More than Just Paper Shuffling and Regulations​

Yvonne Nanciu joined the Safety Signals Podcast to explain how Pharmacovigilance can be a rich and rewarding field. A doctor with a background as a geneticist, Yuvonne Nanciu switched to pharmacovigilance after a family move to Germany. She started out at the very bottom, and now serves as Country Head Pharmacovigilance Germany at Bayer Pharmaceuticals.

Dr. Nanciu also lectures on pharmacovigilance at various universities in Germany. Noting that there’s no single path to a fulfilling career in pharmacovigilance, she’s encouraged to see that the field is attracting curious, innovative minds from diverse backgrounds. “For me, I was also working in the laboratory,” she recalls of her transition to the field. “As a scientist that’s helped me look to the data in a very thorough and analytical manner. And then my clinical genetics is the part where I was looking at patients, which has been [helpful]  to see the bigger picture.”

Dr. Nanciu stresses that pharmacovigilance is a lot more exciting than it may seem. “You are not only moving papers…or entering data in a database,” she says. “When you receive a report, you have to think about what has happened before…the entire drug development phase until the product was provided to the first patient. And then also the journey of this product, once it’s on the market….When you get out there in the real world and you have all those patients, you really have to consider everything to make sure that the risks are always less than the benefits of the drug. And you consider always the whole, not only one product, not only one adverse event, but you have to consider patient population types, drug interactions, etc.”

Pulling What You Need from Massive Amounts of Data

One of the biggest challenges in teasing out safety signals, according to Dr. Nanciu, is to “separate lentils from ashes, if you’d like to go with the story of Cinderella.” Pharmacovigilance professionals have access to massive amounts of data, but it’s important to know what information is valuable and what isn’t. For example, she warns practitioners to avoid “alert fatigue,” or the condition of being faced with so many low-level alerts that the significance of high-level alerts are missed.

Dr. Nanciu is hopeful that predictive analytics will help safety scientists better understand risk profiles as products move from clinical trials and commercial launch to the post marketing phase. Gene prescription data, for example, could be used to predict adverse events in human beings taking specific drugs and to identify new targets, according to Dr. Nanciu.

The Importance of Patient Centricity

Patient centricity is another issue that’s important to Dr. Nanciu. “There are regulations and guidance updated from global…authorities, and they are requiring the marketing authorization holder to provide information on how patients…interact with the product in the real world,” she says. “And we need to ensure that we are able to generate these insights from the real world regarding the patient’s disease, the preferences of patients, or sit down and say, what would make a patient compliant with his or her medication? What are the patient’s expectations for an outcome? What they would like, and what is acceptable for them as an adverse event or quality of life, because this might be different than what we think it is. And actually, we should include behavioral sciences in drug development as well. This…has been introduced in generic product development, not drug development, for a long time now, but we should also consider this to create these patient centered guides, applications, and tools, and help us in the end, create better drugs for our patients.”

Dr. Nanciu is eager to see pharmacovigilance professionals and marketing teams work together to create “patient guides that are really for a patient, not written by scientists for scientists.”

This would require using simple language to explain what might happen to the patient when they take a drug. She also believes that patients should be able to choose the level of detail they want in that explanation. “Of course, [in] our summary of product characteristics you list everything there because it’s a regulatory obligation,” she says. “But if you ask the patient, depending on the disease of course, but they will say, ‘You know what, I don’t want to hear about all these adverse events in the tiniest of details, just give me…the big picture.’ Or other ones, they really want to go into detail. And we have to try to build these possibilities for them as well.”

This post is based on an episode of the Safety Signals podcast. To hear more, check us out on Apple Podcasts, Spotify, or on our website.

The views of the hosts and guests featured on Safety Signals are their own and do not necessarily reflect the views of Saama or the individual companies for which the guests may work.