Christopher Storbeck
Company: Health Canada
Job title: Senior Scientific Evaluator
Seminars:
Potency Assays for Cell Therapy Products: A Regulatory Perspective 2:30 pm
• Understanding the regulatory basis for the necessity of potency assays • Discussing phase appropriate expectations regarding potency assays for cell therapy products • Identifying challenges for potency assays for cell therapy products • Optimizing potency assay design for cell therapy productsRead more
day: Conference Day Two - PM
Panel Discussion: Late-Stage Potency Assay Development & Preparing for BLA 3:00 pm
• What are the important considerations for developing a potency assay fit for a commercial product? • What learnings can we take from products that are already commercialized? • What are the regulators looking for when submitting BLA?Read more
day: Conference Day Two - PM