Focus Session
Organized by Novo Nordisk A/S
There are many challenges in moving an academic discovery towards clinical application. A major hurdle to overcome is how to understand and characterise the composition and behaviour of the cellular drug product. Technologies, methodologies, and the level of detail required for academic publication do not always match those required for large scale manufacturing, or by regulators for clinical trial approval and, ultimately, the granting of marketing authorisation. In this Focus Session, we will address issues such as scale up, prevention of off-target differentiation, in vitro prediction of function, and in vivo proof of engraftment and viability. An expert academic and industry faculty will discuss these issues, the techniques that currently exist to address them, and the innovation challenges facing the field in order to close the technological gaps that exist in these areas.