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This contract provides gap-filling support services for HIV prevention drug developers including academic (investigators), for-profit and not-for-profit small and large companies, and other product innovators (henceforth identified as Sponsors) for the development of HIV non-vaccine biomedical prevention (nBP) strategies and products.
This service program supports the development and manufacture, of a wide variety of pharmaceutical dosage formulations, including tablets, capsules, semi-solid preparations, injectibles, and sustained-release products. If requested, manufacturing can be done under GMP.
The Interventional Agent Development Services program provides services to facilitate preclinical development of therapeutics and new in vivo diagnostics for infectious disease-causing pathogens and/or toxins.
Note: Devices are excluded.
Part of the Therapeutic Development Services program.
The Preclinical Development Support Master Contract (PDSMC) supports all phases of preclinical development, including process and product development, GMP manufacturing and clinical lot production, analytical and formulation, preclinical enabling studies and associated tasks leading to the filing of investigational new drug (IND) applications.
The Chemical Countermeasures Research Program (CCRP) supports the discovery and early development of medical countermeasures (MCMs) to treat the acute and/or long-term chronic toxicities after exposure to highly toxic chemicals.
The Therapeutic Development Services program offers a collection of preclinical services to support the development of products intended for use in the cure, mitigation, diagnosis, or treatment of disease caused by a pathogen or certain toxins.
The Vaccine Development Services program offers a collection of preclinical services to support the development of vaccines intended for use in the investigation, control, prevention, and treatment of a wide range of infectious agents (other than HIV).