FEATURED ARTICLES
Unlocking Gentler, Cost-Efficient TIL Therapy For Cold Tumors
CuraCell Head of Clinical Operations Torbjörn Ström discusses, in the context of CC-38 and CytoPLY-derived tumor-infiltrating lymphocytes (TILs), the utility of named-patient experience, dosing and preconditioning, and T-cell therapy capabilities in cold solid tumors.
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Navigating The New EU Pharmaceutical Legislation: Key Implications For Pediatric Drug Development
UCB’s Senior Development Strategy Lead Pediatrics Martine Dehlinger-Kremer, Ph.D., discusses updates to the new EU Pharma legislation and how they impact pediatric drug development, including earlier pediatric investigational plans .
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Beyond The IND Clock: What Operation TrialBlazer Gets Right — And Where It Stalls (Part 1)
The FDA's Operation TrailBlazer includes a proposal to speed up IND review and approval. But will it work? Kimberly Chew and Odette Hauke identify where the initiative succeeds and where the structural gaps begin.
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Beyond The IND Clock: The Legal Architecture Of QRIs And What Industry Must Say Before July 22 (Part 2)
The FDA's Operation TrailBlazer includes a proposal to speed up IND review and approval. But Kimberly Chew and Odette Hauke say its legal architecture is unresolved and reveals compliance issues that are hard to ignore.