Preclinical Services Program

The Catalyze Program initiatives support product development, including product definition small molecules, biologics, devices, diagnostics and enabling technologies and transformative platforms through five grant funding opportunities.

Catalyze preclinical services support preclinical development activities from end-stage proof-of-concept, through preclinical development and US regulatory approval. Applicants request specific services to advance their technology. Applications are sent to external reviewers for evaluation and if a project is selected for support, the level of support and services is negotiated between the PI and NHLBI.

Applicants interested in both preclinical and regulatory services should submit a single preclinical application, which allows an applicant to request both preclinical and regulatory services. Applicants only interested in regulatory services should submit a regulatory only application.

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.

What support is covered?

Preclinical services support can include:

  • Animal studies (efficacy, PK, toxicology studies)
  • Chemistry, manufacturing and controls (CMC) activities (non-GMP and GMP)
  • Device and Diagnostics (prototype development and validation, class determination, scale manufacturing, 510K process)
  • Regulatory support (regulatory submissions and FDA meetings)

Informational Webinar

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How do I apply?

Step 1

All applicants must submit an expression of interest form (EOI).

The recent EOI submission period ended on October 6, 2024. Please check back for future application submission periods.
Contact us to request more information

You may download a preview of the EOI form:
Download EOI form

Step 2

Selected EOI applicants will be invited to submit a full application.

Application guidelines:

  1. The application may take 4-6 hours to complete.
  2. Applications with Contract Research Organization (CRO)/Contract Manufacturing Organization (CMO) quotes will be stronger, and it is recommended to initiate the process shortly after EOI submission.
  3. We encourage you to utilize the PDF copy of the Catalyze Application to gather information needed for submission. You may draft your response and copy/paste into the Catalyze website.
  4. 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).
  5. The Catalyze program will not support any GLP/GMP requests before a pre-submission meeting. You may request regulatory support for an FDA meeting.
  6. Please note that Catalyze Preclinical Services will be provided by CROs/CMOs and managed by RTI International (Catalyze Coordinating Center). The funds will not be given directly to applicants.
  7. The Catalyze Coordinating Center will contact you by email if there are questions about your application.
  8. Applicants will be notified of the final decision by email within 4-6 months.

You may download a preview of the application form:
Download application form (PDF) Download application form (Word)

Step 3

If approved for Preclinical Services, a requirement of the program is to complete Business Development milestones, which will be negotiated by NHLBI with the PI during the first quarter of preclinical support, and PIs will be expected to complete those milestones. One or more milestones may be required, including, but not limited to the following:

  1. Engaging with potential partners
  2. Attending n number of conferences/competing in n pitch events
  3. Applying to additional funding opportunities
  4. Discreet goals for end-user engagement (i.e., conduct n interviews across n stakeholder types)
  5. Performing a competitive analysis and further refining value proposition and competitive advantages
  6. Developing a business model canvas
  7. Developing a commercialization plan
  8. Mapping out funding needed for commercialization
  9. Market sizing to understand revenue, understanding potential market opportunity

What can I do now to prepare?

  • Prepare the key information needed for completion of the application:
    • Project plan with key milestones and goals to be achieved at the completion of the project.
    • The competitive landscape for the proposed technology and the market size
    • The regulatory and reimbursement strategy for your product
  • Obtain at least one quote from US-based vendors (CROs, CMOs) within the past 3 months
  • Prepare an investor pitch deck
  • Identify an accelerator partner
  • Demonstrate access to non-federal funds or obtain letters of support for non-federal matching funds

Frequently Asked Questions

Please visit the Preclinical section of our FAQ:

Preclinical Services FAQ