NHLBI’s Catalyze 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.

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?

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