Aldevron recently hosted a webinar through Endpoints news titled: Plasmid DNA Insights: Expanded Focus on CMC in Gene and Cell Therapy Development.
Arsalan Arif, the publisher and founder of Endpoints News moderated the well-balanced, industry expert guest panel featuring Dr. Anthony Davis, Chief Executive of Dark Horse Consulting, Ken Bonnell, SVP of Quality and Regulatory at Aldevron; Biswarup Dasgupta, Director of Quality Assurance at Sarepta; and Frank Bonnelly, Director of Supply Chain at Encoded.
The first question set the stage for what resulted in a dynamic dialogue with the panelists: “What impact has the various FDA and EMA regulatory pathways had for cell and gene therapy developers?”
Dr. Davies’ responded “these pathways that the FDA and the EMA and honestly, all of the world's major regulatory jurisdictions have put in place in recent years have each been impactful in their own particular way…. But Breakthrough, Fast Track, Priority Review, and Accelerated Approval …. They all have specific impacts.”
The panel discussed those areas of impact all while fielding questions such as: what’s the perspective of regulatory agencies with regard to these pre-commercialization activities relating to plasmid DNA? What are regulatory expectations shifting in the context of CMC and the manufacturing of plasmid DNA? What are the most important elements of concept design that you consider for use in viral vector production?
Hundreds of people logged in to the live webinar, which is a reflection on how important this subject really is to many people, and how expert and experienced insight is highly valued. The entire hour-long webinar is now accessible for anyone to view and share.