Industry Insights

  1. Closing The MES Value Gap: Why Technology Isn't The Problem 5/14/2026

    Manufacturing execution system (MES) technical maturity is rising, but adoption across manufacturing sites is uneven. Organizational readiness may hold the key.

  2. Prevascularized Bio-hybrid Organ Platforms Are Redefining Cell Therapy Delivery 5/14/2026

    Cell therapy success depends on a durable implantation environment, making delivery and sustainability central to efficacy and functional outcomes.

  3. Dr. Peter Marks On Why Gene Therapy May Need A New Regulatory Playbook 5/13/2026

    At the 2026 @Philly Cell and Gene Therapy Annual Conference, Dr. Peter Marks highlighted how gene therapy science is surging ahead and called for smarter regulatory evolution to unlock treatments for thousands of rare disease patients.

  4. Can A Biotech Create A CDMO Market? 5/11/2026

    Can a biotech create a CDMO market? GeoVax, an infectious disease/oncology biotech, may have just done so. David Dodd, CEO, believes we should all concentrate more on whether the outsourcing model can align with evolving technology platforms. Both sponsors and CDMOs may need to change things up.

  5. 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.

  6. 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.

  7. Cell And Gene Therapies: The Emerging Reality For Scalable Market Readiness 5/8/2026

    Mainstream biopharma’s commercialization playbook isn’t working for cell and gene therapies. Orgs that invest in scalable platforms (and more) will see better success.

  8. Tackling The Cell & Gene Therapy Sector's Practical Post-Approval Problem 5/6/2026

    As the regulatory landscape continues to evolve, cell and gene therapy companies must plan post-approval change programs with regulatory monitoring built in from the start.

  9. 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.

  10. 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.