Newsletter | April 10, 2026

04.10.26 -- Regulatory Flexibility In CGT: Key Shifts And Implications With Monika Swietlicka

FEATURED ARTICLE

Regulatory Flexibility In CGT: Key Shifts And Implications With Monika Swietlicka

On episode 125 of Cell & Gene: The Podcast, host Erin Harris speaks with Halloran Consulting Group’s Monika Swietlicka on FDA flexibility in cell and gene therapy — using a risk‑based, holistic approach without lowering evidentiary standards.

INDUSTRY INSIGHTS

Why Recruitment Alone Isn’t Enough In Clinical Trial Rescue

Recovering a clinical trial requires more than just outreach; it demands a clear strategy to bridge the gap between initial patient interest and final enrollment to restore study momentum.

Advancing ADCs With Expertise In Payloads And Linkers

Discover how integrated containment, high‑potency expertise, chromatography, and optimized linker–payload processes speed ADCs from development to commercial supply.

Leveraging Technology To Automate Patient, Site, And Trial Logistics Fulfillment

Streamline clinical trial operations by leveraging automation to simplify patient support, financial workflows, and supplier management while improving efficiency, accuracy, and real-time visibility.

Designing Successful Cell And Gene Therapy Trials

Designing cell and gene therapy trials requires specialized strategies to navigate unique complexities, ensuring successful and compliant development.

EMPQ In New Facilities: An Industry-Harmonized Approach

Harmonized approaches streamline facility qualification. This guide shares best practices for EMPQ, promoting consistency, compliance, and readiness in new facilities.

Engineering The Next Wave Of CHO Performance

Combining productivity with speed and reliability, S‑CHOice® 2G helps biopharma optimize manufacturing, reduce costs, and respond faster to market demand.

AI, Open Source, And The Future Of Biostatistics

Embrace the transformation by integrating AI, open-source innovation, and evolving data standards to shape the future of statistical programming and drive the next wave of clinical discovery.

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