Guest Columns & From The Editor

  1. A Much-Improved Approach For Understanding And Managing Safety Risks 8/18/2026

    Learn how causal mechanism and effect analysis (CMEA) and its principles can be used to develop and maintain safer working environments in the pharma/biotech and medical device industries.

  2. Immune Reset In Rheumatology: Moving Beyond Disease Suppression Toward Durable Remission 8/18/2026

    EULAR 2026 highlighted growing momentum behind “immune reset,” an approach adapted from oncology that is quickly gaining traction in autoimmune rheumatic diseases.

  3. CSV Assumes The AI System Sits Still — It Doesn't. 8/17/2026

    The computer system validation playbook was written for software that holds its shape. AI doesn't. Validating it has to become an act of governance.

  4. Building Antigen-Specific Immune Tolerance For Autoimmune Disease 8/10/2026

    Antigen-specific immune tolerance could redefine autoimmune disease treatment by precisely retraining the immune system rather than broadly suppressing it.

  5. July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing 8/7/2026

    Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.

  6. Combination Cell Therapy's Clinical Success Hinges On Manufacturability 8/5/2026

    Cell therapy could help unlock checkpoint inhibitors’ potential in solid tumors, but combination regimens raise the bar for manufacturing consistency and scalability.

  7. Are Biopharma Companies Outsourcing Their Ability To Think? 8/5/2026

    Amid gaining immediate access to external manufacturing capabilities, sponsor companies can lose the foundational understanding required to govern that capability.

  8. June 2026 — CDMO Opportunities And Threats Report 7/30/2026

    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.

  9. The Decision Rights Matrix: Making Sponsor-CDMO Governance Enforceable 7/29/2026

    In LVV manufacturing, the quality target product profile and the DRM are designed to work together. One defines what is being governed, the other names who governs it.

  10. Defining Quality In A Sponsor-Owned QTPP Before The CDMO Even Starts 7/29/2026

    Version-controlled quality target product profiles, authored by the drug sponsor, close any gaps between the CDMO's and sponsor's definitions of quality.