1:00pm Workshop D: Building Differentiated Preclinical Strategies for Novel Cell Therapies and Emerging Modalities
Time: 1:00 pm
day: Workshop Day Track B P2
Details:
While CAR-T dominates current approvals, advancing novel modalities such as NK, γδ T, or iNKT cells could present a new set of challenges. New targets, engineering approaches, and the pursuit of greater efficacy with improved safety require strong and well documented preclinical evidence. The integration of predictive biomarkers, AI, and other technologies adds value but also complexity, cost, and potential delays. Early engagement with regulatory agencies and sharing both successes and setbacks are becoming critical to streamline pathways and accelerate the development of innovative therapies.
Join this workshop to:
- Exchange experiences in designing preclinical packages for novel modalities and technologies
- Share approaches to overcoming unique scientific and regulatory challenges
- Identify key success factors in building a strong IND package for differentiated platforms
- Explore strategies to strengthen dialogue with regulators, particularly in areas where limited prior expertise exists
