Mimetas Contract - Development of 3D Human Blood Brain Barrier Formation Assay (

The Food and Drug Administration is seeking external contract research support to develop a novel 3D human blood-brain barrier formation assay within the High Priority Research Area of developmental neurotoxicity. This initiative aims to advance in vitro models that better reflect human physiological responses to neurotoxic agents during critical stages of nervous system development. The research will focus on creating a reproducible, scalable, and biologically relevant 3D assay platform that can be used to evaluate potential developmental neurotoxicants with increased accuracy compared to traditional methods. The work is aligned with the FDA’s mission to strengthen safety assessment tools for products impacting human health, particularly in vulnerable populations such as children and developing fetuses. The contract is forecasted under NAICS code 541990 for other scientific and technical consulting services, and while the solicitation has not yet been formally released, interested parties can anticipate competitive bidding once the opportunity is formally posted. The point of contact for program inquiries is the HFP Acquisition Liaison at hfpacquisitions@fda.hhs.gov, with the contracting officer position still to be determined. The performance location and specific funding details are not yet available, but the project will require expertise in tissue engineering, neurobiology, and assay validation using human-derived cell lines. Organizations with demonstrated experience in 3D cell culture systems, organ-on-a-chip technologies, or neurotoxicity modeling are encouraged to prepare for forthcoming procurement activities.