The Catalyze Preclinical Services Program focuses on services not typically part of R33 activities in the companion Catalyze Product Definition awards. The Catalyze Preclinical Services Program supports activities after end-stage proof-of-concept through preclinical development and US regulatory approval. Preclinical services support can include animal studies (efficacy, pharmacokinetic, toxicology), GMP/non-GMP chemistry, manufacturing, and controls (CMC) activities, and regulatory support (regulatory submissions and FDA meetings). A pre-recorded webinar including more information is available for interested applicants here.

Online Expression of Interest (EOI) submissions will open on October 30, 2023, and close on November 17, 2023. Within 4 weeks of the end of the EOI application period, applicants will receive notification of nonacceptance or an invitation to submit a full application. External and programmatic review of full applications will be complete within 3 months.

Applicants must be US-based, and the technology must support NHLBI indications. Applicants will need to prepare a project plan with key milestones, describe the marketing strategy for the proposed technology, and provide a regulatory and reimbursement strategy for the product. Additionally, applicants will be asked to obtain a quote from at least one US-based vendor (CRO or CMO) for each service requested, prepare an investor pitch deck, identify an accelerator partner, and demonstrate access to non-federal matching funds.