In recent years there has been unprecedented progress in the development of new cellular therapies for cancer culminating in the first FDA approvals of Chimeric Antigen Receptors or CAR-T cellular therapies for the treatment of hematological malignancies. Unlike traditional small molecules and biologics where the testing procedures are well established and a large historical database of pharmacological information exists to guide drug makers and regulators, preclinical testing for cellular therapy products is not standardized. The level of testing required varies from product to product, depending upon the unique characteristics of each therapy – and specifically for CARs – the specificity of the chimeric antigen receptor.

In this webinar you will learn how to move your CAR-T cellular therapy program successfully and rapidly to market with a focus on the following topics:

  • Perspectives on current trends in cell therapy R&D
  • Choosing the right animal models
  • The right biomarkers to support pharmacology
  • Benefits of an integrated approach to efficacy & safety testing
  • Bioanalytical platforms for evaluating biodistribution
  • Optimizing IND-enabling study designs to meet regulatory requirements

Presenter

  • David Harris, PhD, Research Director, Oncology, Charles River

Panelists

  • Lauren Black, PhD, Distinguished Scientist, Scientific Advisory Services, Charles River
  • Shawna Jackman, PhD, Principal Research Scientist, Photobiology and Cellular Therapeutic Safety

Additional Information