Newsletter | November 6, 2026

11.06.26 -- Is Your Supply Chain Ready For The End Of Class VI?

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As cell and gene therapies advance toward commercialization, scalable supply chains are critical to reaching patients reliably. On November 12, 2026 at 11 AM ET join Cell & Gene Live’s Erin Harris with Lineage Cell Therapeutics CEO Brian Culley and Allogene CTO Ben Beneski to explore cryopreservation, materials planning, inventory visibility, predictive analytics, chain-of-identity, and digital infrastructure. Register now for insights on building resilient, launch-ready operations.

FOCUS ON SUPPLY CHAIN

Is Your Supply Chain Ready For The End Of Class VI?

Revisions to USP <87> and <88> update biological reactivity testing — changes that are especially important for companies that rely on single-use technology.

Integrate Cryopreservation Into The End-To-End Supply Chain

Cryopreservation should be integrated across the entire supply chain to ensure traceability, reduce risk at handoffs, and support consistent, scalable therapy development and delivery.

What You Need To Know About Fluoropolymer Bag Cold Chain Durability

Drug manufacturers seek packaging that maintains integrity during processing and freezing, scales up to larger volumes easily, and remains robust throughout the temperature-controlled supply chain.

FOCUS ON CLINICAL TRIALS

How Decentralized Clinical Trials Deliver Quantifiable Value

Through dedicated staffing, operational oversight, and close collaboration with site teams, discover how a struggling cardiology study was transformed into a revitalized recruitment effort.

De-Risking The Neurology IND: Lessons From Early FDA Engagement

Learn how early regulatory alignment can help your neurology program move forward with greater clarity, confidence, and readiness by anticipating hurdles before submitting your application.

Exploring The Future Landscape Of Cell And Gene Neuroscience

What does the future of cell & gene therapy in neuroscience look like? Industry experts dig into the real patient experience, emerging challenges, and clinical development pathways.

The Answer To Advance Your Allogeneic CAR-T Cell Clinical Trial

Dozens of assays, a shifting sample analysis plan, and a network of specialty labs: see how coordinated oversight kept an allogeneic CAR-T trial on track.

Navigating Complex Phase 2 Endpoints In Neuro Trials

Phase 2 neuro endpoints can miss subtle changes. Understand when composites help or hinder, and how to align cognition, function, and biomarkers with real-world data for go/no-go decisions.

CLINICAL TRIALS SOLUTIONS

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Purpose-Built For ADC Development - Worldwide Clinical Trials Oncology

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Clinical Trial Management System (CTMS) Interface - McCreadie Group

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Tissue-Driven Insights For Discovery And Trials - Precision for Medicine

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Connecting Manufacturers And Providers To Patient And Order Management - Cencora

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