Industry Insights

  1. ARM's Tim Hunt On Expanding Patient Access, Smarter Regulation, And A More Sustainable Market In 2026 1/12/2026

    ARM's Tim Hunt outlines how smarter regulation, evolving payment models, and global competition are reshaping CGT into a more accessible and commercially sustainable industry.

  2. Deploying A Vendor Life Cycle Oversight Model 1/9/2026

    A practical guide for adding oversight, based on a hierarchy of metrics, to quality agreements to transform them into living, metrics-driven control instruments.

  3. Moving Leukopaks From GTP To GMP Is One Cell Therapy Trend To Watch In '26 1/9/2026

    Cell therapy stumbled in 2025. Solving the variability in starting material quality is critical to stabilizing manufacturing in 2026.

  4. Metrics, Not Audits, Should Lead Vendor Accountability 1/9/2026

    Episodic vendor audits are better suited for high-risk areas. An oversight system, based on a hierarchy of metrics, provides greater value.

  5. Global Shifts And Strategic Resilience Will Shape CGT In 2026 1/7/2026

    Dr. Miguel Forte, CEO of Kiji Therapeutics and President of ISCT, and Ali Pashazadeh, Founder of Treehill Partners share why CGT developers are now navigating a landscape defined not only by technological innovation but also by geography, regulatory agility, and investment dynamics.

  6. Sales & Operations Planning for Small Teams: Aligning Clinical Supply 1/6/2026

    Small clinical teams don’t fail at S&OP from missing systems—they fail from unclear demand and decisions. Alignment comes from discipline, shared visibility, and acting on reality before timelines slip.

  7. 2026 CDMO Forecast: The 7 Shifts Sponsors Need To Prepare For 1/5/2026

    2026 is shaping up to be a year in which operational discipline, strategic alignment, and regulatory preparedness will differentiate high-performing sponsors from those facing avoidable delays.

  8. A Deeper Look At Pharma's Structural Supply Chain Vulnerability 12/31/2025

    Fixing limited capacity in pharmaceutical CMC development starts with understanding a complex web of root causes.

  9. Allogeneic Cell Therapy's Success Hinges On Perfecting The Platform 12/29/2025

    The industry remains far from realizing a manufacturing platform with a repeatable, standardized process that can support broad clinical and commercial deployment.

  10. Harnessing Mitochondria: A New Frontier In Therapeutic Innovation 12/26/2025

    What if we can replace damaged mitochondria with young and healthy mitochondria? In recent years, a new therapeutic field has evolved: mitochondrial transplantations.