Cell therapy specificity screening: Assessing off-target liabilities and generating tox data for INDs
December 8, 2020
11 am to 12 pm EDT

Webinar Description:

The adverse effects of off-target mediated CAR T activation in healthy tissues could be catastrophic for patients who receive novel cell therapies. As such, ensuring that cell therapies are specific to their intended targets is vital, particularly when assessing potential safety implications prior to clinical studies.

The Human Cell Microarray technology is the only platform for specificity screening of final, whole cell therapies (such as CAR T cells), as well as profiling precursor molecules (ScFv, antibodies etc.). This allows any potential off-target liabilities to be monitored and managed throughout discovery and development, from lead selection through to safety assessment prior to regulatory submission. Cell Microarray data confirming protein and cell therapy specificity have been included in IND and BLA submissions to several major regulatory agencies, including the FDA (US), EMA (Europe), NMPA (China) and PMDA (Japan), either in complement to tissue cross reactivity (TCR) data or as a replacement to TCR studies.

This webinar provides an overview of the Cell Microarray technology, with a particular focus on the specificity/off-target screening and de-risking of cell therapy programs, particularly in the CAR T sphere. Industry case examples will show the utility of the platform from early lead candidate selection through to pre-IND safety, and clinical trial stages.

Learning Objectives:

  • Understand how data generated with Cell Microarray screening are used in lead selection and safety assessment.
  • Learn how specificity data supports IND submissions as either an adjunct to, or replacement for, tissue cross reactivity studies.
  • Learn more about identifying and mitigating the risk of clinical toxicity caused by off-target effects of cell therapies.

Speaker:

Diogo Rodrigues Ferreirinha, MSc
European Business Development Manager
Retrogenix Ltd.

Diogo is responsible for growing Retrogenix’s European business portfolio and is based at our UK headquarters in the Peak District. Diogo is fluent in Portuguese & English and also speaks Spanish & French.

Prior to Retrogenix, Diogo worked in technical sales roles for a global chromatography manufacturer and a clinical management software provider. His pharmaceutical R&D experience includes: biocomputational analyses of virus proteases to uncover novel inhibitor therapies; the development of silica nanoparticles for diagnostics; and neurotoxicity studies focusing on the combined consumption of opiates and cocaine.

Diogo holds an MSc degree in Biochemistry from the University of Oporto in Portugal.


Cost: No Cost!