NHLBI Catalyze Preclinical Services Program Application

NHLBI Catalyze Preclinical Services Program Application

17nov11:59 pmNHLBI Catalyze Preclinical Services Program Application

Event Details

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.


(Friday) 11:59 pm(GMT-05:00)