Jutta Kristen

What does patient safety actually mean? After our Patient Safety Day Daiichi Sankyo Europe GmbH, I am more convinced than ever: it is about seeing the whole person, not just the treatment. We were privileged to hear directly from Diana Dragu and Katharina Bauer about the realities shaping their lives during treatment – from fertility and lactation, to the safety of their families at home, to the need for honest conversations about future plans. These are not “side topics” – they are central to patient safety. Pharmacovigilance helps us capture these lived experiences and turn them into knowledge we can act on. Listening alone is not enough. It is our responsibility to ensure these insights lead to tangible changes – in how we design our studies, how we counsel patients, and how we make sure our approach to treatment considers real-world needs. I cannot emphasize enough that patient safety is truly a shared mission. From Medical Affairs to Pharmacovigilance, from clinical teams to affiliates, each of us plays an important role in making sure treatments are not only effective but also safe and supportive. To patients and families – what aspects of safety matter most to you during and after treatment? 

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We hear it too often: healthcare systems are under immense cost pressure, and millions of patients still lack access to essential treatments. On October 13, I’ll be joining a panel of global health experts for the first ever @Sandoz Talking Biosimilars event, held at the World Health Summit in Berlin, in partnership with IQVIA. This discussion comes at a pivotal moment for healthcare systems worldwide. Over the next decade, biologic medicines worth more than USD 300 billion in peak sales are due to lose exclusivity. In Europe alone, an IQVIA study estimates that 110 biologics will lose IP protection by end 2032. However, the same study shows that approx. 80% of these products by value are currently unlikely to face competition, resulting in a missed opportunity for payers and patients: the so-called ‘biosimilar void’. Bringing together stakeholders from across the healthcare ecosystem, the session aims to drive action to address the biosimilar void and expand patient access to biosimilars. I’m looking forward to exchanging ideas with leaders who share our commitment to access and equity. 🔗 Register now to join online and in-person: https://lnkd.in/eCcX5jGV #WHS2025 #PioneeringAccess

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💡 Valuable input to the ongoing discussion on equitable access to medicines: Roche CEO Thomas Schinecker highlighted that it would be “very easy” to cut US drug prices by 50%—by removing intermediaries and enabling direct-to-patient distribution. According to Schinecker, half of supply chain earnings currently go to middlemen who take “zero risk” in the innovation process. This dialogue underscores a key challenge: ensuring broad access to life-saving therapies while preserving the necessary incentives for those who invest heavily and take the scientific and financial risks to innovate for patients in need. HealthcarePolicy #PharmaInnovation #DrugPricing #AccessToMedicine #Biopharma

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Where do we stand on the Section 232 investigation in pharmaceuticals – and what should the EU do? The announcement on U.S. tariffs is a reminder that we cannot take the global competitiveness of Europe’s pharmaceutical and biotech sector for granted. For decades, medicines were rightly excluded from tariffs under WTO rules. Now, with a 15% cap in place, innovation has been disadvantaged — while generics were prioritized. But without innovation, there are no generics. We appreciate that the European Commission has taken the importance of pharmaceuticals into account and avoided reciprocal tariffs on finished medicines. A compromise was needed — but the real question is how Europe responds. 👉 The answer must be competitiveness. That means not only adopting new initiatives such as the Biotech Act, the Critical Medicines Act and the pharma package — but also making sure they work together coherently. 👉 It also means enforcing existing legislation, like the Transparency Directive, and implementing the EU HTA system in a way that is scientifically sound and genuinely welcomes innovation. 👉 And it means addressing looming risks like “most favoured nation” pricing, which could impact patient access just as seriously as tariffs. If Europe wants to remain an attractive home for R&D, manufacturing, and biotech clusters, it must provide predictability in reimbursement and ensure incentives for innovators. Otherwise, we risk seeing the kinds of access problems already visible in the UK, where a breast cancer medicine was recently not made available to patients due to the financial environment. The next months will be decisive. Europe has the chance to build an innovation-friendly framework that strengthens its pharmaceutical and biotech sector — not undermine it. https://lnkd.in/eFtbUHNy

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Gather around and let me tell you a story about science, real-world data, and weight-loss drugs!   I promise you that it’s got it all: High-profile presentations. Contradictory results. Bold claims. Huge investments. Major public health impact. Big pharma. And a guy called Nils.   The scene is the European Society for Cardiology’s 2025 congress held in Madrid.   A session is going on. New data is presented: How do the new weight-loss drugs  Wegovy and Mounjaro perform when it comes to protect the heart?   First up is a pharmaceutical company presenting post-hoc results from their open-label, 72 week SURMOUNT-5 trial. This trial showed that Mounjaro “won” over Wegovy regarding weight loss. In their new analysis, they translate this into a large reduction in “10-year risk of cardiovascular disease” and—after some extrapolation—estimate that millions of deaths could be prevented if the drug was widely used.   Next is another pharmaceutical company, presenting their observational STEER study based on US claims data. They found that Wegovy (semaglutide) was associated with a much lower risk of cardiovascular disease than Mounjaro (tirzpeatide). Up to 60%! They conclude that the cardiovascular preventative potential of Wegovy is huge.   Finally, there’s the guy called Nils. He presents results from a study conducted by an independent academic group, which has just been published in JAMA (DOI: 10.1001/jama.2025.14092). Their study shows that both drugs provide important cardiovascular benefits and that the two drugs are equally effective.   You might expect me to end the story here, declaring Nils the hero. But no...   The thing is that this situation is not particularly unique. Often, we are faced with several studies with conflicting results. And we need to decide what to do.   The situation can often not be resolved. "It’s probably slightly different patient populations". "The numbers are what they are". "Not much we can do about it".   But this time it was different. Because the independent study had one feature that made interpretation easier:   Transparency!   All of their decisions during the planning of the study were documented in a protocol that they pre-registered in a public repository. Amendments to the protocol were updated contemporaneously. And once the study was complete, they had also published all of their analytical code.   This level of transparency gives users of this evidence a much better understanding of what was done and why. And it is instrumental in allowing us to interpret differences between studies.   It also makes me much more trusting of the evidence generated.   For real-world evidence to realize its full potential, we need to do better in terms of transparency and reproducibility.   The path forward is the one so wonderfully illustrated by this independent group. I hope the field will follow! 

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"𝐇𝐨𝐰 𝐭𝐨: 𝐬𝐮𝐜𝐜𝐞𝐬𝐬 𝐝𝐫𝐢𝐯𝐞𝐧 𝐀𝐈 𝐢𝐧𝐢𝐭𝐢𝐚𝐭𝐢𝐯𝐞𝐬" - I presented a 𝐬𝐞𝐭 𝐨𝐟 𝐚𝐜𝐭𝐢𝐨𝐧𝐚𝐛𝐥𝐞 𝐚𝐝𝐯𝐢𝐜𝐞𝐬 yesterday at Arvato Life Science Symposium. 𝐇𝐞𝐫𝐞 𝐭𝐡𝐞𝐲 𝐚𝐫𝐞 𝐟𝐨𝐫 𝐲𝐨𝐮 ⬇️ After a day full of learnings and panels I had the privilege of giving a closing keynote of the day The brilliant Dr. Danica Hilliard was so kind to introduce me to the stage and help me with my opening note: 𝐋𝐚𝐬𝐭 𝐦𝐨𝐧𝐭𝐡 𝐌𝐈𝐓 𝐩𝐮𝐛𝐥𝐢𝐬𝐡𝐞𝐝 𝐭𝐡𝐚𝐭 𝟗𝟓% 𝐨𝐟 𝐀𝐈 𝐩𝐢𝐥𝐨𝐭𝐬 𝐟𝐚𝐢𝐥 𝐚𝐧𝐝/ 𝐬𝐭𝐫𝐮𝐠𝐠𝐥𝐞 𝐭𝐨 𝐬𝐜𝐚𝐥𝐞 The reason is not the technology itself. The reasons named in the paper will seem familiar to you since they have been a topic that I have been observing across #pharma and posting about here for the last 2,5 years: - AI is treated as a technology to deploy instead of transformation  - change management has been underestimated  - senior leadership focus has not been maintained and founds were redirected  - initiatives were driven by technology possibilities and not tied to business strategy  - #AI Literacy & upskilling were not prioritised enough  - adoption rates were higher where line managers (instead of AI Labs) drove change 𝐖𝐡𝐚𝐭 𝐈 𝐚𝐝𝐯𝐢𝐬𝐞𝐝: Start with understanding the scene! (Take a look at the statistics on the slide in the picture!) Fear, fear, we need AI, but how to do it?? There was a 5th statistics presented: Over 40% of leaders who are extremely familiar with the technology plan to redesign processes from the ground up in the next 5years! Last year, I led scoping of a one-source-of-truth initiative aimed at providing tailored and instantaneous insights into Genmab's pipeline and research data - status and plans - based on high quality data. 𝐇𝐨𝐰 𝐭𝐨 𝐝𝐫𝐢𝐯𝐞 𝐬𝐮𝐜𝐜𝐞𝐬𝐬? - problem statement came from our CEO - I asked for a senior team (SR director - VP) to align on the vision (we had 5 different ones to start with) once we aligned these people became ambassadors of the project - clear on what we are doing & why - clear on what we are NOT doing and why - I conducted >50 interviews to scope well - we used these to asses stakeholder readiness and change management needed - we early on communicated up! that this is not just a sexy AI project, this actually is a long term investment into our data structure & quality  - our early roadmap already planned what scale will look like If you want to see my 𝟓 𝐚𝐝𝐯𝐢𝐜𝐞𝐬 that were the take-aways for the audience - see the first comment. Did you know that I advise companies on AI initiatives? DM me. What do you think needs to happen to support the success of AI initiatives? ⬇️ ---- Hi, I’m Marcelina, I help life science companies adopt AI and Senior Leaders - lead this transformation by example, with vision & confidence.

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