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| Join Jon O'Connell and experts on this Cell & Gene Live event, exploring whether minimum viability can help gene therapy developers make smarter sourcing decisions — from research-grade production through clinical and commercial phases, where cost and quality can make or break a product. Registration is free with support from Roche CustomBiotech. |
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By Adam Boyer, Lee Buckler, Quinn Civik, Alessia Deglincerti, Ph.D., Joe DePinto, Rahul Mirchandani, and Sanjay Srivastava, Ph.D. | Decentralizing CGTs to community hospitals presents a crucial opportunity to improve patient access by reducing travel burdens, but requires overcoming significant challenges such as building specialized clinical infrastructure, coordinating complex care pathways, ensuring data interoperability, and more. | |
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| Webinar: Enhancing viral vector sterile filtration: process efficiency and GMP alignment | Sterile filtration is vital to viral vector manufacturing success—impacting yield, quality, and compliance. Join Cytiva to explore advances with Supor™ EKV and Supor™ Prime filters for AAV and lentivirus workflows. Learn how optimized filtration strategies boost recovery and streamline downstream operations, plus gain practical guidance on implementing PUPSIT in line with EU GMP Annex 1. Click here to learn more. |
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On episode 114 of Cell & Gene: The Podcast, Host Erin Harris talks to Brian Culley, CEO of Lineage Cell Therapeutics, about advancing cell therapy beyond oncology and into transformative treatments for conditions such as spinal cord injury and blindness. |
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| Writing Effective Clinical Regulatory Documents For Therapy Trials | Article | By Robin Johnson and Molly Shea, inSeption Group | Clinical medical writing for gene therapy regulatory documents is a highly demanding, detail-oriented task that diverges significantly in scope and complexity from medical writing for more traditional therapies. |
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| Navigating What's Next For Global Drug Development | Podcast | Novotech | Early-stage trial sponsors must proactively adapt to evolving global regulations, strategic trial design, and CRO innovations to successfully navigate FDA changes and accelerate market entry in 2025 and beyond. |
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| The High Cost Of CRO Turnover (And How You Can Avoid It) | Article | By Ben Edwards and Liz Hawes, Avance Clinical | CRO turnover can derail timelines and disrupt continuity. Uncover how sponsors can promote team stability, evaluate CRO consistency, and reduce the risks of staff changes throughout the course of a clinical trial. |
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| EHR-To-EDC Success In A Complex, Adaptive Platform Trial | Case Study | OpenClinica | I-SPY 2, one of the longest-running and innovative adaptive platform trials in oncology, is revolutionizing breast cancer research through a dynamic, data-driven approach that accelerates the evaluation of novel therapies. |
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CLINICAL TRIALS SOLUTIONS |
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| Advancing the Future of Cell & Gene Therapy | This 11-12 November, Cell 2025 unites 1,000+ leading experts across the CGT value chain to solve key challenges, from scalable bioprocessing and regulatory hurdles to accelerating development timelines. Gain practical strategies across cell culture, therapy development, and CGT manufacturing, and hear from world-renowned leaders Bobby Gaspar (CEO, Orchard Therapeutics), Christof Von Kalle, (Director & BIH Chair, Research Clinic Luxemburg), and Dame Molly Stevens (University of Oxford). Register Now |
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