Day 1 : Tuesday, January 31
12:00 pm - 1:00 pm
Boot Camp / Seminar
Science and Manufacturing
By the end of this session, attendees will be able to:
- Understand the scientific principles driving cell and gene therapies
- Explain the difference between in-vivo, ex-vivo genetic manipulation and autologous and allogeneic therapies
- Relate how the science and manufacturing processes being used create both clinical and commercial supply chain challenges
Speakers:
1:00 pm - 2:00 pm
Boot Camp / Seminar
Labeling and Regulatory
By the end of this session, attendees will be able to:
- Identify ‘made to order’ and ‘make to stock’ portions of an autologous cell and gene therapy supply chain
- Describe the three ecosystems of a cell and gene therapy value chain
- Understand how traceability begins with the cell collection label and continues to the drug product label for infusion
Day 2 : Wednesday, February 1
12:00 pm - 1:00 pm
Boot Camp / Seminar
Sites and Systems
By the end of this session, attendees will be able to:
- Broadly describe the processes/best practices to be undertaken to build out the user requirements for internal and site use
- Operate and maintain business systems for ongoing communication and supply chain management
- Understand the different scaling of IT systems from clinical to commercialization
Speakers:
1:00 pm - 2:00 pm
Boot Camp / Seminar
Clinical to Commercial
By the end of this session, attendees will be able to:
- Describe the differences between autologous and allogenic cell therapy supply chains
- Understand commercial regulatory & quality supply chain requirements
- Differentiate between clinical and commercial operational requirements
- Recognize a commercial scale up or scale out strategy
Speakers:
Day 3 : Thursday, February 2
12:00 pm - 1:00 pm
Boot Camp / Seminar
Supply Chain Considerations (Temperature, Chain of Identity, Chain of Custody, Scalability, Regulations for Transport)
By the end of this session, attendees will be able to:
- List two (2) major strategies employed for delivering a robust personalized medicine supply chain
- Identify at least two (2) concerns in the handling of cell and gene therapy clinical materials
- Describe potential labeling solutions appropriate to the labeling of cell and gene therapy products for transport
- Create better outcomes for patients via the creation of a robust supply chain
Speakers:
1:00 pm - 2:00 pm
Boot Camp / Seminar
Biostorage
By the end of this session, attendees will be able to:
- Understand the potential storage requirements for autologous and allogeneic therapies and associated materials
- Recognize the challenges to scaling the advanced therapy supply chain
- Describe the differences between small molecule / biologics and advanced therapy supply chains
Speakers:
