The U.S. Food and Drug Administration (FDA) is seeking a contractor to perform CNS organoid neuropharmacological analysis. The contractor will be required to characterize acute and chronic neuromodulatory effects of a marketed small molecule drug in human CNS-3D brain organoids. The analysis will include evaluating transcriptional changes induced by chronic exposure to the drug. The contractor must use 28Bio's specialized human iPSC-derived 3D cortical organoid model. The contract will be a firm-fixed-price contract, and the period of performance is estimated to be from August 1, 2026, to April 30, 2027.
Some key tasks include:
• Characterizing acute and chronic neuromodulatory effects of a marketed small molecule drug in human CNS-3D brain organoids
• Evaluating transcriptional changes induced by chronic exposure to the drug
• Providing all deliverable data generated under the contract in electronic format
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