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🫂 Happy Thanksgiving Week 🙏 🌟 COG: CRO Summit Content Preview 🌟 Section E: Site Relationships Catherine Gregor (Florence Healthcare) will explore site enablement technology and its impact on trial efficiency. Her session will demonstrate how innovative tools can streamline study start-up, improve data quality, and optimize resource allocation. She will provide practical insights for implementing these technologies to enhance site performance. Chris A. Learn, Ph.D, PMP (Parexel) will discuss site collaboration in cell and gene therapy trials. He will address site identification best practices across the US and Europe, focusing on staff upskilling strategies. The presentation will cover training approaches and site selection criteria specific to these specialized trials, aiming to optimize site engagement in advanced therapeutic studies. COG: CRO Summit brings together #contractresearchorganization leaders to discuss the latest innovations, challenges, and opportunities in the global #clinicaldevelopment landscape. Held on the 3rd & 4th December, at the Raleigh Marriott City Center. Free registration, and further information found here: https://lnkd.in/ew8U_6nq

Next week, we’ll be in Dallas for #ATW25! We recently sat down with Boro Dropulić to capture 3 Key Topics ahead of the event. His activity on-site spans several areas with many groups of industry leaders. We’ve distilled some of his thoughts below to start the discussion around vector and gene therapy workflows. 1️⃣ – 💰 A Refocus on Costs and Manufacturing: CAR-T and other cellular therapies are too expensive. This limits access to transformative therapies for patients in need. We need to lower their cost of production and develop alternative modalities for their distribution beyond the current centralized manufacturing paradigm. Lowering the cost of manufacturing can be addressed in several ways. Lowering the cost of materials, e.g., vector, will create a rippling effect that lowers the bar for development and manufacturing. Vector BioMed, Inc. (VBM) was founded to help address the high cost of vector. VBM has developed a more efficient process and has passed on these savings to partners. VBM GMP vector is about half the price of leading offerings. 2️⃣ – 🏥 Point of Care: We also need alternative modalities for distribution since centralized manufacturing is not cost effective. Point of care offers an alternative approach for reducing the cost by manufacturing therapeutics where patients come for care. 3️⃣ – 🌐 Global Advancement: One major hurdle that still burdens the industry’s progress is global access and localization of development and manufacturing. There needs to be a push and an enablement so that developing areas of the world can manufacture their own products. This removes borders and puts processes and products into the hands of LMIC – where there are limited resources. In which case, it will be easier to support growing healthcare needs in those countries. 📖 Learn more about Vector BioMed, Inc. lentiviral vector services 👉 https://lnkd.in/ehymXDUp 🤝 Request a meeting at #ATW25 with our team members using the ATW Event App https://lnkd.in/eXUbz9TZ, our contact form https://lnkd.in/eD4wbBES, or email us directly at partner@vectorbiomed.com. #ATW25 #CGT #AdvancedTherapies #advancedtherapiesweek #cellandgenetherapy #lentiviralvector #BiotechLeaders #NextGenTherapies #CARTcellTherapy

Kate Cullen, PhD, MRes, and Isobel Owens-Smith, MSc, will be presenting on The Cost of Innovation: Evaluating the Evolution of Willingness-to-Pay for CAR-T Therapies in Germany at ISPOR 2024. Don't miss this opportunity to gain critical insights into the evolving landscape of CAR-T therapy reimbursement! Join us at Poster Session 5 on Wednesday, November 20, 2024, from 9:00 AM to 10:00 AM to explore the changing dynamics of CAR-T therapy pricing and reimbursement in Germany since 2018. Our analysis provides valuable insights into how the German market has adapted to these groundbreaking therapies since their introduction. Understanding these trends is essential for: • Developing effective pricing and market access strategies • Anticipating future reimbursement challenges for innovative therapies • Balancing innovation with healthcare system sustainability Don't miss this opportunity to stay ahead of the curve in the rapidly evolving field of cell and gene therapies. Our experts will be available to discuss how these findings can impact your specific projects and challenges. Ready to optimize your approach to innovative therapy development and commercialization? Let's connect at ISPOR 2024 and schedule a meeting to explore how these insights can benefit your organization. 🔴 🧠 🔬 #ISPOR2024 #CART #MarketAccess #HealthcareInnovation #Reimbursement

🌟 A Landmark Event for GenScript Europe! 🌟 We are thrilled to announce the successful debut of the GenScript Biotech Global Forum in Europe, held in the vibrant city of London, UK! 🎉 Since its launch at the J.P. Morgan Healthcare Conference in San Francisco in 2020, the GenScript Biotech Global Forum has become a cornerstone for discussions on advancing cell and gene therapy (CGT). This year, we brought this prestigious platform to Europe for the first time, marking a significant step in fostering global innovation and collaboration in CGT. The forum provided a stage for leading experts, researchers, and industry pioneers to discuss some of the most pressing topics in CGT: 🔬 Strategies for accelerating the translation of cutting-edge research into life-saving therapies. 🌍 The critical role of global partnerships in overcoming regulatory and scalability challenges. 💡 Innovations in manufacturing technologies and solutions driving efficiency in therapeutic development. This event underscores GenScript’s commitment to empowering the scientific community and bridging the gap between discovery and clinical breakthroughs. A big thank you to all our speakers and attendees for making this such a remarkable event! 📖 Click here to learn more about the event here: https://bit.ly/4fZHX7o 🌐 And don't miss our upcoming one on Wednesday 15th January 2025 at San Francisco Marriott Marquis in the US on Challenges and Opportunities of Cell and Gene Therapy in the New Era: https://lnkd.in/eZ8ykjsY #CellAndGeneTherapy #GeneTherapy #JPMorgan #HealthcareConference #Innovation #GlobalCollaboration

Today, I found a fascinating webinar: The Simple Way to Advance Protein Research presented by Chris Heger, Ph.D. Bio-Techne, where the revolutionary LEO Simple Western Technology was unveiled! 🌟 This cutting-edge innovation is a game-changer, offering a fully automated alternative to traditional Western blotting and other Simple Western methods. LEO stands out with its impressive capabilities: it requires minimal sample volumes, processes up to 100 samples per run, enhances protein quantitation with exceptional specificity and size resolution, and even enables the quantification of protein isoforms. 🚀 This breakthrough immunoassay method is set to transform research in fields like vaccine development, cell and gene therapies, and clinical biomarker discovery by significantly boosting speed and accuracy. A huge thanks to Labroots for hosting such an insightful event! 👏 #protein #westernblot #research

On the second day of #LogiPharma, Tamas Masztis Masztis, Frank Binder and Scott Ohanesian emphasized the need to improve #HCP experience. They indicated that one way to achieve this is to let go off proprietary and customized treatment center portals that enable HCP-facing processes. It's great to see that the #CGT industry discourse has evolved, and that we're not alone in proposing this concept anymore. When we started preparing for the first CAR-T launches, there was only one school of thought: proprietary, custom portals are needed for competitive differentiation. Now, we recognize that proprietary portals are not required for positive differentiation. Instead, the focus ought to be on process execution and the product. Thanks to our partnership with #Roche, together, we took a leadership role and stood up a cross-sector industry consortium to identify opportunities to harmonize HCP-facing processes. We leveraged collective information and designed and built #Unify, a universal treatment center portal for Cell and Gene that is currently being used for a commercial gene therapy. #LogiPharma #CGT #Unify #HCP #CellTherapy #GeneTherapy Stuart Henderson, Brad Michel, James Crowley, Dr. Petra Jantzer, Ray Pressburger, Martin F. Brunner Tony Romito

🚀 Exciting Updates from ISCT 2024! Last week, our CCRM Nordic team members Fredrik Wessberg, Sarah Callens, Juliana Kovacka, and Stephanie Mattsson had the privilege of attending the ISCT, International Society for Cell & Gene Therapy 2024 conference, and we're thrilled to have witnessed groundbreaking developments and discussions that are shaping the future of cell and gene therapy. Among the notable unveilings was Cytiva's new platform for autologous CAR-Ts, a testament to the industry's growth and continuous innovation in cell processing technologies. Below are some additional highlights: 🔬 CMC - A Persistent Challenge: The conference reaffirmed that CMC remains a hot topic. The field is grappling with a knowledge and resource gap, underscoring the importance of a robust plan from inception to ensure quality and compliance. 💡 Innovative Risk Mitigation: CMC is core to de-risk investments in regenerative medicine. The industry is working on several ways of evolving CMC and risk mitigation, which we think is prudent and paves the way for more confident investments in ATMPs. 🧬 The Promise of iPSCs: The potential of iPSCs continues to excite the scientific community. However, the lack of standardized protocols and benchmarks is a hurdle that needs to be addressed to fully harness their promise. At CCRM Nordic, we're committed to staying at the forefront of these discussions, contributing to the solutions, and driving the industry forward. Reach out if you’re interested in discussing these topics further! Do you have any takeaways worth highlighting? Please share! #ISCT2024 #CellTherapy #GeneTherapy #CMC #iPSC #Innovation #CCRMNordic

Have you checked out the Azenta Life Sciences #BridgingTheGap webinar series focused on current and future state of the cell and gene therapy space? Featuring prominent guest speakers spanning fields from scientific discovery to clinical introduction of cell and gene therapies, this webinar series roundtable is created by leaders in the field for their peers. Join us and be sure to register for the series! #celltherapy #genetherapy

🚀Introducing Our New ICEX VIVES Fellow!   We are excited to welcome Jurgi Perez, our new ICEX VIVES fellow, who will be collaborating with PROGEN in Heidelberg to support the commercial efforts of DIVERSA's advanced lipid nanoparticles for drug delivery and gene therapy 💊🧬 After an intensive two-week training with our team, Jurgi is ready to work alongside our partners in Germany, applying the valuable insights gained from DIVERSA’s innovative technology. As highlighted by Jurgi, here are the key strengths of DIVERSA’s technology: 🔹User-friendly formulation: "Simple calculations and pipetting-based formulation. Ready to go!" 🔹Biocompatibility: "Transfected cells thrive with DIVERSA!" 🔹Modularity and Flexibility: "Comprehensively and effortlessly customizable." 🔹Scalability: "A huge gain vs viral vectors! Forget costly and tedious purification processes and cell culture." With Jurgi now in Heidelberg, we look forward to strengthening our collaboration with PROGEN and expanding the reach of our lipid nanoparticle solutions. #InnovationInBiotech #DrugDelivery #GeneTherapy #LipidNanoparticles #Biotechnology #ICEXVIVES #Nanomedicine #NextGenTherapies

CROs: The Key to Unlocking Cell & Gene Therapy Access With over 2,500 CAGT trials underway, top research centres are at capacity, limiting patient access and diversity. CROs—you hold the power to scale this innovation. Here's how: ➡️ Support Community Sites: Bridge gaps, build partnerships with hospitals and blood centres. ➡️Advocate for Simplified Protocols: Help sponsors streamline trials to reduce site strain. ➡️Drive Collaboration: Facilitate connections between sponsors and emerging research hubs. Read more on how CROs can drive this change: https://lnkd.in/dU6WtgcY #CROs #CellAndGeneTherapy #ClinicalTrials #Innovation