Industry Insights

  1. Building Harmonized Real‑World Data In Oncology 3/13/2026

    Experts at PMWC 2026 emphasized that regulatory‑grade real‑world data in oncology will require prospectively collected, harmonized datasets that integrate multimodal clinical information.

  2. Where Contamination Control Really Breaks Down In Practice 3/13/2026

    Contamination control gaps arise when two dynamics merge — when processes become familiar and workloads increase. Here's how to spot them before they spin out of control.

  3. Lessons From Bringing A Novel T Cell Class For Autoimmune Diseases Into The Clinic 3/13/2026

    Tr1X Bio Co-founder and CEO David de Vries explains how moving Type 1 regulatory T Cell (Tr1) therapies into new indications reshapes every facet of first-in-human trial design.

  4. Trends In FDA FY 2025 Warning Letters 3/13/2026

    The FDA issued a total of 303 warning letters to drug and biologics products in Fiscal Year 2025 (FY25), an increase from FY24. This article reveals key agency focal points and trends.

  5. SUS Interchangeability Assessment And Qualification Best Practices 3/12/2026

    Establishing a robust single-use systems (SUS) interchangeability program can be a pivotal feature of a supply chain resiliency initiative.

  6. Delivery Strategy For Next-Gen Cardiac Gene Therapies 3/12/2026

    As the field matures, the most transformative gene therapies in heart health are treating delivery not as an afterthought but as a fundamental principle.

  7. Accelerating Technology Diffusion In Cell And Gene Therapy 3/11/2026

    Unlike most other drugs, advanced therapies require complex, purpose-built supply chain networks. Making them requires cross-sector collaboration.

  8. 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.

  9. 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.

  10. 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.