Digital Measures in Clinical Trials: FDA vs EMA Pathways
Explore how novel digital measures gain regulatory acceptance in clinical trials, comparing FDA-structured pathways with EMA engagement-led frameworks.
“The pharma industry is beginning to look at biological age as a surrogate endpoint to improve clinical trials."
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Explore how novel digital measures gain regulatory acceptance in clinical trials, comparing FDA-structured pathways with EMA engagement-led frameworks.
The FDA’s 2026 gene editing draft guidance could change your regulatory strategy. Explore the new NGS requirements for cell and gene editing therapies.
Over 90% of oncology NMEs that succeed in animal studies fail in clinical trials. This analysis examines how to optimise preclinical pharmacology models to improve translational success.
The FDA's March 2026 draft guidance on alternatives to animal testing marks a pivotal shift in preclinical drug development. Here's what pharma R&D teams need to know.
Explore how AI-driven drug discovery is evolving through Pharmaceutical Superintelligence and what your organisation can do to keep up.
Pharmacy is emerging as a critical but overlooked route to faster patient access. In this episode of Digital Pulse, Judit Mora explains how innovation, digital workflows, and pharmacy-led models can bypass traditional delays in healthcare delivery.
Phenotypic drug discovery is reshaping how pharma finds first-in-class drugs. This analysis covers the methods, AI integration, and strategic decisions R&D leaders face in 2026.
Cell therapy for solid tumours faces unique biological barriers. This analysis unpacks the engineering strategies pharma leaders must understand for R&D success in 2026.
Precision alone isn’t enough in oncology drug discovery. See why execution, biomarkers, and trial design determine scalable success in precision medicine.
Trisha Pillay speaks with Adriaan Kruger, CEO of nuvoteQ, as they unpack why clinical research is still heavily reliant on paper-based systems in many regions.
Pharmacoinformatics is redefining drug discovery strategy. This analysis covers the AI platforms, molecular design tools, and regulatory frameworks shaping R&D pipelines in 2026.
From 2012 through 2024, the FDA only approved 22 drugs for the treatment of psychiatric conditions. Pharma R&D teams must rethink development strategies to unstall drug innovation in psychiatry