Pulse Network’s Post

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

Are you finding the path to commercializing cell and gene therapies complex and uncertain? Join us as we explore this intricate landscape with our guest, Wajiha Ali. Highlights: - Uncover the hurdles of patient referrals and manufacturing regulations, amplifying the complexity of these therapies. - Explore essential commercialization strategies and infrastructure needs while balancing innovation with necessity. -Learn about navigating regulatory scrutiny and stakeholder management for safer, more accessible therapies. What do you believe are the keys to facilitating the journey from scientific breakthroughs to real-world applications? #cellculture #processdevelopment #bioprocessing #celltherapymanufacturing #cellandgenetherapy #leadbiotech

BLOG – Tailoring automation for tailored medicines. The #lifesciences industry is changing from being focused on mass-produced blockbuster drugs to personalized treatments like cell and gene therapies. This change requires companies to adopt flexible, targeted automation strategies instead of a one-size-fits-all approach. Emerson life sciences expert, Christian Berg discusses how these changes demand new, adaptable solutions in manufacturing and operations. Read the full blog . #software #analytics #mes http://emr.as/3j9w50T2kWu

What do you believe are the keys to facilitating the journey from scientific breakthroughs to real-world applications?

🧬 Developing Cell and Gene therapies presents unique quality control challenges, traditional 28-day mycoplasma testing methods which were initially designed for less time-sensitive applications are not suitable any more to meet the urgent demand for expedited therapy delivery to patients. 💡 Discover BIOFIRE® Mycoplasma: a rapid and easy-to-use system with a lab-in-a-pouch technology that helps bring overall efficiencies to the manufacturing process through both simplified workflows and accurate, actionable results to help ensure patient safety. 👉 More on BIOFIRE® Mycoplasma | Pioneering Diagnostics (biomerieux.com) #WeArebioMérieux

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.

Cell and gene therapy (CAGT) is following a rapid upwards trajectory, but the best methods for post-trial long-term follow-up (LTFU) are still evolving. With the FDA and EMA issuing guidelines for the design and key data elements of required LTFU studies for CAGT, IQVIA Biotech’s Erin Finot, MS, MBA and IQVIA’s Barbara Isquith Arone, MS consider how best to meet them head-on. Read now. https://bit.ly/3zSO25X #biotech #genetherapy #CAGT #celltherapy #clinicaltrials

SFBN Feed: The surprising outperformance of a new drug against existing competitors, and other biotech updates https://lnkd.in/gzCzPCVG Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Today, we see a gene therapy succeed in helping patients with a rare liver [...] #BayArea #SanFrancisco #Biotech #Lifescience #News

BLOG – Tailoring automation for tailored medicines. The #lifesciences industry is changing from being focused on mass-produced blockbuster drugs to personalized treatments like cell and gene therapies. This change requires companies to adopt flexible, targeted automation strategies instead of a one-size-fits-all approach. Emerson life sciences expert, Christian Berg discusses how these changes demand new, adaptable solutions in manufacturing and operations. Read the full blog . #software #analytics #mes http://emr.as/3j9w50T2kWu

🧬 New webinar: Navigating Extractables and Leachables (E&L) in Cell and Gene Therapy (CGT) Manufacturing. 🌟 Join our latest webinar taking place on June 12, 2024, 3.00 PM - 4.00 PM CEST. 🧬💉Cell and Gene Therapies (CGTs) are shaping the future of medicine offering groundbreaking treatments. CGTs are primarily manufactured via single-use systems (SUS) which consist of many different components. Manufacturers need to face unique challenges of evaluating the extractables and process equipment-related leachables. 💻 This webinar will delve into the challenges faced by manufacturers in developing a successful E&L testing strategy, offering practical advice on study design and result interpretation. 🎧 Our expert speakers Stefano Baila and Daniele Zarini will provide insights into handling E&L studies for components that are specifically utilised in CGTs, in order to meet regulatory requirements and expectations, and ultimately ensure product quality and patient safety. 🎯 The risk of extractables and leachables in cell therapy manufacturing and how the new USP<665> and <1665> chapters could be adapted to CGTs will be specifically addressed. Learn more and register here: https://lnkd.in/d2WqUEAH #testingforlife #testing #genetherapy #extractables #leachables #CGT #ATMP #eandl #USP665