NIAID Preclinical Models of Infectious Diseases (PMID)

Provide non-traditional animal models as well as models that could serve as replacements for animals in product screening and efficacy studies. The program will continue to provide the capability and capacity to develop and employ animal and animal replacement models (e.g., organ-on-a-chip technology) of infectious diseases for screening and product evaluation and address a critical stage in this pipeline by bridging in vitro testing and eventual clinical evaluation, including, as needed studies conducted under the guidance of 21 CFR 58, “Good Laboratory Practices”. In addition, for candidate products that are unable to be assessed for clinical efficacy in phase II or III trials for ethical or practical reasons, contracts awarded under this solicitation will enable regulatory approval or licensure via the guidance of the Food and Drug Administration’s (FDA) Animal Efficacy Rule.