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NHLBI’s Catalyze Preclinical Services Program

March 17, 2023

NHLBI Catalyze logo

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.

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) and chemistry, manufacturing and controls (CMC) activities (non-GMP and GMP) and regulatory support (regulatory submissions and FDA meetings).

How do I apply?

Step 1

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

The current EOI submission period ends March 17, 2023.

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.
You may download a preview of the application form: Download application form

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

Details

Date:
March 17, 2023
Event Category:
Event Tags:
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Website:
https://nhlbicatalyze.org/preclinical

Venue

Online

Organizer

NHLBI Catalyze
View Organizer Website

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