- Regulatory submissions must adhere to evolving guidelines, focusing on compliance and communication
- During the startup phase, critical steps can include establishing partnerships with academic institutions, hospitals, and stakeholders to ensure therapy accessibility
- Site selection is vital, requiring experienced teams and proper infrastructure
- Logistics play a pivotal role, encompassing the secure transportation and storage of biological materials
- Data management strategies must address the unique considerations of the substantial data volume associated with cell and gene therapies
- Patient engagement presents challenges, requiring long-term monitoring (five to 15 years) after treatment
This webinar aims to comprehensively address these challenges, offering insights and strategies. By understanding and proactively managing logistics, startup procedures, data management, regulatory compliance and patient engagement, participants can pave the way for successful cell and gene therapy trials. The goal is to ensure these therapies become safe, effective and accessible options for patients in need, ultimately transforming the landscape of medical treatments.
Join experts from Allucent, Desmond Cabrera, VP, Project Management, Americas; Joyce Moore, Global Head, Patient Engagement; Marita Kruskopf Osterberg, Senior Manager, Study Start-Up; and Francisca Samson, MSc, Director, Data Management, EMEA, for the live webinar on Wednesday, November 29, 2023, at 10am EST (4pm CET/EU-Central).
For more information, or to register for this event, visit Cell and Gene Therapy Clinical Trials: How to Successfully Operationalize a Trial of Prolonged Duration.
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