Tuesday, April 23
9:00 am Registration & Morning Coffee
WORKSHOP A | 9:00 am – 12:00 pm
Critical Steps for Transitioning to Clinical Trials – Navigating Regulations & Pre-IND Studies
- Scott Norberg Associate Research Physician, National Cancer Institute (NCI) in NIH
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
12:00 pm Lunch Break & Networking
WORKSHOP B | 1:00 pm – 4:00 pm
Accelerating Innovation: Mastering Early Phase Development & Scale- Up for Commercial Success!
The evolution of T-cell receptor (TCR) therapy necessitates a closer examination of critical elements in manufacturing, analytical tools, patient selection strategies, and innovative approaches to address regulatory and reimbursement complexities. This discussion serves as a pivotal forum for insights into streamlining these essential components for wider clinical implementation and enhanced patient outcomes.
This workshop will cover:
- Streamlining TCR therapy manufacturing processes for scalability, cost-effectiveness, and reproducibility
- Developing advanced analytical tools and assays to ensure consistent cell quality and potency, meeting evolving regulatory standards
- Improving strategies for patient selection, treatment optimization, and biomarker identification to enhance clinical outcomes and market adoption
- Innovating cost-effective manufacturing approaches for personalized TCR therapies, addressing regulatory barriers, and navigating reimbursement complexities for broader clinical implementation