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| Webinar: Mastering the Complexities of Gene Therapy Document Writing | Gene therapy is complex—and so is writing about it. From viral vectors to cell types, every element demands deep understanding. Safety reporting adds further complexity: is an adverse event from chemotherapy, a procedure, or the gene therapy itself? These challenges require a thoughtful, flexible approach to document strategy and execution. Explore common hurdles and practical solutions for gene therapy document writing and submissions. |
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In this Cell & Gene Live segment, experts from Forge Biologics and REGENXBIO discuss key considerations for early AAV gene therapy trials, including dose, safety, models, and patient targeting. |
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| Is Your Clinical Research Site GCP-Ready? | Article | BRANY | Explore a comprehensive overview of Good Clinical Practice (GCP) guidelines. By fostering a culture of continuous improvement through internal audits, research sites can enhance their research practices. |
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| The Critical Role Of The Medical Monitor | Article | By Katie Dawson, inSeption Group | Medical Monitors interact with nearly all functional roles on a study team and more experienced monitors often support and mentor less-experienced colleagues. |
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| Discover the future of iPSC-based therapies in this free Cell & Gene Live digital event. Experts will share insights on emerging applications, regulatory challenges, gene editing advancements, and key safety considerations in scalable iPSC manufacturing. Don't miss this opportunity to hear from leaders at the forefront of regenerative medicine. Supported by Invetech. |
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CLINICAL TRIALS SOLUTIONS |
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By Md Saddam Nawaz, head of quality assurance, ACI HealthCare Ltd. | In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades. | |
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| What You Need To Know About Fluoropolymer Bag Cold Chain Durability | Article | By Joe Cintavey and Meghan Meeuwissen, W.L. Gore & Associates | Drug manufacturers seek packaging that maintains integrity during processing and freezing, scales up to larger volumes easily, and remains robust throughout the temperature-controlled supply chain. |
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