• Understanding why unexplained Serious Adverse Events happen can be very challenging.
• ELS’ guiding belief is that behind most ‘idiopathic’ adverse drug responses lie specific mechanisms. With enough effort, insight, and scientific innovation ELS believes the causal relationship behind these adverse events can eventually be fully understood.
• When studying an adverse event, ELS and its collaborators use a wide variety of analytical techniques to generate credible causal hypotheses. Did it arise due to a physical difference or a genetic mutation? Is it linked to the presence of a specific disease, virus, or co-administered medication?
• If a hypothesis survives critical review, ELS will then fund the necessary clinical or genomic work to quantitatively determine if a causal relationship exists using test designs and standards developed by the FDA and other global regulators.