• Higher Education Institutions
• Nonprofits Other Than Institutions of Higher Education
• For-Profit Organizations
• Local Governments
• Federal Government
• Other
• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
• Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
• Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

NHLBI R35 Awardees may apply to the Catalyze Program: However, the PI must document any overlap in the Just-In-Time submitted for the Catalyze application (per standard NIH rules) and explain how potential overlap due to the nature of the R35 will be mitigated. Before applying, investigators should consider whether the proposed research could be accomplished under the R35 award. It is recommended that R35 awardees contact their Program Director or the R35 group to discuss their plans.

Each publication, press release, or other document about research supported by an NIH award must include an acknowledgment of NIH award support and a disclaimer such as:

Research reported in this publication was supported by the National Heart, Lung, And Blood Institute of the National Institutes of Health under Award Number [insert award number]. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Prior to issuing a press release concerning the outcome of this research, please notify the NIH awarding IC in advance to allow for coordination.

• The NHLBI Catalyze program provides a comprehensive suite of support and services to facilitate the translation of basic scientific discoveries into viable therapeutics, devices, and diagnostics ready for human testing.
• The program has two main goals:
  • To drive development of new potential heart, lung, blood, and sleep (HLBS)-related therapies and cures — including drugs, devices, diagnostics, and biologics — by supporting early product definition studies and safety testing
  • To support development of novel, enabling platform technologies that catalyze next-generation predictive, diagnostic, and therapeutic products. These products will specifically address HLBS-related disorders and diseases.
  • To train a diverse, globally competitive biomedical workforce that is well-versed in scientific research, technology development, and entrepreneurship
• Currently, the Catalyze program supports five funding opportunities, and their funding mechanisms differ in their budget limits, cost sharing expectations, application materials, and project period.
• This funding supports three overall categories of product development and preclinical research:
  • Therapeutics (small molecules and biologics)
  • Devices, diagnostics, and research tools
  • Enabling technologies and transformative platforms

What's new?

Major changes to the Product Definition Notice of Funding Opportunities renewals (issued November 22, 2024)

• Maximum Direct Cost increased for all NOFOs
• All Combination products with a drug component should apply to the therapeutic NOFOs (HL-26-017 (R61/R33) or HL-26-018 (R33))
• In addition to New and Resubmission applications, the R33 NOFOs for Therapeutics (HL-26-018) and Devices (HL-26-020) now accept Renewal applications of Catalyze R33 awards.

Catalyze Funding Opportunities

Currently, there are five funding opportunities: two that target therapeutics (dependent on early or late entry stage of development), two that target devices, diagnostics, and tools (dependent on early or late entry stage of development), and one that targets enabling technologies and transformative platforms. The five funding opportunities are summarized in the table below.

FOA # and Title	Funding Mechanism	Funding Purpose
RFA-HL-26-016 Catalyze: Enabling Technologies and Transformative Platforms for HLBS Research (R33 - Clinical Trials Not Allowed)	R33 (Direct to R33) R33 Exploratory/Developmental Grants Phase II	This NOFO solicits R33 applications where major feasibility gaps for the enabling technology or transformative platform have already been overcome, as demonstrated with supportive preliminary data, but still requires further development and rigorous validation to encourage downstream demonstration, utilization and adoption. Well-suited applications must offer the potential to accelerate and/or transform the areas of early detection and screening, model development, clinical diagnosis, treatment, control, prevention or epidemiology, while addressing issues associated with HLBS-related diseases and disorders. Projects proposing application of existing technologies where the novelty resides in the biological or clinical target/question being pursued are not appropriate for this solicitation. Applications considered nonresponsive to the NOFO will not be reviewed.
RFA-HL-26-017 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)	R61/R33 (Phased Award) R61/R33 Phase 1 Exploratory/Developmental Grant/ Exploratory/Developmental Grants Phase II	This Notice of Funding Opportunity (NOFO) will provide the early stage translational support needed to identify and characterize potential therapeutic candidates (compound and lead series) to treat heart, lung, blood, and sleep (HLBS) diseases and disorders.
RFA-HL-26-018 Catalyze: Product Definition for Small Molecules, Biologics, and Combination Products - Preliminary Product/Lead Series Identification and Combination Product Prototype (R33 - Clinical Trial Not Allowed)	R33 (Direct to R33) R33 Exploratory/Developmental Grants Phase II	This Notice of Funding Opportunity (NOFO) will provide the early stage translational support needed to identify a lead compound series toward development of potential therapeutic agents to treat heart, lung, blood, and sleep (HLBS) diseases and disorders.
RFA-HL-26-019 Catalyze: Product Definition – Medical Device prototype design/testing and disease target identification and assay development (R61/R33 - Clinical Trial Not Allowed)	R61/R33 (Phased Award) R61/R33 Phase 1 Exploratory/Developmental Grant/ Exploratory/Developmental Grants Phase II	This Notice of Funding Opportunity (NOFO) will provide the early stage translational support needed to develop and test device prototype designs, identify diagnostic disease targets and develop associated assays, and develop research tools for use in the treatment of heart, lung, blood and sleep (HLBS) diseases and disorders.
RFA-HL-26-020 Catalyze: Product Definition – Medical Device Prototype Optimization (R33 - Clinical Trial Not Allowed)	R33 (Direct to R33) R33 Exploratory/Developmental Grants Phase II	This Notice of Funding Opportunity (NOFO) will provide the early stage translational support needed for prototype testing/design modification, assay development for diagnostic disease targets, and development of research tools for use in the treatment of heart, lung, blood, and sleep (HLBS) diseases and disorders.

Catalyze Key Dates to Remember

Application Due Dates			Review and Award Cycles
New	Renewal / Resubmission / Revision (as allowed)	AIDS	Scientific Merit Review	Advisory Council Review	Earliest Start Date
February 11, 2025	February 11, 2025	April 21, 2025	July 1, 2025	October 1, 2025	December 1, 2025
June 18, 2025	June 18, 2025	August 21, 2025	November 1, 2025	January 1, 2026	April 1, 2026
October 21, 2025	October 21, 2025	December 22, 2025	March 1, 2026	May 1, 2026	July 1, 2026
February 11, 2026	February 11, 2026	April 21, 2026	July 1, 2026	October 1, 2026	December 1, 2026
June 18, 2026	June 18, 2026	August 21, 2026	November 1, 2026	January 1, 2027	April 1, 2027
October 21, 2026	October 21, 2026	December 23, 2026	March 1, 2027	May 1, 2027	July 1, 2027
February 11, 2027	February 11, 2027	April 23, 2027	July 1, 2027	October 1, 2027	December 1, 2027
June 17, 2027	June 17, 2027	August 23, 2027	November 1, 2027	January 1, 2028	April 1, 2028
October 21, 2027	October 21, 2027	December 23, 2027	March 1, 2028	May 1, 2028	July 1, 2028

Phased Awards (R61/R33) and Direct to R33

Catalyze funding mechanism requirements (budget limits, cost sharing, Accelerator Partnerships, etc.) differ according to the type of technology under development, the stage of development, and the duration of the project. For therapeutic and device/diagnostic/tool development, both phased (R61/R33) and R33 awards are available. Researchers with projects that are earlier in development may apply for phased awards, while those with more advanced projects may apply directly for an R33 opportunity. In a phased award, transition from the R61 phase to the R33 phase is based on successful completion of the R61 phase and meeting additional R33 requirements.

This table summarizes the differences between the funding mechanisms:

FOA #	RFA-HL-26-016	RFA-HL-26-017	RFA-HL-26-018	RFA-HL-26-019	RFA-HL-26-020
Technology Type	Enabling Technologies & Transformative Platforms	Therapeutics	Therapeutics	Devices/Diagnostics/Tools	Devices/Diagnostics/Tools
FOA Name	Catalyze: Enabling Technologies and Transformative Platforms for HLBS Research	Catalyze: Product Definition for Small Molecules, Biologics and Combination Products - Target Identification and Validation, and Preliminary Product/Lead Series Identification	Catalyze: Product Definition for Small Molecules, Biologics, and Combination Products - Preliminary Product/Lead Series Identification and Combination Product Prototype	Catalyze: Product Definition – Medical Device prototype design/testing and disease target identification and assay development	Catalyze: Product Definition – Medical Device Prototype Optimization
	(R33 - Clinical Trials Not Allowed)	(R61/R33 – Clinical Trials Not Allowed)	(R33 - Clinical Trial Not Allowed)	(R61/R33 - Clinical Trial Not Allowed)	(R33 - Clinical Trial Not Allowed)
Budget amounts	Application budgets must not exceed $350,000 direct costs per year.	Application budgets must not exceed direct costs of $400,000 per year during the R61 phase and also must not exceed direct costs of $400,000 per year during the R33 phase. The total budget (Federal award and non-Federal matching contributions) should reflect the actual needs of the overall proposed project. Annual project budgets should reflect the actual costs anticipated in each year.	Application budgets must not exceed direct costs of $400,000 per year. The total budget (Federal award and non-Federal matching contributions) should reflect the actual needs of the overall proposed project. Annual project budgets should reflect the actual costs anticipated in each year.	Application budgets must not exceed direct costs of $300,000 per year during the R61 phase and also must not exceed direct costs of $300,000 per year during the R33 phase. The total budget (Federal award and non-Federal matching contributions) should reflect the actual needs of the overall proposed project. Annual project budgets should reflect the actual costs anticipated in each year.	Application budgets must not exceed direct costs of $300,000 per year. The total budget (Federal award and non-Federal matching contributions) should reflect the actual needs of the overall proposed project. Annual project budgets should reflect the actual costs anticipated in each year.
Cost sharing expectations	No cost sharing required	For the R33 portion of this award, the recipient is expected to provide at least a 0.25:1 non-Federal match of the Federal direct costs requested.	The recipient is expected to provide at least a 0.25:1 non-Federal match of the Federal direct costs requested.	For the R33 portion of this award, the recipient is expected to provide at least a 0.25:1 non-Federal match of the Federal direct costs requested.	The recipient is expected to provide at least a 0.25:1 non-Federal match of the Federal direct costs requested.
Letter of support for cost sharing funds	No cost sharing required	Required to transition from R61 to R33 phase	Required at time of application	Required to transition from R61 to R33	Required at time of application
Special Requirements	Requires a separate attachment that describes the milestones, timeline and project management plan. In addition, within the Research Section applicants are required to include a subsection to describe performance measures.		Requires a separate attachment that describes the milestones, timeline and project management plan. In addition, within the Research Section applicants are required to include a subsection to describe performance measures.		Requires a separate attachment that describes the milestones, timeline and project management plan. In addition, within the Research Section applicants are required to include a subsection to describe performance measures.

Letter of Intent

• Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information it contains allows Institutes and Center (IC) staff to estimate the potential review workload and plan the review.
• Part 1. Overview Information provides the due date for the letter of intent. Prospective applicants should include the following information in the letter:
  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity
• The letter of intent should be sent to:
  • Director, Office of Scientific Review
    National Heart, Lung, and Blood Institute
    Email: NHLBIChiefReviewBranch@nhlbi.nih.gov

R61/R33 Transition for development of therapeutics (RFA-HL-26-017) and devices/diagnostics/tools (RFA-HL-26-019)

• For phased awards, evidence of the cost match and identification of the Accelerator Partner is not required for the initial application.
• To transition from the R61 to R33 phase, awardees must do the following:
  • Achieve acceptable progress toward milestones.
  • Demonstrate the ability to secure third-party investment by providing evidence of non-federal cost match by inclusion of a letter of support addressed to NIH.
  • Provide a letter of support as evidence that an Accelerator Partner has been identified.
• Expectations for phased awards (RFA-HL-26-017 and RFA-HL-26-019)
  • Proof of matching funds is not required at the time of initial application and activation of the R61 phase of these awards.
  • As the R61 phase nears its end, evidence of non-Federal matching funds must be provided to NIH in the form of a letter of support prior to the meeting of the NHLBI committee that makes the advancement decisions. NHLBI recommends a minimum of a 0.25:1 non-Federal cost match of the Federal direct costs.
  • To be considered responsive to these FOAs, applicants are expected to include a description in the Budget Justification of how the matching funds will be used for the R33 phase of the award. Evidence of the cost match is expected prior to release of R33 federal funds.
  • The Enabling Technologies and Transformative Platforms for HLBS research RFA (RFA-HL-26-016) does not have a cost sharing component.
• Progress and achievement of these requirements will be evaluated by an NHLBI committee tasked with making advancement decisions.

Cost Matching Component

• Expectations for the non-phased R33 awards for therapeutics (RFA-HL-26-018) and device / diagnostics/tools (RFA-HL-26-020)
  • The non-phased applications must include a letter of support from the non-Federal source(s) of cost matching. Applications that do not include this letter will be considered nonresponsive and will not be peer reviewed.
  • Evidence of the cost match equivalent to at least 25% of the direct federal costs of the award is required prior to release of R33 federal funds. This requirement is not negotiable.
  • The Enabling Technologies and Transformative Platforms for HLBS Research RFA (RFA-HL-26-016) does not have a cost sharing component.
• Cost Matching Component Requirements
  • Sources of non-federal funding could include, but are not necessarily limited to, foundations, participating institutions, a state or local governmental body, angel investors, venture capital firms, individual benefactors, or any combination of the above.
  • In-kind contributions are encouraged, but do NOT apply to the cost matching requirements. Institutions must be able to document their actual contributions to the project and provide assurances that the organization(s) are committed to providing the funds and resources for their share of the project.
  • It is acceptable for an Accelerator Partner to provide cost matching funds for the R33 stage, but it is not required.
  • Federal funds may NOT be used as a source of cost sharing.
  • Generally, cost share requirements may NOT be met from the following sources:
    • Costs borne by another Federal grant or sub award
    • Costs or contributions toward cost sharing on another Federal grant, a Federal procurement contract, or any other award of Federal funds
    • Cost of services or property financed by income earned by contractors under a contract from the recipient (or sub recipient)
    • Program income
    • Patient incentives

Intellectual Property (IP) or Regulatory Strategy Requirements

• Applicants are required to submit their IP and regulatory strategies in their applications. Projects that are appropriate for these FOAs must be at the stage of development where IP and regulatory strategies are being considered. For phased awards, continued development of IP and regulatory strategies will be required and considered for a transition from the R61 phase to the R33 phase of the award.
• While IP and regulatory strategy are not required for the Enabling Technologies and Transformative Platforms funding opportunity (RFA-HL-26-016), funded awardees will be expected to develop IP and regulatory strategy as the technology develops.

Accelerator Partners

Accelerator Partner Definition

• Accelerator Partners are commercialization experts working as development partners with innovators whose projects are funded through the Catalyze program. Accelerator Partners help innovator-researchers achieve the necessary multidisciplinary approach for developing technologies. Accelerator Partners provide skills development and mentoring to enable innovator-researchers to assess the medical and commercial potential of their projects. They also help advance the proposed projects to a stage suitable to continue product development in the private sector or to apply for support through the NHLBI Catalyze Preclinical or other translational programs.
• Accelerator Partners do this by connecting innovator-researchers with people such as:
  • experienced entrepreneurs and scientists, including those who can facilitate interactions with businesses, industries, sources of private capital, and research-performing institutions,
  • potential licensing and commercialization partners who can offer advice soon after the researcher gets an award,
  • ecosystem partners, such as those from biotechnology or pharmaceutical companies, who are knowledgeable about the process for developing therapeutics, devices, and diagnostics,
  • experts such as clinicians and biostatisticians who are familiar with how the desired product should look to meet vested shared interests,
  • potential partners who have complementary development expertise and resources for successful project development.

Accelerator Partners Expectations

• Accelerator partners are encouraged to provide access to expertise and mentoring related to: product development stages, business development and commercialization strategy, market analysis, preparation of regulatory submissions, intellectual property protection, and reimbursement strategy. Awardees are highly encouraged to use Accelerator Partners for this kind of career development, as these experts can facilitate exposure to the myriad processes required to translate discoveries into therapies.
• Applicants are expected to consider how they will identify and foster relationships with Accelerator Partners. At least one Accelerator Partner is required for the R33 portion of the phased awards and the R33 only awards. An Accelerator Partner is not required for RFA-HL-26-016.
• For phased awards, awardees will be expected to search for an Accelerator Partner early in the R61 phase. For phased awards, proof of an Accelerator partner is not required at the time of application; however, evidence that an Accelerator Partner has been identified must be provided to NIH in the form of a letter of support prior to the meeting of the NHLBI committee that will decide whether an awardee will transition from the R61 to the R33 award. Transition from R61 to R33 is contingent on procurement of an Accelerator.

Milestones

Milestone Definition

• Milestones are an event or moment in time in a project that indicates progress toward a Specific Aim has been made or that a Specific Aim has been completed. The project Specific Aims and milestones should be laid out as a timeline or GANTT chart as a part of the application. Specific Aims or a list of activities planned for each year are not considered milestones because they do not provide decision-making goals. Applicants are expected to propose activities and milestones, with an associated timeline, to be completed during the proposed duration of award. Successful awardees will develop specific, measurable, achievable, relevant, and time-bound Specific Aims for their project. Each Specific Aim should have at least one milestone associated with it.

Milestone Requirements

• Milestones will be peer reviewed as well as programmatically reviewed and if needed will be negotiated with the awardee before they are included in the terms of the award. NHLBI staff will monitor program progress against proposed milestones through quarterly meetings and make non-competing award decisions annually based on achieving milestones. NHLBI emphasizes the importance of the robustness and reproducibility of experimental results in evaluating progress.
• Milestones are required for all RFAs (RFA-HL-26-016, 017, 018, 019, and 020).
• Phased awards (RFA-HL-26-017 and RFA-HL-26-019). To be responsive to this FOA, applicants must meet the entry criteria to be eligible for the award and propose two separate sets of clear, quantifiable milestones with timelines (one set each for the R61 and R33 phases) to be completed sequentially within a three-year period, but with no more than two years in either stage.
• Milestones for the R61 and R33 activities must be submitted at the time of application and will be reviewed simultaneously; however, receipt of funding for the R33 component of phased awards is contingent on achieving pre-specified milestones during the R61 component. Completion of milestones will ensure sufficient progress during the R61 phase to provide the feasibility and scientific rationale to conduct the product definition activities proposed in the R33.
• Non-phased R33 awards (RFA-HL-26-016, RFA-HL-26-018 and RFA-HL-26-020). To be considered responsive to the FOA, applicants must meet the entry criteria to be eligible for the award and propose milestones to be completed during the duration of award. These milestones will ensure that projects are sufficiently progressing to be in a position to for further development, including entering into preclinical programs following completion of the award.
• Milestones must be identified in the application and may be negotiated, pre-award, by the NHLBI team based on comments from the peer review panel. NHLBI emphasizes the importance of the robustness and reproducibility of experimental results in evaluating progress. For the phased awards, investigators must exhibit successful completion of milestones for consideration of transition to the R33 phase.

Project Management

• Each project is expected to use a robust, milestone-driven project management processes that make it possible to assess progress on a continuous basis, relative to established milestones. Applicants should describe their project management strategies and name the individual(s) who will be responsible for implementing them. For more information about developing project management strategies prior to application submission, please contact the NHLBI Catalyze team at catalyze_info@rti.org.

Please navigate to the NIH RePORTER links below to see funded projects for each FOA #:

FOA #	Title
RFA-HL-26-016 RFA-HL-23-010 RFA-HL-20-022	Enabling Technologies and Transformative Platforms
RFA-HL-26-017 RFA-HL-23-011 RFA-HL-20-023	Product Definition - Small Molecule and Biologic Target Identification and Validation, Assay Development, and Screening
RFA-HL-26-018 RFA-HL-23-012 RFA-HL-20-027	Product Definition - Small Molecule and Biologic Lead Series Preliminary Product/Lead Series Identification
RFA-HL-26-019 RFA-HL-23-013 RFA-HL-20-024	Product Definition - Device Prototype Design/Testing and Diagnostic Disease Target Identification and Assay Development, Research Tool Development
RFA-HL-26-020 RFA-HL-23-024 RFA-HL-20-028	Product Definition - Device prototype testing and Diagnostic disease assay development, and Research Tool Development

To apply, an applicant can complete an Expression of Interest (EOI) form, which is subsequently reviewed by the NHLBI. If selected, applicants are invited to complete a full online application through a secure Catalyze website. Full applications have an open period of ~4 weeks for applicants to submit their requested services.

Applications are completed through an online portal. Applicants are encouraged to utilize the PDF / Word copy of the Catalyze Application to gather information needed for submission. The applicant may draft responses on the Word version and use it as a template to copy/paste into the Catalyze website. The application can take between 4-6 hours to complete. After the submission period ends, the Catalyze Coordinating Center (RTI) may contact the applicant by email if there are questions about the application. Applicants will be notified of the final decision by email within 6 months.

The application should demonstrate an understanding of the necessary steps to advance the technology from its current stage to FDA clearance, as well as the steps to advance from FDA clearance to commercialization. If the goal is market approval, applicants may request several services but in general, the program does not support projects above $1,000,000/year. NHLBI may work with applicants to adjust which services can be supported by Catalyze. Other funding sources may be required.

While the Catalyze program does not enforce a fixed budget cap on applications, in general the program does not support projects above $1,000,000/year, however this can vary depending on product type (e.g., biologics, cell therapy, gene therapy).

For more information about applying for preclinical services, please visit the Preclinical Services page.

Applicants can request a range of preclinical services including preclinical efficacy studies, dose range finding studies (i.e., early toxicology studies), GLP toxicology studies, or in vivo animal studies for devices.

Applicants can also request services for manufacturing.

Please note that the Catalyze Preclinical Services Program will not support any GLP/GMP requests before a pre-IND meeting. The applicant may request regulatory support for a pre-IND meeting.

Clinical trials are not supported by Catalyze Preclinical Services.

Within 4-6 weeks of submitting an EOI, applicants will receive notification of rejection or an invitation to submit a full application.

Future submission dates for EOIs are not yet determined but will be announced and posted on the website when finalized. A downloadable version of the EOI and full application are accessible on the Preclinical Services Program page. NHLBI anticipates 1-2 submission cycles for fiscal years 2023 and 2024.

Funds will not be awarded to the applicant.

Accurate CRO/CMO quotes must be provided with the preclinical application. If accurate CRO/CMO quotes are not provided, the application will be noted as "unresponsive" and will not go out for peer review.

The Catalyze Coordinating Center (RTI) will manage the services and work with the investigators to ensure that tasks are being completed correctly at the CROs/CMOs. The Catalyze Coordinating Center (RTI) will select CROs/CMOs that will provide preclinical services.

Additional commercialization milestones will be required of the investigator.

List of potential studies/information to share with Vendors in the Preclinical Phase
Investigators are not expected to have all this information.

Drug substance information

• Starting material quality (quality e.g. USP, endotoxin-free)
• Route of synthesis/manufacture
• In-process controls
• Procedures (precursor to SOPs)
• Analysis Methods (also used for Stability Testing)
• Purity
• Stability Data
• Stability Plan

Drug Product

• Formulation (solubility, pH, osmolality, etc.)
• Stability
• Stability Plans
• Test Methods
• Sterility
• Quantitative Assay
• Potency Assay

Pharmacology assays

• Primary pharmacology
• Formulation used
• Secondary pharmacology

ADME including in vitro studies

• Safety/Tox studies in vitro and in vivo
• Dose range finding on early formulations
• Therapeutic index (narrow or broad)
• Formulation, route of administration

Any special tox testing (SC, IM, inhalation, ADA, anaphylaxis, hemolysis)

While not a requirement, applicants are encouraged to have an accelerator partner. NHLBI expects applicants to pursue fundraising to increase the likelihood that the technologies will advance to the marketplace.

Small businesses may seek support from the SBIR Program NHLBI Small Business Program | NHLBI, NIH.

Either academic PIs or accelerator partners may apply, but the applicant must ensure the support of a specific suitable development team to support the technology.

Accelerator Partner Definition

• Accelerator Partners are commercialization experts working as development partners with innovators whose projects are funded through the Catalyze program. Accelerator Partners help innovator-researchers achieve the necessary multidisciplinary approach for developing technologies. Accelerator Partners provide skills development and mentoring to enable innovator-researchers to assess the medical and commercial potential of their projects. They also help advance the proposed projects to a stage suitable to continue product development in the private sector or to apply for support through the NHLBI Catalyze Preclinical or other translational programs.
• Accelerator Partners do this by connecting innovator-researchers with people such as:
  • experienced entrepreneurs and scientists, including those who can facilitate interactions with businesses, industries, sources of private capital, and research-performing institutions
  • potential licensing and commercialization partners who can offer advice soon after the researcher gets an award
  • ecosystem partners, such as those from biotechnology or pharmaceutical companies, who are knowledgeable about the process for developing therapeutics, devices, and diagnostics
  • experts such as clinicians and biostatisticians who are familiar with how the desired product should look to meet vested shared interests
  • potential partners who have complementary development expertise and resources for successful project development

Accelerator Partners Expectations

• Accelerator partners are encouraged to provide access to expertise and mentoring related to: product development stages, business development and commercialization strategy, market analysis, preparation of regulatory submissions, intellectual property protection, and reimbursement strategy. Awardees are highly encouraged to use Accelerator Partners for this kind of career development, as these experts can facilitate exposure to the myriad processes required to translate discoveries into therapies.
• Applicants are expected to consider how they will identify and foster relationships with Accelerator Partners. At least one Accelerator Partner is required for the R33 portion of the phased awards and the R33 only awards. An Accelerator Partner is not required for RFA-HL-23-010.
• For phased awards, awardees will be expected to search for an Accelerator Partner early in the R61 phase. For phased awards, proof of an Accelerator partner is not required at the time of application; however, evidence that an Accelerator Partner has been identified must be provided to NIH in the form of a letter of support prior to the meeting of the NHLBI committee that will decide whether an awardee will transition from the R61 to the R33 award. Transition from R61 to R33 is contingent on procurement of an Accelerator.

Contract Research Organization (CRO) / Contract Manufacturing Organization (CMO) Quotes

• Applicants are expected to provide cost estimates for services requested from the Catalyze Program as part of their full application. It is recommended that quotes are requested from CROs/CMOs shortly after EOI submission.
• Following selection, the Catalyze Coordinating Center (RTI) will verify cost estimates and qualify the CRO/CMOs prior to the initiation of the studies. The Catalyze Coordinating Center (RTI) may obtain additional bids for comparison to identify the most appropriate vendor. These bids will be obtained from vendors in compliance with federal procurement regulations.
• If an applicant has been accepted into the program and previously worked with a CRO/CMO, it may be more cost/time efficient to continue working with that vendor although other vendor estimates may be obtained by the Catalyze Coordinating Center (RTI) for comparison.
• The Catalyze Coordinating Center (RTI) will perform a qualification for all vendors to ensure that the vendor meets the appropriate requirements and has experience providing reports and documentation sufficient for regulatory submission.
• CROs/CMOs located outside of the US will need to comply with U.S. State Department regulations as well as NIH policies. Please note, the use of international vendors will require additional clearance from the State Department and may delay the start of Catalyze services.
• Services provided by CROs can range from preclinical efficacy studies, non-GLP dose range finding studies, GLP toxicology studies, or in vivo animal studies for devices. Please note that the Catalyze Preclinical Services Program will not support any GLP/GMP requests before a meeting with FDA. The applicant may request regulatory support for a pre-IND/pre-Sub meeting.
• The Catalyze Coordinating Center (RTI) has expertise in toxicology, manufacturing, and regulatory strategy/regulatory submissions and will share Request for Proposal (RFP) templates that investigators can use to request quotes from CROs and CMOs.
• Applicants are welcome to contact NHLBI_catalyze@mail.nih.gov to request assistance identifying potential CROs or CMOs.
• If a technology already has a non-exclusive license executed with a CRO, please email NHLBI_catalyze@mail.nih.gov to initiate a discussion.