Newsletter | September 11, 2026

09.11.26 -- Why Autoimmune CAR T Needs A New Patient-Centered Playbook — With Dr. Panteli Theocharous

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Webinar: Beyond the Starting Material: Building a Path to GMP Manufacturing Success

Cell therapy manufacturing success starts long before the GMP cleanroom. Join experts from New York Blood Center Enterprises’ Comprehensive Cell Solutions (CCS) team to explore how starting material sourcing, collection strategies, process development, and technology transfer shape manufacturing outcomes. Gain practical insights for reducing variability, strengthening process robustness, and preparing cell therapy programs for clinical and commercial manufacturing. Click here to learn more.

FOCUS ON SUPPLY CHAIN

 

Freeze Containers Protect High-Value Gene Therapy Batches

With each batch of cell and gene therapy product representing a wealth of lifesaving potential, this biopharma company needed the right packaging solution for its relatively new therapy applications.

 

CNS Trials Are Difficult — Do They Have To Be?

Clinical trials for central nervous system therapies face significant obstacles to approval, including subjective endpoints and complex patient selection. Consider a strategic approach for success.

FOCUS ON CLINICAL TRIALS

Why Autoimmune CAR T Needs A New Patient-Centered Playbook — With Dr. Panteli Theocharous

On episode 136 of Cell & Gene: The Podcast, Host Erin Harris welcomes back Dr. Panteli Theocharous, FIBMS, M.S., Ph.D., FRCPath to discuss why autoimmune CAR T is moving rapidly from an emerging concept toward a potentially transformative treatment approach.

 

 

Scaling Investigational Drug Services: Overcoming Operational Bottlenecks

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

 

Why CGT Success Depends On Redefining Pharmacovigilance For Long-Term Risk

Long-term and potentially life-threatening safety risks from CGTs require pharmacovigilance teams to move beyond traditional drug safety models and adopt lifecycle-based monitoring approaches.

 

End-To-End Clinical, Biometrics, And Regulatory Support In Neurology

Discover how an integrated NDA strategy aligned data, vendors, and regulatory execution to achieve an on-time submission and approval without major FDA queries.

CLINICAL TRIALS SOLUTIONS

Your IRB, Simplified: Fast, Friendly, And Focused - Univo IRB

Drug Safety And Pharmacovigilance Services - Parexel International

Flow Cytometry Clinical Development Testing - Eurofins

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