[Free Online Symposium] Preclinical and Clinical Development of Cell-based Immunotherapies: Translational PKPD, Safety, Biomarker, CMC, Clinical Pharmacology & Clinical Trials


10/19/2020 - 10/20/2020

8:00am - 1:30pm

The symposium will cover the preclinical and clinical strategies employed in the development of cell-based therapies. Topics include preclinical data package to support first in human studies, clinical pharmacology, design of early clinical trials, CMC considerations and regulatory expectations. The symposium will discuss the current strategies employed and address some of the challenges we face while advancing these therapies to patients. Additionally, topics such as biodistribution and “clearance” mechanisms, immunogenicity, translational PKPD, the relevance of preclinical models, projection of efficacious dose, etc will be addressed. Case studies will include development of CAR T-cells such as Kymriah® and Yescarta®.

* Understand factors that govern cellular kinetics, dynamics, biodistribution, toxicity and immunogenicity of cell-based therapies
* Develop a preclinical FIH package from a pharmacology/PKPD/safety/immunogenicity perspective
* Understand manufacturing processes and challenges
* Develop a Clinical Pharmacology Plan for cell therapies
* Understand clinical development and regulatory strategy for cell therapies

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Online via Zoom