Cell and Gene Regulatory

  1. Implementing AI Solutions In GMP While Managing Risk 8/28/2026

    When using artificial intelligence in GMP settings, risk management extends far beyond  validation. This discussion explores moving AI solutions out of the pilot phase.

  2. Europe's ATMP Opportunity Still Requires Local Navigation 8/27/2026

    European nations offer a welcoming environment for clinical-phase cell and gene therapies. Don't assume the same flexibility carries through to commercialization.

  3. The Unspoken Truth About Cell Therapy Product Understanding 8/27/2026

    Developers often discover important attributes after it's too late to act on them. A well-designed program asks what's needed for commercialization and works backward.

  4. A Comprehensive Solution With Targeted And Non-Targeted Approaches 8/26/2026

    Explore how non-targeted NGS and targeted molecular assays can work together during cell line characterization to provide broad virus detection while supporting evolving regulatory expectations.

  5. The Rise Of Chinese Biotechs And The Global CRO Question 8/25/2026

    As innovative therapies move beyond home markets, early planning across regulators and geographies helps avoid costly delays and protect trial budgets.

  6. Sticky Situations: Tackling Residue Inside The Cleanroom With Dave Nobile 8/24/2026

    Learn how to effectively manage chemical residue buildup in cleanrooms through proper solvent selection, dwell time, and mechanical removal to support regulatory compliance.

  7. Advancing IHC Assays From RUO To Clinical Trials And CDx 8/21/2026

    Examine how an exploratory IHC assay evolved into a multi-indication clinical program through integrated assay development, validation, regulatory strategy, and scientific collaboration.

  8. Protocol Design Choices That Trigger IRB And Regulatory Requirements 8/20/2026

    Learn how protocol choices like AI, adaptive designs, and decentralized methods impact IRB review, participant protections, consent, and key regulatory requirements in clinical research.

  9. Operationalizing Global Oncology Trials: Fast-Track Development Timelines 8/20/2026

    Running oncology trials across multiple regions? Learn how coordinated planning, oversight, and expertise keep complex studies on track from start to registration.

  10. Scaling Investigational Drug Services: A Case Study in Overcoming Operational Bottlenecks 8/20/2026

    Are operational bottlenecks holding back your research site? Explore a blueprint for automating investigational product workflows and giving staff time back for patient care.