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Science Made Me discover the power of data to ensure patient safety
Maria is one of Grünenthal’s Global Safety Leads and takes responsibility for two assets in our portfolio – an investigational medicine and an established brand, a product that has already been on the market for a while. She covers the entire spectrum of the patient safety landscape. In clinical development, an initial safety profile is created with data obtained in the clearly defined framework of clinical trials. Beyond that, medicines are being monitored under real-life conditions to capture the learnings that can only be gained when a product is used outside controlled conditions.
Pharmaceutical Development – safety first, from the very beginning
In pharmaceutical development, the safety of future medicines is the top priority - Safety Leads like Maria are part of the development team from the very start. One of the first things researchers want to exclude when looking at a new compound is that it has the potential to cause serious harm. Therefore, the compound is investigated in a dish (in-vitro) or a living, non-human organism (in-vivo). These so-called pre-clinical trials already provide safety information and how the compound acts in an organism.
While pre-clinical research answers basic questions about a compound’s safety, it is not a substitute for clinical research – trials of how the compound acts in the human body. During Phase I trials, researchers usually test a new drug in healthy volunteers. These trials include close safety monitoring and provide a solid basis for understanding the safety profile of the substance in the targeted dose range. As the compound moves through later clinical trials, the safety profile becomes more evident, but some unknowns usually remain.
Above and beyond clinical trials - real-world evidence
Once a compound succeeds in clinical development, it may be approved by the regulatory authorities. With marketing approval, the medicine is accessible to many patients who will likely not take it under controlled, trial-like conditions. In this phase, Maria and her colleagues play a vital role in monitoring and updating the product’s safety profile. This would be impossible without analysing real-world evidence. Such includes, for instance, reports received directly from healthcare professionals and patients. In addition, various forms of patient records are increasingly available for analysis, many of which are digital – from smartwatch data to sophisticated clinical patient record databases. This provides an incredible amount of data - there is only one problem: the red thread is missing. The data comes from uncontrolled settings, where it is hard to distinguish between the true effects of medications and those occurring due to other exposures.
Maria uses her epidemiology skills to clear the fog, work out patterns and separate real warning signals from the noise. And she doesn’t just do this from behind a desk - being a Global Safety Lead means meeting doctors, nurses and patients, and talking to them about their real-life observations. Maria and her colleagues incorporate essential findings into the product label and co-decide how the product’s safety profile is communicated to patients and healthcare professionals.
Based on careful scientific analysis of various data and driven by high ethical standards, Maria and her colleagues work to make this year’s World Patient Safety Day slogan a promise for patients: “Medication Without Harm”.