CNS Organoid Neuropharmacological Analysis

The U.S. Food and Drug Administration (FDA) is conducting market research to support the National Center for Toxicological Research (NCTR) requirement for CNS Organoid Neuropharmacological Analysis. The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the required supplies. The work includes functional examination of neuromodulatory effects of a drug and related transcriptomic changes in human Central Nervous System (CNS)-3D brain organoids. Key aspects of the work include: • Characterizing acute and chronic neuromodulatory effects of a marketed small molecule drug in human CNS-3D brain organoids • Characterizing the role of the 5-HT5A receptor in drug-induced effects in human CNS-3D brain organoids • Evaluating transcriptional changes induced by chronic exposure to the drug in human CNS-3D brain organoids • Delivering reports and data electronically, including study design, experimental conditions, and results analyzed