PRE-CONFERENCE WORKSHOP DAY - TUESDAY DECEMBER 14, 2021

Workshop A

Regulatory Deep Dive into Effective Potency Testing

9am - 12pm EST

Achieving regulatory approval on potency assays is a huge issue for the cell therapy space with many submissions being rejected due to the not hitting the standards for the complex product needs.

This group discussion will take a deep dive into the following:

• Overcoming hurdles to potency assay changes from early through to late-stage clinical development
• Long term program management for potency assays
• How to shape your potency assay strategy in accordance with lot release schedule, product availability and regulatory feedback
• Standardizing these processes to be sustainable in a commercial market

Taby Ahsan

Taby Ahsan
Head of Biologics Analytical Development & Characterization, Therapeutic Discovery
MD Anderson Cancer Center

knut

Knut Niss
Chief Technology Officer
Mustang Bio

Lunchtime Refreshments & Networking 12-1pm EST

Workshop B

Process Automation to Speed Up Turnaround Time for Release and Meet Patients Needs

1pm - 4pm EST

Manufacturing timelines are the greatest rate-limiting step in cell therapy drug development, but when drilling deeper it is in fact the release timelines in analytical development that is the critical bottleneck in the vein-to-vein delivery of autologous cell therapies.

Join this collaborative session to discuss:
• Outline the need to shorten the process for critical analytical tests
• Review current safety tests which provide a bottleneck to timeline, meeting the balance of ensuring safety but also providing the product to the patients as soon as possible?
• Accelerate testing by increasing the sensitivity of the assay to shorten timelines, design a better matrix to determine the results sooner
• Reduce human error and variation through automation, and discuss the growing need for automation due to scale up across multiple sites and products

Aniket Patel

Senior TRD Analytical and Data Steward

Novartis

Carla Smith

QC Manager

Novartis

Roberto Zoino

Senior Scientist

Novartis

Sahul Patel

Senior Manager

Novartis