Gene & Cell Therapy Clinical Trials

This session explores the rapidly evolving field of gene and cell therapy, highlighting clinical trial design, regulatory considerations, and safety monitoring. Topics include CAR-T cell therapy, gene editing technologies such as CRISPR, stem cell therapies, and personalized cellular therapeutics. Subtopics cover trial endpoints, dosing strategies, patient selection, and ethical considerations for high-risk therapies. Attendees will learn about preclinical validation, risk management, and strategies to ensure patient safety, including immune response monitoring and long-term follow-up. Case studies will demonstrate successful clinical applications in oncology, rare genetic disorders, and regenerative medicine, highlighting challenges such as scalability, manufacturing, and regulatory approval. The session will also explore global regulatory frameworks, standardization of protocols, and collaborative strategies for multi-center trials. By the end of this session, participants will gain practical knowledge to design and manage gene and cell therapy trials, balancing innovation with patient safety and regulatory compliance.

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