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FEATURED ARTICLES
What It's Like To Advance A Cell Therapy Through The Japan Entry Acceleration Program
Ernexa Therapeutics President & CEO Sanjeev Luther details having one the of 10 coveted spots in the Japan Entry Acceleration Program (JEAP) that supports cell therapy development and market entry in Japan.
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Why Clinical Data Standards Matter In An AI-Driven World
Novartis technology and scientific computing expert Bill Illis discusses what changes sponsors must make to the R&D data landscape to achieve sustained, meaningful progress — with the help of AI — to bring new therapies to patients faster.
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How The Quiet Data Standards Revolution Is Impacting Drug Approval
Principal Statistical Programmer Varun Debbeti details the role data standards play in approval timelines, detailing shortfalls of current the model and CORE, Dataset-JSON, and SDTM v3.0 stand to make an impact.
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How Pharmacometrics Informs Dose Selection And Biomarker Decisions
Quantitative modeling informs dose selection and biomarker insights early, reducing uncertainty, improving study design, and enabling faster, more confident decisions from first trials to clinical progress.