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Regulators have become increasingly concerned about the potential for medical devices to become a vector for spreading malware attacks across hospital networks, resulting in untold patient harm and billions of dollars globally.
Medical Affairs plays a critical role when it comes to driving adherence to evidence-based medicine (EBM) – the principle that clinical decisions should be informed by the best available scientific evidence, along with clinical experience and patient preference.
“Precision medicine” is a term we have heard a lot over the last two decades, promising to improve health outcomes by pairing the patient with the right treatment. In cancer, we do this primarily with biomarkers. Our understanding of biomarkers – signatures of key features of a tumor – and their role in disease has grown considerably. Currently, testing for biomarkers in the clinic is often time consuming and costly. Recent advancements in artificial intelligence (AI) may reshape how we detect existing biomarkers and identify new biomarkers entirely. AI-assisted, digital biomarker assays may help make precision medicine available for more patients than ever. Seeing beyond to improve patient care Digital biomarker assays are task-specific AI models that can identify specific features on a digitized version of slide tissue to improve diagnosis or predict how well that tumor will respond to a particular treatment. To build these assays, AI is developed that can spot pattern
A drug developed by Protalix BioTherapeutics and Chiesi Group is now FDA approved for treating Fabry disease, a rare inherited metabolic disorder. The drug, Elfabrio, is an enzyme replacement therapy.