Contributing Editors

1. Field Notes: Freeing Process Data For Automation At Kivi Bio AI Summit 5/22/2026

   The missing link between data generation and unleashing it to power automation often lies in well-governed cloud infrastructure.

2. Rethinking CQV In A Digital, Agile Manufacturing Landscape 5/21/2026

   While commissioning, qualification, and validation (CQV) remains foundational, the way it is planned and executed must evolve to keep pace with modern manufacturing realities.

3. Will FDA's One-Day Inspection Pilot Stand The Test Of Time? 5/19/2026

   FDA's complementary pilot could help weed through a persistent examination backlog, but uncertainty and upheaval in leadership at the top puts its future in question.

4. A Multi-Agent Audit Intelligence Framework For CDMO Quality Oversight 5/18/2026

   A Takeda quality executive demonstrates how a team of AI agents uses synthetic data to provide decision support ahead of CDMO audits.

5. Why Contamination Control By Design Should Matter To Your CDMO 5/18/2026

   EU GMP Annex 1 mandates a documented contamination control strategy, and FDA expectations are substantively equivalent. Let's look at why CDMOs are disproportionately exposed.

6. Closing The MES Value Gap: Why Technology Isn't The Problem 5/14/2026

   Manufacturing execution system (MES) technical maturity is rising, but adoption across manufacturing sites is uneven. Organizational readiness may hold the key.

7. Why Isolators Do Not Automatically Ensure Annex 1 Compliance 5/12/2026

   Isolators are powerful tools, but they do not automatically ensure compliance with EU GMP Annex 1. RABS are frequently dismissed too quickly. The difference is not the technology itself, but how it is applied.

8. Why Are Life Science Companies So Poorly Prepared For RIM's Future? 5/11/2026

   Most organizations have modernized their global regulatory information management (RIM) systems and improved data quality. Yet modernization and readiness are not the same thing.

9. April 2026 — CDMO Opportunities And Threats Report 5/8/2026

   Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

10. GLP-1 Receptor Agonists: Metabolism, Reward Biology, And AI-Driven Drug Discovery 5/6/2026

    For drug discovery teams, the central question is whether metabolic signaling pathways can serve as a tractable new entry point into addiction therapeutics.