Critical Steps for Transitioning to Clinical Trials – Navigating Regulations & Pre-IND Studies
Time: 9:01 am
day: Pre-Conference Workshop Day
Details:
As the T-cell receptor (TCR) therapy landscape continues to expand, the challenges encountered in its development demand focused attention and collaborative strategies. This session explores regulatory complexities, safety imperatives, study design optimization, and resource constraints stands at the forefront of current TCR research and development. Join us as we delve into pivotal strategies aimed at overcoming these challenges and propelling TCR therapies towards successful clinical translation.
This workshop will cover:
- Regulatory Complexity: Negotiating dynamic and evolving regulatory frameworks specific to TCR therapy, demanding expertise, and constant adaptation
- Safety and Efficacy Imperatives: Establishing robust safety profiles, demonstrating efficacy against targeted antigens, and addressing potential adverse effects in preclinical settings
- Study Design Optimization: Striking a balance between meeting regulatory expectations and ensuring scientific validity, including selecting appropriate animal models, dosages, and endpoints
- Resource and Time Constraints: Requiring substantial investments, expertise, and meticulous planning, posing challenges for comprehensive pre-IND studies, especially for smaller research entities
