Listen again – Cell therapy webinar: Assessing off-target liabilities and generating tox data for INDs
Our recent webinar features guest speakers from Juno/BMS and Novartis discussing their experiences of off-target safety assessment of biologics and cell therapies, including CAR T.
Novartis experience with the Retrogenix platform to assess the specificity of biologics and cell therapies
Dr Axel Vicart, Senior Principal Scientist (Research), Novartis
Use of cell based off-target screening in CAR T-cell programs
Yen Ho, Associate Scientist, Bristol Myers Squibb
Specificity screening of mAbs, scFvs & CAR Ts against expressed receptors, heterodimers & secreted protein targets
Diogo Rodrigues Ferreirinha, European Business Development Manager, Retrogenix
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.
Specificity screening using the Human Cell Microarray platform allows any potential off-target liabilities to be monitored and managed throughout discovery and development. 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 for TCR studies.
This webinar provides an overview of the Cell Microarray technology, with a particular focus on 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.
Axel Vicart, PhD, PharmD – Novartis
Axel Vicart is a pharmacist by training (University of Montpellier, France) and obtained a PhD in immunology at the University of Marseille, France. In 2007, Axel joined the Discovery and Investigative Safety department at Novartis, in Basel, Switzerland. He is leading a team of scientists with expertise in complex in vitro models and protein biochemical methods. Axel is also driving investigative activities to explore mechanisms of toxicity and resolve drug safety issues and acts as a Preclinical safety representative in some project teams. Axel was instrumental in building the Novartis strategy to assess specificity of biologic drugs.
Yen Ho – Juno / Bristol Myers Squibb
Yen is an associate scientist in the Nonclinical Research and Development team at Juno Therapeutics, a Bristol Myers Squibb company in Seattle, WA, USA. She has 15 years of scientific experience working in preclinical and nonclinical research, in both academia and pharmaceutical industry. At BMS she develops methods and tools to evaluate the nonclinical safety of CAR T-cells and engineered TCRs, and provides toxicology support for adoptive T-cell therapy programs.
Diogo Rodrigues Ferreirinha, MSc – Retrogenix
Diogo is responsible for Retrogenix’s European business portfolio. He is fluent in Portuguese, English & Spanish, and also speaks French & German. Diogo has worked in various technical sales roles. His pharma R&D experience also includes: biocomputational analyses of viruses proteases to uncover novel inhibitor therapies; the development of nanoparticles for diagnostics; and neurotoxicity studies on the combined consumption of opiates and cocaine. Diogo has an MSc in Biochemistry from University of Oporto, Portugal.
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