Want to learn more about Cell & Gene Therapy? Join us for Society of Actuaries upcoming webcast: "Pricing Cell and Gene Coverage - Actuarial Update" 🗓️ Date: November 4, 2024 🕒 Duration: 12:00 - 1:30PM EST ✅ Credits: 1.80 SOA CPD; 1.50 CIA Credits In this session, Sarah Emond, MPP, President and CEO, Institute for Clinical and Economic Review (ICER), Ashley Hume, President at Emerging Therapy Solutions, and David Wilson, FSA, FCIA, MAAA, Founder at Windsor Strategy Partners, Inc., will explore: 🔍 How ICER assesses the value of these innovative therapies 💰 Insights on manufacturer pricing strategies 📊 Key actuarial factors in determining reinsurance costs 🚀 The FDA’s expanding approval pipeline for new therapies This session is relevant for all experience levels and promises valuable insights into pricing and product development, risk management, and more! Don’t miss the chance to enhance your skills and stay ahead in this rapidly evolving Cell and Gene therapy world! 👉 Register now at https://lnkd.in/gRd7VC_C #Cell&GeneTherapy #StopLoss #SOAWebcast
Windsor Strategy Partners, Inc.’s Post
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📢NOW AVAILABLE: Our latest report, Cell and Gene Therapy Deals Analysis: 2021-2024, dives deep into financing, M&A, tech transfers, and more. Discover key trends, top deal-makers, and regional breakdowns that are shaping the field. Stay informed and capitalize on key opportunities: https://hubs.la/Q02DC-dl0
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How do you balance patient-centric considerations and the complexities cell and gene therapy manufacture and administration in a single suite of operational software? 📋 Ensuring regulatory and quality components are upheld ⏳ Automating those elements so users don’t waste time flitting between systems and piles of paper ⭕️ Simplifying the complex Below is a snippet of an interview with Heather Purvis and Carol Houts: 'Manufacturing Advanced Therapies: Clinical Center Operational Considerations for Decentralized Manufacturing’ at Phacilitate's Advanced Therapies Week. You can watch the whole interview at https://hubs.ly/Q02Gm3Qy0
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The cell and gene therapy manufacturing development gap. CGT manufacturing is a rapidly evolving industry across the globe. However, the world of precision medicine is no equal playing field. There are stark differences between the CGT manufacturing markets of the Western world and the Asia–Pacific region. Even when comparing North America to Europe, there are key considerations which have resulted in the European market lagging behind. Read more to learn about the regional differences in capabilities, regulatory landscapes, and market dynamics that characterise this development gap. https://lnkd.in/ewhi2543 #CGT #celltherapy #genetherapy #GCTmanufacturing
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📢 Attention gene therapy developers! 📢 Are you looking to optimize your AAV production process? Join us for an exclusive webinar where we will delve into the key considerations of productivity, product quality, scalability, and cost in AAV production. Register now to secure your spot.
Mastering AAV production: best practices For small- to large-scale manufacturing success and reduced development time
insights.bio
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Our poster from ASGCT 2024 highlights a groundbreaking approach to overcoming complex data analysis challenges in cell and gene therapies. Learn how our custom-designed solution, powered by ETL techniques, automates data analysis to reduce time and improve data quality. Download the poster here to see how AmplifyBio is transforming data workflows in advanced therapies: https://bit.ly/3YtFcpb #CGT #AdvancedTherapies #AmplifyBio
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Exclusive insights into the dynamic cell and gene therapy markets are here! Dive deep into market summaries, competitive analyses, and regional breakdowns to stay ahead in this rapidly evolving industry. Learn more about the report and explore the table of contents here: https://hubs.la/Q02wsS--0
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Join GenScript for an insightful webinar on gene editing component manufacturing! Delve into crucial stages of manufacturing gene editing components for cell and gene therapy development. Explore product quality, regulatory compliance, and requirements for research, preclinical, and clinical grade components. Learn from case studies and experimental data tackling challenges like off-target insertions and component degradation. Discover proprietary technologies, advanced manufacturing and QC facilities, and analytical capabilities vital for CGT component characterization. Receive guidance on scientific and regulatory support crucial for successful IND submissions.
🔍 Join GenScript for an informative webinar on gene editing component manufacturing! Dive deep into the critical stages of manufacturing gene editing (GE) components for cell and gene therapy (#CGT) development. This webinar will highlight the intricacies of product quality, #regulatorycompliance, and the specific requirements for research use only, preclinical, and clinical grade components. Dr. Jianpeng Wang will provide insights from case studies and experimental data addressing common challenges like off-target insertions and component degradation. Learn about proprietary technologies, state-of-the-art manufacturing and QC facilities, and analytical capabilities vital for characterizing CGT components. Plus, get guidance on the scientific and regulatory support essential for successful IND submissions. ➡️ 🔗 REGISTER HERE: https://buff.ly/3VIvtKn #PharmaceuticalRegulation #PharmaManufacturing #CellAndGeneTherapy
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At the Economist Impact’s Cell and Gene Therapy (CGT) 2024 Summit, experts from across the industry discussed numerous topics and challenges in the introduction of CGTs: 📌 Regulatory 📌 Manufacturing and supply chain 📌 Clinical and scientific 📌 Commercial See the attached white paper capturing important themes and takeaways from the summit, including regulatory changes and new delivery models, the need to keep conversations and practices focused on patients, and how to structure clinical trials, gather real world evidence and streamline manufacturing to help improve access to treatment. #CellAndGeneTherapy #CGT #Innovation #biopharma #EconomistImpact #curiousminds
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🔔 Check out our new white paper! 👀 It offers a detailed look at how traditional manufacturing processes aren’t set up to produce the small batches of custom reagents that gene therapy developers require—and how Teknova can help. Download the full white paper to see the key requirements that gene therapy manufacturers should consider when evaluating their unique reagent needs during commercialization: https://ow.ly/eAI950TN05j #MakingSolutionsPossible #GeneTherapy #Reagents #WhitePaper
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CellSeal® Connect Vials help close gaps in your cell and gene therapy manufacturing with two weldable fill and retrieval tubes that allow for closed-system, sterile processing of your intermediates. This line extension of our CellSeal platform gives you greater downstream flexibility. Connect Vials can be stored at -80°C/ultra-low, while our CellSeal Vials are ideal for -196°C/cryogenic temperatures. Both are compatible with semi-automated and automated fill & finish systems like the Sexton Biotechnologies Signata CT-5™ or CellSeal AF-500 system. Curious? We’re here to discuss your processes and specific use case. https://lnkd.in/eRAZrPMu #fillandretrieval #cellprocessing #downstreamprocessing #CGT #therapyvials
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