Two Labs ’s Post

🚀 "From LEAP to launch" - Fierce Pharma. After five years of work behind the scenes, we've launched IRO® to industrialize precision medicine manufacturing. By automating the longest, most manually-intensive part of the CGT workflow and digitizing data management, IRO® brings scalability and flexibility to cell and gene therapy manufacturing. Through our LEAP program we've worked with multiple partners, including CTMC, to generate technical feasibility data on biological performance and ability to accelerate therapy development. The first IRO® units are being deployed this month with partners as we enter the next stage in our journey to enable widespread patient access to cell and gene therapies. Read more ➡️ https://lnkd.in/gJ7fqjp5 #ManufacturingBrighterFutures #CellTherapy #GeneTherapy #PatientAccess #Biotechnology CTMC / A joint venture between Resilience + MD Anderson Cancer Center

🔬 Reducing the high costs of manufacturing advanced therapies is crucial to ensuring widespread patient access. Academic institutions and nonprofits play a key role in the development of complex gene therapies, but doing so requires significant investment and commercial viability concerns, and often sees the development of promising treatments for rare diseases paused before they can reach patients who could benefit. By streamlining cell therapy manufacturing and automating labor-intensive steps, throughput can be increased, costs lowered, and reliability improved – addressing many of the barriers to viability. Our CEO Jason C. Foster talked to Pharmaceutical-Technology to outline how IRO®, our manufacturing platform, can support manufacturers to scale up production and reduce costs – making therapies more affordable for providers and patients. Find out how IRO® could scale your impact. Book a demo today ➡️ https://lnkd.in/eXEXEGZZ Thank you Pharmaceutical-Technology for the feature: https://lnkd.in/dewsVbcd #IRO #TheNewStandard #AutomateBetterBiology #AccelerateProductDevelopment #ScaleYourImpact

In the third installment of our #2024Predictions series, Parijat Jain, our VP of #CellandGeneTherapy, shares his perspectives on the critical need for process standardization in the evolving landscape. Dr. Jain emphasized that with increasing prevalence of platform technologies and preference for standardized processes, the regulatory pathway for cell and gene therapies may become more navigable, expediting approvals and expanding patient access. Looking ahead to 2024 and beyond, he’s optimistic that industry-wide collaboration will help shift the focus from discovery and development towards manufacturing and commercialization of these therapies. "Looking to 2024, one area that is top of mind for me is the need for process standardization for cell and gene therapies. A significant streamlining of manufacturing and production protocols shall not only ensure consistency and reliability in the development of these groundbreaking therapies, but will also enhance efficiency, reduce costs, and accelerate the translation of research findings into clinical applications.“ - Parijat Jain, VP, Cell and Gene Therapy #BioIVTvision #CellTherapy #GeneTherapy #ManufacturingChallenges

𝗧𝗵𝗲 𝗨𝗻𝘁𝗼𝗹𝗱 𝗦𝘁𝗼𝗿𝘆 𝗼𝗳 𝗖𝗲𝗹𝗹 𝗧𝗵𝗲𝗿𝗮𝗽𝘆 𝗧𝗿𝗶𝗮𝗹𝘀 🚚 Starting a cell therapy trial is exhilarating—the innovation, the potential to change lives… I felt that 8 years ago. Back then, I thought, “How different could this be from managing other clinical trials?” Turns out, it’s both the same... and completely different 😅 Here’s why: - Regulatory complexities 📝 - Logistical hurdles 🚚 - Complex clinical designs 📊 - Product-specific requirements 🧫 - High development costs 💸 …and more. 👉 Today is the 𝗟𝗔𝗦𝗧 day to register for a free webinar, where we’ll deep dive into the unique challenges of cell & gene therapy trials. This session is packed with insights, whether you’re just starting or have years of experience. Don't miss out—𝘀𝗶𝗴𝗻 𝘂𝗽 𝗻𝗼𝘄𝗅 💡 Let’s tackle these challenges together. Mustapha NAJIMI Moroccan Society for Regenerative Therapies (MSRT) ⭐⭐⭐ Hi, I'm Virginie! I support innovative pharma companies in planning and executing their early clinical phases smoothly. Activate the 🔔 to follow me and share your experiences. Let's create a supportive clinops community together!

🚀 Cell 2024 is here to address the biggest challenges in the Cell & Gene Therapy (CGT) field! Join us for 3 days of cutting-edge discussions aimed at solving key issues, from early-stage discovery to successful manufacturing and commercialization. Cell 2024 will tackle: 🔬 Manufacturing Bottlenecks: Streamlining complex cell & gene therapy production through collaboration and process innovation. 💡 Integrating New Technologies: Discover how leading experts are incorporating advanced technologies into CGT workflows to accelerate development. 🤝 Cross-Industry Collaboration: Specialized programs and combined networking opportunities will foster collaboration between pharma, biotech, and regulatory leaders to push the CGT field forward. This is your chance to gain insights from the Cell Culture Congress, Advanced Therapy Development Congress, and Cell & Gene Therapy Manufacturing Congress. Let’s solve CGT’s biggest challenges together! #Cell2024 #CellTherapy #GeneTherapy

🔬 Driving the future of cell and gene therapy manufacturing with automation Recently, Jason C. Foster, CEO of Ori Biotech, and Jason Bock, CEO of CTMC, joined Fierce Pharma’s Fraiser Kansteiner on The Top Line podcast to explore the transformative potential of advanced manufacturing in cell and gene therapy. Current manufacturing technologies cannot keep pace with the potential of personalized medicines. Innovative approaches focusing on scalable solutions that enhance efficiency and reduce costs are essential to overcome these hurdles. "The Jasons" spoke with Fraiser about our manufacturing platform IRO® and how, by supporting scalability and efficiency, we are helping to make these life-changing therapies approvable, accessible and affordable for patients. By automating labor-intensive processes and increasing throughput, IRO® can lower overhead costs and improve the scalability of personalized treatments. Learn more about how IRO® can help scale your impact ➡️ https://oribiotech.com/iro 🎧Listen now: https://lnkd.in/eZqcG6F4 #IRO #TheNewStandard #AutomateBetterBiology #AccelerateProductDevelopment #ScaleYourImpact @ CTMC / A joint venture between Resilience + MD Anderson Cancer Center

🚀 Cell 2024 is here to address the biggest challenges in the Cell & Gene Therapy (CGT) field! Join us for 3 days of cutting-edge discussions aimed at solving key issues, from early-stage discovery to successful manufacturing and commercialization. Cell 2024 will tackle: 🔬 Manufacturing Bottlenecks: Streamlining complex cell & gene therapy production through collaboration and process innovation. 💡 Integrating New Technologies: Discover how leading experts are incorporating advanced technologies into CGT workflows to accelerate development. 🤝 Cross-Industry Collaboration: Specialized programs and combined networking opportunities will foster collaboration between pharma, biotech, and regulatory leaders to push the CGT field forward. This is your chance to gain insights from the Cell Culture Congress, Advanced Therapy Development Congress, and Cell & Gene Therapy Manufacturing Congress. Let’s solve CGT’s biggest challenges together! #Cell2024 #CellTherapy #GeneTherapy

Our mission is to enable widespread patient access to lifesaving cell and gene therapies. Here's how we're making this a reality... Collaborations with our LEAP partners have provided invaluable feasibility data for IRO®, demonstrating performance in real-world scenarios. At this year's ISCT, Jason Bock, Founder and CEO of CTMC shared his direct experience using the platform. Here are his key insights: 👇 ➡️ Automate Better Biology IRO® delivered higher CAR+ yields and more efficient transduction (~69% vs ~45%) versus the control. ➡️ Accelerate Product Development Process establishment on IRO® took <5 weeks from kick-off, and met all target release criteria by day 6 across two independent sites. ➡️ Scale Your Impact Vector copy number remained below the FDA-recommended <5 per transduced cell, meaning IRO® maintained safety and consistency. By empowering scientists with a new standard of tools for therapy development, we're pushing the boundaries in CGT manufacturing to enable widespread patient access and scale the impact of advanced therapies. Read more of our case study data: https://lnkd.in/gKUgg39R #IRO #TheNewStandard #AutomateBetterBiology #AccelerateProductDevelopment #ScaleYourImpact CTMC / A joint venture between Resilience + MD Anderson Cancer Center

Don't miss Miloš Miljković, M.D. who will be joining our panel discussion on Cell & Gene Therapy Manufacturing: A Look at Supply Chains, Treatment Centers, and Patient Slots at the Cell and Gene Virtual Event on November 20. https://ow.ly/yP6y50TKZAY Since the introduction of CAR-T cell therapies like Novartis' Kymriah, production challenges have been a key focus for developers. In this session, we’ll explore the innovations in manufacturing that are addressing these challenges, from supply chain issues to capacity management, ensuring patients receive the treatments they need. Get ready for an in-depth discussion on the latest manufacturing advancements and how they're shaping the future of cell and gene therapies! Register now: https://ow.ly/yP6y50TKZAY #CellandGene #Biotech #Manufacturing #CAR-T #SupplyChain #FierceCellAndGene #HealthcareInnovation

🚀 2023 was a year where breakthroughs became the norm for the CGT industry The FDA's Peter Marks' and Alliance for Regenerative Medicine's Tim Hunt's presentations at the JPM 2024 Biotech Showcase signaled a positive outlook for the industry in 2024 ⬇️ 🧬 With 11 CGTs awaiting FDA approval this year, ARM’s "5x5x5" milestone (five gene therapies for five rare diseases approved within five years) is looking promising... 🧬 Gene therapy revenues are projected to hit $7.5 billion by 2030, a testament to the sector's growing influence within healthcare 🧬 High manufacturing costs bring complexities to the commercialization of CGTs, and the FDA has pledged their commitment to the industry to support the development of new models for manufacturing Read more at Cell & Gene ⬇️ https://lnkd.in/egeACeMZ #manufacturingbrighterfutures #celltherapy #genetherapy #biotechnology #digitalhealth