Company: Atara Biotherapeutics Inc.
Job title: Director
Reviewing Regulatory Guidance for Potency Testing in Cell Therapy Products 8:30 am
Potency remains a critical regulatory bottleneck when it comes to the approval of cell therapy products, with many recent examples of submission being rejected due to concerns surrounding potency. Attend to Discuss: • How should we align cell therapy potency assays with FDA and EMA guidelines? • What do regulators in US and EU look for regarding potency…Read more
day: Pre-Conference Workshop Day - Track B - AM