Industry Insights

  1. 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.

  2. 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.

  3. 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.

  4. Transendocardial Cell Delivery In Post‑Acute Myocardial Infarction 5/4/2026

    Optimized delivery technologies will be central to next-generation therapies, serving as key differentiators for both clinical efficacy and operational feasibility.

  5. Inside March Biosciences' CD5-Targeting CAR-T Approach 5/4/2026

    Fratricide is one of the key reasons T-cell therapies targeting T-cell malignancies have faltered. March's approach aims to solve that with its MB-105 candidate.

  6. Causal Mechanism And Effect Analysis (CMEA): FMEA's Simpler, Effective Alternative 5/1/2026

    This article describes causal mechanism and effect analysis (CMEA) as an alternative to failure mode and effect analysis (FMEA) for analyzing and managing the industry’s risks.

  7. Regeneron Advances In Vivo Gene Therapy For Hearing Loss 5/1/2026

    Regeneron’s Otarmeni marks a major CGT milestone, showing that in vivo gene therapy can restore hearing in OTOF-related deafness while expanding the field’s clinical and delivery possibilities.

  8. Cell And Gene Therapy CDMOs: On The Path To $75 Billion in Services? 4/30/2026

    Cell and gene therapy (CGT) developers – and thus their service providers – have had their share of ups and downs. But what do the promise and uneven realities of these therapies add up to in the development and manufacturing outsourcing sector? According to a Towards Healthcare report, despite the bumps in the road, in 2025 the global CGT CDMO market grew to $8.2 billion. What of future predictions? Here's a detailed analysis.

  9. The Stepwise Path Lilly Mapped From Paper To Digital Logbooks 4/30/2026

    Eli Lilly and Company started at the front lines, on the shop floor gathering operator input, when switching from paper to digital logbooks.

  10. Sana, Mayo Clinic Advance A New Model For Cell Therapy Delivery In T1D 4/27/2026

    Sana Biotechnology and Mayo Clinic are partnering to standardize delivery of a one-time hypoimmune cell therapy, aiming to scale access and redefine care for type 1 diabetes.