Silvia Benko

Do you have clinical trial nightmares? 🤔 Ilknur Lechthaler, a seasoned expert in clinical operations, research, and startup investments, has over 30 years of experience and has faced many challenges in running clinical trials. She has valuable insights to share from her extensive career on both the CRO and sponsor sides. Ilknur, based in Switzerland, has a strong background in building high-performing teams and achieving outstanding results to improve patient outcomes. She worked as a Global Clinical Operations Director, now advising biotech companies, and pursuing a Master's including AI in Life Sciences. Her expertise lies in global operations, and navigating country-specific requirements affecting decision-making, timelines, and budget constraints. Explore the comments for a snippet of the insightful conversation with Ilknur. 🤗 #clinicaltrials #standardofcare #studyfeasibility #biotech #clinicalresearch #patientrecruitment

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🔍 Freelance Clinical Research Associates (CRAs) are the unsung heroes in the European pharmaceutical landscape. As we navigate through an era where medical innovation is at its peak, the demand for skilled CRAs is skyrocketing. 🚀 In the heart of Europe's bustling healthcare industry, freelance CRAs bring a unique blend of flexibility and expertise. They're the agile operatives behind successful clinical trials, ensuring that new treatments meet the stringent regulatory standards. 📋💊 But why are they so crucial, you ask? Here's the scoop: 1️⃣ Adaptability: With the healthcare sector evolving rapidly, freelance CRAs can adapt to diverse projects with ease, making them invaluable during times of unexpected shifts or when niche expertise is required. 2️⃣ Cost-Effectiveness: For organizations, the ability to hire CRAs on a project-by-project basis is a game-changer. It means access to top talent without the long-term overheads. 💸 3️⃣ Expertise on Demand: Europe's diverse regulatory environment calls for CRAs who can navigate multiple jurisdictions. Freelancers often come with a wealth of experience from various regions and therapeutic areas. 4️⃣ Work-Life Harmony: For the CRAs themselves, freelancing offers a coveted balance. They can choose projects that align with their interests and manage their schedules to fit their lifestyle. 🌟 The bottom line? Freelance CRAs are the linchpin in the wheel of clinical research. They ensure that Europe remains at the forefront of medical advancements while supporting the dynamic needs of the healthcare sector. If you're a freelance CRA based in Europe or looking to dive into this field, now is your time to shine. The industry needs you more than ever! 💪 #ClinicalResearch #FreelanceCRA #HealthcareInnovation #EuropeanPharma #Science #HRS

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Parexel has welcomed Dr. Benedikt Egersdörfer as SVP and Head of Global Data Operations! His 25 years of pharmaceutical and CRO experience will be key as we work to reduce site and patient burden through innovative data collection methods. Read his Q&A to learn what exciting opportunities he sees for GDO in clinical development 👇 #dataoperations #clinicaltrials #clinicaldata

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Roche announced today data from a five-year follow-up of the pivotal phase III POLARIX study evaluating Polivy® (polatuzumab vedotin) in combination with MabThera®/Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) in people with untreated diffuse large B-cell lymphoma (DLBCL). Data were presented in an oral session at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, 7-10 December 2024 in San Diego, US. This latest analysis conducted after a median follow-up of 60.9 months, includes descriptive data on primary and secondary endpoints, as well as safety results. “POLARIX was the first trial to elevate treatment standards for frontline diffuse large B-cell lymphoma in 20 years and we are additionally encouraged by the five-year follow-up results,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “More than 38,000 people worldwide have been treated with Polivy in combination with R-CHP and these data continue to underscore its potential to improve outcomes for people diagnosed with this aggressive lymphoma.” Follow-up exploratory analysis after five-years indicated a positive trend in overall survival (OS) in the intent-to-treat (ITT) population in favour of Polivy in combination with R-CHP compared to MabThera/Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP). Results showed a trend in reduction in the risk of death (HR 0.85; 95% CI: 0.63–1.15) for people with previously untreated DLBCL with the Polivy combination, an improvement on the three-year follow-up data (HR 0.94; 95% CI: 0.67–1.33). The five-year analysis of POLARIX indicates that the full difference in OS between treatment arms has yet to be observed and an additional two years of follow-up will continue. “Diffuse large B-cell lymphoma is a notoriously challenging cancer to treat, however, Polivy in combination with R-CHP has shown to be a critical advance for patients by helping to reduce relapse and disease progression,” said Gilles Salles, MD, PhD, Chief of Lymphoma Service, Division of Hematological Malignancies, Memorial Sloan Kettering Cancer Center, US. “The survival trend seen in this follow-up analysis reinforces the potential impact of frontline treatment with Polivy in combination with R-CHP and its role as a standard of care therapy.” Polivy in combination with R-CHP is currently approved for the treatment of first-line (1L) DLBCL in more than 90 countries worldwide including the US, countries throughout the EU, the UK, Japan, Canada and China. Roche continues to work with health authorities around the world to bring this treatment regimen to even more patients. #clinicalstudy #POLARIX #lymphoma #DLBCL #Polivy #Genentech #Roche

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Learn how our Market Access & Reimbursement Strategy services can help your organization navigate the complex landscape of pricing and reimbursement in Europe.

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THE FUTURE OF THE CRA CRA demand has outrun supply for some time now, driven by increasing trial sizes and the rise of more complicated scientific assets (and therefore complex trial data). Side note: this has also been the main driver in the considerable increase of salaries for experienced CRAs. ⏪ Let’s rewind a bit.. 🔍 The CRA in history: Site assessments, onsite visits for data monitoring, face-to-face site contact, site personnel supervision, post-visit report writing and more. So what’s changed?.. 😷 The CRA was one of the most affected roles during the pandemic, with questions over face-to-face contact and patient safety. 🌍 This, coupled with technology revolution and increasing globalisation of clinical trials, gave further permission to the use of decentralized trials (that is where clinical trial activities take place at locations other than the clinical trial site e.g. a patient’s home or nearby care facility) and remote monitoring (that is, virtual data collection with the use of new digital technology). ✋ Both methods enable more patients to participate in a clinical trial, ultimately increasing participation numbers, retention and diversity. What does this mean for the CRA? 💻 With huge increases in data quantity (and arguably quality), coupled with different data formats and collection methods, the CRA will be required to expand their skill set to data monitor, data analyst and risk analyst. ✍ It is also anticipated that AI will take over a lot of the CRA’s admin responsibility such as data collation and document review, shifting their priorities. 🏥 Whilst historically a CRA would often be seen as site owner, demanding travel schedules often prevented full embracement of this role. With less travel comes more time to dedicate to sites, relationship building, patient flow and ultimately being a true site expert. Will CRAs become data scientists? 🤝 Whilst technology advances are changing the role of a CRA, it’s likely that this may increase the need for the ‘human touch’ with clinical trial sites. ⚙ Without CRAs being on hand to train trial-sites, answer queries and engage site staff, clinical trials would not function. 💡 Having said that, CRA training will need to be re-considered: digital tools, altered data handling and collection, virtual monitoring to name a few. 📚 The CRA is being forced to adapt. Different skills are being required and therefore different candidates will be selected to perform the role if they do not keep up, or are not offered appropriate upskilling support. #CRA #Clinicalresearchassociate #Clinicalresearch #Pharma

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Next stop, #OCTDACH in Zurich! Let’s connect and discuss latest developments in clinical data science. #datascience #clinicaltrials #OCT #biometrics

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#FreelanceStaff #ClinicalTrials #Europe In Europe's dynamic Clinical Trials space, the demand for Freelance Staff is rapidly escalating. 🌟 From navigating regulatory nuances to ensuring trial integrity, freelance professionals bring unparalleled expertise and flexibility to the table. 💼 As trials evolve, the need for specialized skills grows, making freelancers a pivotal resource. Let's collaborate and elevate clinical research together! 💬 #ClinicalResearch #IndependentExperts #InnovateEurope #HRS #Science

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𝗪𝗵𝗮𝘁’𝘀 𝘁𝗵𝗲 𝗯𝗶𝗴𝗴𝗲𝘀𝘁 𝗵𝘂𝗿𝗱𝗹𝗲 𝗶𝗻 𝗳𝗶𝗻𝗱𝗶𝗻𝗴 𝘀𝗲𝗻𝗶𝗼𝗿 𝗖𝗥𝗔𝘀 𝘄𝗶𝘁𝗵 𝗻𝗶𝗰𝗵𝗲 𝗲𝘅𝗽𝗲𝗿𝘁𝗶𝘀𝗲? (𝘏𝘪𝘯𝘵: 𝘪𝘵’𝘴 𝘯𝘰𝘵 𝘢𝘣𝘰𝘶𝘵 𝘵𝘩𝘦 𝘊𝘝..) When it comes to senior-level CRAs for niche trials, there’s a problem: ***** 𝘈 𝘱𝘦𝘳𝘧𝘦𝘤𝘵 𝘊𝘝 𝘢𝘭𝘰𝘯𝘦 𝘸𝘰𝘯’𝘵 𝘤𝘶𝘵 𝘪𝘵. ***** For critical clinical trials in areas like oncology, the stakes are high. A CV might look impressive, but… …without 𝗲𝘅𝗽𝗲𝗿𝗶𝗲𝗻𝗰𝗲 𝗺𝗮𝗻𝗮𝗴𝗶𝗻𝗴 𝗰𝗼𝗺𝗽𝗹𝗲𝘅, 𝗺𝘂𝗹𝘁𝗶-𝘀𝗶𝘁𝗲 𝘁𝗿𝗶𝗮𝗹𝘀 …demonstrated 𝗽𝗿𝗼𝗯𝗹𝗲𝗺-𝘀𝗼𝗹𝘃𝗶𝗻𝗴 𝘀𝗸𝗶𝗹𝗹𝘀 𝗶𝗻 𝗰𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗶𝗻𝗴 𝘀𝗲𝘁𝘁𝗶𝗻𝗴𝘀 …and a solid 𝘂𝗻𝗱𝗲𝗿𝘀𝘁𝗮𝗻𝗱𝗶𝗻𝗴 𝗼𝗳 𝗱𝗶𝘃𝗲𝗿𝘀𝗲 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗱𝗲𝗺𝗮𝗻𝗱𝘀 → 𝗧𝗿𝗶𝗮𝗹𝘀 𝗰𝗮𝗻 𝘀𝘁𝗮𝗹𝗹. Each delay costs time and resources. After 15 years recruiting for niche areas, I’ve learned it’s about much more than ticking boxes. The right CRA: ** 𝘋𝘳𝘪𝘷𝘦 𝘳𝘦𝘴𝘶𝘭𝘵𝘴 ** 𝘖𝘷𝘦𝘳𝘤𝘰𝘮𝘦 𝘴𝘪𝘵𝘦 𝘤𝘩𝘢𝘭𝘭𝘦𝘯𝘨𝘦𝘴 ** 𝘒𝘦𝘦𝘱 𝘵𝘳𝘪𝘢𝘭𝘴 𝘰𝘯 𝘵𝘳𝘢𝘤𝘬 ** 𝘍𝘪𝘵 𝘴𝘦𝘢𝘮𝘭𝘦𝘴𝘴𝘭𝘺 𝘸𝘪𝘵𝘩 𝘵𝘩𝘦 𝘵𝘦𝘢𝘮 That’s the standard I bring to every client - ensuring trials don’t just start strong but stay on course. ------------------- Check out the featured section on my profile to see how I've helped successful trials

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https://lnkd.in/d9BMazVF Interesting article from IQVIA about a tendency of "Near Patient Care" The healthcare sector has increasingly moved towards treating patients at an individual level, both in terms of patient centricity and personalised medicine. As part of this phenomenon there is a growing focus on providing patients with greater flexibility with where and when they receive care. It is important to stress that this movement is not merely looking to increase at-home delivery of medicines, but instead to introduce structural changes to healthcare systems, focusing on treating patients outside of the hospital where feasible. A near-to-patient care system involves moving healthcare closer to the patient, bringing a range of benefits to stakeholders.

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Parexel has welcomed Dr. Benedikt Egersdörfer as SVP and Head of Global Data Operations! His 25 years of pharmaceutical and CRO experience will be key as we work to reduce site and patient burden through innovative data collection methods. Read his Q&A to learn what exciting opportunities he sees for GDO in clinical development 👇 #dataoperations #clinicaltrials #clinicaldata

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Breaking ground in Oncology: Europe's Next Chapter 🌍💡 In an unprecedented move, leading pharmaceutical giants are gearing up for a series of large-scale clinical trials in oncology across Europe. With innovative therapies on the horizon, the focus is sharpening on the critical role of staffing to ensure these trials succeed. Groundbreaking research promises not just hope, but real change. From targeted therapies to immunotherapies, these trials could redefine cancer treatment as we know it. As each phase demands precision and expert knowledge, the need for top-tier clinical researchers, data analysts, and medical professionals is at its peak. Europe stands at the forefront of this endeavour, and it's our shared mission to see it thrive. We're talking cutting-edge science meeting top talent to transform lives. Join the conversation - what's your take on Europe's potential to lead the next wave of oncology breakthroughs? #OncologyInnovation #ClinicalTrials #PharmaCareers #HRS #Science

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The 14th Annual #SalesForceEffectiveness and #DigitalMarketing in #Pharma Summit is coming closer! 📆 Date: 16– 17 October 2024 📍 Location: Berlin Are you a solution provider? Join us as pharmaceutical experts from renowned companies like Galderma , Merck, CSL Vifor, Menarini, Daiichi-Sankyo, Takeda, UCB, Novartis and others are ready to share their expertise, present insightful case studies, and engage in lively discussions. Our top priority is to leave you with only positive impressions, a handful of ideas, and a fruitful ground for innovative discoveries. Here is a sneak peek into some of the central topics: ✅ The most booming pharma marketing trends in 2024 ✅ Artificial Intelligence (AI) and the Cloud ✅ Evolving Commercial Strategies & Models and New Trends in SFE ✅ Customer Centricity & Customer Engagement ✅ Effective marketing strategies to ensure digital marketing success ✅ Commercials team of the future — Changing pharma sales force 📢 RSVP Today! Spaces are limited, so make sure to secure your spot. Connect on LinkedIn Tel: +421 221 021 348 ext: 580 Mail: ardit.saliasi@allanlloyds.com #summit #conference #berlin #digitalmarketing #salesforceeffectiveness  #sales #marketing #pharma #pharmaceutical #speaker #pharmamarketing  #salesforceeffectiveness #pharmacrm #digitalpharma #digitaltransformation #hcp  #pharmaceuticalmarketing #hcpengagement

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Developing an oncology treatment? A holistic, strategic plan from the start is key for success. Fortrea's blog explores considerations for clinical trials, real-world data, and navigating a global landscape. https://lnkd.in/eZXGrY9E #clinicaltrials #research #drugdevelopment

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Recent changes including EUCTR and IVDR are all well intended, but remain to fully realize their benefit. Related delays and other inadvertent consequences contribute to the reduction in availability of trials in for patients across Europe...

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Case Study in 60 seconds Its harder than you think…. Octapharma is one of the worlds largest plasma collection organizations. Plasma is a highly regulated asset requiring ongoing temperature monitoring. Thats hot….sorry Paris A global organization was monitoring temperature…..BY HAND! This leads to human error, asset loss, operational inefficiency and more. The solution - Checkit (LSE: CKT) Sensors and monitoring technology built to eliminate these challenges. Automated monitoring, real time notifications and alerts, security and reliability to monitor your assets even when worst case scenario hacks occur. https://lnkd.in/ecxUdxtP #sensors #temperaturemonitoring #plasma

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𝐅𝐃𝐀 𝐃𝐞𝐜𝐢𝐬𝐢𝐨𝐧 𝐍𝐞𝐰𝐬! The FDA has granted a priority review for Roche's inavolisib, in combination with fulvestrant and Pfizer’s Ibrance (palbociclib), for treating PIK3CA-mutated, HR-positive, HER2-negative breast cancer. This decision sets a date of 27 November for the FDA to evaluate the therapy. The therapy targets adult patients with locally advanced or metastatic breast cancer, especially those experiencing recurrence within 12 months of adjuvant endocrine treatment. Inavolisib, an oral PI3 kinase inhibitor, disrupts PI3K/Akt/mTOR pathway signaling, crucial for cell growth and survival. It also recently received breakthrough therapy designation. The priority review is based on promising results from the Phase III INAVO120 trial, where the combination therapy showed a progression-free survival of 15 months compared to 7.3 months with the standard fulvestrant and Ibrance regimen. Roche is also pursuing regulatory approval in other regions, including with the European Medicines Agency. More detailed data will be presented at the upcoming ASCO Annual Meeting in Chicago from 31 May to 4 June. in other FDA news, Eli Lilly and Company have secured accelerated approval for Retevmo, their treatment for pediatric cancers. Follow Warman O'Brien for all the latest news in life sciences! #oncology #goodnews #fdaapproval #nextsteps

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This is such an exciting project we in MILE - Medical Information Leaders in Europe are undertaking with Datapharm to bring more scientific information directly to healthcare professionals. If we want to say we are #CustomerCentric we must be where they are and in the places they trust. This project will support clinicians finding additional scientific information from our #MedicalInformation departments when they search for the Summary of Product Characteristics (prescribing information) to aid in treating their patients. This pilot project started in the UK on the eMC portal and has now expanded to the Rote Liste in Germany. Our mission in MILE is to create strong frameworks for the provision of robust, balanced medical information and to expand the reach of reliable scientific information for HCPs supporting the safe and effective use of medicines. Please feel feel free to enquire about joining MILE if you are not yet a member company. Please access our website that has freely available the guidance and activities we are undertaking to move Medical Information formation forward in Europe. #medicalcommunication #healthcare #patientsafety #pharma #biotech #multichannel

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🏆OPTIMA Oncology is a complex project with many moving parts that must work cohesively together for us to succeed in our task. 🔬🏥🧩 After 2️⃣ intense days of project updates and open, honest discussions, I am now more aligned with what’s needed from me and also what’s needed from the consortium to successfully move us forward for the benefit of our patients and their families 📊🤝🚀 Let’s let’s keep up the momentum 💙🤍💗 https://lnkd.in/dHwKfYCJ #patientadvocates #lungcancer🤍 #prostatecancer💙 #breastcancer💗 Innovative Health Initiative (IHI) EFPIA - European Federation of Pharmaceutical Industries and Associations European Association of Urology Bayer Pfizer James N'Dow OBE DL Hagen Krüger, MD EMBA Bertrand De Meulder Dr. med. Frederic Kube, MBA Juan Gómez Rivas Torsten Blum Cheryl Tan Eng Hooi (PhD) Lisa Schneider Imran Omar Steven MacLennan ttopstart ARTTIC Mutabor European Lung Foundation

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