CNS Organoid Neuropharmacological Analysis

The U.S. Food and Drug Administration’s National Center for Toxicological Research is seeking industry capabilities for a contract to perform neuropharmacological analysis using human CNS-3D brain organoids derived from induced pluripotent stem cells. The work, scheduled to occur between August 1, 2026, and March 31, 2027, will evaluate the acute and chronic neuromodulatory effects of a marketed small molecule drug on spontaneous calcium burst patterns, viability, and transcriptomic profiles across 10 treatment groups totaling 32 organoids per group. The contractor must use 28Bio organoids to ensure continuity with prior FDA research, employ FLIPR Tetra® for calcium imaging, LDH-Glo™ for viability assays, and RNA sequencing for transcriptomic analysis, delivering all data electronically with precise metadata tagging for time points, dose groups, and experimental conditions. All generated data will be owned exclusively by the FDA, with strict prohibitions on public disclosure or transfer without written approval. The contractor must demonstrate extensive experience in CNS organoid neuropharmacology, computational analysis of calcium dynamics, and RNA-seq bioinformatics, along with proven capability to meet FDA comparability benchmarks and Section 508 accessibility standards. Offerors must provide their SAM Unique Entity Identifier, declare size status including Small Business, Veteran-Owned, or Disadvantaged classifications, and affirmatively disclose if any IT infrastructure or biological data processing occurs outside the United States, as foreign data handling triggers additional compliance scrutiny. No physical packaging, military standards, or government-furnished property are involved; all work occurs at the contractor’s facility with electronic submission required solely via email to nick.sartain@fda.hhs.gov by May 4, 2026, excluding any external links or references. The anticipated contract type is Firm Fixed Price, with no options or extensions defined, and no formal evaluation factors or pricing details are included as this is a market research notice aimed at identifying qualified vendors prior to potential solicitation.