Preclinical Services Program

NHLBI's Catalyze Preclinical Services Program has launched!

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)
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

The February Catalyze Webinar was held on February 22nd at 12:00 PM ET and featured Catalyze Scientific Director, Dr. Mike Pieck, announcing and describing a new suite of support services offered by the Catalyze Program.

In this presentation, Dr. Pieck will explain what the program seeks to accomplish in providing preclinical services, along with details of the application process.

Download slides

In this presentation, Dr. Pieck explained what the program seeks to accomplish in providing preclinical services, along with details of the application process.

How do I apply?

Step 1

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

The recent EOI submission period ended on March 17th, 2023.
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.

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