Session Details

This workshop is intended for those with an existing CMC knowledge base who want to take a deeper dive into analytical issues. The workshop will focus on multiple modalities including both cell and gene therapies. Discussion will focus more on development at later phases – Phase II/III through BLA.

It is generally accepted today that there is not one specific analytical roadmap that works for every cell and gene therapy product. Rather, sponsors adopt a holistic approach, taking into consideration existing regulatory guidelines, their product characteristics, and how their therapy will be used. In this workshop, attendees will learn about the tools and general frameworks that can be tailored for their specific drug product as they progress through the drug development life cycle. Presenters will first share insights on the current state of CMC analytics, followed by an overview of the trends likely to shape the future of the CGT field. Time will be reserved for extended Q&A.