GLP Embryo-fetal Development (EFD) Toxicity Study in Pregnant Rats for a Malaria Therapeutics Candidate
Past New Requirement Updated
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $700,000 to $1,500,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Points of contact
-
- Miranda Adams miranda.adams@nih.gov (240) 669-5344
- Catherine Bigger catherine.bigger@nih.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The National Institutes of Health is forecasting a new requirement for a Good Laboratory Practice embryo-fetal development toxicity study in pregnant rats for a malaria therapeutics candidate, with an estimated solicitation release date and estimated award date of June 1, 2026. The study performs in vivo preclinical safety, toxicity, and pharmacokinetic work under 21 CFR part 58 to meet FDA reproductive and juvenile toxicity profiling requirements under guidance S5(R3) before Phase 3 clinical studies. The oral candidate is co-administered with tafenoquine for P. vivax malaria and combined with suitable drugs for P. falciparum malaria, and the agency expressed the need for this study at the Phase 1 FDA meeting. The forecast uses no set-aside and falls under NAICS 541715.
The estimated award value range is $700,000 to $1.5 million. Miranda Adams, Contracting Officer in Legal - Contracts at the National Institutes of Health, is the primary point of contact (miranda.adams@nih.gov, +1 (240) 669-5344), with Catherine Bigger also listed at catherine.bigger@nih.gov.
Forecast text
The objective of Task Area D is to perform in vivo preclinical safety, toxicity, and pharmacokinetic studies of therapeutic agents under current Good Laboratory Practice (GLP) requirements according to those outlined in 21 CFR part 58. The candidate oral drug is intended to be co-administered with tafenoquine for the elimination of P. vivax Malaria and in combination with suitable drugs for the elimination of P. faciparum malaria. Executing the requested GLP embryo-fetal development study will enable the investigator to meet FDA requirements for reproductive and juvenile toxicity profiling prior to Phase 3 clinical studies based on FDA guidance S5(R3) "Detection of Reproductive and Development Toxicity for Human Pharmaceuticals." The need for this study was expressed by the agency at the of the Phase 1 FDA meeting.
On GovTribe
Work this forecast
- Track it in your pipeline
- Find teaming partners
- Similar forecasts
- Ask GovTribe AI about this forecast