Ralf Kuenzi

🔖 We're pleased to share that Heidelberg Pharma AG was featured in Biocentury, in an article titled - Cambrian explosion of ADCs at AACR24 - spotlighting the groundbreaking advancements in #ADCs at #AACR2024. 🔖   The article highlights our #ATAC platform, and its exceptional versatility in targeting both proliferating and quiescent tumour cells. 📚 Read the full article here: https://bit.ly/3VUAb8h   During AACR, we presented Phase I/IIa data on our lead ATAC compound, HDP-101, designed to target BCMA. Promising results were observed in multiple #myeloma patients, with notable responses and manageable side effects.   We look forward to sharing further insights at our R&D webinar on 23 April at 16.00 CEST/15.00 BST, where you can hear directly from the Heidelberg Pharma team, alongside leading Key Opinion Leaders. 🎯 Register to attend the R&D webinar here https://bit.ly/3VYr4U7 #ATAC #ADC #CancerResearch

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+++ 𝗤𝟭 𝗿𝗲𝘀𝘂𝗹𝘁𝘀 𝟮𝟬𝟮𝟰 𝗮𝗻𝗱 𝗰𝗼𝗿𝗽𝗼𝗿𝗮𝘁𝗲 𝘂𝗽𝗱𝗮𝘁𝗲 +++ We started the year with good progress across our oncology pipeline and our commercialization activities. Some key events: 🔬 𝗢𝗻𝗰𝗼𝗹𝗼𝗴𝘆: We and our collaboration partner Duality Biologics dosed the first patient in a Phase 3 clinical trial with our #ADC candidate BNT323/DB-1303 in breast cancer patients, advancing towards BioNTech’s goal of ten or more potentially registrational trials running by the end of 2024. 🩹 𝗖𝗢𝗩𝗜𝗗-𝟭𝟵: We are focusing on preparing for variant-strain adaptation of our COVID-19 vaccine to be ready for a commercial launch ahead of the upcoming 2024/2025 vaccination season, pending approvals. 🌎 𝗖𝗼𝗺𝗺𝗲𝗿𝗰𝗶𝗮𝗹 𝗿𝗲𝗮𝗱𝗶𝗻𝗲𝘀𝘀: We appointed our General Manager Fatma Ocak for the U.S. in line with our commercial preparations to drive our first expected global #oncology product launch. 𝗟𝗶𝗻𝗸 𝘁𝗼 𝗣𝗥 𝗮𝗻𝗱 𝗳𝗼𝗿𝘄𝗮𝗿𝗱-𝗹𝗼𝗼𝗸𝗶𝗻𝗴 𝘀𝘁𝗮𝘁𝗲𝗺𝗲𝗻𝘁𝘀: https://lnkd.in/ePDQiHbH  

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🚀 Exciting News from Kranus Health: Kranus Lutera is now permanently listed and reimbursable 🚀 🎉 We're excited to announce that Kranus Lutera has been granted permanent approval by the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) as a DiGA (digital health application). This marks our second DiGA in the market, reinforcing our mission to transform urology care.  🩺 To the doctors within our network: Kranus Lutera is now available for prescription and reimbursable by German healthcare insurances! 💡 Kranus Lutera translates guidelines for treatment of male Lower Urinary Tract Symptoms (LUTS) into practice. Supported by a rigorous RCT study, Kranus Lutera leads to a significant and clinically relevant improvement in symptom burden, as well as enhancing disease-related quality of life. 🔬 The study, a Level Ib evidence RCT. led by Priv.-Doz. Dr. med. habil. Sandra Schönburg, FEBU (University Hospital Halle) and Prof. Dr. med. Christian Gratzke (University Hospital Freiburg), confirmed Kranus Lutera's efficacy with notable outcomes: - IPSS: Treatment effect of -7 points  - OAB-q-SF-1: Relative improvement of 40.58% in the intervention group  - OAB-q-SF-2: Relative improvement of 46.27% in the intervention group    🚀 Building on these achievements, Kranus Lutera is set to become a new standard therapy for frequent urination caused by BPH or OAB. Kranus Lutera not only aligns with our mission to elevate urology care but also offers a practical option for healthcare professionals looking to improve their patients' quality of life with a holistic therapeutic approach. 

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Together with Corden Pharma - A Full-Service CDMO , we are proud to serve the German government in its pandemic preparedness plans, officially entering the pandemic readiness state as of 1 June 2024. Following a successful expansion and qualification phase, the companies are now in stand-by phase for at least five years. Follow the link to learn more http://wch.ag/c90XE #mRNA #Pandemiebereitschaft #pandemicpreparedness

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The #NotifiedBody plays a central role in the process of becoming a medical device manufacturer. We spoke to Dietmar Schaffarczyk, auditor at QS Schaffhausen AG, to find out more about what the NB expects from young #MedTech startups.   Our key takeaways: ◾ NBs must maintain their independence in their assessments, which is why they must not offer direct advice. ◾ While each company must be compliant, NBs take into account the current status of a company. ◾ Long-term success can only be guaranteed by building internal expertise in addition to external support. ◾ When you first contact an NB for a QMS audit, for example, 65% of the documentation should be ready. Read the full interview here 👉 https://lnkd.in/gTvz9a5e

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Our CEO, Hubertus von Baumbach, underscores in today's edition of Handelsblatt the critical role our votes play in shaping the future of Europe, especially amidst the current challenges. As a company deeply invested in life sciences and pharmaceutical R&D, we echo his call for strengthening European competitiveness in these fields. Let's use our votes to build a stronger, more innovative Europe. Learn more here: https://lnkd.in/enbXBV4n #EuropeanElections #VoteForEurope

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Danke Berlin, Danke Regulatory Affairs Professionals Society (RAPS)! 💡 Our Purdie Pascoe PMCF team attended RAPS Euro Convergence last week, where the plenary session kicked off asked the question: "𝗜𝘀 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗮𝗳𝗳𝗮𝗶𝗿𝘀 𝘀𝗰𝗶𝗲𝗻𝗰𝗲 𝗼𝗿 𝗮𝗿𝘁?" We certainly believe there is an art to ensuring the approaches taken for MDR / IVDR compliance are appropriate! Here are four key learnings that our team observed from the event and shared with us 💡 Tonika Chester / Chris Webb / Alice Robertson Did you attend & learn anything different? If so, please comment below 👇 #RAPS #RAPSEuroConvergence #pmcf #pmcfsurveys

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At MedtecLIVE, Michael M. Kania discussed the current situation between manufacturers and notified bodies and the excessively long certification processes with Christian Johner from the Johner Institut GmbH, Harald Rentschler from mdc medical device certification GmbH and Andreas Purde from TÜV SÜD. The common consensus among the panelists was clear. The solutions must be digital and no longer rely on documents. Only in this way can processes run without friction and the capacities on both sides be used efficiently. #EUMDR #IVDR #MedicalDevices #MedTech #RegulatoryAffairs #Medizintechnik

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🗓️ Happy Factful Friday! According to Susanne Ozegowski, Digitalization & Innovation Lead at the Bundesministerium für Gesundheit, 80% of all laboratory results should be stored in the German electronic patient record (#ePA) by 2027. This ambitious goal highlights the ongoing transformation within our healthcare system towards a more integrated and efficient future. At DasLab, we are dedicated to supporting this transformation by ensuring that lab results are easily accessible and securely stored in #electronicpatientrecords. Having lab results in the ePA is essential for making the ePA useful and relevant for patients and all healthcare stakeholders. Technology can accelerate this transformation. We are proud that our CEO and Co-Founder, Dr. Daniel Fallscheer, is contributing his practical experience as a member of the gematik GmbH Interop Council to help ensure this transformation succeeds as quickly as possible.  🌱 How we contribute:  ✔️Seamless Integration: Our platform ensures that lab results are directly integrated into electronic patient records, enabling healthcare professionals to access comprehensive patient data swiftly and efficiently. ✔️ Improved Patient Care: With lab results readily available in electronic records, healthcare providers can make more informed decisions, leading to better patient outcomes. Join #DasLab in pioneering a future where accessible, secure health data transforms patient care. Together, we can create a seamless healthcare experience that puts patients first. Learn more: https://daslab.health/de Wishing you a healthy and happy weekend! 🌞 #FactfulFriday #DasLab #digitalhealth #ePA #interoperability #healthcare #digitaldiagnostics

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This year, Tenthpin will be a part of Future Labs Live 2024, a leading event dedicated to the future of laboratory innovation and technology. Stefan Kubick and Christoph Matt from Tenthpin will be discussing how Tenthpin Quality Management Evolved (T/QME) supports digital transformation. Their session will cover the benefits of a highly integrated software solution covering Quality Control (QC) and Quality Assurance (QA) processes while leveraging latest SAP technologies.    Future Labs Live brings together over 200 industry leaders to explore advancements in lab automation, digital transformation, and cutting-edge scientific research. The event will feature over 100 exhibitors and attract over 3,000 attendees from around the globe.   Topics including digital transformation in laboratories, lab automation, data analytics and AI in lab environments, quality management and compliance, and future trends in laboratory technology will be covered by industry experts from companies such as Roche, Pfizer, Novartis, Merck Group, Thermo Fisher Scientific, and Bayer, among others.   Join us in Basel on June 26th and 27th, to learn more about the future of lab innovation and how Tenthpin is contributing to this dynamic field. For more details about the event, visit Future Labs Live 2024 -https://lnkd.in/gHvk3Be   #FutureLabsLive2024 #Tenthpin #DigitalTransformation #LabInnovation

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Yesterday, at our Arzneimittelforum, we were privileged to host Swantje Winkler, Senior Preclinical Manager at AOP Health Orphan Pharmaceuticals GmbH. She delivered an insightful talk on 'Toxicology in Drug Development'. Dr. Winkler illuminated the pivotal role of toxicological studies, emphasizing their significance not only in preclinical stages but also in phases 1-3 of clinical trials. Understanding the intricacies of toxicology is crucial in ensuring the safety and efficacy of pharmaceuticals throughout their development journey. A truly enlightening session! #clinicalpharmacology #DrugDevelopment #Toxicology #research #pharmaceuticals #clinicalstudies #learning

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Exciting Times Ahead in Biotech! We are thrilled to share insights from an inspiring event hosted at the Swiss Ambassador’s Residence celebrating the launch of Lonza’s “Cocoon® Cell Therapy Manufacturing Platform”, an automated, scalable cell therapy manufacturing platform, and over four decades of groundbreaking achievements of Lonza in the Japanese market. #Innovation #Healthcare #Biotech 🔬 Lonza's long-standing commitment to fighting global health challenges was highlighted, notably its collaboration with Moderna during the COVID-19 pandemic which significantly scaled up mRNA vaccine production. This partnership is a prime example of how strategic collaborations can accelerate solutions to urgent global health issues. 💡 The event focused on Lonza's "Cocoon® Cell Therapy Manufacturing Platform," a game-changing innovation in biotech. This platform is revolutionizing how we approach cell therapy, making treatments more accessible by enhancing the efficiency and cost-effectiveness of drug development from clinical trials to commercial manufacturing. It's exciting to note that dozens of patients have already benefited from cancer immunotherapies produced using this technology. 🌐 The event also emphasized the critical role of open innovation and private-public partnerships in advancing medical science. The diverse audience, including leaders from Japanese pharma, venture capital, academia, and government, underscores a collective commitment to transformative healthcare solutions. Let's continue to support and drive the spirit of collaboration for a healthier future! 🌍💪 #Lonza #CocoonPlatform #MedicalInnovation #PublicPrivatePartnership #openinnovation Thank you to Lonza and the Embassy of Switzerland in Japan for orchestrating such a forward-thinking gathering together with us. Here’s to more breakthroughs and partnerships that lead us toward a brighter, healthier world! 👏👏👏

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𝐓𝐨𝐝𝐚𝐲 𝐢𝐬 "𝐖𝐨𝐫𝐥𝐝 𝐈𝐁𝐃 𝐃𝐚𝐲" 📅 𝐓𝐡𝐞𝐫𝐞 𝐢𝐬 𝐧𝐨 𝐜𝐮𝐫𝐞 𝐟𝐨𝐫 𝐢𝐧𝐟𝐥𝐚𝐦𝐦𝐚𝐭𝐨𝐫𝐲 𝐛𝐨𝐰𝐞𝐥 𝐝𝐢𝐬𝐞𝐚𝐬𝐞. 𝐓𝐡𝐞 𝐜𝐚𝐮𝐬𝐞𝐬 𝐚𝐫𝐞 𝐮𝐧𝐤𝐧𝐨𝐰𝐧 𝐚𝐧𝐝 𝐭𝐡𝐞 𝐥𝐞𝐯𝐞𝐥 𝐨𝐟 𝐬𝐮𝐟𝐟𝐞𝐫𝐢𝐧𝐠 𝐢𝐬 𝐨𝐟𝐭𝐞𝐧 𝐡𝐢𝐠𝐡 𝐟𝐨𝐫 𝐚𝐟𝐟𝐞𝐜𝐭𝐞𝐝 𝐩𝐞𝐨𝐩𝐥𝐞 𝐨𝐟 𝐚𝐥𝐥 𝐚𝐠𝐞𝐬. This is why it is so important not only to raise awareness of these indications, but also to optimize processes in the healthcare system in order to bring treatment alternatives to patients as quickly as possible. Our path goes through the #pharma companies that want to reach the relevant #HCPs. For Crohn's disease and ulcerative colitis, we have carried out a rough #targeting exclusively on these two terms, which on the one hand takes into account the global research situation and on the other hand also examines the treatment situation specifically in Germany. This is obviously not sufficient for our pharmaceutical projects. A content frame would completely refine the targeting and the figures below can therefore change dynamically in both directions depending on the specificity. The #AI of Vertical Search Health identifies the papers relevant to these two indications worldwide in order to filter out research-relevant HCPs around the world that have recently devoted themselves to this topic or which HCPs have collaborated on it. This would be a possible segmentation approach. For individual countries, a further segmentation approach is added that relates to the relevant practices. Using Germany as an example, we have analyzed the entire outpatient healthcare market so that 2 segmentations are possible, as in the example below. Other options, such as web search or the patient perspective, can also be added. The pharmaceutical industry is working tirelessly on new drug innovations in the indication of #IBD - we are pleased to be part of it with our data to identify exactly the most relevant doctors who then bring the innovations to the patients. Marcus Bergler Karsten Schmidt Gaby Perfahl Wolfgang Höfers Torsten B. Christann AbbVie Bristol Myers Squibb Immundiagnostik AG Takeda in Deutschland Dr. Falk Pharma Alfasigma Biogen Fresenius Kabi Amgen Nestlé Health Science

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The 26 May deadline for manufacturers to have an MDR compliant QMS and to lodge an application with a Notified Body, is almost here! Join Maddalena Pinsi, Senior Regulatory Lead & Associate Head of Medical Devices at BSI, as she walks you through our “Steps towards MDR transition” last episode. Stay tuned for the upcoming video series and visit our MDR dedicated webpage: https://bit.ly/3KvcrRj #BSI #MedicalDevices #StepsTowardsMDRTransition

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PharmaLedger Association Welcomes Stefan Schwarzfischer, Dr.-Eng. as Vice Chairperson of our Board of Directors! As a patient-centered organization, PharmaLedger fosters collaboration among member companies like Spectral Engines to develop innovative tech solutions. From Spectral Engines, Stefan has a strong background in AI and blockchain integration that aligns well with PharmaLedger's mission to build a secure and efficient digital healthcare ecosystem. In the following LI article you can read Stefan's ideas about how vulnerabilities in medical supply chains can be solved with blockchain technology to improve efficiency, security, and product authenticity. https://lnkd.in/eDEvXuNS A strong advocate for user-friendly solutions, Stefan's leadership, coupled with the dedication of our members, positions PLA to build a secure and efficient future for Healthcare 4.0, with patient well-being at the forefront. We are happy to have him on board! #collaboration #digitalhealthcaresolutions #healthcare4.0

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Workshops play a vital part in the success of our products, giving us a chance to tailor our methods for the customers needs. In this episode of RHÔNE infobites Claire Milligan and Christine Maria Gutschelhofer, Territory Manager at R-Biopharm AG, discuss the trainings offered by R-Biopharm and how they can be beneficial. Listen or watch the episode here - linktr.ee/rhoneinfobites #rbiopharm #rbiopharmrhone #training #customertraining

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Successful internationalization of Key2Compliance As a consultant for Quality and Regulatory Affairs, Claudia Dannehl is our cornerstone for successfully advising medical device manufacturers in German-speaking countries. Get to know her now in our interesting interview and make an appointment to talk to her about current challenges! What brings you to the GBA Group? I am the first colleague for Quality and Regulatory Affairs for the DACH region and work closely with colleagues from Key2Compliance in Sweden and Denmark. What background and experience do you have with medical devices? I studied physics and did my doctorate in biophysics. I then helped build up the QA/RA department in two medical technology start-ups. Before I joined the GBA Group, I worked as a QA/RA consultant at another Scandinavian company. Thus, I am familiar with both the regulatory requirements and the specific challenges that (young) medical technology companies face in Germany and Scandinavia. Additionally, I am an active member of the German Society for Quality (DGQ e.V.). There I am part of the Berlin regional committee and also co-organizer of the supra-regional exchange of experience on medical devices. Where do you see the greatest potential in integrating Key2Compliance into the GBA Group? Key2Compliance has an excellent network of experts. During my time with manufacturers, I would have appreciated the opportunity to obtain testing and documentation from a single sourceCompanies often fear that obtaining all services from a single source will be more expensive. However, by allowing colleagues at the service provider to coordinate with each other, the opposite is often the case. Do you have experience with biological assessments? Yes, I have written several biological assessments according to ISO 10993-1. From feedback on the submission of clinical studies, I know that biological evaluation is one of the most challenging topics for manufacturers, next to clinical evaluation, as it requires a deep understanding of the underlying processes. Toxicology is not something you can learn on the side. What topics are you particularly interested in? The exciting thing about medical devices is the variety - both in terms of products and the tasks that need to be mastered. QA/RA is more than just documentation, it's often like a puzzle with 5,000 pieces. It's fascinating to be able to look at each piece in detail. Incidentally, I also do this in my podcast, which I regularly publish with my co-host on all common platforms. The quickest way to find our 'medical product talk' is here: https://lnkd.in/ecwC9fvS #GBAGroup #Key2Compliance #medicaldevices #quality #international

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Curious about how Origify can transform pharmaceutical authentication 🏥? Explore our approach in the latest pharmind article by ECV - Editio Cantor Verlag GmbH titled "Digitaler Fingerabdruck: Authentifizierung für Medizin- und Pharmaprodukte“. Discover more by following this link 🔗: https://lnkd.in/ejdzrWkU, and don't hesitate to share your thoughts in the comments section below 📝.   #Bosch #Origify #ProductAuthentication #PharmaceuticalAuthentication #DigitalFingerprint #Pharmind  

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