Cell and Gene Regulatory

  1. Accelerating Rare Disease Access Through Global Alignment 7/20/2026

    Rare disease innovation is accelerating, but fragmented regulations, inconsistent data standards, and limited natural history data can slow progress. Global alignment is key to faster patient access.

  2. At The Turning Point – Shaping The Future Of Hematology 7/20/2026

    Hematology is at a turning point. Turn complexity into strategy with smarter trial design, stronger patient engagement, confident regulatory navigation and real-world evidence insights.

  3. What's Next In Biopharma And CGT? 7/20/2026

    Evaluating single-use bioprocess modalities requires aligning capital strategy, standardized extractables frameworks, and updated biocompatibility testing to ensure compliance.

  4. What Is Pre-Use, Post-Sterilization Integrity Testing (PUPSIT)? 7/20/2026

    Sterile filter integrity testing helps confirm performance, reduce risk, and support stronger processing controls as global regulatory guidance increasingly emphasizes PUPSIT where feasible.

  5. Mechanical Engineering Design Process For Combination Products 7/17/2026

    Mechanical engineering for combination drug-delivery devices demands more than good design — it requires data-driven risk management from specs through simulation. Learn how a structured phase approach ensures global manufacturing readiness.

  6. Mitigating Risk With The Right Contract Manufacturing Partner 7/17/2026

    West Vantage™ delivers end-to-end contract manufacturing solutions for pharmaceutical, diagnostics, and medical device companies.

  7. Considerations In Design And Development Of Novel Combination Drug-Delivery Devices 7/17/2026

    Poor scoping kills drug delivery device programs before they start. Learn how to define the right problem, assess risk early, and set boundaries that protect your timeline and budget.

  8. Full FDA Approval For TECELRA Marks More Than A Regulatory Win For Solid Tumors 7/17/2026

    US WorldMeds' expanded FDA approval for TECELRA represents another important step forward for engineered cell therapies in solid tumors.

  9. Let's Stop Treating Allogeneic Cell Therapy As One Thing 7/14/2026

    Industry is beginning to accept that allogeneic cell therapy spans categories, and success depends on aligning biology, regulation, and economics unique to each product.

  10. Leveraging 3Rs For Superior Cell Line Characterization 7/13/2026

    Explore how non-animal methods, including next generation sequencing, are advancing biologics safety testing through the 3Rs while supporting faster adventitious virus testing and more.