Newsletter | September 25, 2026

09.25.26 -- The Promise Of MRD-Guided CAR-T Treatment

FOCUS ON SUPPLY CHAIN

Reshoring Pressure Meets Manufacturing Reality

U.S. pharma can't reshore what domestic capacity can't absorb. Senior leaders from Takeda, Biogen, Eli Lilly, and others reveal why tariff pressure is colliding with a sterile fill-finish shortage, workforce gaps, and ADC capacity bottlenecks.

 

 

When Local Variation Becomes Global Risk In Phase III

Late-stage therapy trials demand strict execution. Learn how local handling variations escalate into global risks and how early standardization safeguards therapeutic integrity and compliance.

FOCUS ON CLINICAL TRIALS

The Promise Of MRD-Guided CAR-T Treatment

Minimal residual disease markers can reveal relapse before clinical signs appear, when off-the-shelf cell therapy may have its greatest advantage.

 

 

Closing The Readiness Gap For CGTs In Community-Based Care

Only one in five eligible cell and gene therapy patients receives treatment. Expanding access into community hospitals requires overcoming significant operational and readiness barriers.

 

Mitigating High-Risk Labeling Errors In Complex Clinical Trials

Investigational products present a distinctly high-risk environment for labeling and barcoding. Explore best practices for barcoding solutions that allow for improved medication safety in clinical trials.

 

Next-Generation ADC Trials – Turning Complexity Into Execution

As ADC science advances, operational strategy becomes critical. Read how smarter protocol design, real-time monitoring and collaborative execution can accelerate next-generation ADC trials.

 

Trends, Challenges, And Opportunities In Lung Cancer Clinical Development

Discover how precision medicine and novel therapeutics reshape lung cancer clinical development. Gain insights to overcome modern trial execution and global enrollment challenges.

 

Reducing The Burden Of Patient Retention And Improving Continuity

Immunology trials often place a sustained burden on participants. However, integrating Home Trial Support (HTS) into a Phase 3 immunology trial can help improve the overall study experience.

 

Expanding Clinical Trial Access In Underserved Tribal Healthcare

Kelsey Powell explores the urgent need for better clinical research access in tribal healthcare, while Michele Baptista shares how her cancer journey led to a research opportunity that changed her life.

CLINICAL TRIALS SOLUTIONS

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Proven Expertise With Global Solutions For U.S. Biotechs - Avance Clinical

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Why Central IRBs Matter For Efficient Clinical Trials - BRANY

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Speed, Precision, Impact: The CRO Revolutionizing Bioanalysis - Dash Bio

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