Newsletter | September 18, 2026

09.18.26 -- Autoimmune CAR T Has Hit A Critical Moment. Are We Asking The Right Questions?

FOCUS ON CLINICAL TRIALS

Autoimmune CAR T Has Hit A Critical Moment. Are We Asking The Right Questions?

By Erin Harris, Editor-In-Chief, Cell & Gene

The promise of autoimmune CAR T is enormous, but recent safety pauses from Novartis and BMS underscore why the field needs a more patient-centered approach to risk, clinical outcomes, access, and real-world delivery.

Advancing IHC Assays From RUO To Clinical Trials And CDx

Case Study | By Kennon Daniels, Ph.D., and Angelique Heckmann, Ph.D., Precision for Medicine

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

Inside A Live IRB Board Review: How Experts Evaluate Protocols

Webinar | Univo IRB

See a mock IRB review. Watch industry experts evaluate a fictional protocol to uncover insights into board decision-making, master the review process, and improve your future submissions.

Ethical & Regulatory Considerations For Pediatric Gene Therapy

Article | By Raffaella Hart and Linda Reuter, BRANY

Understanding risk thresholds, consent requirements, and IRB expectations early can prevent redesign, reduce delays, and improve trial feasibility for vulnerable patient populations

CLINICAL TRIALS SOLUTIONS

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Advancing Lung Cancer Trials With Precision - Worldwide Clinical Trials Oncology

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Make A Difference, Unlock Your Therapy's Potential - Cencora

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Empowering & Supporting Global Research Sites - MRN - Medical Research Network

FOCUS ON SUPPLY CHAIN

Biopharmaceutical Packaging Solution Advancements And Considerations

Article | By Joe Cintavey, W.L. Gore & Associates

Explore how to develop a strong packaging system, and learn more about why a reliable supply chain is critical for drug substance and drug product transport.

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