initiative is crucial for advancing research that addresses significant health challenges associated with HLBS disorders. Interested applicants can submit proposals starting January 3, 2025, with a maximum project period of five years, and should direct inquiries to grantsinfo@nih.gov. For more details, visit the official announcement at https://grants.nih.gov/grants/guide/pa-files/PAR-25-026.html.
    Notice of Intent to Publish a Funding Opportunity Announcement for NHLBI SBIR Phase IIB Small Market Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is preparing to publish a Notice of Funding Opportunity (NOFO) for the NHLBI SBIR Phase IIB Small Market Awards aimed at accelerating the commercialization of technologies for heart, lung, blood, and sleep disorders. This funding opportunity is designed to support small businesses in advancing promising biomedical projects that have previously received SBIR or STTR Phase II funding, specifically targeting products that address rare diseases or pediatric populations. With an estimated total program funding of $21 million and an award ceiling of $3.5 million, the anticipated application due date is February 25, 2025, with awards expected to be made by December 1, 2025. Interested applicants are encouraged to prepare their proposals in advance to meet the requirements integral to this initiative.
    NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R61/R33 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH), through its National Heart, Lung, and Blood Institute (NHLBI), has announced a funding opportunity (FON: PAR-24-173) aimed at supporting Phase I clinical trials for therapeutics and diagnostics related to heart, lung, blood, and sleep (HLBS) disorders in both adults and children. This initiative utilizes a bi-phasic R61/R33 award mechanism, where the R61 phase focuses on preparatory activities such as finalizing trial protocols and gathering preclinical data, while the R33 phase is dedicated to executing the clinical trial. The funding limits include up to $250,000 annually for the R61 phase and $1,515,000 for the R33 phase, with total support available for a maximum of five years. Interested applicants must adhere to NIH guidelines and submit their proposals by January 7, 2027, to be considered for this opportunity. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov.
    Notice of Intent to Publish a Funding Opportunity Announcement for NHLBI SBIR Phase IIB Bridge Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is forecasting a funding opportunity for the Small Business Innovation Research (SBIR) Phase IIB Bridge Awards aimed at accelerating the commercialization of technologies related to heart, lung, blood, and sleep disorders. This initiative seeks to support small businesses in advancing promising biomedical projects that have previously received SBIR or STTR Phase II funding, addressing the critical funding gap that often hinders the transition to commercialization and regulatory approval. The program is designed to foster partnerships between SBIR Phase II awardees and third-party investors, with a total estimated funding of $52.5 million and individual awards capped at $3.5 million. Interested applicants should prepare to submit proposals by February 25, 2025, with the anticipated award date set for December 1, 2025.