Morning Workshops
*Virtual Event | All Timings: Eastern Time*
WORKSHOP A
Managing Digital Transformation with the End-User in Mind
Tuesday October 26, 9.00am - 11.00am
Workshop Leaders
Alicia Dixon
Senior Director CGT Patient Services US
Gamida Cell
William Shingler
Senior Director Patient & Cell Management
Autolus
- Designing a user-friendly ‘dream’ digital system to manage end-to-end supply chains for CGT
- Considering the key features to include, and discussing how digital systems could support decentralized care
- Linking digital systems to create a full patient profile with long-term follow up from previous and post-treatments
- Building a data ecosystem to capture the entire patient journey and product characteristic
- Providing an overview of enabling systems for digital transformation, and highlighting remaining areas of unmet need
WORKSHOP B
Transferring Tech to a Contract Manufacturing Organization Effectively whilst Maintaining IP and Quality
Tuesday October 26, 9.00am - 11.00am
Workshop Leader
Cindy McNab
Supply Chain Director
Allogene Therapeutics
Daniel Bright
Director of Manufacturing Operations
Cellectis
- Sharing experience and best practice of working with CMOs, addressing concerns over IP protection, and creating agreements which ensure reliable, high-quality production
- Creating a reliable and trust-worthy network with clear channels of communication to do scale up and tech transfer
- Forecasting demand and securing manufacturing slots with the required expertise
- Creating a ‘one-stop-shop’ for tech transfer covering cryopreservation, packaging, shipping, labelling and logistics
- Discussing formulation development from a supply chain perspective and ensuring shipments are ready
Afternoon Workshops
*Virtual Event | All Timings: Eastern Time*
WORKSHOP C
Optimising Leukapheresis and Cryopreservation for Autologous and Allogeneic Products
Tuesday October 26, 1.00pm - 3.00pm
Workshop Leaders
Lizette Caballero
CAR-T Apheresis Site Liaison
The Janssen Pharmaceutical Companies of Johnson & Johnson
Blair Grimes
Clinical Supply Chain Manger
Precision BioSciences
- Designing logistics networks for cryopreserved and fresh products and comparing in house to outsourced cell collection and cryopreservation
- Ensuring continuous supply during times of global disruption by sourcing back up donors, and implementing safety measures for clinical operations in a pandemic
- Contrasting the use of fresh vs. frozen products, the pros and cons for patients, and sharing case studies around handling each
- Setting up centralized vs. distributed leukapheresis and cryopreservation centers, discussing the advantages of consistency and challenges of transport and distance
- Providing an introduction to cryobiology for the supply chain expert, and how cryopreservation steps, temperature control, and shipping can impact quality attributes and patient outcomes
WORKSHOP D
Carrying Out Internal Supply Chain Tech Transfer With Diverse Sites in Large Multi-National Networks
Tuesday October 26, 1.00pm - 3.00pm
Workshop Leader
Mary Sell
CAR-T Cell Collection Operations Senior Manager
Janssen Pharmaceuticals
- Sharing experience of scaling supply chains to new sites within a company
- Managing the internal diversity of sites and site expertise whilst maintaining quality and integrity of supply chain and logistics networks
- Creating a feedback loop from sites on tech transfer best practice, needs and challenges
- Outlining the potential variation between sites such as GMP experience vs. CAR-T experience, and how to manage this diversity
- Managing formulation development operations