Session Details

Strategies for Commercialization Track Session 1 - Think Big and Think Early to Prevent Failure at Commercial Scale
Thursday, May 30, 2019 11:00 AM - 12:15 PM
Room 219
The impact of failure within platforms like manufacturing, clinical, logistics, can all prevent a patient from receiving their treatment and a developer either being reimbursed or generating clinical data.  All these parts of the therapies value chain are interlinked, meaning that if you make a decision in one area it impacts all the others (e.g. developing cryopreservation enables a single manufacturing site and optimises logistics, but means you have to manage a lower cell viability, develop an in clinic thawing strategy).

To manage this, it is critical to have a vision of what the final, commercial scale, strategy is going to look like.  Therapy developers can then align process, clinical, manufacturing, logistics platform strategies to build, test and optimise through clinical trials.  The value of this, forward thinking, has been proven by the application of Quality by Design principles within process development.  There is now, a recently published, concept of Logistics by Design that has the same forward thinking, risk based approach.  All of which means that therapy developers now have the opportunity to plan the development of their entire value chain.

Using current manufacturing exemplars, this session will investigate the value of planning early.  The speakers are all from a technical backgrounds and will look to provide practical advice to help therapy developers build viable platforms.

Chair:
Simon Ellison, MBA, World Courier, UK

Speakers:

Data Capture and Analysis Through the Cell Therapy Value Chain
Heidi Hagen, MS, MBA, Vineti, Inc, USA

Learning objectives:
•      How can you manage and control the value chain from order to infusion for cell therapy
•      The data captured throughout the value chain during clinical trials will establish the parameters of your commercial operations
•      Demonstrate how complex work flows, multiple points of data capture, and intervention by multiple stakeholders in disparate geographies can be orchestrated successfully and enable your product to have a high trust level by physicians and patients.

Plans for Global Roll Out of An Off-The-Shelf Allogeneic Cellular Therapy
Kilian Kelly, PhD, Cynata Therapeutics, Australia

Learning objectives:
•      Regional distribution - import/export and use of depots
•      Site/patient level distribution, local storage and just-in-time delivery
•      Point of care considerations

Plan to Purpose
Andrew McDonald, World Courier, Australia

Learning objectives:
•      Explore the logistics stages involved for your production cycle and ensure they are commensurate with your objectives
•      Investigate the possible pitfalls and engage contingencies to ensure continuity and compliance
•      Create, optimise and execute the plan to deliver healthier futures

Considerations for Cell and Gene Manufacturing
Robin Ng, PhD, Cellular Biomedicine Group, China
- How operations can drive efficiency
-Managing supply chain is critical for the success of delivery therapy to the patients
-Manufacturing needs to consider both the availability and affordability to the patients