Novel clinical trial assay solutions for next-generation CAR-T therapies – historical and new case studies
Chimeric antigen receptor (CAR) T-cell therapies have revolutionized the treatment of blood cancers. Accurate quantification and characterization of CAR-modified and unmodified immune cells are critical for understanding therapeutic efficacy of next-generation therapies. Navigate BioPharma scientists have developed a bioanalytical toolbox critical for supporting the approval of first generation CAR-T therapy.
Based on nearly 10 years of experience, Navigate BioPharma have developed novel multiplexed solutions for simultaneously monitoring manufacturing success, cellular kinetics, pharmacodynamic activity, efficacy and safety leveraging specialized technologies. This webinar will discuss the best practices employed for the characterization of 1st generation CAR-T treatments and novel clinical trial tools to address the next generation of bi-specific and multifunctional CAR-modified investigational agents.
What will you learn?
- The history of CAR-T therapies
- Mechanisms to measure CAR-T levels
- Future trends in CAR-T therapies and access to new disease spaces
- Critical considerations for designing assays to assess new CAR-T modalities
Who may this interest?
- Academic researchers
- Clinical lab scientists and clinical trial managers
- Business development associates
Speakers
Naveen Dakappagari
Head of Biomarker and Diagnostic Development
Navigate Biopharma Services (CA, USA)
Naveen is a cancer immunologist focused on guiding a team of talented scientists developing patient-centric biomarker assays and has supported the approval of the first CAR-T Therapy. Over the past 25 years, Naveen played critical roles in drug and regulated biomarker development and authored multiple best practice papers on behalf of AAPS and WRIB.
Nathan Riccitelli
Associate Director, Innovative Technologies
Navigate Biopharma Services (CA, USA)
Nathan Riccitelli graduated from the University of California Irvine with a PhD in Chemical Biology. He has worked in the molecular assay development space for >10 years, with an emphasis on PCR and NGS-based approaches for precision medicine and cell and gene therapies.
This webinar was recorded on Wednesday 15 March 2023.
In association with
