Industry Insights

  1. Pharmaceutical Sovereignty: The Resilience We Cannot Outsource 4/15/2025

    Pharmaceutical sovereignty is no longer a theoretical concern. Sovereignty in this context does not imply isolation, but rather strategic resilience: building robust national and regional capabilities that ensure security while enabling global collaboration. 

  2. From Tissue Donation To Distribution: Understanding EU Regulatory Requirements In Cell Therapy Clinical Trials 4/14/2025

    Understanding how the European Union's Directive 2004/23/EC interacts with GMP — and where its jurisdiction begins and ends — is essential for successful clinical trial planning, compliance, and execution.

  3. The Cell and Gene Therapy Dilemma: Centralized Vs. Decentralized Manufacturing 4/11/2025

    This article explores key factors to consider when determining whether a centralized or decentralized model is best suited to support access for a specific CGT product, depending on the condition and context.

  4. How Cynata Therapeutics is Unlocking the Power of iPSCs to Transform Regenerative Medicine 4/11/2025

    Cynata Therapeutics is pioneering a scalable, iPSC-based platform to produce consistent, high-quality MSCs that are showing strong clinical promise across multiple indications, including GvHD, diabetic foot ulcers, and osteoarthritis.

  5. Smart Trial Design In Cell Therapy: Fast-Tracking Without Compromising 4/10/2025

    Discover clinical trial designs and real-life examples that enable fast and safe studies in cell therapy.

  6. How AI Is A Game-Changer For Auditing Compliance And Efficiency 4/9/2025

    In the life sciences, audits have long been bogged down by repetitive tasks. AI is changing the way auditors operate, making compliance more seamless than ever.

  7. March 2025 — CDMO Opportunities And Threats Report 4/8/2025

    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.

  8. Emerging Technologies For Cell Therapy Manufacturing 4/7/2025

    This summary of the Cell & Gene Live, Emerging Technologies in Cell Therapy Manufacturing, explains why automation, robotics, AI, and digital tools offer a clear path to scalable, efficient, and patient-centric manufacturing.

  9. 4 Key Solid Tumor Therapy Objectives iPSCs Can Help Achieve 4/4/2025

    Induced pluripotent stem cells offer some key biologic, technical, and financial advantages over more established PBMC-derived therapies.

  10. Struggling With GxP Systems? There's A DAP For That 4/2/2025

    A typical life sciences enterprise now has 500+ software applications. A digital adoption platform (DAP) is an overlay to help with user adoption, like an advanced version of the MS Word "paperclip" assistant.