Frequently Asked Questions


FAQ pages are for informational purposes only and FOA language supersedes any content included herein.

Webinars

January 26, 2021

Product Definition Informational Webinar

General Information

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 requirements, application materials, and project periods.

Catalyze has a coordinated and comprehensive array of activities and support services which are personalized to meet participants’ individual needs. The Catalyze Coordinating Center works with investigators to develop individualized milestone-driven pathways to success

In addition to funding opportunities, Catalyze has a network of experts who share best practices, provide technical assistance, offer advisory services, and conduct entrepreneurial education and training. The Catalyze network includes experts in regulation, product development, toxicology, marketing, commercialization, and many other areas that help bring products to market. The program also creates opportunities for cohort-based learning so participants can benefit from the experiences of other participants.

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
This is a visual depiction of an overview of the Catalyze Program.  The image shows five boxes feeding into a box labeled Catalyze Program below. The first box is titled 'Funding' and says 'Leverages federal investment with matching commitments and flexibility to adjust to challenges'.  The second box is titled 'Coordinated Approach' and says 'Continuum of programs to advance research from validation to first-in-human trials'.  The third box is titled 'Individualized Support' and says 'Milestone-driven project management and support'.  The fourth box is titled 'Program Flexibility' and says 'Ability to adjust the program as needed and to share best practices'.  The fifth box is titled 'Network of Experts' and lists 'Access to key technical experts, Advisory services from NIH and mentoring network, Entrepreneurial education and training, and Cohort-based learning'. The five boxes feed into a final overarching box titled 'Catalyze Program' that says 'Provides a bridge from basic to clinical research across the entire Heart, Lung, Blood, and Sleep research spectrum/Trains a scientific workforce in product development and entrepreneurship'

This is a visual depiction of the early translational research supported by the Catalyze Program.

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-20-023

Product Definition- Small Molecule and Biologic Target Identification and Validation, Assay Development, and Screening

R61/R33

phased award

To identify, validate, and screen compounds of interest and to identify a lead compound series to move into preclinical testing for optimization, safety, and efficacy

RFA-HL-20-027

Product Definition - Small Molecule and Biologic Lead Series Preliminary Product/Lead Series Identification

R33

(Direct to R33)

To develop and move a lead compound series forward to preclinical testing

For projects that have already identified, validated and screened compounds of interest and are therefore far enough along in development to skip R61 stage

RFA-HL-20-024

Product Definition - Device Prototype Design/Testing and Diagnostic Disease Target Identification and Assay Development, Research Tool Development

R61/R33

phased award

For initial development of prototypes through testing, identifying diagnostic disease targets and developing associated assays, and developing research tools

RFA-HL-20-028

Product Definition - Device prototype testing and Diagnostic disease assay development, and Research Tool Development

R33

(Direct to R33)

To develop and test existing device prototypes, explore assay components for diagnostics validation, and develop research tools

For projects that have already identified and tested initial prototype designs, that have identified a disease target and generated experimental design, or that identified, tested and piloted research tools, and are therefore far enough along in development to skip R61 stage

RFA-HL-20-022

Enabling Technologies and Transformative Platforms

R33

(Direct to R33)

To develop enabling technologies and transformative platforms to catalyze next-generation predictive, diagnostic, and therapeutic products.

applications must offer the potential for projects to accelerate progress and/or transform current protocol in the areas of early detection and screening, model development, clinical diagnosis, treatment, control, prevention, or epidemiology

Applications for non-AIDS related applications are due on July 9, 2021. AIDS-related applications are due on August 11, 2021. The earliest start date for both AIDS and non-AIDS related funding opportunities is April 2022.

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-20-23

RFA-HL-20-027

RFA-HL-20-24

RFA-HL-20-028

RFA-HL-20-22

Technology Type

Therapeutics

Therapeutics

Devices/Diagnostics/Tools

Devices/Diagnostics/Tools

Enabling Technologies & Transformative Platforms

FOA Name

Product Definition for Small Molecules and Biologics - Target Identification and Validation, and Preliminary Product/Lead Series Identification (R61/R33 – Clinical Trials Not Allowed)

Product Definition for Small Molecules and Biologics - Preliminary Product/Lead Series Identification (R33 - Clinical Trial Not Allowed)

Product Definition – Device Prototype Design and Testing, Diagnostic Disease Target Identification and Assay Development, and Research Tool Development (R61/R33

Clinical Trial Not Allowed)

Product Definition – Device Prototype Testing and Design Modification, Diagnostic Disease Target Assay Development and Design Characterization, and Research Tool Testing and

Validation (R33 - Clinical Trials Not Allowed)

Enabling Technologies and Transformative Platforms for HLBS Research (R33 - Clinical Trials Not Allowed)

Budget amounts

Maximum direct costs of $350,000 per year in either the R61 or R33 phase

Maximum direct costs of $350,000 per year

Maximum direct costs of $250,000 per year in either the R61 or R33 phase

Maximum direct costs of $250,000 per year.

Maximum direct costs of $300,000 per year

Cost sharing requirements

For the R33 portion ONLY: minimum 0.25:1 non-federal cash match of the federal direct costs

Minimum of 0.25:1 non-federal cash match of the federal direct costs

For the R33 portion ONLY: minimum 0.25:1 non-federal cash match of the federal direct costs

Minimum of 0.25:1 non-federal cash match of the federal direct costs

No cost sharing required

Letter of support for cost sharing funds

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

No cost sharing required

Project period

Maximum combined R61 and R33: 3 years

Up to 2 years in either R61 or R33 allowed

R61 and R33 awards not allowed in same fiscal year

Maximum: 2 years

Maximum combined R61 and R33: 3 years

Up to 2 years in either R61 or R33 allowed

R61 and R33 awards not allowed in same fiscal year

Maximum: 2 years

Maximum: 2 years

Letter of support from Accelerator Partner

Required to transition from R61 to R33

Required at time of application

Required to transition from R61 to R33

Required at time of application

Not required

To transition from the R61 to R33 phase, awardees must do the following:

Progress and achievement of these requirements will be evaluated by an NHLBI committee tasked with making advancement decisions.

For phased awards, evidence of having secured the cash match and the Accelerator Partner is not required at the time of application, but will be needed at the time of R61 milestone review to transition to an R33 award.

Matching Funds

Proof of matching funds is not required at the time of application and onset of the R61 phase of these awards, but will be required as part of the transition process to the R33 award. As the R61 phase nears its end, evidence of 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. 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 cash match 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-20-022) does not have a cost sharing component.

The non-phased applications must include a letter of support from the non-federal source(s) of cash matching. Applications that do not include this letter will be considered unresponsive and will not be peer reviewed. Evidence of the cash match 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-20-022) does not have a cost sharing component.

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 cash matching requirements and do not need to be reported to the NIH. 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.

Federal funds may NOT be used as a source of matching funds.

Generally, cost matching 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

Accelerator Partners

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 may 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 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-20-022.

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 Partner. For R33 only awards, the Accelerator Partner must be identified at the time of application.

Yes. It is acceptable for an Accelerator Partner to provide cash matching funds for the R33 stage, but it is not required.

Milestones

Milestones are goals that are clear and quantifiable for measuring success that can be used for go/no-go decision making and have timelines and quantitative criteria associated with them. All milestones should be useful as a measure of progress toward the overall goal of the project. Milestones must be identified in the application, and based on comments of the peer review panel, they may be negotiated pre-award by the NHLBI team. NHLBI staff will meet annually to monitor progress against proposed milestones and make non-competing award decisions.

Specific aims or a list of activities planned for each year are not considered milestones because they are not always measurable and do not provide decision-making goals.

Milestones are required for all RFAs (RFA-HL-20-023, 024, 027, and 028) except the Enabling Technologies and Transformative Platforms for HLBS Research (RFA-HL-20-022) RFA.

Phased awards (RFA-HL-20-023 and RFA-HL-20-024). 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-20-027 and RFA-HL-20-028). 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.

Intellectual Property, Regulatory and Project Management Requirement

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.

No IP or regulatory strategy requirements are required for the Enabling Technologies and Transformative Platforms funding opportunity (RFA-HL-20-022).

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.

Project management processes are not required for the Enabling Technologies and Transformative Platforms funding opportunity (RFA-HL-20-022).

The Enabling Technologies and Transformative Platforms funding opportunity has a funding mechanism similar to more traditional ones and does not require cost sharing, formal project management, IP and regulatory strategies, milestones, or accelerator partnering.

FAQ pages are for informational purposes only and FOA language supersedes any content included herein.