In this free webinar, gain valuable knowledge of key considerations and processes involved in the start-up of cell and gene therapy studies, including site selection and staff training, ethics approvals, patient recruitment and sample management. The featured speakers will discuss the critical importance of logistics in the field of cell and gene therapies and the specialized requirements in handling for safety and viability. Participants will gain a comprehensive understanding of the challenges and crucial role of long-term patient follow-up in cell and gene therapy for optimal outcomes. They will also acquire valuable insights into unique data flow patterns to inform customization of data management strategies tailored to the specific characteristics of cell and gene therapy trials. The speakers will also share best practices in how to navigate the complex and evolving regulatory landscape for cell and gene therapies with a focus on EMA's CTIS.
TORONTO, Nov. 15, 2023 /PRNewswire-PRWeb/ -- Cell and gene therapies hold revolutionary potential for treating various diseases, however operationalizing trials of such duration and complexity is a significant task. Their development demands meticulous planning and expertise across multiple disciplines.
To successfully navigate this intricate landscape:
- 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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