Industry Insights

  1. The In Vivo Cell Therapy Shift On Display At PMWC 2026 3/10/2026

    At PMWC 2026 in Santa Clara, we saw how in vivo CAR T and MRD‑guided strategies could reshape cell therapy by moving curative intent earlier while balancing bold innovation with practical scalability.

  2. Inside SynaptixBio's Mission To Develop A Therapy For H-ABC 3/9/2026

    SynaptixBio's Dr. Dan Williams discusses the company’s effort to develop an antisense oligonucleotide therapy that silences the mutant TUBB4A gene in the ultra-rare leukodystrophy H-ABC, highlighting the scientific, regulatory, and funding challenges of advancing treatments for extremely small patient populations.

  3. The FDA Plausible Mechanism Framework Just Changed Rare Disease Drug Development 3/9/2026

    Discover how the new FDA Plausible Mechanism Framework changes the game for rare disease research by formalizing an approval pathway for individualized treatment of ultra-rare genetic diseases.

  4. 5 QMS Blind Spots You Should Know About 3/6/2026

    Companies often underestimate the complexity of standing up an eQMS. These are five of the most common issues that lead to regulatory and GMP exposure risk.

  5. New MIT Consortium Links Innovation With Real-World Biomanufacturing 3/6/2026

    In one area, the Initiative for New Manufacturing is exploring whether microfactories, championed by the EV industry, can help biopharma iterate facility design faster.

  6. Injecting Cancer Killers: Intratumoral Therapy For Solid Tumors 3/5/2026

    Intratumoral injection bypasses the tumor’s physical defenses entirely, killing cancer cells and creating a personalized immune response that destroys solid tumors.

  7. Proteomics Tools: A Resurrection 3/4/2026

    For decades, the evolution of proteomics has lagged. Now, a resurrection is underway. New tools are dismantling limitations, signifying a maturation of systems biology.

  8. Powering AI And Synthetic Biology In Therapy Design 2/27/2026

    AI-driven cell therapies depend on high-quality, well-structured data to accelerate discovery, development, and clinical success.

  9. Six Specialized Modalities Testing CDMO Readiness In 2026 2/27/2026

    As biopharma pipelines shift toward more complex therapies, sponsors are finding that CDMO readiness now depends less on general capacity and more on highly specific technical capabilities.

  10. Green Supply Chains Rarely Start With A Pledge; Target Waste Instead 2/27/2026

    Effective sustainability strategies in pharma supply chains reduce rework and overage. Three leakage points offer the most practical starting point for rooting out waste.