D4.8 Pilot IV: First Report

Semalytix provides solutions to customers in the pharmaceutical industry in order to foster patient centricity in medical drug development through text analytics on real-world data. According to the FDA, patient-centric drug development is “a systematic approach to help ensure that patients’ experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into drug development and evaluation. As experts in what it is like to live with their condition, patients are uniquely positioned to inform the understanding of the therapeutic context for drug development and evaluation”. Crucially, the aforementioned definition refers to real-world patient experience (“what it is like to live with their condition”) rather than clinical outcomes that are regularly measured and evaluated under laboratory conditions in clinical trials. Real-world insights of this kind, comprising self-reported disease burdens,
treatment experience and unmet needs of particular patient populations, are increasingly gaining importance in regulatory approval and value assessment procedures of new drug products. Semalytix provides access to these insights via their Pharos Pharma Analytics platform, based on text analytics from large volumes of patient-reported narratives that are gathered in social media. As an additional source of evidence, health outcomes reported through
medical experts are used to complement the patients’ perspective.