---
title: CRO Daily News — September 15, 2026
slug: daily-news-2026-09-15-cro
site: cro
post_kind: news
byline: BioBM
description: September 15 CRO daily: FDA Expedited IND Pilot Opens Applications to Accelerate First-in-Human Trials; Single Cell Discoveries Acquires TATAA Biocenter to…
canonical_url: https://www.cro.directory/posts/daily-news-2026-09-15-cro
published_at: 2026-09-15T23:59:46.602Z
last_updated: 2026-09-16T00:02:00.856Z
---

### 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](https://www.fda.gov/news-events/press-announcements/fda-launches-expedited-ind-pilot-begins-accepting-applications)*

---

### Single Cell Discoveries Acquires [TATAA Biocenter](/companies/tataa-biocenter) to Span Discovery Through Clinical Bioanalysis
- Single Cell Discoveries completed acquisition of [TATAA Biocenter](/companies/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](https://pharmasource.global/content/news/cro-news/single-cell-discoveries-extends-cro-services-from-discovery-to-clinical-development)*

## References

1. [FDA What's New Drugs RSS — FDA Expedited IND Pilot Opens Applications to Accelerate First-in-Human Trials](https://www.fda.gov/news-events/press-announcements/fda-launches-expedited-ind-pilot-begins-accepting-applications)
2. [PharmaSource RSS — Single Cell Discoveries Acquires TATAA Biocenter to Span Discovery Through Clinical Bioanalysis](https://pharmasource.global/content/news/cro-news/single-cell-discoveries-extends-cro-services-from-discovery-to-clinical-development)

Source: https://www.cro.directory/posts/daily-news-2026-09-15-cro