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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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By Amy Hay, CBO, CTMC | CTMC's Amy Hay provides 3 recommendations for teams developing cell and gene therapies, from clinical research through commercialization. | |
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| Delivering Specialist Neurology Support | Case Study | MRN - Medical Research Network | Explore a strategic approach to a Parkinson’s disease trial that leveraged a global infrastructure and multilingual workforce to provide seamless operational and clinical support. |
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| Smartphone-Based Biomarker For Estimating Depression Severity | White Paper | By A. Zhuparris, G. Maleki, L. van Londen, I. Koopmans, V. Aalten, et al., CHDR | The study investigates the potential of using smartphones and wearables to create objective biomarkers for mood disorders, specifically focusing on unipolar depression. |
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| Mobilizing Community Hospitals To Improve Patient Access To CGTs | Article | By Rahul Mirchandani, Accenture Life Sciences, Joe DePinto, McKesson, and Dr. Sanjay Srivastava, InspiroGene | The patient, product, and value chains for cell and gene therapies are far different than traditional healthcare delivery and requires new and specialized sets of capabilities at hospitals. |
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CLINICAL TRIALS SOLUTIONS |
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By Eric Marshall and Elizabeth Hassett, Leavitt Partners | The phased exemption periods of the Drug Supply Chain Security Act (DSCSA) expire on different dates throughout 2025 (including one quickly approaching in May), marking a series of milestones for implementation. | |
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| One HEK Of A Viral Vector To Develop | Article | Single Use Support | Here we explore the use of viral vectors in gene therapies, as well as factors that negatively affect them during manufacturing. |
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| Connect With Cell & Gene: |
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