Contributing Editors

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Why Your MES RFP Is Failing Before It Starts 5/6/2026

    Many manufacturing execution system requests for proposals fail. Not because vendors cannot deliver or the tech is immature, but because the requirements are written backward.

  6. Here's How FDA's Accelerated Approval Pathway Has Evolved Since '24 5/5/2026

    FDA's accelerated approval guidance kicked off a rebalancing of new drug approval pathways. Since its 2024 release, the agency has been building on it in a few key areas.

  7. Gaining An Edge In GLP-1 Production 5/5/2026

    The shortage-driven production of GLP-1 drugs of the past few years is giving way to a long-term operation model characterized by digital enablement and supply chain resilience.

  8. GLP-1 And Addiction: Mechanism, Missteps, And What Comes Next 5/4/2026

    Evidence suggests GLP-1R agonists may influence reward pathways and craving, raising important questions for addiction research and drug development.

  9. How Generic Pharma Manufacturers Can Rebuild Margins Inside The Four Walls 5/4/2026

    The pricing dynamics for generic drugs turns formerly attractive products into high-volume, low-margin commodities. Lean and Six Sigma in four key areas can unlock efficiencies.

  10. Causal Mechanism And Effect Analysis (CMEA): FMEA's Simpler, Effective Alternative 5/1/2026

    This article describes causal mechanism and effect analysis (CMEA) as an alternative to failure mode and effect analysis (FMEA) for analyzing and managing the industry’s risks.