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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 pr
The Feasibility of Novel Diagnostics for TB in Endemic Countries (FEND for TB) program supports the evaluation of early-stage diagnostics and novel diagnostic strategies for TB, in TB endemic countries to address an urgent need for improved tuberculosis (TB) diagnostics.
This service can be used to develop and perform a variety of analytical assays to assess the properties of drug substances and their formulations.
This service provides follow-up studies of products which already have been evaluated in a biochemical or cell-based assay and shown to possess an activity profile that warrants further development of the product as an HIV therapeutic.
This service provides evaluation of products in animal efficacy models. A product must demonstrate a potent and selective activity profile in vitro against the HIV strain used in the model prior to its acceptance as a candidate for this service.
This service can be used to provide pharmacokinetic and safety assessments of products in mice, rats, rabbits, dogs, and nonhuman primates.
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.
This service provides chemical synthesis of lead compounds for use in additional drug development studies. Compounds must previously have been successfully synthesized to be candidates for this service. Synthesis of new analogs is not supported.
The In Vitro Assessment for Antimicrobial Activity program provides capability in a broad range of in vitro assessments to evaluate promising candidate countermeasures for antimicrobial activity against microbial pathogens and vectors, including those derived from clinical speci
This service provides evaluation of products that have already been evaluated in a biochemical or cell-based assay and shown to possess an activity profile that warrants further development as a microbicide.
The National Institutes of Health (NIH) HIV Reagent Program provides critical research reagents and resources to the scientific community.
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
This contract program supports the development and refinement of animal models and animal replacement technologies and provides in vivo preclinical testing services, ranging from screening and proof-of-concept to GLP efficacy studies.
The Process Development and Analytical Support Contract (PAS) supports two key critical components: process development and analytical characterization activities.
This contract is with the International Aids Vaccine Initiative (IAVI).
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 tox
The SVEU provides the nonhuman primates for studies to evaluate candidate SIV or HIV vaccines.
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.