Making Sense of the Regulatory Path to Accelerate Therapies to Approval & Treat Patients with Solid Tumors

Time: 2:00 pm
day: Pre-Conference Workshop Day


Despite over a decade of research, clinical translation of cell therapies has been slow, partly due to a lack of a pre-defined regulatory pathway. As we utilize new innovations and engineer techniques to devise cell therapies which are better at treating solid tumors, there is a growing need for clarification of the regulations required for clinical approval.

This session will discuss:

  • Elucidating the regulatory pathways to utilize safe gene editing for multi-functional cell therapy development
  • Leveraging the correct safety, purity, translocation and potency tests required to characterize cell therapies and speed up the approval process
  • Understanding the challenges in defining efficiency and safety of multiple edits & impact on clinical development