PRE-CONFERENCE WORKSHOP DAY - TUESDAY DECEMBER 14, 2021

Workshop A

8am - 9am EST

For those joining the workshop in person, please arrive from 8am to check in at the registration desk.

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

Copy of Iram speaker photos (9)

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

Hosted by:

BD-Biosciences-5

12pm - 1pm EST

For those joining the workshop in person, please arrive from 12pm to check in at the registration desk.

Automating Analytical Testing to Speed Up Turnaround Time for Product Release to Meet Patient Needs: Automated Sample Preparation, Handling, and Flow Cytometry

1pm - 4pm EST

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

Join this collaborative session to discuss:

  • The need to shorten the process for critical analytical tests
  • How to accelerate testing by automation of previously established tests without sacrificing assay precision and accuracy
  • Reducing human error and variation through automation
  • How automation can facilitate scale up across multiple sites and products
  • Challenges to develop and implement automated assays
  • Standardizing and automating flow cytometry testing and analysis

Aniket Patel

Senior TRD Analytical and Data Steward

Novartis

Carla Smith

QC Manager

Novartis

Roberto Zoino

Senior Scientist

Novartis

Sahul Patel

Senior Manager

Novartis

Scott Bornheimer

Associate Director Medical & Scientific Affairs

BD Biosciences