New and rapid innovations in cell and gene therapy (CGT) development are making the promise of personalized medicine closer to reality. However, processes for developing cell and gene therapies are inherently complex, posing new challenges that may impact therapeutic effectiveness and safety. Of note, there have been several recent delays to product approvals and clinical holds on various late-stage CGTs due to lack of product characterization and their correlation with de novo pathologies arising during clinical trial, respectively.
In this webinar, Dr. Scott Burger (Principal, Advanced Cell & Gene Therapy), Dr. Azadeh Golipour (CTO, AVROBIO), J. Kelly Ganjei (President & CEO, AmplifyBio), and Matt Cato (Director, Cell & Gene Therapy, Mission Bio) will sit on this engaging panel discussion to examine the state of analytical characterization today, current regulatory guidance, best practices, and forward-looking considerations in early drug development that can lead to process improvement in the hopes of mitigating clinical holds. Lastly, this expert group with provide a view on the latest technologies and innovative approaches in CGT development and manufacturing, including how early-stage deep characterization at the single-cell, multi-omic level can provide the critical molecular insights that drives a successful path to the clinic.