Industry Insights

31. January 2026 — CDMO Opportunities And Threats Report 2/12/2026

    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.

32. Why In Vivo Therapies Fail When We Treat Them Like Ex Vivo Ones 2/9/2026

    For the next-generation cell and gene therapies, we must rethink design and controls, and we must reframe the problem from modality to architecture.

33. Leveraging Conventional Therapeutics Skills For Cell And Gene Therapy 2/6/2026

    Cell and gene therapies share fundamental objectives with conventional biologics. Their common challenges offer a natural starting point to solving downstream bottlenecks.

34. Why Clinical Supply Risk Starts With Demand Signals 2/5/2026

    Clinical supply risk often begins long before manufacturing or distribution. Flawed demand signals and enrollment forecasts can quietly create shortages, delays, and costly material waste.

35. A Year Of Separation: Which Advanced Modalities Are Built For Commercial Scale In 2026? 1/30/2026

    In 2026, advanced therapies diverge: winners pair proven biology with scalable manufacturing, delivery, and workflow fit, while others advance more slowly under operational and economic limits.

36. New ISPE Framework Targets Uncertainty In Pharma's AI Deployment 1/29/2026

    International Society for Pharmaceutical Engineering members developed the guide to offer a risk-based framework for evaluating, implementing, and maintaining AI systems.

37. Disciplined CGT Will Win On 2026 Regulatory Flexibility 1/29/2026

    Wilson Bryan, M.D., and Daniela Drago, Ph.D., RAC, joined our our first Cell & Gene Live of 2026 to unpack what a more mature era of regulatory oversight means for sponsors.

38. In Vivo's Biggest Threat — Comparison To Old Models 1/23/2026

    In vivo CAR-T is not simply ex vivo without a manufacturing step. It is a different modality that relies on biological systems to regulate outcomes.

39. The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing 1/21/2026

    The promise of AI is colliding with the harsh reality of data chaos in pharma manufacturing. This article explores why most AI investments fail, and a 5-layer solution.

40. Why Use Total Organic Carbon Analysis For Cleaning Validation? 1/21/2026

    Total organic carbon analysis is probably the most “fit for use” analytical method to validate cleaning processes, particularly within a science- and risk-based approach.