FDA Expedited IND Pilot Opens Applications to Accelerate First-in-Human Trials
- FDA launched the Expedited IND Pilot to reduce first-in-human trial timelines by pairing drug sponsors with qualified research institutions (QRIs) for rolling-review IND preparation.
- The pilot accepts applications through October 30, 2026, with 8–10 sponsor-QRI pairs expected to be selected for the initial cohort.
- Rolling component review and coordinated IRB/site-activation planning aim to reduce clinical-hold risk and accelerate the path from discovery to trial initiation.
Operational Impact
CROs and clinical research institutions that qualify as QRIs may capture expanded roles in early-stage IND preparation and rolling-review coordination, potentially increasing demand for specialized regulatory and scientific consulting services during the pre-IND phase.
Source: FDA What's New Drugs RSS
Single Cell Discoveries Acquires TATAA Biocenter to Span Discovery Through Clinical Bioanalysis
- Single Cell Discoveries completed acquisition of TATAA Biocenter, combining discovery transcriptomics with GLP/GCLP-compliant bioanalysis and assay development.
- Combined organization employs ~50 scientists across Utrecht and Gothenburg, enabling sponsors to move molecular targets from discovery through validated, regulatory-ready analysis within one CRO.
- Integrated service portfolio eliminates need to transfer projects between discovery and validation providers, with combined capabilities available September 2026.
Operational Impact
CRO buyers can now move single-cell-identified targets through spatial transcriptomics, proteomics, and GLP/GCLP-validated qPCR or RNA-seq assays within Single Cell Discoveries' combined organization, reducing project transfer friction and timeline risk.
Source: PharmaSource RSS