Guest Columns

1. September 2026 — CDMO Opportunities And Threats Report 10/28/2026

   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.

2. An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs? 10/28/2026

   FDA’s real-time CRL releases face legal and operational hurdles. Could AI-assisted redaction make transparency faster and more consistent?

3. Navigating Outsourced Pharmaceutical Testing Through Today's Geopolitical Uncertainty 10/22/2026

   Geopolitical shocks are reshaping outsourced pharmaceutical testing. Learn how procurement teams can strengthen resilience and protect continuity.

4. Is Your Supply Chain Ready For The End Of Class VI? 10/21/2026

   Revisions to USP <87> and <88> update biological reactivity testing — changes that are especially important for companies that rely on single-use technology.

5. Beyond API Sourcing: Avoiding Supply Disruptions For Small Molecule Drugs 10/14/2026

   Supply resilience should be assessed across the complete drug product pathway rather than measured by the number of vendors listed in a procurement system. 

6. Why We Need Pharmaceutical Engineering Project Management As A Distinct Discipline 10/13/2026

   Applying general project management to a regulated setting as a variant of PMP or PRINCE2 is one of the most consistent, and most avoidable, causes of cost overrun and delayed start-up.

7. Your 7 Decisions To Make Before MES Configuration 10/7/2026

   Don't wait until manufacturing execution system (MES) configuration to answer these 7 questions. Define your manufacturing process before digitizing it.

8. Complete Response Letters For CGTs Share This Common Theme 10/7/2026

   One expert’s analysis found CMC-related concerns in about 75% of complete response letters. He outlines a path to stronger CMC readiness for cell and gene therapies.

9. The Orange Book's Blind Spot: Process Stability And Capability 10/5/2026

   The current system for assuring therapeutic equivalence contains structural blind spots. Companies must evolve rather than merely adding corrective actions.

10. Are You Falling Behind On Intelligent Pharmaceutical Manufacturing? 10/2/2026

    With a focus on small molecule drug product manufacture, let's take a closer look at the efficiencies gained through closed-loop control, PAT, digital twins, and more.